U.S. Veterans Study: Revised Budget Completed, Seventh Subject Treated
The seventh subject out of 24 has now received their first MDMA-assisted psychotherapy session in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD. We have expanded the study from 16 to 24 subjects, added the possibility of enrolling local firefighters and police officers with work-related PTSD, and revised and updated the budget to accommodate the study expansion.
This study has been ongoing for the past two years, and has an estimated two additional years before completion. We have incorporated into this budget more precise cost estimates based on a review of the actual costs of treating the initial subjects. The total estimated budget for this study is $1.25 million. We have already $600,000, and are seeking to raise the additional $650,000 to complete this study.
The revised budget for this crucial study represents a further professionalization in MAPS’ clinical research procedures. MAPS Director of Clinical Research Amy Emerson created a new budget template for our clinical studies, based on her extensive experience budgeting and monitoring multi-site clinical studies for Novartis. The updated budget distinguishes between start-up costs, site- and procedure-specific patient costs, and internal MAPS staff costs to enable more accurate budget projections for our larger, multi-site Phase 3 studies. The ability to track expenses on a per-patient, per-procedure basis will allow us to understand the implications of protocol changes on clinical research budgets, and by linking our budget to our outcome data analysis to estimate the impact of budgetary changes on our treatment method and clinical results.
U.S. Intern Study: FDA Gives Official Go-Ahead for New Boulder Study
On May 4, 2012, the U.S. Food and Drug Administration notified the MAPS clinical team that our new “intern study” of MDMA-assisted psychotherapy for subjects with PTSD had been cleared for initiation. The study will take place in Boulder, Colorado with Marcela Ot’alora as Principal Investigator. The FDA cleared the study as it was designed, with no changes required prior to initiation. The new study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The use of interns is an effort both to reduce costs and to train the next generation of psychedelic psychotherapists. The study will be initiated once the study physician has received his Schedule I license from the DEA, which we anticipate will take place within the next month.
U.S. Intern Study: DEA Conducts Inspection of MDMA Storage Facility
On May 3, 2012, an official from the Denver office of the Drug Enforcement Administration conducted an inspection of the safe and facility to be used to store the MDMA for our upcoming intern study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The inspection is required to establish that the MDMA storage site is adequately secure and compliant with federal regulations. However, since the safe was at the study physician’s office rather than where the treatments will take place, it will need to be unbolted from the floor and moved to the treatment location. Once the safe has been moved, a new inspection will be required. Once we have met the DEA’s security requirements, the study physician will be granted his Schedule I license and we will proceed with the study initiation and begin screening subjects.
U.S. Relapse Study: First Subject Completes Follow-Up Evaluation after Successful Treatment
On April 27, 2012, the first subject completed their follow-up interview in our ongoing relapse study of MDMA-assisted psychotherapy for PTSD in two or three subjects whose symptoms returned several years after participating in our completed U.S. proof of principle study. The co-therapists for this study are Dr. Michael Mithoefer and Annie Mithoefer, B.S.N., who also conducted the original proof of principle study. The two-month follow-up evaluation revealed that a single additional open-label MDMA-assisted psychotherapy session was sufficient to reduce this subject’s score on the Clinician-Administered PTSD Scale (CAPS) below the diagnostic cutoff for PTSD. The results suggest that people who relapse after the initial series of treatments as a result of additional life stressors could benefit substantially from a single additional MDMA-assisted psychotherapy session.
DEA Approves License for MDMA Transfer to New Storage Facility
On April 23, 2012, we learned that the U.S. Drug Enforcement Administration had approved the application for a Schedule I MDMA distributor’s license by a contract research firm specializing in synthetic, organic, and medicinal chemistry. This will enable us to transfer the supply of MDMA we use in our U.S. clinical studies to this new facility. The MDMA was originally manufactured in 1985 by Dr. David Nichols at Purdue University, and paid for by MAPS’ predecessor non-profit, Earth Metabolic Design Labs, at a cost of $4/gram. Since Dr. Nichols is retiring from Purdue on June 30, 2012, he will not be able to store the MDMA under his existing Schedule I license after that date. Without an alternative location to store and distribute the MDMA, it would have been destroyed.
Our next step is to identify a facility certified under Good Manufacturing Practices (GMP) that can reprocess the MDMA and certify it as compliant with GMP. Phase 3 trials generally require that investigational drugs be compliant with GMP. The alternative would be to pay to have new MDMA manufactured from scratch. Certifying our existing batch of MDMA as GMP would save MAPS the cost of remanufacturing the drug to be used in our remaining Phase 2 and Phase 3 studies, perhaps as much as $200,000. Obtaining GMP certification for MAPS MDMA would enable us to export it around the world for our international studies, though the facilities storing and distributing the MDMA would need to obtain additional licenses.
U.S. Proof of Principle Study: Revised Long-Term Follow-Up Paper Submitted to Scientific Journal
On April 16, 2012, Dr. Michael Mithoefer, the lead investigator for our recently completed long-term follow-up of subjects who participated in the initial U.S. proof of principle study, submitted a revised version of the paper in response to comments from reviewers. We’re hopeful the paper will soon be accepted for publication. The long-term follow-up, conducted an average of 3½ years after the last MDMA-assisted psychotherapy session, found that the benefits persisted over time, though a few subjects had relapsed due to new life stressors.
U.S. Intern Study: Therapist Teams Complete Training in South Carolina
From April 8-11, 2012, the therapist teams for our MDMA-assisted psychotherapy for PTSD “intern” study completed therapist training in Charleston, South Carolina, with MDMA-assisted psychotherapy researchers and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. The new intern study will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. The intern study will take place in Boulder, Colorado, and will be our second clinical trial site in the United States.
U.S. Proof of Principle Study: Reviewers Respond to Long-Term Follow-Up Paper
On March 27, 2012, reviewers for a scientific journal responded with their comments on the paper describing the results of our long-term follow-up of subjects who participated in our initial U.S. proof of principle study of MDMA-assisted psychotherapy for PTSD. In their comments and feedback, all four reviewers concluded that it was a strong paper that substantially contributed to the existing scientific research on MDMA-assisted psychotherapy for PTSD. We have incorporated the reviewers’ feedback into the paper, which will be resubmitted for publication in the next few days.
The study, conducted by lead investigator Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., found that the benefits of MDMA-assisted psychotherapy for PTSD persisted for an average of 3½ years after the last treatment. The study found no evidence of harm associated with the administration of MDMA, either immediately following treatment or during the long-term follow-up. These results are even more important than the remarkable results of our initial proof of principle of study as measured at the two-month follow-up, confirming that the benefits of MDMA-assisted psychotherapy persist over time.
U.S. Intern Study: Protocol Passes 30-Day FDA Review Period, Cleared for Initiation
On March 27, the study protocol for our upcoming U.S. intern study of MDMA-assisted psychotherapy for PTSD was cleared for initiation by the FDA after we received no response during the mandated 30-day review period. We contacted the FDA to verify the status of the protocol and learned that they are very busy and we should hear from them in about three weeks. Our research team originally submitted the protocol to the FDA on February 27. This is not a setback, since the study physician is still waiting on his Schedule I license from the DEA.
U.S. Veterans Study: Seventh Subject Enrolled, Site Visit Completed
On March 20, 2012, the seventh subject out of 24 was enrolled in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. This study, led by Principal Investigator Michael Mithoefer, M.D., and co-therapist Annie Mithoefer, B.S.N., will enroll 24 U.S. veterans suffering from chronic, treatment-resistant PTSD occurring as a result of war-related PTSD.
On March 19-23, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., completed a monitoring visit at the site to ensure data accuracy and compliance with Good Clinical Practice (GCP) guidelines.
U.S. Intern Study: IRB Grants Unconditional Approval for Study Protocol
On March 9, the protocol for our planned U.S. intern study of MDMA-assisted psychotherapy for PTSD received approval from the Institutional Review Board, conditional on the pending approval of the study physician’s Schedule I license. The day before, on March 8, the IRB had requested several changes to the subject informed consent documents. MAPS’ clinical team made the changes, resubmitted the documents, and obtained approval in less than 24 hours. The study initiation meeting will be scheduled once the DEA approves the study physician’s license application, which was submitted on March 6. The DEA has no time limit on its response, but we are hopeful that we will be able to begin the study before the summer.
U.S. Intern Study: IRB Grants Conditional Approval, Protocol Submitted to FDA
On March 8, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD received conditional approval from the Institutional Review Board (IRB) pending a few minor modifications to study documents. The protocol was submitted to the FDA on February 27, and is now awaiting review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. This approach will help train a new generation of therapists as well as help reduce study costs. The key question is whether outcomes will be similar to when the male/female co-therapist team is composed of two trained therapists.
The protocol was submitted to the IRB on March 1 and reviewed on March 8, the same day conditional approval was granted. This study will take place in Boulder, Colorado, and will be our second U.S. trial site. The study will explore the effectiveness of MDMA-assisted psychotherapy for PTSD using two different doses of MDMA (125 mg followed by a 62.5 mg supplemental dose, and 40 mg followed by a 20 mg supplemental dose). We are evaluating whether a slightly larger low dose (40 mg) than in our previous studies will be a way to create an effective double blind with just two treatment groups. The study will also enable us to make formal comparisons of the effectiveness of the therapy between different therapeutic teams. The Boulder team will participate in our therapist training program in Charleston, SC, from April 8-11, 2012, before beginning the study.
We have already received pledges of $125,000 for this study—about half the total cost—and are seeking the remaining $125,000.
On February 27, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD was submitted to the U.S. Food and Drug Administration for review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure.
Switzerland: Results Submitted for Publication in Peer-Reviewed Journal
On February 27, 2012, the lead investigator for our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD submitted a paper describing the results to a peer-reviewed scientific journal. The paper is co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The study found clinically significant reductions in scores on the Clinician-Administered PTSD Scale (CAPS)—larger than those associated with Zoloft and Paxil, which are the currently approved medications for PTSD. The small number of subjects in this preliminary pilot study contributed to the results approaching but not reaching statistical significance. The investigators are now awaiting the reviewers’ response to their submission.
U.S. Veterans Study: Sixth Subject Treated, Protocol Amendments Accepted
On February 25, 2012, the sixth subject was treated in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. The fourth protocol amendment (PDF) for this study received “unconditional approval” from the Institutional Review Board on February 22. The FDA has until March 10 to complete its own review. The amendments include expanding the study from 16 to 24 subjects, adding the possibility of enrolling local firefighters and police officers with work-related PTSD, and changing outcome assessment procedures to enable more exact comparisons with other studies. The clinical team is now working on incorporating the amendments into study documents. We have raised the funds for the initial 16 subjects and are now developing the budget for the additional eight subjects.
U.S. Veterans Study: IRB Approves Fourth Protocol Amendment
On February 22, 2012, the fourth protocol amendment for our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD received “unconditional approval” from the Institutional Review Board.
On February 22, 2012, the first subject was treated in our relapse study of MDMA-assisted psychotherapy for subjects whose PTSD symptoms returned after participating in our now-completed U.S. flagship study. The initial results are promising. While the long-term follow-up to this study found that the therapeutic benefits of MDMA-assisted psychotherapy were on average sustained over time, two subjects experienced a relapse. This study is an open-label proof-of-principle study, intended to determine whether a single additional MDMA-assisted psychotherapy session and four non-drug psychotherapy sessions can once again eliminate these subjects’ PTSD symptoms. We are seeking $20,000 to complete this study.
Australia: Ethics Committee Rejects Study Protocol, Researchers Prepare Response
On February 22, 2012, an Australian ethics committee rejected the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The committee raised issues relating to study design that MAPS and the Australian research team believe can be successfully addressed, and that in some cases represented misunderstandings on the part of the reviewers. MAPS and the Australian psychedelic research group Psychedelic Research in Science and Medicine (PRISM) are now preparing a reply. We are hopeful that a version of the protocol can eventually be approved.
U.S. Veterans Study: Fourth Protocol Amendment Submitted to IRB
On February 14, 2012, the fourth protocol amendment for our ongoing U.S. study of MDMA-assisted psychotherapy for PTSD in veterans of war was submitted to the IRB.
U.S. Veterans Study: Expanded from 16 to 24 Subjects
On February 10, 2012, MAPS’ clinical team submitted a protocol amendment to the FDA with several important changes to our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with chronic, treatment-resistant PTSD. We’ve decided to increase the size of study from 16 to 24 subjects, enhancing the statistical power of the study and enabling us to make more conclusive observations about the therapeutic effectiveness of MDMA-assisted psychotherapy in veterans with service-related trauma. We hope that investigating a treatment for this especially vulnerable group will eventually lead to research funding from the U.S. Department of Defense and/or the Veterans Administration.
The amendments include the added possibility of enrolling firefighters and police officers suffering from PTSD as a result of their service. The addition of these subjects will increase local recruitment and reduce study costs, and will provide further evidence of MDMA-assisted psychotherapy’s effectiveness for an important social group. The study design has also been changed to make the post-second session outcome assessment the primary endpoint for the study. PTSD symptoms will now be assessed after the second experimental MDMA-assisted psychotherapy session rather than the third, as in our upcoming Israeli and Australian studies. This will enable us to conduct a more accurate comparison of results across our international research sites, and to help clarify whether the best treatment model involves two or three experimental MDMA-assisted psychotherapy sessions. The sixth subject in this study was enrolled on January 12.
On February 7, 2012, the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD was submitted to an independent Human Research Ethics Committee (HREC). Subjects in this study will receive two experimental sessions instead of three (as in our U.S. flagship study), enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our future Phase 3 studies. Once HREC approves the protocol, it will be submitted to the Australian Therapeutic Goods Administration (TGA) for review.
As in our ongoing study in U.S. veterans, this study will compare the effectiveness of a full dose (125 mg) and a low dose (30 mg) of MDMA in combination with psychotherapy. Unlike our U.S. veterans study, this study will omit the medium dose (75 mg) in order to determine whether we can achieve an effective double-blind with a two-arm (low and medium dose) study.
One of the ways we are expanding our capacity to conduct international clinical trials is by working closely with international affiliates. MAPS is collaborating with the newly formed Australian non-profit organization Psychedelic Research in Science and Medicine (PRISM) to design, fund, obtain approval for, and conduct this first-ever Australian study of the therapeutic application of MDMA.
U.S. Proof of Principle Study: Results of Long-Term Follow-Up Submitted to Scientific Journal
On February 5, 2012, after extensive work, the lead investigator of our first U.S. study of MDMA-assisted psychotherapy for PTSD and co-authors submitted a paper describing the results of our long-term follow-up of subjects who participated in the flagship study. The paper was submitted to a peer-reviewed scientific journal and is now being reviewed for publication. In the original study, 17 of 21 subjects no longer qualified for a diagnosis of PTSD after treatment with MDMA-assisted psychotherapy. The long-term follow-up, conducted an average of 3.5 years after treatment, demonstrates that these benefits were, on average, maintained over time. Additionally, of the subjects who were seeing a therapist prior to the study, 45% were no longer seeing one at the time of the follow-up survey; and 55% of those who were receiving psychiatric medications prior to the study were no longer taking them. Two subjects who participated in the original study experienced a return of symptoms during the long-term follow-up period and will be offered enrollment in our relapse study of MDMA-assisted psychotherapy for PTSD, where they may receive one additional full-dose MDMA session.
On February 1, 2012, the independent rater for MAPS’ upcoming Israeli study of MDMA-assisted psychotherapy for PTSD completed training on the Clinician-Administered PTSD Scale (CAPS). The CAPS is the primary outcome measure by which our research teams assess the severity of PTSD symptoms before and after treatment with MDMA-assisted psychotherapy. MAPS developed this training program in order to standardize how the CAPS is administered across our diverse study sites. The training includes reviewing of MAPS’ training manual for independent raters, viewing videos of real CAPS interviews produced by the Veterans Administration, and completing assessments of the rater’s ability to reliably administer the CAPS questionnaire. After a final meeting with the clinical team, the site will begin screening and enrolling subjects. Many of the Israeli subjects will be referred by the Israeli Defense Forces.
MDMA-Assisted Treatment for Adult Asperger’s Syndrome: Qualified Research Team Found
On January 26, 2012, the MAPS clinical team finalized negotiations with a qualified research team who responded to our Request for Proposals for an upcoming study of MDMA-assisted treatment for Adult Asperger’s syndrome. MAPS has agreed to contribute $10,000 for protocol development expenses. Asperger’s syndrome is characterized by difficulties in interpreting social cues and nonverbal communication. This study will seek to evaluate how individuals experience certain types of empathy, as well as larger questions of global functioning, before and after MDMA-assisted treatments. The research team will collaborate with the MAPS clinical team to develop a protocol for submission to the FDA, enabling us to begin exploring a new indication within our overall research program into the risks and benefits of MDMA used in a therapeutic setting. We have preliminary budgeted $200,000 for this study, and will refine that estimate as the protocol is developed.
On January 20, 2012, the first of two subjects eligible for our relapse study of MDMA-assisted psychotherapy for PTSD was screened. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our U.S. flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again heal these subjects.
MDMA-Assisted Psychotherapy Relapse Study Initiated
On January 16, 2012, the official study initiation took place for our upcoming relapse study of MDMA-assisted psychotherapy for PTSD. The first subject will be enrolled shortly thereafter. This study will enroll two subjects whose PTSD symptoms eventually returned after participating in our flagship study of MDMA-assisted psychotherapy for PTSD, which was completed in July 2010. This is an open-label proof-of-principle study intended to test whether an additional MDMA-assisted psychotherapy session and several associated non-drug psychotherapy sessions can once again free these subjects from a diagnosis of PTSD. This study is the first time we are offering an additional MDMA-assisted psychotherapy session after a considerable amount of time has passed (up to 64 months) after completing assessments following the initial therapy.
Protocol Design Completed for New Australian Study of MDMA-Assisted Psychotherapy for PTSD
On January 8, 2012, our clinical team finalized the basic design of the protocol for our planned Australian study of MDMA-assisted psychotherapy for PTSD. The study, which will be led by Clinical Investigators Dr. Stuart Saker, MBBS, and Fiona MacKenzie, MPsych(Clinical), will compare the effectiveness of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD using two different dosages of MDMA: a full dose of 125mg (with a supplemental 62.5mg) and a low dose of 30mg (with a supplemental 15mg). Seven subjects will be allocated to the full dose condition, with the remaining five to the low dose condition. Subjects in this study will receive two experimental sessions instead of three, enabling us to compare the results with our upcoming Israeli study and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies. The lead investigators both completed MAPS’ training course for MDMA-assisted psychotherapy researchers, which took place in Israel last January. The protocol will be submitted to an Independent Human Research Ethics Committee (HREC) by February 8, and to the Australian Therapeutic Goods Administration (TGA) once it has been approved. MAPS has pledged $25,000 to this study, which the researchers already matched with their own $75,000. We are now offering an additional $25,000 if they can raise an additional $75,000 in matching funds.
Contracts Finalized for Israeli Study of MDMA-Assisted Psychotherapy for PTSD
On December 25, 2011, MAPS and the Research Fund at Beer Ya’akov Mental Hospital finalized the contracts for our upcoming Israeli study of MDMA-assisted psychotherapy for PTSD. The Ethics Committee at Beer Ya’akov Mental Hospital approved the insurance certificate for the study on November 29, which was the final document required prior to finalizing the study contract. The Ministry of Health and the Ethics Committee has already approved the protocol. The second of three Israeli therapists have received MDMA in our therapist training protocol, with the third to receive MDMA in a few weeks. Our clinical team is now preparing for a study kick-off meeting with the site to prepare for screening Israeli subjects.
MDMA-Assisted Psychotherapy Intern Study Protocol Under Development
On December 9, 2011, the MAPS clinical team met with the site team at Cartographie Psychedelica to plan for our planned intern study of MDMA-assisted psychotherapy for PTSD. This study will investigate the effectiveness of MDMA-assisted psychotherapy when one member of the standard male/female co-therapist team is a healthcare intern. The study will be led by Marcela Ot’alora G., M.A., L.P.C., and will take place in Boulder, CO. At the December 9 meeting, the clinical team began planning for a visit to the study site, and made some final adjustments to the study design. The team discussed the logistics of the trial site and Schedule I license application, reviewed investigator responsibilities according to Good Clinical Practice (GCP) guidelines, and determined how investigators could best prepare themselves for conducting the study. The protocol design stage has now been completed, and documents are being prepared for submission to FDA and Institutional Review Board. Discussions are underway for scheduling a five-day therapist training seminar for the Boulder team.
MDMA-Assisted Psychotherapy for Autism Study Proposals Accepted Until December 16
We are welcoming proposals for a MAPS-sponsored pilot study of MDMA for Asperger’s syndrome and Autism Spectrum Disorders from interested researchers until December 16. A number of people with high-functioning autism and Asperger’s Syndrome have reported improvements after taking MDMA outside of research contexts. MDMA shows promise for treating Autism Spectrum Disorders since the effects of MDMA that increase empathy and enhance communication are precisely the abilities that autism tends to degrade.
MAPS is offering a grant of $10,000 for protocol development expenses for this pilot study. We have prepared a Request for Proposals (RFP) for researchers based in the U.S. We’re looking for an established research team that would also have a good chance of obtaining funds for research from other grant agencies, as autism research is currently a well-funded field. At present, we have not yet raised funds for the study itself, but we do have funds for protocol development. Once we have a completed protocol, we will develop a budget and a fundraising plan. We will also work to raise additional funds through MAPS and perhaps other sources.
To facilitate the protocol development process, MAPS has collected numerous anecdotal reports from individuals with Autism Spectrum Disorders who have used MDMA. Many of these accounts are from people who considered MDMA to be helpful. If you or someone you know has heard of MDMA having either positive or negative effects on symptoms of Autism Spectrum Disorders or Asperger’s syndrome, we would like to hear from you. Please contact MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., at .(JavaScript must be enabled to view this email address).
Health Canada Requests Additional Changes to Canadian MDMA/PTSD Study Pharmacy
On December 2, 2011, Health Canada sent a report of the results of their second security inspection to the manager of the pharmacy where the MDMA will be stored for our planned Canadian study of MDMA-assisted psychotherapy for PTSD. The report summarizes several changes that will be needed at the pharmacy before Health Canada grants it the license to store the study MDMA. These include (1) the installation of an additional alarm system for the area surrounding the safe, (2) the reinforcement of the windows, door, and lock to the room containing the safe, and (3) the addition of the words “Restricted Drug” to the MDMA label. Health Canada requested additional information after their initial May 10 inspection, after which a follow-up took place on October 18. A third security inspection will be scheduled once we have made the required changes to the pharmacy site. The creation of additional security regulations following the initial inspection has delayed the security clearance, and therefore the study initiation, by almost six months.
The process of meeting the security requirements of Health Canada is exceedingly frustrating. At times, the amount of security required for about $1500 of MDMA seems absurd, as compared to security for other items at the pharmacy worth much more. Nevertheless, our policy is still to comply with whatever is required and to continue to persevere until we are able to start this study.
U.S. Veterans Study of MDMA-Assisted Psychotherapy for PTSD Screens Eighth Subject
On December 1, 2011, the eighth (out of 16) veteran passed in-person screening for participation in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with PTSD. Five subjects have now been enrolled and treated, and have entered the long-term follow-up portion of the study, which will last twelve months following their final experimental treatment session. As of January 9, our clinical team had received 172 inquiries about participation in the study, emphasizing the widespread need among veterans for more effective treatments for PTSD resulting from military service. We are now seeking an additional $250,000 to expand this study from 16 subjects to 24.
Two essential parts of conducting methodologically rigorous and state-of-the-art MDMA-assisted psychotherapy research are standardizing the method of MDMA-assisted psychotherapy itself and the method by which data is collected about subjects’ PTSD symptoms. We have standardized our treatment in our MDMA-assisted psychotherapy treatment manual and related adherence criteria. Having a consistent, reliable way to measure PTSD symptoms at baseline and over time during and after treatment is also essential.
MAPS has recently completed the development of a training manual for independent raters who conduct the Clinician-Administered PTSD Scale (CAPS) interviews in our international series of Phase 2 MDMA/PTSD pilot studies. The CAPS is the primary measure used by clinicians and therapists worldwide for evaluating the severity of PTSD symptoms, and is the principle measure we use to assess the effectiveness of our treatment method.
The CAPS training manual will be supplemented by video tutorials of CAPS interviews, drawn from actual recordings of interviews with subjects enrolled in our ongoing study of MDMA-assisted psychotherapy for PTSD in veterans of war. By building on the training materials provided by the U.S. Veterans Administration, creating Hebrew and Arabic versions of the CAPS through rigorous double back translation methods, and providing a uniform set of training tools for independent raters, we will be able to standardize how the CAPS is administered across study sites. This is a necessary step before moving on to the larger Phase 3 studies required for federal approval of MDMA-assisted psychotherapy as a legal treatment for PTSD.
Two More Subjects Pass In-Person Screening for U.S. MDMA/PTSD Veterans Study
As of October 21, 2011, our ongoing Phase 2 study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD has enrolled five out of 16 subjects. Three subjects have started the long-term follow-up portion of the study, and two are still in treatment. Two additional veterans have passed in-person screening, involving thorough assessments of PTSD severity and medical eligibility, with their treatment sessions soon to be scheduled. One subject has chosen to discontinue treatment after just one experimental MDMA-assisted psychotherapy session, reporting being cured and needing no further sessions.
Health Canada Conducts Follow-Up Pharmacy Inspection for MDMA/PTSD Study
On October 18, 2011, Health Canada conducted a follow-up inspection of the pharmacy for our planned Phase 2 Canadian study of MDMA-assisted psychotherapy for PTSD. We expect that Health Canada will report on the results of this inspection within four to six weeks. Frustratingly, even though we followed Health Canada’s exact written requirements, the requirements have now changed and additional security measures may be needed. This will delay the start of the study for several additional months. The pharmacy inspection is required under Canadian regulations to ensure that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. Once we obtain clearance from Health Canada we will be able to import the MDMA for the study into Canada from Switzerland.
We’ve done everything Health Canada requested in their written communication but the inspector has now stated that new regulations have been created and that we may need to comply with them as well. The inspector said that she will submit her report to officials in Ottawa, and that we should hear back from Health Canada by the end of November. We have now been told we will receive the report the first or second week of December. Some of the changes that may be necessary could be to replace the glass door to the pharmacy with a solid wood or metal door and to replace the windows of the room with shatterproof/bulletproof glass. We haven’t heard back from Health Canada yet about their verdict, but the video certainly shows the lengths to which the pharmacy has gone to protect the MDMA supply.
Watch this brief video made by Canadian documentary filmmaker Arwen Hunter featuring a personal interview with pharmacist Colin Holyk discussing the challenges of negotiating the strict security requirements required by Health Canada and for a look inside the Vancouver pharmacy where the MDMA will be stored.
MAPS’ International Clinical MDMA Research Presented at Horizons Conference 2011
On October 15, 2011, Lead Clinical Research Associate Berra Yazar-Klosinski, PhD, gave a presentation on MAPS’ international clinical MDMA-assisted psychotherapy research program at the Horizons: Perspectives on Psychedelics conference in New York City. Download the presentation here (PDF).
Swiss MDMA/PTSD Study Final Report Submitted to SwissMedic
On October 14, 2011, MAPS’ clinical research team submitted the final clinical study report for our recently completed Phase 2 Swiss study of MDMA-assisted psychotherapy for people with chronic, treatment-resistant PTSD to SwissMedic, the Swiss equivalent of the U.S. FDA. SwissMedic confirmed that the report had been received on October 18. The report, authored by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and MAPS Research and Information Specialist Ilsa Jerome, Ph.D., is required under International Council on Harmonization/Good Clinical Practice (ICH/GCP) and FDA regulations. The report contains information about the study protocol, information about the conduct of the study, and all study data in both raw and analyzed formats. The study team is now preparing the results for publication in a peer-reviewed academic journal.
A statistical analysis of the results reveals clinically significant decreases in scores on the Clinician-Administered PTSD Scale (CAPS), with an average reduction of 15.6 points. Due to the small number of subjects in this small pilot study, however, these decreases did not reach statistical significance. We did, however, observe trends toward statistical significance in both the CAPS and the Posttraumatic Diagnostic Scale (PDS), the two measures used to evaluate symptom severity in study subjects.
Independent Raters Trained in Preparation for Israeli MDMA/PTSD Study
On October 12, 2011, the new Independent Rater in MAPS’ Israeli study of MDMA-assisted psychotherapy for PTSD began working on the training videos that we have created to standardize how the Clinician-Administered PTSD Scale is administered across all of our treatment sites. This CAPS training is the last major element to complete before we can start enrolling and treating subjects. The official study initiation took place on July 24, when representatives from Antaea Medical Services, Ltd., the clinical research organization assisting MAPS with managing our Middle East studies, visited the site to finalize documents and provide training to the study staff. The study has all necessary clearances from Israeli regulatory bodies, including the Israeli Ministry of Health and an independent Ethics Committee. We have also submitted the protocol to the U.S. FDA, which is required because we are conducting the study under a U.S. Investigational New Drug application. The Israeli Defense Forces are already prepared to begin referring Israelis with chronic, treatment-resistant PTSD once we are ready to enroll subjects, probably before 2012.
Health Canada Schedules Follow-Up Pharmacy Inspection for MDMA/PTSD Study
On October 18, 2011, Health Canada has scheduled a follow-up inspection of the pharmacy for our planned Canadian study of MDMA-assisted psychotherapy for PTSD.
DEA Approves US MDMA/PTSD Relapse Study Protocol; Study Initiation Scheduled
On September 14, 2011, the Drug Enforcement Administration (DEA) notified MAPS that it had approved the Schedule 1 licenses required to transport, store, and administer the MDMA for our new “relapse study” of MDMA-assisted psychotherapy for PTSD. The Food and Drug Administration (FDA) cleared the protocol on May 24 and an Institutional Review Board on June 9. Now that we have received all necessary clearances, we will schedule the study initiation and begin enrolling subjects.
Five subjects (out of 16) have now received at least one experimental treatment session in our ongoing U.S. Phase 2 Study of MDMA-assisted psychotherapy for veterans with chronic, treatment-resistant PTSD. Of these subjects, three have completed all three experimental treatment sessions in Stage 1 and one has completed the entire study. The long line of veterans now awaiting in-person screening for this study is both encouraging and saddening—encouraging because it means we will certainly have enough subjects for the study, saddening because there are so many people for whom conventional PTSD treatments have failed to provide sufficient relief.
Female combat veterans and veterans living near Charleston, SC, are especially encouraged to apply for study participation. Clinical Investigators and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., will be hosting a workshop at Cartographie Psychedelica, our 25th Anniversary conference and celebration in Oakland from December 8-12.
U.S. Veterans Study: Third Protocol Amendment Submitted to FDA
On August 4, 2011, the third protocol amendment for our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD was submitted to the FDA.
U.S. Veterans Study: Third Protocol Amendment Submitted to IRB
On August 2, 2011, our clinical team submitted the third protocol amendment for our recently initiated U.S. study of MDMA-assisted psychotherapy for veterans with PTSD to the IRB for review.
Jordanian FDA Delays Study Approval; Additional Questions Anticipated
On July 30, 2011, we learned that the JFDA decided not to approve the protocol for our Jordanian study of MDMA-assisted psychotherapy for PTSD at this time, based in part on comments from an expert reviewer chosen by the JFDA. We anticipate receiving a further set of questions from JFDA soon, and we are hopeful this study will eventually be approved.
On July 24, 2011, our new Israeli study of MDMA-assisted psychotherapy for PTSD was officially initiated. Representatives from Antaea Medical Services, Ltd., the clinical research organization assisting MAPS with managing our Middle East studies, visited the site to finalize documents and provide training to the study staff. The study has all necessary clearances from Israeli regulatory bodies, including the Israeli Ministry of Health and an independent Ethics Committee. We have also submitted the protocol to the U.S. FDA, which is required because we are conducting the study under a U.S. Investigational New Drug application. We expect to begin enrolling Israeli subjects with chronic, treatment-resistant PTSD this Fall.
Researchers Debate Scientific, Ethical Implications of Harvard Ecstasy/Neurocognition Study
The July 2011 issue of the peer-reviewed scientific journal Addiction published a series of letters addressing the purpose, design, and implications of a recent study of the effects of recreational Ecstasy use on neurocognition by Harvard scientist John Halpern, M.D. The results of the study were published in the April 2011 issue of Addiction and shed new light on the risks of recreational Ecstasy use after overcoming some of the methodological flaws of previous research.
The Harvard study, for which MAPS provided both the concept and $15,000 for the initial pilot study, found no link between long-term Ecstasy use and cognitive damage. The most significant methodological issue addressed by the new study was previous studies’ use of subjects who had used Ecstasy as well as other drugs, confounding the results by making it impossible for researchers to determine whether long-term changes in cognitive skills were due to Ecstasy, another drug, a combination of drugs, or some other factor entirely. The Harvard study used subjects whose drug use had been entirely or almost entirely limited to Ecstasy, and suggested that the risks of Ecstasy are significantly less than previously thought.
Although MDMA is not the same as Ecstasy (illegal Ecstasy pills often contain substances other than MDMA, and MAPS’ clinical studies use only pure MDMA), these results will encourage additional research into the possible therapeutic benefits of MDMA. According to commentary published in the April 2011 issue of Addiction by Bond University psychologist Michael Lyvers:
“Given that MDMA is being administered to human patients to assess its efficacy as a treatment for post-traumatic stress disorder, ethical arguments against an experimental within-subjects approach to detecting possible long-term brain, cognitive and memory effects of MDMA in human volunteers may now be less relevant. Once such research has been replicated consistently across a range of typical dosing regimens, the chimera of MDMA-induced neurotoxicity in human ecstasy users may finally be put to rest.”
US Veterans MDMA/PTSD Study Enrolls First Five Subjects
On July 14, 2011, the second subject had their second open-label MDMA-assisted psychotherapy session in our ongoing US Phase 2 Study of MDMA-assisted psychotherapy for PTSD in veterans of war. This study is taking place in Charleston, SC, and is led by Clinical Investigators and co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. A total of five subjects (out of 16) with chronic, treatment-resistant, combat-related PTSD have now been enrolled and a sixth has passed the initial phone screening.
While the significant number of PTSD sufferers now awaiting in-person screening for this study is encouraging (in that we will certainly have enough subjects for the study), it also highlights the pressing need for this research (since there are so many individuals for whom conventional PTSD treatments fail). Female combat veterans and either male or female veterans living near Charleston, SC, are especially encouraged to apply.
Health Canada Reports on Inspection of Pharmacy for MDMA/PTSD Study, Requests More Information
On July 6, 2011, we received a letter from Health Canada (dated June 17, 2011) explaining the results of its May 10 inspection of the Vancouver pharmacy that will be used to store and label the MDMA capsules for our upcoming Canadian study of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD. In the letter, Health Canada requested additional information about the site and about how we proposed to transfer the MDMA from the pharmacy to the treatment facility.
Canadian regulations require that the facility used to store and label the MDMA to be used in the study is adequately secure, and that the proper accountability procedures are in place. The information requested by Health Canada included clarifications about the address of the pharmacy, the security measures available at the site, the method of transportation of the MDMA between the pharmacy and the research site, and the format of the labels to be used on the capsules. Health Canada also requires that we include an alarm system at the site. We anticipate that it will be relatively easy to address these issues. Once we do, our final hurdle is to obtain the license to import the MDMA for the study into Canada from Switzerland (where another MAPS MDMA/PTSD study was recently completed).
Ethics Board Approves US MDMA/PTSD Relapse Study Protocol
On June 9, 2011, our Institutional Review Board (IRB) approved the protocol for our new “relapse study” of MDMA-assisted psychotherapy for PTSD. The Food and Drug Administration approved the protocol for this study on May 24, but the DEA must now conduct its own review before granting us the license to store and administer the MDMA. On June 14, Clinical Investigator and co-therapist Michael Mithoefer, M.D., submitted the protocol for the relapse study to the DEA. We anticipate that the DEA will approve the study soon, allowing us to schedule the study initiation and begin enrolling subjects.
This study, which will take place in Charleston, SC, is limited to up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. Over 80% of the subjects in our previous study no longer met criteria for PTSD two months after treatment. These benefits tended to persist over time until our long-term follow-up, conducted an average of 41 months after treatment. However, for several subjects symptoms did eventually return. This relapse study will attempt to determine whether a single additional open-label MDMA-assisted psychotherapy session along with several non-drug psychotherapy sessions can be effective for once again enabling these subjects to be free of a diagnosis of PTSD.
PTSD Rating Scale Translated for Middle East MDMA/PTSD Studies
With our Israeli study approved and our Jordanian study awaiting final government approval, we have been working hard to make our research tools accessible to clinical researchers in the Middle East. One of these tools is the Clinician Administered PTSD Scale (CAPS), which is the primary measure used by our researchers to determine the severity of PTSD symptoms before and after treatment. MAPS has now completed the translation of the CAPS into both Hebrew and Arabic, and we are working on back-translations which will verify the accuracy and consistency of the translations. By sharing these translations freely with the Veteran Administration’s National Center for PTSD, and with researchers throughout Israel and the Arab world, MAPS is promoting the development of effective PTSD treatments by fostering collaborations between international research teams and across different cultures.
Training Manual Completed for Independent Raters in MDMA/PTSD Studies
The increasing number and global reach of MAPS’ MDMA-assisted psychotherapy studies means that maintaining consistency of therapeutic approach across study sites is essential. In light of this challenge, MAPS has created a training manual for the blinded independent raters involved in our studies of MDMA-assisted psychotherapy for PTSD. The purpose of this manual and its accompanying video tutorials is to provide instruction in the reliable administration of the Clinician Administered PTSD Scale (CAPS), the primary outcome variable in our studies used to evaluate the severity of PTSD symptoms before and after treatment with MDMA-assisted psychotherapy.
The CAPS was one of the first diagnostic interviews developed specifically for PTSD. Because of the flexibility of the CAPS interview format, there can be differences between how interviewers use it to evaluate PTSD symptoms. By standardizing how these interviews are conducted and scored, we will obtain more consistent data and in doing so enable our research staff to conduct meta-analyses and compare data across sites—of major importance when conducting international clinical trials.
The manual will enable our independent raters to (1) identify symptoms of PTSD, (2) understand the history and purpose of the CAPS, (3) become familiar with the features of the CAPS, (4) become familiar with techniques in completing the CAPS interview, (5) understand the benefits and limitations of using the CAPS for assessing the effects of exposure to traumatic events, and (6) score the CAPS interview reliably and effectively. Based on training materials provided by the US Veterans Administration, the manual was collaboratively developed by MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., MAPS Research and Information Specialist L. (Ilsa) Jerome, Ph.D., and MAPS Clinical Program Manager Amy Emerson. Videos of real CAPS interviews will be used to assess the effectiveness of the training manual.
On June 1, 2011, MAPS’ clinical research team completed their quality inspection of the database for our Swiss study of MDMA-assisted psychotherapy for PTSD. The database has been closed and locked (with a 0.04% error rate, far below the 0.5% required to pass), officially concluding the data collection phase of the study. With the final data set ready, the research team can now begin analyzing the data and assisting the investigator in preparing a manuscript to be published in a peer-reviewed scientific journal. The article will be co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The locked database will also be used for our final report to the US FDA.
Israeli Ministry of Health Approves MDMA/PTSD Study
On June 1, 2011, Israel’s Ministry of Health approved our Israeli study of MDMA-assisted psychotherapy for PTSD. This approval indicates that the Ministry was satisfied with our response to their April 28 request for additional information. Now that the study has the full approval of Israeli regulatory bodies, we have begun preparing to submit the protocol to the US FDA, which must prospectively approve the study before we can start enrolling subjects since it is being conducted under a US Investigational New Drug application. The study initiation will take place in approximately one month, during which time we will finalize the study insurance documents and contracts with the study site. Training materials containing the measures to be used in the study have been provided to the investigators and independent raters, and we continue working with clinical research organization Antaea Medical Services, Ltd., to prepare the remaining documents and forms.
On May 24, 2011, the FDA approved our study of MDMA-assisted psychotherapy for up to three subjects whose PTSD symptoms returned after participating in our flagship Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD. After participating in our initial study, subjects were interviewed using the Clinician Administered PTSD Scale (CAPS), a diagnostic tool used by psychiatrists and researchers to assess the severity of PTSD symptoms. At the two-month follow-up after treatment, over 80% of subjects no longer met the diagnostic criteria for PTSD. In the long-term follow-up (conducted an average of 41 months after treatment) we found that CAPS scores had declined even further, demonstrating that benefits persisted over time. For several of these subjects, however, some symptoms did eventually return. The new study will be limited to these subjects, and is intended to determine whether a single additional open-label MDMA-assisted psychotherapy session can be effective for eliminating these relapse symptoms.
The FDA approval came just one week after the agency received our protocol submission on May 17—the fastest turnaround we have ever seen for an FDA protocol approval. This expediency could be attributable to the fact that the risks of treatment are low: Eligible subjects have already been through treatment and been shown to tolerate MDMA in a clinical context.
First Subject Unblinded in US MDMA/PTSD Veterans Study
On May 20, 2011, the first subject was unblinded in our ongoing US Phase 2 study of MDMA-assisted psychotherapy for PTSD in veterans of war. Now that the research team knows which dose of MDMA the subject received (low, medium, or high), they can determine whether the subject is eligible to participate in Stage 2 of the study or continue on to the long-term follow-up portion of the study. Stage 2 involves giving the subject an additional MDMA-assisted psychotherapy session, and is reserved for those subjects who received either low (“active placebo”) or medium dose of MDMA in Stage 1 in order to provide all subjects with the same opportunity to experience the effects of a full dose. If the subject received a full dose of MDMA, they will advance to the long-term follow-up portion of the study in which treatment effects (if any) are evaluated 12 months following treatment by the re-administration of the Clinician Administered PTSD Scale (CAPS). This study is our first to compare the safety and effectiveness of three (rather than two) different doses of MDMA in combination with psychotherapy. All MAPS MDMA/PTSD studies with the exception of our completed Phase 2 pilot study have used active placebos in order to effectively maintain the study blind.
Health Canada Completes Pharmacy Inspection for Canadian MDMA/PTSD Study
On May 10, 2011, officials from Health Canada completed their inspection of the Vancouver pharmacy that will be used to store the MDMA capsules to be used in our upcoming Canadian study of MDMA-assisted psychotherapy for PTSD. According to Canadian regulations, the pharmacy must have adequate security and accountability before we can be granted a license to import MDMA from Switzerland in Canada. Health Canada has told us to expect the results of the inspection before the end of June. Once the import license has been approved, we will submit the final study documents to Health Canada and schedule the study initiation. We have now been working for about two years (since Health Canada approved the protocol) to obtain the import permits for the study, and we are hoping to start this study soon.
Israeli Ministry of Health Requests More Information about Planned Study
On April 6, the Israeli Ministry of Health reviewed our proposed protocol for our Israeli study of MDMA-assisted psychotherapy for PTSD. This protocol was originally submitted to the Ministry on March 15 after being approved by the ethics committee. On April 28, the chair of the ethics committee received a letter from the Ministry of Health (PDF; Hebrew) requesting more information about the study prior to approval. Briefly, the Ministry has asked us to provide:
More detailed data about the cardiovascular risks of MDMA, and the extent to which the site is equipped to handle these risks
Information regarding possible or perceived conflicts of interests involving the Clinical Investigator
A complete summary of the commercial and professional relationship between MAPS and the investigators
Additional assurances about the objectivity of our research methodology
We are now collaborating with the Israeli clinical team to draft a response to this request. Once we submit the response and the Ministry is satisfied, we expect that they will approve the protocol.
First Subject Treated in MDMA-Assisted Psychotherapy Training Study
On April 22, the first subject was treated in our training study for MDMA-assisted psychotherapy researchers. The protocol was designed as a Phase 1 study of the psychological effects of MDMA administered in a therapeutic setting to healthy volunteers. We are not actively recruiting for this study, participation in which is limited to individuals selected to be investigators in MAPS’ MDMA-assisted psychotherapy studies. In addition to providing new information about the effects of MDMA-assisted psychotherapy in healthy volunteers, the study will enable us to train therapists to conduct our MDMA/PTSD studies. With MAPS preparing to expand its research program to move even closer towards regulatory approval of MDMA as a prescription medicine, there will be more need for therapists trained in MAPS’ approach to MDMA-assisted psychotherapy than ever before.
Now that we’ve completed our Swiss study of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD, the clinical team is analyzing the data and assisting investigator Peter Oehen, M.D., in preparing a manuscript for publication. A preliminary analysis suggests that the Clinician-Administered PTSD Scale (CAPS), which is the primary measure of PTSD symptom severity, showed a trend towards improvement after treatment, with CAPS reductions somewhat larger than in comparable studies of Zoloft and Paxil. The Posttraumatic Diagnostic Scale (PDS), which is the secondary measure of PTSD symptoms completed by the subjects, also showed statistically significant improvements in symptoms after treatment.
The therapeutic results obtained in our previously completed U.S. flagship study of MDMA-assisted psychotherapy for PTSD were larger than those from our Swiss study. In order to determine how methodological, personnel, and/or cultural differences may have led to these differences, we are asking a series of questions about whether there were differences in (1) the population from which subjects were drawn, (2) the recruitment process, (3) the screening process, (4) the demographics of the subjects enrolled, (5) Swiss and American cultural approaches to PTSD, (6) the approaches of the various independent raters, and (7) the way in which subjects’ PTSD symptoms were treated and/or evaluated by the clinicians. The answers to these questions will help MAPS understand how best to maximize therapeutic outcomes.
On March 27, 2010, Prof. Andrew Parrot (Swansea University) wrote a letter to the editor criticizing Prof. John Halpern’s (Harvard) recent study finding no association between heavy recreational Ecstasy use and cognitive damage. Below, Prof. Stephen Kish of the University of Toronto points out that in his rush to attack the study, Parrott actually misinterpreted the results of Kish’s own Ecstasy study, undermining Parrott’s critique. Debate may be important for the progress of science, but so is accuracy.
Rick Doblin, Researchers Meet with Wellcome Trust to Seek Support for UK MDMA/PTSD Study
On April 1, 2011, two officials from the Wellcome Trust, the largest private philanthropic organization in the UK with assets of about $20 billion, meet at their London office with MAPS Executive Director Rick Doblin, Ph.D., British psychiatrist Ben Sessa, M.D., Swiss MDMA/PTSD study Clinical Investigator and lead psychiatrist Peter Oehen, M.D., and Swiss co-therapist Verena Widmer. The purpose of the meeting was to discuss possible Wellcome Trust interest in a grant application for a MAPS-sponsored MDMA/PTSD pilot study to take place in England. The meeting took Rick Doblin about two months to arrange, with crucial assistance from Ben Sessa and senior British scientist David Nutt, M.D.
The outcome of the meeting was that the Wellcome has invited us to submit a grant proposal. Wellcome staff indicated that they were more interested in the neuroscience of psychedelics than the therapy, so as a result we will be designing the new study with an emphasis on physiological and neurophysiological changes related to PTSD before and after treatment. While there is no guarantee that Wellcome will agree to fund the study, this is the first time that MAPS has ever been invited to submit a grant application to a major public (non-family) foundation, and therefore represents a major step forward. Although Wellcome officials thought they would be taking a “reputational risk” by agreeing to fund an MDMA/PTSD study, they also agreed with Rick Doblin’s comment that doing so could also be a “reputational opportunity.” Those foundations that decide to support psychedelic research at this stage will in the future be recognized for their prescient contributions to this growing field.
Jordanian MDMA/PTSD Study Meets Final Requirements
On March 29, 2011, Kamila Novak of Antaea Medical Services, the clinical research organization that MAPS has hired to work on our Jordanian and Israeli MDMA/PTSD studies, met with the Jordanian Food and Drug Administration (JFDA) to discuss the status of our Jordanian study of MDMA-assisted psychotherapy for PTSD. The JFDA confirmed that the study had met the liability insurance requirements for subjects enrolled in the study and that the protocol was satisfactory, and that they will allow the study to proceed once a few final documents have been submitted, probably by the end of April.
What follows is a letter to the editor published on Sunday, March 27, 2011, in the Guardian, signed by abut 40 scientists all objecting to the findings of Dr. John Halpern’s paper in the journal Addiction, which found no association between long-term recreational Ecstasy use and cognitive damage. On April 3, Prof. Stephen Kish responded to the letter with one of his own.
US MDMA/PTSD Veterans Study Enrolls Third and Fourth Subjects
On March 25, 2011, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., visited Charleston, SC, to evaluate the progress of our ongoing Phase 2 pilot study of MDMA-assisted psychotherapy for PTSD in veterans of war. The study is led by Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. Two out of 16 subjects have now completed their MDMA-assisted psychotherapy sessions. On April 2, the third subject had his first experimental MDMA psychotherapy session. On April 4, the fourth subject was enrolled, with his first experimental therapy session scheduled for April 16. In past studies, recruitment has been the primary challenge of conducting these studies; now that we have improved our recruitment techniques, the major challenge now is making sure that all of the subjects complete the study (some could choose to drop out). It is advantageous that both of these new subjects live in the Charleston vicinity, since it dramatically reduces travel costs. Conserving resources is an important task as we conduct this study, as we still need to raise $200,000 in order to complete the study. If you would like to help us complete this crucial study, please consider making a contribution.
First Subject Screened in MDMA-Assisted Psychotherapist Training Protocol
On March 22-24, 2011, MAPS Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D., and MAPS Clinical Research Intern Katie Hendy, M.A., and MAPS Director of Finance and IT Josh Sonstroem (who is also responsible for encapsulating and randomizing study MDMA) visited Charleston, SC, to initiate our therapist training protocol for MDMA-assisted psychotherapy for PTSD. The study has now screened its first participant. The protocol was designed as a Phase 1 study of the psychological effects of MDMA in healthy volunteers, with subjects limited to people in MAPS’ therapist training program. In addition to providing new information about the effects of MDMA-assisted psychotherapy in healthy volunteers, the study will enable us to train therapists to conduct future MDMA/PTSD studies. With MAPS preparing to expand its research program to move even closer towards regulatory approval of MDMA as a prescription medicine, there will be more need for therapists trained in MAPS’ approach to MDMA-assisted psychotherapy than ever before. The study is led by Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N. Julie Holland, M.D., is the official medical monitor.
Israeli MDMA/PTSD Study Protocol Awaits Ministry of Health Review
On March 16, 2011, the Israeli Ethics Committee at Beer Ya’akov Mental Hospital submitted the application for our Israeli study of MDMA-assisted psychotherapy for PTSD to the Israeli Ministry of Health (the Israeli equivalent of the U.S. Food and Drug Administration). The Ministry of Health is now reviewing the protocol, and we anticipate that they will approve it. If that happens we will be able to initiate the study.
Dr. John Halpern Responds to UK National Health Service Critiques of New MDMA Study
An article from the U.K. National Health Service (NHS) adeptly summarizes the purpose, methods, and results of Dr. John H. Halpern’s latest study of the risks of Ecstasy. which showed no evidence of cognitive damage associated with heavy recreational Ecstasy use (MAPS press release; Addiction journal press release). However, while it rightly acknowledges that “this research cannot confirm that Ecstasy is a safe drug,” it does make some glaring errors in its conclusions about the study’s significance. After reading the NHS article, see below for Dr. Halpern’s careful and well-reasoned response.
NHS: “However, the number of participants was low and the researchers highlight that the small sample size may have prevented an effect from being observed.” JHH: No study can exclude completely that there are methodological limitations. That being said, the sample size was not low or small. In fact, this is (I believe) the largest neurocognitive study of Ecstasy users ever attempted or reported. Where were these critics when all prior studies with even smaller sample sizes were relied upon almost without question just because those studies had findings of harm? There is no credibility to the claim that our study was “relatively small.”
NHS: “Additionally, the study did not follow the participants over time to assess whether their brains had changed with ecstasy use.” JHH: This is irrelevant if not meaningless, because we took people who had used ecstasy 20 or more times (range: 22-450 lifetime experiences). We don’t need to study individuals repeatedly to evaluate chronic, long term effects. If someone is an alcoholic for 20 years, do we need to do serial testing to confirm that damage worsens over time? That is a different study. We can compare heavy alcoholics to non-users, and such a study will indeed reflect the cumulative effect of use—no different from the study we completed.
NHS: “While the study was well conducted, illicit drug use can be difficult to research, and this research cannot confirm that ecstasy is a safe drug.” JHH: Who said our study was about confirming “that ecstasy is a safe drug?” In fact, we specifically stated that our report should not be twisted into asserting that MDMA is “risk-free.”
NHS: “Without further research, it is not possible to say conclusively that this statement is correct [statement is that there is no evidence that ecstasy causes brain damage].” JHH: As if these people ever said that about any of the prior studies that had negative findings with much smaller samples and tons of confounds. What is critical to understand here is that we don’t have these sorts of debates over the damage from alcohol. The fact is that there are 20-plus years of research in this field and it still isn’t conclusive for harm: This alone is quite telling. We don’t have this sort of debate over alcohol, so why with MDMA? I suspect that it’s quite likely that our findings have zoomed in on what has achieved the wide range of results in studies of the cognitive performance of Ecstasy users: Confounds were poorly controlled for in the past.
NHS: “The participants had been asked to refrain from taking ecstasy for 10 days before these tests.” JHH: In fact, we required at least 21 days from last use. This is important because almost all other research evaluated users after little to no delay from last use. Only a few other studies waited at least 14 days from last use. Why delay? So that we don’t test people in some sort of prolonged recovery phase. We were striving to evaluate for long-term effects, not capture decreased performance from most recent use. In fact, only 4 subjects were tested within 40 days from last use, with the shortest time being 25 days from last use.
NHS: “Some exclusion criteria, such as having fewer than 50 sustained drinking sessions, were relatively restrictive given that the study looked at illegal drug use. Therefore, the participants may not have been representative of typical ecstasy users. It also suggested that participants may not have mixed their ecstasy use with drinking or other drugs, a behavior that might potentially have some effect on the brain.” JHH: I don’t believe the NHS ever complained about polydrug use as the culprit in prior evaluations of Ecstasy users. Our study showed that any harms found in polydrug Ecstasy users may be due to other drugs or combinations of drugs. This must now be dealt with more directly than just using statistics to control for other drug use. We purposely sought out relatively exclusive users of ecstasy to zero in on the neurocognitive performance of those users, free from the confound of polydrug use. The NHS commentary points out a confound in opposition: If we just stick with polydrug users in this type of research, then the picture remains murky on harm, enabling them to stay “on message” that all drugs cause damage. Our ambition is only to engage the scientific method to elucidate useful data. We published our findings, and doubters are free to follow the published methodology and attempt to replicate our work. By the way, we did publish mostly similar results in 2004: that was our pilot data and constitutes a separate study. Our present study does not include any data from the 2004 paper, meaning that the majority of our findings are already replicated in our present report.
NHS: “This study looked at cognitive function using various tests, but did not look at brain structures (such as by using brain scans). As this study was not designed to detect brain damage and did not follow people over time, any differences it might have found in brain function could not have been confirmed as permanent or temporary.” JHH: This is quite bizarre from my perspective. It appears that the NHS believes that only by looking at “brain structures (such as by using brain scans)” is it possible to prove brain damage. This is false (except, of course, for visualizing images of tumors, strokes/infarctions, or other neuroanatomical damage). Images of the brain will not show that a person has damaged cognitive performance. Poor cognitive performance indeed can, however, indicate brain damage. Indeed, the Revised Strategic Application Test (RSAT) was developed specifically to evaluate those with traumatic brain injury and other physical injuries to the brain. As for the complaint about not following people over time, this is not a limitation of our research (see my comments above). The issue of “permanent” versus “temporary” just makes no sense: We evaluated longstanding users of Ecstasy versus non-users and we waited a long time from last use in order to focus on the longer-term functional consequences of use. Or, rather, is the NHS claiming that healthy brain function is “temporary?” It is true that no study is perfect, and that there are limitations and benefits to each approach. That being said, let’s see what other research teams might find if they follow our lead in removing the types of confounds that have plagued this area of research for far too long. I suspect that most will soldier on explaining away their study confounds rather than addressing them (which, in all fairness, is exactly what I am doing in offering up my perspective on the limitations of our present work raised by the NHS). I salute the NHS for offering a mostly fair, reasoned, and reasonable commentary on which then to debate this science.
New Study Published in Addiction Shows Ecstasy Not Associated with Cognitive Decline
On February 15, 2011, the journal Addiction published online the results of a neuroscience study finding no evidence of impaired cognitive performance in users of Ecstasy, the street name for the chemical known as MDMA.
The study, conducted by researchers at Harvard-affiliated McLean Hospital and led by Dr. John H. Halpern, improves on earlier studies in several ways. It used subjects who used few or no other drugs or alcohol, compared those subjects to others from the same all-night dance community who had not used Ecstasy, performed complete psychiatric assessments, and utilized hair analysis and other drug testing procedures.
Since previous studies of the neurocognitive effects of Ecstasy did not address these issues, their reports of damage to memory, strategic planning, and other cognitive tasks may have been due to confounded study design rather than to Ecstasy itself.
The study was funded for five years by the National Institute on Drug Abuse (NIDA) and was based on pilot data collected with the assistance of MAPS.
Read the rest of MAPS’ press release for more information about the design, results, and implications of the study.
Final Closeout Takes Place for Swiss MDMA/PTSD Study
From February 13-16, 2011, MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., visited Switzerland for the official closeout of our Swiss study of MDMA-assisted psychotherapy for PTSD with lead researcher Peter Oehen, M.D. This visit included cleaning up data, reviewing the investigator’s files, collecting originals of essential documents and recordings, reviewing source records and case report forms, and preparing all materials for archiving. Some of the treatment session recordings from the Swiss study will also be used to compare and contrast the treatment methods of U.S. and Swiss therapists, since professional and cultural differences can lead to differences in approaches to treatment. One of MAPS’ goals is to create a manualized treatment methodology that can be applied internationally, making comparisons especially important.
Jordanian MDMA/PTSD Clinical Team Meets; Study Awaits Final Approval
On January 30, 2011, MAPS Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., led a one-day course for the therapists who will conduct the treatment sessions in our upcoming Jordanian study of MDMA-assisted psychotherapy for PTSD. Although the Jordanian therapists were trained in using our MDMA-assisted psychotherapy treatment manual prior to our April 2010 conference, the manual has since then undergone several revisions to its adherence criteria. The course gave them the opportunity to learn the new criteria and ask questions about their implementation.
The visit to Jordan was also a chance to gather the clinical team together in preparation for initiating the study once the Jordanian FDA has decided on insurance requirements for subjects enrolled in the study. These insurance requirements are necessary should subjects experience any negative effects as a result of study participation, a necessary legal precaution even though over 480 subjects have taken MDMA in clinical or laboratory research settings to date without evidence of a single drug-related Serious Adverse Event. Since this study will be the first psychedelic research in Jordan, the first time a non-profit drug developer has requested permission to conduct a study in the country, and the first time researchers have sought to use a drug administered just a few times as part of the therapeutic process, regulators in the country must develop a brand new set of research requirements. Once the Jordanian FDA has informed us about these requirements and approved the study, and we have obtained a permit to import the MDMA from Switzerland, we will be able to begin recruitment for the study.
On January 31, 2011, the Jordanian clinical team held an Investigators’ Meeting during which the lead investigators, therapists, and representatives from Antaea Medical Services (the clinical research organization hired by MAPS to monitor both our Israeli and Jordanian studies) discussed the process for initiating and conducting the study once it has cleared the Jordanian FDA review. Antaea will be responsible for monitoring the quality of the data gathered during the study, ensuring therapists’ compliance with the protocol, and ensuring that all the paperwork is in order in case the U.S. or Jordanian FDA decides to audit the study. The meeting included a welcome by MAPS Founder and Executive Director Rick Doblin, Ph.D., and Antaea CEO and Managing Director J.R. Roussos; a presentation by Dr. Mithoefer on the pharmacology and safety profile of MDMA; a presentation by MAPS Clinical Research Associate Berra Yazar-Klosinski, Ph.D., on the study protocol itself; and another by Antaea’s Kamila Novak on investigator responsibilities.
Closeout Scheduled for Previous Israeli MDMA/PTSD Pilot Study
On January 27, 2011, MAPS Clinical Research Associate Berra
Yazar-Klosinski, Ph.D., will meet with Kamila Novak, Program Manager of the contract
clinical research organization (CRO) Antaea Medical Services, which MAPS has
hired to monitor both our Jordanian and Israeli studies. Berra and Kamila will conduct
a closeout visit for MAPS’ previous Israeli study of
MDMA-assisted psychotherapy for PTSD. An abbreviated report has already
been written for submission to the FDA and the Israeli Ministry of Health, and
it will be made available on our website after it is submitted. The study was concluded
on March 26, 2010, after five subjects were treated.
Three Australian Therapists Participate in Training Program in Israel
Three Australian clinicians are joining the Israeli
therapist training program: Stuart Saker, M.D., a psychiatrist with the
Australian armed forces; Fiona MacKenzie, a clinical psychologist (and Stuart’s
partner); and Marty Downs, M.D., a psychiatric resident and student of Dr.
Sandy McFarlane, the chief psychiatrist of the Australian military. The
clinicians met Rick Doblin in early December when he was the keynote speaker at
the Entheogenesis Australis (EGA)
Symposium. MAPS offered a $25,000 matching grant for an Australian MDMA/PTSD
study, and the Australians raised $75,000 for the study, a 3-to-1 match! The
Australian study is in the early development stages. After the Australian
therapists return home, they will gather information about whether the study
could take place in formal association with the Australian military or within
an academic research context.
MDMA research has already been approved and conducted in
Australia, which suggests that beginning our own study there is a real
possibility. The completed study was a dissertation involving healthy
volunteers who had been administered MDMA as part of a driving study (and who were
given unscheduled time near the peak of their MDMA experience) and studying its
effects on facial and emotion recognition. While this previous research did not
directly address the effectiveness of MDMA or MDMA-assisted psychotherapy
against PTSD symptoms, it is related in the sense that PTSD is an affective
disorder that affects sufferers’ ability to respond to social and emotional cues.
This previous study provides evidence that justifies further explorations into
MDMA’s therapeutic efficacy, and it makes it more likely that Australian
regulators will approve our own study.
Clinical Team to Conduct Training Course for Jordanian MDMA/PTSD Study
On January 30, 2011, co-therapists Michael Mithoefer, M.D.,
and Annie Mithoefer, B.S.N., will lead a one-day training course for the
therapist team for our Jordanian
study of MDMA-assisted psychotherapy for PTSD. The course is a refresher
for the therapists who will be conducting the treatment sessions, as the team already
went through our standard training program in
Charleston, SC, immediately prior to our conference “Psychedelic
Science in the 21st Century” in April 2010. The one-day refresher
course will familiarize the therapists with the latest revisions to the
adherence criteria in MAPS’ treatment manual and ensure that they are ready to
begin once the study protocol has been approved. The protocol already has the
approval of the Al Rashid Institutional Review Board (IRB) and was submitted to the Jordanian FDA in December.
On January 31, Michael, Annie, MAPS Executive Director Rick
Doblin, Ph.D., and MAPS Clinical Research Associate Berra Yazar-Klosinski,
Ph.D., will participate in an investigators’ meeting with the Jordanian team,
including Principal Investigator Nasser Shuriquie, M.D. The meeting is part of
the study initiation activities, and will provide an opportunity for the
investigators and therapists to plan for the study and work out any last-minute
issues. The face-to-face meeting is important because it allows the team to ask
questions about the study protocol and to start a dialogue about how the study
will proceed. The next step will be to get final approval from the Jordanian
FDA, after which we can start the import/export permit process to bring the
MDMA from Switzerland to Jordan. We could then begin enrolling subjects, which
we expect will include Iraqi refugees living in Jordan as well as Jordanians
suffering from PTSD.
Security Inspection Scheduled for Canadian MDMA/PTSD Pilot Study
Health Canada has confirmed that an inspection of our Canadian MDMA/PTSD
study site will take place on February 10, 2011. The study pharmacist is
currently preparing the safe for installation at the pharmacy in Vancouver,
BC. The representative from Health Canada will visit the site and confirm that
the MDMA capsules to be used in the study can be safely stored and accounted
for in the safe, and will verify that the pharmacy and study site are
adequately secure according to Canadian regulations. Once the safe installation
has been approved, we can apply for the necessary import and export permits to
ship the MDMA from Switzerland to Canada.
Since the study protocol already has the full approval of both
the Canadian Institutional Review Board (IRB) and Health Canada, we will begin
enrolling subjects as soon as the MDMA has been imported into Canada.
Michael and Annie Mithoefer to Conduct Training Course for Israeli Therapists
From January 23-27, 2001, co-therapists Michael Mithoefer,
M.D., and Annie Mithoefer, B.S.N., will conduct a therapist training program
for the new Israeli clinical team. The meeting will appropriately take place in
the basement of the first three-story house in Tel Aviv, a historical landmark
built by Rick Doblin’s great-grandfather in 1923. The Canadian HESEG
Foundation, which now owns the house, has given MAPS permission to do aboveground
MDMA research several floors underground.
In a refinement to our previous Israeli MDMA/PTSD study,
which used traditional psychiatrists at Beer Yaakov Mental Health Center to
conduct the therapy sessions, the new study pairs the traditional psychiatrists
with Israeli therapists from outside Beer Yaakov who have more direct
experience with PTSD and transpersonal psychology. One of the therapists for
the present study is an Israeli who was trained at the California Institute for
Integral Studies (CIIS), and another is a mind-body practitioner who works with
an Israeli medical team in disaster areas doing PTSD counseling. Another big
difference between the present and previous Israeli studies is that the Israeli
Defense Force has now agreed to help recruit subjects for the study.
Therapists Trained for Israeli MDMA/PTSD Study; Revised Protocol Prepared for Ministry of Health
From January 23-27, 2011, MAPS Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., conducted a training course for therapists who will be conducting the treatment sessions in MAPS’ new Israeli study of MDMA-assisted psychotherapy for PTSD. The training took place over five days, with the first three days in Tel Aviv in the basement of a house built by Rick Doblin’s great-grandfather in 1923. The therapists reviewed MAPS’ treatment manual of MDMA-assisted psychotherapy for PTSD and were familiarized with the study protocol. As part of the training, they also studied several videos of actual treatment sessions from our completed U.S. MDMA/PTSD study.
The last two days of the program took place at Be’er Ya’akov Mental Health Center outside Tel Aviv. During their visit, the study team met with hospital administrators, who have agreed to provide us with a dedicated area in a standalone building separate from the main facility for conducting the clinical sessions, including a separate bathroom and kitchen. Although the hospital itself dates back to the 1940s, it is currently undergoing several renovations and improvements. The grounds include orange groves and walking paths, and we are excited to have access to such a secure and comfortable site for conducting the sessions.
Building on our experience with our previous Israeli study, MAPS has determined that pairing traditionally trained psychiatrists with others with more direct experience working with altered states of consciousness is likely to produce a more effective therapeutic team. After this last meeting, the clinical team has decided to use three (rather than two) male/female co-therapist teams in order to increase enrollment rates and to provide more opportunities for therapists to learn from each other. The variety of expertise brought to the therapeutic sessions by these co-therapist teams should make them more effective at achieving positive treatment outcomes.
During the visit, the clinical team also fine-tuned the study protocol by adding the third co-therapist team, a secondary self-report measure of PTSD symptoms, and a measure of sleep quality. Although the original protocol was already approved by the Israeli Institutional Review Board (IRB), the revisions required us to resubmit it to the IRB. These revisions have been submitted to the IRB by the end of this week, which will review the protocol and forward it to the Israeli Ministry of Health (the Israeli equivalent of the U.S. FDA) for final approval. On April 6, the Ministry of Health will meet to discuss the protocol and inform MAPS about whether the study may proceed. Since we have already imported the MDMA from Switzerland into Israel for the previous study, getting the go-ahead from the Ministry of the Health will be the last step before we can initiate the new study.
New Israeli MDMA/PTSD Study Approved by Institutional Review Board
On January 10, 2011, our clinical team submitted the
documents detailing our new protocol for our new Israeli study of
MDMA-assisted psychotherapy for PTSD to the Institutional Review Board
(IRB) at Beer Yaakov, Israel. On January 19, the IRB committee approved the
protocol, allowing us to move forward with the study approval process. The next
step is to submit the protocol to the Israeli Ministry of Health for approval.
Since we already imported the MDMA to be used in the study for our previous
Israeli MDMA/PTSD study, once we have the Ministry’s approval we will be able
to have the initiation visit and start the study. We anticipate that it will be
several months before we are able to begin treating subjects.
Final Long-Term Follow-Up Visit Completed in Swiss MDMA/PTSD Pilot Study
On January 10, 2011, the final long-term follow-up visit was
completed in MAPS’ Swiss
study of MDMA-assisted psychotherapy for PTSD. The final subject (out of 12
total) was interviewed 12 months after the last treatment session, which took
place on January 8, 2010. This is the final piece of data that will be
collected for the study. The interviewers evaluated the subject to determine
whether the effects of the treatment were maintained in the year following
treatment, which involved evaluating the subject for symptoms of PTSD using the
Clinician-Administered PTSD Scale (CAPS). The clinical team, led by Principal
Investigator Peter Oehen, M.D., and co-therapist Verena Widmer, R.N., will now
focus on writing a paper for publication and submitting the final report to
SwissMedic. This study, which is part of MAPS’ clinical plan to develop MDMA into a prescription medicine approved by both US and European government regulatory agencies, is our first study using an active placebo dose of 25 mg MDMA.
When the final report is completed, we will learn if the active placebo helped
us to achieve an effective blind.
MAPS
Clinical Research Associate Berra Yazar-Klosinski, Ph.D., will be joining the
study team in Switzerland to assist with the study closeout, which will take
place from February 13-16, 2011, after her work in Israel and Jordan.
US MDMA/PTSD Veterans Study Begins Treatment of First Subjects
On January 7 and January 9, 2011, the first experimental
sessions took place in our new
study of MDMA-assisted psychotherapy for US veterans with chronic,
treatment-resistant PTSD. Both patients underwent the first of three
sessions with co-therapists Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N.
These patients have also each received three preparatory non-MDMA psychotherapy
sessions. The full study will eventually evaluate the safety and effectiveness
of MDMA-assisted psychotherapy in 16 veterans with PTSD, and we are still in
the process of recruiting additional subjects. As of January 19, 12 additional subjects
have passed prescreening and are waiting on in-person medical and psychological
screening. If you or someone you know might be eligible for the study and lives
in the area of Charleston, SC, please contact .(JavaScript must be enabled to view this email address).
Two independent raters will simultaneously screen
each of the first five subjects to assess baseline PTSD symptoms. In this
process, both raters will score the same test (the Clinician- Administered PTSD
Scale, or CAPS) to evaluate baseline PTSD symptoms. By using multiple
independent raters, we can make sure that we are getting accurate and reliable
information about the severity of each patient’s PTSD as well as train new
raters. For both of the first two subjects, the raters have achieved an extremely
high level of agreement, with ratings falling within three points of each other
on a 136-point scale. This is also the first time we have used our internally generated
web-based randomization software, which randomly assigns subjects to one of the
three experimental conditions (pertaining to different dosages of MDMA). We are
pioneering this randomization
method because it is an extremely reliable and efficient way to randomly assign
subjects to different conditions, which ensures the scientific validity of our
results by increasing the effectiveness of the blind.
This new study builds on our recently
completed study of MDMA-assisted psychotherapy (published July 2010 in the Journal
of Psychopharmacology) in several ways. First, by separating the subjects
into three groups (each group receiving different doses of MDMA) rather than
two (each group receiving either a full dose of MDMA or an inactive placebo),
we hope to get more detailed information about the role of MDMA in determining
treatment effectiveness. Second, we hope to show that we can maintain an
effective blind in these studies and affirm the scientific validity of clinical
trials of psychedelic psychotherapy. Finally, since our previous study primarily
involved female survivors of sexual abuse and assault, we hope this study will
show that the benefits of MDMA-assisted psychotherapy extend to the population
of veterans with war-related PTSD.
First Two Subjects in U.S. Veterans Study Scheduled for MDMA Session in January
The first two veterans in our newest MDMA-assisted psychotherapy study are now scheduled for their experimental sessions in January. Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., are leading this MAPS-sponsored study at their private office in Charleston, SC. In this study we are only enrolling veterans suffering from war-related PTSD who have tried other treatments and failed. In preparing the study, we found that veterans are different from survivors of sexual abuse and assault in that they are more likely to be taking opiate medications for pain. In the current protocol, we are using fixed dosages and cannot increase the dose of MDMA if the opiates blunt the effect. The team was concerned that opiates could cause MDMA to be less effective. When we learned that one of the potential subjects was prescribed opiate pain medication, our clinical team conferred with medical monitor Julie Holland, M.D., to create a policy for enrolling patients with chronic pain. We decided we would enroll subjects who are currently taking opiate medications for pain as long as they agreed to forego or reduce their medication on the day that they receive MDMA. We’ll use what we learn in this pilot study to decide whether, and under what conditions, it makes sense in future studies to continue to enroll subjects on opiate pain medications.
On Dec. 9, 2010, MAPS’ clinical research team submitted our annual report about MAPS’ MDMA/PTSD research to the FDA. Annual reports are designed to give the FDA an overview of completed, ongoing, and planned studies for specific Investigational New Drug (IND) Applications. In our report, which covered all study activity between June 22, 2009, and October 1, 2010, we provided information about enrollment, including the total number of subjects enrolled for each study. Demographic information for all subjects (such as height, weight, race, and cause of PTSD) was included. We also created overview charts of all serious and severe adverse events experienced by the subjects. Although we reported four serious adverse events to the FDA (a fractured clavicle due to auto accident, a fainting episode, a complication due to cancer, and one psychiatric hospitalization), none of them were related to the administration of MDMA.
On Nov. 26, 2010, three days after MAPS’ clinical research submitted the amendment for our Vancouver study of MDMA-assisted psychotherapy for PTSD, it was approved by the Canadian Institutional Review Board. The amendment changes the protocol to align it with our other MDMA/PTSD studies and adds several new aspects, including: a long-term follow-up data collection point one year after the final experimental treatment session, a measure of suicidality as required by the U.S. Food and Drug Administration (FDA), a personality inventory, a new informed consent form, and video recording of the sessions. By aligning the new protocol with past studies, the amendment enables us to compare results side-by-side and conduct future meta-analyses.
We’ve also recently heard back from Health Canada in response to our pharmacist’s Nov. 1 application to serve as the licensed provider of MDMA for the study. As the licensed provider, the pharmacist would be able to import MDMA from our supplier in Switzerland for the study. We were also informed of the type of safe and alarm systems that the pharmacist will be required to install for the MDMA. We will submit the protocol amendments to Health Canada after our pharmacist has received the import license. At this point we still cannot predict a start date, but we continue to be optimistic about starting in early 2011.
MAPS’ clinical research team has completed creating a master drug tracking system for all MAPS’ MDMA studies. This database keeps records about manufacturing, shipping, quality control, and analysis of the drugs over years. We now have a central method of drug accountability to review at the conclusion of a MDMA trial, which gives a comprehensive assessment of what happened to the MDMA from start to finish. Our records go back to 2003 when the first MDMA was shipped for our pilot study in Charleston, S.C.
US Veterans’ Study Begins Recruitment: First Subject Screened In!
We are currently in the recruitment phase of our newest U.S. study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) exclusively with U.S. veterans from the Iraq, Afghanistan and Vietnam wars. Nearly three-dozen veterans have inquired about being subjects in the study, and one subject has passed the screening process. Our research team is screening the other potential subjects to determine eligibility. Pre-screening happens over the phone using an IRB-approved phone script. When a subject passes prescreening and continues to express interest in being a part of the study, they are scheduled for an in-person medical and psychological assessment. One more person is scheduled for screening during November and another is scheduled for screening in December. Clinical Investigators Michael Mithoefer, M.D., and Annie Mithoefer, B.S.N., are able to treat two or three subjects a month. We are currently on track for the study to move forward at a steady pace. We are actively recruiting subjects from the Charleston area, if you know anyone who may be eligible to participate in the study, please have them contact: .(JavaScript must be enabled to view this email address)
Our Swiss MDMA/PTSD study collected video from nearly all of the sessions with treatment subjects. We are now preparing a method to archive the videos for future research purposes. This collection of video footage is a wealth of information about therapy techniques and subjects’ responses to MDMA-assisted psychotherapy. The archives will allow future researchers to do post-hoc analysis on the videos from a third-party perspective. These researchers may or may not be directly affiliated with MAPS. For example, this dataset could prove invaluable to Ph.D. dissertations or other scientific studies. We are currently investigating methods to duplicate and archive all this video data, which will be time-consuming and presumably costly. Should any researchers be interested in access to these videotapes, contact .(JavaScript must be enabled to view this email address)
On Nov. 5, 2010, at the International Society for Traumatic Stress Studies annual conference in Montreal, Michael Mithoefer, M.D., presented findings, in poster form, from the long-term follow portion of MAPS’ first completed MDMA-assisted psychotherapy study. The poster showed overall therapeutic results were sustained over time. Dr. Mithoefer presented the short-term results from the study at the ISTSS conference in 2008. The new poster provides a comprehensive overview of the study, including short-term and long-term data. Dr. Mithoefer and others are preparing a paper about the results of the long-term follow-up to the US pilot study for submission to a peer-reviewed journal.
Database for U.S. MDMA/PTSD Long-Term Follow-Up Study Finalized
MAPS’ clinical research team completed their review of the data from our flagship MDMA/PTSD study. On Nov. 10, the team closed and locked the database, officially bringing the data collection phase of the study to an end. Now that we have the final data set, the research team can analyze the data and write a paper for submission to a peer-reviewed scientific journal. Twenty of 21 subjects from the study successfully completed the long-term follow-up study and, and the review showed that the benefits were maintained over time. This is especially significant because these subjects were all treatment-resistant, meaning they had tried other medicines and therapies without relief. Additionally, of the subjects who were seeing a therapist prior to the experiment, 45% were no longer seeing a therapist at the time of the follow-up survey; and 55% of the subjects who were previously receiving psychiatric medications were no longer taking them.
On Nov. 1, 2010, Pharmacist Colin Holyk from Kerrisdale Pharmacy resubmitted his application for a “licensed dealer permit” to Health Canada in order to import MDMA for our Canadian MDMA/PTSD study. The application was originally submitted in September 2009. It took Health Canada nine months to respond with several questions about what activities the pharmacist would be conducting in order to be a licensed dealer. It took our team some time to clarify the Canadian regulations, after which we resubmitted the application. We look forward to Health Canada’s response, and will do whatever is required in order to start this long anticipated study.
Is Ecstasy an Empathogen? MDMA and Autism Spectrum Disorders
Anecdotal reports have suggested to some researchers that MDMA could be useful in the treatment of autism and related illnesses. However, this letter published in the peer-reviewed academic journal Biological Psychiatry argues that using MDMA in the treatment of autism spectrum disorders may not be effective, and could even be counterproductive.
Jordanian MDMA/PTSD Study Receives Full Approval From Hospital Ethics Committee
On October 20, Rick visited with Clinical Investigator Nasser Shuriquie, M.D., at Al-Rashid Hospital to discuss our Jordanian MDMA/PTSD study. The protocol was approved by the Al Rashid Institutional Review Board (IRB) several days before the meeting and is being prepared for submission to the Jordanian FDA. Rick also met with Mona Abdulhamid Alnsour, Ph.D., co-therapist on the study who is married to Dr. Nasser, in yet another husband/wife co-therapist team.
MAPS has hired the Antaea Medical Services LTD to monitor the Jordanian study. On October 21, Rick met in Amman with the primary monitor on the study Kamila Novak, the firm’s founder Mr. Roussos, and their consultant Dr. Mohammad Rawashdeh (former Director of the Jordanian FDA). They also discussed MAPS working with this firm on the monitoring of our Israeli study.
On October 22, Rick’s last meeting in Amman was with two State Department officials, both physicians, working at the U.S. Embassy in Amman. The officials had previously visited Al-Rashid Hospital as part of their Crisis Response evaluation work. There they had been told about MAPS’ sponsorship of the MDMA/PTSD study and had expressed an interest in meeting Rick. The meeting got off to a great start when one of the officials recalled having been in contact with Rick about ten years prior. Rick had contacted the Center for the Treatment of Torture, in Minneapolis, Minnesota, to see if they would be interested in a grant to study MDMA-assisted psychotherapy for PTSD. The Embassy official worked at the Center at that time, but the Center wasn’t in a position to conduct a clinical study. Ten years later, the Embassy official expressed appreciation for Rick’s dedication to develop MDMA/PTSD research including the Jordanian study. The meeting concluded with a discussion about MAPS’ U.S. MDMA/PTSD study with veterans. The two officials acknowledged the need for new treatments for PTSD and were sympathetic with MAPS’ Jordanian MDMA/PTSD project and U.S. study with veterans.
Rick Doblin to Visit Israel to Prepare New MDMA/PTSD Study
From Oct. 18- 23, MAPS Executive Director Rick Doblin, Ph.D. will be in Israel and Jordan, where he will meet with Clinical Investigator Moshe Kotler, M.D., of our Israeli study, to discuss starting a new Israel MDMA/PTSD study. Meanwhile, MAPS’ clinical research team is finishing an abbreviated report about our initial Israeli MDMA/PTSD study to submit to the FDA and the Israeli Ministry of Health. Five subjects were enrolled, of which four completed treatment. There were no safety problems for any subjects. There were too few subjects to conduct a statistical analysis, nevertheless, the report will be a detailed review of the study with all the raw data summarized. Sponsoring the project was an excellent learning experience both for us and for the Israeli team. We feel confident we can conduct a new study in a rigorous manner.
Rick Doblin to Visit Jordan to Prepare MDMA/PTSD Study
On Oct. 2, Jordanian Principle Investigator Nasser Shuriquie, M.D., attended a workshop with the Jordanian Food and Drug Administration (JFDA) to enhance his knowledge about clinical research procedures in preparation for conducting our Jordanian MDMA/PTSD study.
On Sept. 20, the last of the necessary documents were submitted to the Jordanian Ethics Committee (the Jordanian version of an Institutional Review Board) at Al-Rashid Hospital for review. We have had conditional study approval since spring, but were asked to submit several updated documents to the Ethics Committee. The documents include our most recent investigator’s brochure and insurance statements. We have purchased insurance for the subjects, and liability insurance for the therapists and research staff. We are in the process of obtaining insurance for the Clinical Research Organization (CRO) we have hired to monitor the study. After the Ethics Committee reviews and approves the protocol, it will be submitted to the JFDA.
From Oct. 22-24, MAPS Executive Director Rick Doblin, Ph.D., will be in Jordan. While there, he will meet with Dr. Shuriquie, other therapists and administrators from the Al-Rashid Hospital, and staff at Antaea Medical Services, Ltd., the CRO that will monitor the study. Our partnership with the CRO allows us to rely on a local group to monitor the study. At the same time, the CRO is sharing study responsibility.
The Jordanian study has led MAPS to make a major contribution to the PTSD treatment field—we are creating the first Arabic version of the Clinicians Administered PTSD Scale (CAPS), the world’s leading measure of PTSD. Currently there is no Arabic version of the CAPS. We’ll first fund the translation of the English version into Arabic. We will then have the Arabic translation retranslated back into English, making any necessary corrections should the original English version differ from the translated version. Luz, a U.S. translation company, will then certify the final version. We will then donate the Arabic version to The National Center for PTSD, which created the original version of the CAPS. We’re hoping that the availability of an Arabic version of the CAPS will facilitate other PTSD studies and treatments in the Arab world.
The experimental treatments in our Swiss MDMA/PTSD study were completed in January 2010. In January 2011, we will collect follow-up data from one remaining subject. The clinical research team is developing standardized data-entry conventions to aid analysis. Most of the data from the study already has been entered into a validated database. Clinical Research Associate Berra Yazar-Klosinski, Ph.D., will travel to Switzerland in February to collect the final data from Clinical Investigator Peter Oehen, M.D. While Berra is in Switzerland, she will close the study and archive the data the same way she archived the data this past month for our U.S. MDMA/PTSD study.
Abbreviated Clinical Report About Israeli Study Completed
On Oct 14, 2010, Rick Doblin, Ph.D., met in Tel Aviv, Israel, with Moshe Kotler, M.D., Principle Investigator of MAPS’ Israeli MDMA/PTSD study. They discussed the abbreviated clinical report of the results of the first five subjects, and the design of a new protocol. Dr. Kotler and co-therapist Sergio Marchevsky, M.D., signed off on the report. It will be submitted along with our new protocol application, which is still in process, to the Israeli Ministry of Health. While in Tel Aviv and Jerusalem, Rick also met with psychologists who will become co-therapists in the new study.
Conference Call Held Regarding Canadian Import Permits
On October 8, a conference call was held between our Canadian pharmacist, Colin Holyk of Kerrisdale Pharmacy, Vancouver, and MAPS’ clinical research staff. The team planned our continuing negotiations with Health Canada regarding the importation of our Canadian study’s supply of MDMA from Switzerland.
We also are preparing to submit a protocol amendment to our Canadian Institutional Review Board (IRB) to make protocol changes that will align with all of our other MDMA/PTSD studies. This includes adding one-year follow-up measures and audio and video recording of the treatment sessions. This consistency is important so we can conduct a meta-analysis when all studies are complete. The audio and video recording will help us train therapists and independent raters when we move on to the large-scale multi-site studies.
Preparation of Final Report to FDA on Initial MDMA/PTSD Study
From Sept. 27 to Oct. 1, Clinical Research Associate Berra Yazar-Klosinski, Ph.D. and Clinical Program Manager Amy Emerson were in Charleston, SC, where they archived the research data from our first U.S. MDMA/PTSD pilot study for long-term storage in preparation for any FDA audits. The documents have also been duplicated for security measures in case any were damaged or destroyed.
Berra, Amy, Ilsa Jerome, and the Mithoefers are working on a comprehensive Final Clinical Study Report for the FDA, which is set to be finished and submitted early next year. It will contain detailed information about everything relevant to the study, such as how it was conducted, how we worked with the Institutional Review Board (IRB), how and what we communicated to the FDA and the DEA, and all of the data, both analyzed and in its raw form. The FDA may conduct an independent analysis of the raw data to verify our conclusions. Essentially, “the final report is a pretty wrapped package of the entire clinical trial,” according to Berra.
U.S. Veterans Study: Second Protocol Amendment Submitted to FDA
On September 30, 2010, our clinical team submitted the second protocol amendment for our recently initiated U.S. study of MDMA-assisted psychotherapy for veterans with PTSD to the FDA for review.
MAPS Grants $5K to Franz Vollenweider for Physiological Study of MDMA/PTSD Subjects
MAPS donated $5,000 USD to Franz Vollenweider, M.D., University of Zurich, for his research with subjects from our Swiss MDMA/PTSD study. Dr. Vollenwieder evaluated all 12 subjects from the study before and after MDMA/PTSD treatment. The evaluations consisted of EEGs, startle-reflex tests and heart-rate variability, the results of which are related to the severity of PTSD. The analysis is almost complete and a paper is being written for publication. The physiological study cost more than $5,000; Dr. Vollenweider raised the rest of the funds elsewhere.
Paper in Progress About Long-Term Follow-up to First U.S. MDMA/PTSD Study
On Sept. 27, we completed the long-term follow-up study to our initial US MDMA/PTSD pilot study. Our team is now diligently working on preparing a scientific paper about the results. This study demonstrated that treatment benefits were maintained post-treatment. Some subjects improved further and some subjects experienced more PTSD symptoms, with average treatment benefits slightly increasing (getting better) over time. Subjects were interviewed a mean of 40 months after the treatment, so we can conclude treatment benefits were maintained at least 40 months afterward on average. This finding is more important than our initial finding of substantial therapeutic benefits persisting for two months after treatment.
Notably, no subjects reported any harm from participating in the study. Nor did any subject develop a substance abuse problem. Critics of our research expressed concern that giving a drug of potential abuse to PTSD sufferers could result in drug abuse problems. We now have evidence showing that in our initial subjects, this fear did not materialize.
We hope to have the paper finalized by December and submitted to a journal early in 2011. To that end, we’ve enlisted the help of Tim Brewerton, M.D., a statistics expert who has authored numerous journal publications.
MAPS clinical research team visited Charleston, South Carolina to initiate the MAPS-sponsored MDMA/PTSD study with veterans. Clinical Research Associate Berra Yazar-Klosinski and Clinical Program Manager Amy Emerson met with Clinical Investigator Michael Mithoefer, M.D., Co-Investigator Annie Mithoefer B.S.N, Site Coordinator Andrew Stufflebean, and Independent Raters Mark Wagner, Ph.D., and Joy Wymer, Ph.D. The team trained the investigators and site staff on the new protocol and developed the framework for the study. The team discussed with the independent raters how to establish inter-rater reliability and develop a training program for other sites, so that a meta-analysis can eventually be done.
IRB Approves 2nd Amendment to Veterans Study, MDMA arrives
Today the second amendment to our study protocol was approved by the IRB. On Sept. 30, we submitted that amendment and our revised investigator’s brochure to the FDA. The amendment returned the NEO personality inventory test to the protocol, and added the Mystical States of Consciousness Questionnaire, video recording of the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) interview, and the Posttraumatic Growth Inventory (PGI).
The personality test was in our first study, and measures if there are any changes to a subject’s personality as a result of the treatment. Johns Hopkins’ researcher William Richards, Ph.D, developed the Mystical States of Consciousness Questionnaire. We will administer it right after treatment sessions to track any correlation between mystical experiences and overcoming PTSD. Our hypothesis is there will not be a correlation, since some subjects don’t have mystical experiences and yet still benefit from the treatment. We added the PGI measure, which assesses whether people experience significant life improvements as a result of the treatment. Similar to a quality-of-life measure, which was already in the protocol, the PGI measure tracks personal growth, for example when a subject returns to work after participating in our study. In our last study, we gathered anecdotal reports of growth, but could not quantifiably report it to the FDA.
We’ve also added video recording of the CAPS interviews to help us develop training materials for our independent raters.
Health Canada Requests Additional Information from Pharmacist Regarding Importing MDMA for our Study
After more than a month of waiting, Health Canada has requested additional information from the Canadian pharmacist we are working with to obtain import permits and licensing for encapsulating the MDMA to be used in our Canadian study. This study has been inching through the approval process for years and it seems we are moving closer toward obtaining the MDMA required for the study. We have all the necessary approvals for the study design and can start the study as soon as we obtain the MDMA. Our best guess at this point is that it will take several more months to obtain the import/export permits and have the MDMA shipped from Switzerland to Vancouver.
Second Amendment submitted to IRB for Veterans Study
Amendment 2 makes several changes to the study design and a number of changes to protocol text prior to the start of the study. The protocol has been amended to include the addition of two new outcome measures, the Neuroticism Extroversion Openness Personality Inventory and the States of Consciousness Questionnaire, and updates terminology and measures to the most current version. This amendment revises language describing randomization, adverse event and concomitant medication collection, and visit scheduling to improve clarity. This amendment also adds two new inclusion criteria, in addition to improving wording for an inclusion criterion and audio and video recordings. The amended protocol no longer specifies that attendants match participant gender. Participants will receive memory aid cards to assist in their recall of any adverse events or medications when assessed at 12 month follow-up.
On Friday, August 27, 2010, an official from the Drug Enforcement Administration (DEA) informed Michael Mithoefer, M.D. that it had approved his Schedule 1 license for MAPS’ MDMA/PTSD study in veterans with PTSD.
Obtaining the DEA’s approval was our final regulatory requirement. The DEA has now joined the FDA and our Independent Review Board (IRB) by determining it is in the public interest for MAPS’ study of MDMA-assisted psychotherapy in treating veterans of war to proceed.
Canadian MDMA/PTSD Study Gains Institutional Affiliation
On July 19, 2010, Health Canada informed principal investigator Ingrid Pacey, M.D. that they would accept a letter from the director of the University of Victoria’s (UVic) Center for Addiction Research of British Columbia (CARBC) as proof of affiliation with UVic/CARBC. This was a major hurdle in getting the Canadian MDMA/PTSD study started. In Switzerland and the U.S., we have been able to conduct our research without any outside institutional affiliation, but Health Canada required affiliation with a Canadian institute before we could import MDMA for the study. We had obtained approval for the actual protocol from both Health Canada and a Canadian Institutional Review Board (IRB) by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we were not deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.
On July 22, 2010, Tim Stockwell, Ph.D. the Director of CARBC, sent a letter to Health Canada confirming CARBC’s support and affiliation with Dr. Pacey. In the letter, Stockwell wrote, “I have reviewed the paper about the results of the [MAPS-sponsored] U.S. MDMA/PTSD study… As a result, I found the results to be promising and think it is of significant scientific importance that a Canadian MDMA/PTSD study is conducted to see if the results can be replicated with a new co-therapist team in a new location.”
Mark Kozlowski, Acting Manager of the Licenses and Permits Division of the Office of Controlled Substances at Health Canada informed Ingrid Pacey, M.D. that his office has begun a review of the application for Kerrisdale Pharmacy to obtain a controlled substances license. If they approve a license for Kerrisdale Pharmacy, MAPS will move forward with importing the MDMA for our Canadian study from Switzerland to Canada.
Psychological effects on healthy volunteers/therapist-training study recruiting therapists
On October 3, 2009, the FDA approved our protocol for studying the effects of MDMA on healthy volunteers. On December 21, 2009, the protocol was approved by the IRB. In this study the Mithoefers will administer MDMA to healthy volunteers who are part of our therapist-training program. The goal of this study is two-fold: (1) the study will allow us to learn more about the psychological effects of MDMA-assisted psychotherapy in healthy individuals; and (2) the therapists in our training program will have the opportunity to have a firsthand experience with MDMA-assisted psychotherapy, which we suspect will enable them to be better therapists when they administer MDMA to a subject in one of our future studies.
We are anticipating that we will need about 20–30 therapist teams in approximately three years for our two large-scale, multi-site, Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. Applications are encouraged from therapists with some or all of the following qualifications: 1) treated patients with PTSD, 2) worked with non-ordinary states of consciousness, and/or 3) conducted clinical research. Applications from male/female teams are highly encouraged. If interested, please contact Berra Yazar-Klosinski, Ph.D. at: .(JavaScript must be enabled to view this email address)
Mithoefer Receives DEA License for Phase 1 Psychological Effects/Therapist Training Study; License for U.S. MDMA/PTSD Veterans Study Coming Soon
On August 9, Michael Mithoefer, M.D., received a Schedule I license from the Drug Enforcement Administration (DEA) to administer MDMA in our Phase 1 study to investigate the effects of MDMA on healthy volunteers (limited to thera- pists enrolled in our therapist-training program). He waited approximately seven months to receive the license. This is a relatively short period compared with 19 months last time he was licensed. The DEA also told Dr. Mithoefer to expect his license for our Veterans study soon, which would be only 4 months from the time of application. The FDA and Institutional Review Board (IRB) approved both of these studies months ago, so we’ve just been waiting on the DEA’s Office of Drug and Chemical Evaluation (ODE) to issue the licenses. The studies are co-lead by Ann Mithoefer, B.S.N.
Switzerland MDMA/PTSD One-Year Follow-Up Study Proceeds
On January 8, 2010, the last of the experimental treatments were completed in the Swiss MDMA/PTSD study. The study, led by principal investigator Peter Oehen, M.D., with
co-investigator Verena Widmer, R.N., treated 12 subjects with chronic, treatment-resistant PTSD. The investigators are currently collecting data for the one-year, long-term follow-up phase of the study. Eight subjects have already completed the long-term follow-up, three subjects have not yet done so, and sadly, one subject has died from an unrelated cause.
On June 14, 2010, at our office in Santa Cruz, CA, volunteer clinical research intern Tim Whalen finished building and validating the database for this study. On July 19, volunteer research intern Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology) finished entering the preliminary data into the database. Katharina Kirchner, M.A., who is assisting our Swiss end-of-life anxiety study, will also assist the investigators of this study with resolving data queries. The final analysis is scheduled for completion in January 2011, after the last measurements are collected from the final subject. We anticipate that the results will be submitted for publication in Spring 2011.
Long-term Follow-up of U.S. MDMA/PTSD Pilot Study is Complete
On July 27, 2010, MAPS Deputy Director Valerie Mojeiko and Clinical Research Associate Berra Yaza-Klosinski, Ph.D. completed data collection for the long-term follow-up to our flagship U.S. MDMA-assisted psychotherapy for PTSD study led by Principal Investigator Michael Mithoefer, M.D. and Co-Investigator Ann Mithoefer, B.S.N. in Charleston, SC. Independent rater Mark Wagner, Ph.D., from the College of Medicine, Department of Neurology, collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final experimental treatment session and the follow-up data collection was three and a half years. Preliminary analysis of the results suggests the benefits of the treatment were maintained. MAPS’ clinical research volunteers are inputting data into a validated database at the MAPS office in Santa Cruz, CA. After the data is analyzed, Dr. Mithoefer, et al, will write a new paper for submission to a scientific journal around the end of 2010.
Journal of Psychopharmacology publishes paper about MAPS-sponsored U.S. MDMA/PTSD pilot study
The Journal of Psychopharmacology published a paper about the MAPS-sponsored U.S. MDMA/PTSD pilot study.The paper is titled, "The safety and efficacy of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study," and is authored by Michael Mithoefer, M.D., Mark Wagner, Ph.D., Ann Mithoefer, B.S.N., Lisa Jerome, Ph.D. and Rick Doblin, Ph.D.
Recruiting Subjects for MDMA/PTSD Study in War Veterans; Awaiting DEA Review
We are now in the process of recruiting subjects for our study of MDMA-assisted psychotherapy for veterans with war-related PTSD. We are mostly seeking veterans from Iraq and Afghanistan but are looking for a few from Vietnam as well. The study, to be conducted by Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., will be our second MDMA/PTSD study to take place in Charleston, SC. The Mithoefers' previous study of MDMA-assisted psychotherapy included subjects whose PTSD was primarily the result of sexual assault, abuse and violent crime, with just two veterans with war-related PTSD. This new study will only enroll veterans with war-related PTSD. We will also be able to enroll subjects with the previously excluded risk factors of Hepatitis C or controlled hypertension, with additional screening evaluations and safety measures for these subjects.
The final hurdle before the study is able to move forward is that Dr. Mithoefer must obtain a renewed Schedule I license to handle the MDMA required for the study. He has already been waiting over 3 months on the DEA's Office of Drug and Chemical Evaluation (ODE) to complete its review of his license application, which he submitted after obtaining both FDA and IRB permission. Unlike the FDA, the DEA has no time limits for issuing licenses. The ODE informed us on July 13 that the review could take an additional four months or more, meaning we may have to wait until October to start the study unless we can find a way to motivate the DEA to move faster. President Obamas announcement on July 11 that it is a national priority to expedite treatment to veterans with PTSD may prove helpful.
MDMA in Healthy Subjects / Therapist Training Study Awaits DEA Approval
Although our protocol for studying MDMAs effects on healthy volunteers was approved by the FDA on October 3, 2009, and by the IRB on December 21, 2009, we are still waiting on the DEA's Office of Drug and Chemical Evaluation (ODE) to provide Michael Mithoefer, M.D. with a Schedule 1 license for this study. In this study, Principal Investigator Dr. Mithoefer and co-therapist Ann Mithoefer, B.S.N., will be administering MDMA to healthy volunteers who are part of our therapist-training program. The study will also allow us to learn more about the effects of MDMA in healthy individuals, as opposed to patients with chronic, treatment-resistant posttraumatic stress disorder (PTSD). We expect that, as with the study in veterans of war with PTSD, the ODE will grant approval based on Dr. Mithoefers excellent track record. The ODE told Dr. Mithoefer that he could expect to have his license in the mail by June 9, though it has not yet arrived. On July 13, the ODE told MAPS Executive Director Rick Doblin, Ph.D. that the approval letter would be coming soon.
Long-Term Follow-Up of U.S. MDMA/PTSD Pilot Study Nears Completion
Our long-term follow-up to our flagship study of MDMA-assisted psychotherapy for the treatment of PTSD, which has been taking place in Charleston, SC, is coming close to completion. All that remains is for the researchers, led by Principal Investigators Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., to collect follow-up information from a few more subjects. Weve already obtained long-term follow-up data from 16 of the 20 subjects, at an average of about 3 years after their final experimental session. The results so far are encouraging.
Swiss MDMA/PTSD One-Year Follow-Up Study Continues; Data Collection Underway
The experimental treatment portion of our Swiss study of MDMA-assisted psychotherapy for PTSD ended in January 2010. The long-term (one year) follow-up portion of the study is currently underway and will be concluded in January, 2011.
Our new volunteer research intern, Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology), is entering the completed data from the Swiss study into the clinical database at our office in Santa Cruz, CA. Audrey is now entering data from the ninth subject, out of 14 enrolled (12 completed and 2 drop-outs). In the interest of timeliness and accuracy, we will be checking the data as we go.
By the end of August 2010, we expect that this preliminary data entry will be completed. As the remaining subjects complete the long-term follow-up measures, we will be adding their data to the database. The final analysis will be completed shortly after the final subject participates in the long-term follow-up in January 2011. We are tentatively planning to complete the writing of a paper for publication in the spring of 2011.
Doblin, Mithoefers, and Richards present at 17th International Transpersonal Conference in Moscow
From June 23-27, the 17th International Transpersonal Conference took place in Moscow. Vladimir Maykov, Ph.D. and Stanislav Grof, M.D. organized the conference. MAPS was represented by Michael Mithoefer, M.D., Annie Mithoefer, B.S.N. and Executive Director Rick Doblin, Ph.D. MAPS also sponsored the attendance of distinguished psychotherapist and researcher William Richards, Ph.D., from the Johns Hopkins psilocybin research team funded by the Council on Spiritual Practices and the Heffter Research Institute. Also in attendance was Evgeny M. Krupitsky, M.D., Ph.D, who along with Rick chaired the panel on psychedelic research.
In the 1990s, Dr. Krupitsky was the only researcher in the world conducting legal psychedelic psychotherapy studies; he was investigating ketamine-assisted psychotherapy as a treatment for alcoholism and heroin addiction. Sadly, in 2002, the Russian government ended his research and to this day psychedelic research is completely forbidden in Russia. Despite this obstruction of scientific freedom, the Russian and international attendees were especially eager to hear the speakers discuss psychedelic research taking place in the U.S.
View As Single Entry > June 20, 2010 International Federation of Psychotherapy Congress in Lucern, Switzerland hosts Mithoefers, Gasser, Oehen, and Passie
From June 16-19, the International Federation of Psychotherapy convened a Congress in Lucerne, Switzerland. As a sign of the growing acceptance of psychedelic psychotherapy research, this mainstream psychotherapy conference had a seminar devoted to the topic. From the U.S., MAPS sent researchers Michael Mithoefer M.D. and Annie Mithoefer, B.S.N. to present information from our U.S. MDMA/PTSD study. MAPS also brought Swiss MDMA/PTSD researchers Peter Oehen, M.D. and Verena Widmer, R.N. and Swiss LSD/end-of-life researcher Peter Gasser, M.D. Also on the panel was renowned German psychedelic researcher Torsten Passie, M.D. This was the first presentation about new data from psychedelic psychotherapy research to a mainstream psychotherapy conference in over 35 years.
Out of about 800 attendees at the conference, approximately 50 people crowded the room for the two-hour panel. According to MAPS Executive Director Rick Doblin, Ph.D. who also attended the conference, the session on psychedelic research was remarkable because it wasnt remarkable it was a mainstream psychotherapy conference that happened to have a panel on psychedelic psychotherapy research. There were no protestors or vocal dissenters. The promising results were taken seriously and our call for expanding research wasnt even considered controversial.
During the trip to Switzerland, MAPS supporter and friend Vanja Palmers hosted Rick and the Mithoefers at his home in Lucerne, only several blocks from the conference center.
Canadian MDMA/PTSD Study Still Seeking Permission to Import MDMA; Protocol Amendment Being Submitted
We seem to be making slow, gradual progress in getting our Canadian MDMA/PTSD study started. On June 14, 2010, Principal Investigator Ingrid Pacey, M.D., met in person with Health Canada officials in Ottawa. Wed previously been informed that Health Canada requires that we she officially affiliated with a Canadian research institution (and not just with MAPS). Prior to the June 14th meeting, Dr. Pacey had obtained affiliation with two different research institutes, the University of Victorias (UVic)Center for Addiction Research of BC(CARBC) and the University of British Columbias (UBC)Center for Health Evaluation and Outcome Studies(CHEOS),and had provided this information to Health Canada.
The new information that Dr. Pacey was told on June 14 was that we must obtain written proof of affiliation from the Dean of either of the two Universities with which these research institutions are affiliated. This seems to be a politically motivated requirement since the research institutes have already approved our affiliation. In the U.S. and Switzerland, weve been able to conduct our research without any outside institutional affiliation. In any case, Dr. Pacey and the research organizations will be seeking to obtain approval from the Deans of UBC and UVic. We are pursuing both options simultaneously since approval from either of the Deans is difficult to predict. Wed obtained approval for the actual protocol from both Health Canada and a Canadian IRB by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we have not been deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.
While we wait for institutional affiliation that will satisfy Health Canada, along with permission to import MDMA to start the study, MAPS is submitting an amendment to the original research protocol to Health Canada. We are adding additional long-term (one year) measurements of the effectiveness of MDMA-assisted psychotherapy for PTSD, as well as a new measurement that the FDA now requires for evaluating long-term suicidality in subjects taking any psychiatric drug, known as the Columbia-Suicide Severity Rating Scale (C-SSRS).
MAPS Research Specialist Ilsa Jerome Responds to Report that Ecstasy Damages Brain Cells
CBC News reported that “the brains of ecstasy users show low levels of a certain protein, a finding that may explain why many feel they need to turn to higher doses of the drug. This was based on findings reported in the Journal Brain.
Switzerland MDMA/PTSD One-Year Follow-Up Study Proceeds
The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase. The experiential portion of the study was completed in January 2010. Six subjects have completed the long-term follow-up, one subject has withdrawn from the long-term follow-up, and five subjects are yet to complete this portion of the study.
MAPS has built a new database to store the data for this study and the database has been verified for accuracy. We are now recruiting an intern or two to assist with data entry from this study. We will be choosing interns amongst applicants who pass stringent tests of accuracy in data entry. Katharina Kirchner, M.A. who is assisting our Swiss LSD/end-of-life anxiety study, will also be assisting the investigators of this study with data entry and data clean up. We anticipate that the data entry will take two months to complete, with additional time required to ensure accuracy of data in the database. The final analysis won’t be completed until the study ends at the beginning of 2011.
US MDMA/PTSD Veterans of War Study Awaits FDA’s Controlled Substance Staff to Approve Researcher and Protocol
Our study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans of war is waiting for the FDA’s Controlled Substances Staff (CSS) to complete its review of the qualifications of the investigator (Michael Mithoefer, M.D.) and to evaluate the protocol from a diversion control perspective. Since Dr. Mithoefer held a DEA Schedule 1 license for our flagship MDMA/PTSD study and conducted an excellent study with all MDMA properly accounted for, the review by the CSS will almost certainly be favorable. Unfortunately, there is no time limit on how long the CSS can take to review protocols, so we can only wait for CSS to focus on our study. After the CSS approves the investigator and protocol, then the DEA must renew the Schedule 1 license of MAPS’ lead investigator Michael Mithoefer, M.D. and give him permission to order more MDMA for the new study. We hope to start this study soon.
View As Single Entry > May 20, 2010 Health Canada Official to Meet With MDMA/PTSD Researcher Ingrid Pacey, M.D.
An official with Health Canada is working to schedule a meeting in June with MAPS-sponsored researcher and Principle Investigator Ingrid Pacey M.D., to discuss the remaining issues in the authorization process for our MDMA/PTSD study. Frustratingly, our research project in Vancouver, with co-therapists Pacey and Andrew Feldmar, M.A., has been on hold since March 2009, when Dr. Pacey filed for her authorization to administer the MDMA. We had been under the impression that our application to import the MDMA for the study was ready to be approved since we had obtained approval of the protocol from a Canadian Institutional Review Board (IRB) and Health Canada. However, Dr. Pacey heard nothing for many months and then, in November 2009, was informed that before she could be authorized to administer the MDMA and before we could apply for a permit to import MDMA, we needed to obtain affiliation with a Canadian institution. In February 2010, Dr. Pacey obtained institutional affiliation, and in March 2010, she notified Health Canada of this affiliation, again hearing nothing for several months. We are hoping this upcoming meeting with Health Canada will clearly outline the remaining steps we must take before the MDMA can be imported and the study can begin. While it has been discouraging to have waited over a year since the protocol itself was fully approved, we are hopeful that Health Canada will move forward with our effort to start the first psychedelic research project in Canada in over 35 years.
U.S. MDMA/PTSD Paper Revised and Resubmitted; Long-Term Follow-Up Study Continues
On Sunday May 9, a manuscript about our flagship U.S. MDMA/PTSD pilot study was resubmitted to a peer-reviewed journal after receiving initial responses to the original submission from four reviewers. We should learn in the next several weeks if this version of the paper, or a slightly modified version, will be accepted for publication. If so, it will be cause for major celebration since this would become the first published paper about a completed study of MDMA-assisted psychotherapy for PTSD. The authors of the paper include Principal Investigator Michael Mithoefer M.D., Mark Wagner, Ph.D., Annie Mithoefer B.S.N., Ilsa Jerome, Ph.D. and Rick Doblin, Ph.D. While our drug development effort does not require the publication of the results of our research in peer-reviewed scientific journals, our public education efforts will be greatly enhanced if we can manage to publish our results.
The long-term follow-up study for this research project is still ongoing, with just a few additional subjects still to be assessed. The remaining data on long-term effects of MDMA-assisted psychotherapy to be collected from the subjects is extremely valuable to the final data analysis and submission to the FDA. Preliminary results from the long-term follow-up are encouraging.
Jordanian MDMA/PTSD Team Participates in Training Program/Conference
Our Jordanian MDMA/PTSD team, led by Nasser Shuriquie, M.D., participated in a six-day therapist-training program conducted by Michael Mithoefer, M.D. and Annie Mithoefer B.S.N. in Charleston, South Carolina. The Jordanian team, which included Tayseer Shawash, Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social worker Rudiana Abubaker, then traveled to San Jose to attend our conference, Psychedelic Science in the 21st Century.
Our clinical research team has drafted a second amendment to the protocol for our Jordanian MDMA/PTSD study. The new amendment increases collection of safety information. We will send this amendment to the Jordanian IRB in the coming weeks.
View As Single Entry > May 1, 2010 Second MDMA/PTSD Therapist Training Program, Soliciting More Applicants
From April 7 to 12, Michael Mithoefer, M.D., and Annie Mithoefer B.S.N. led an MDMA/PTSD therapist-training program with eight attendees in South Carolina. The group reviewed our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was reviewing videos from past experimental psychotherapy sessions from our first U.S. MDMA/PTSD study. This training program, and those planned for the future, will be used to teach applicants to conduct our future research projects. Applicants who complete the non-drug training program and satisfy screening criteria may have the opportunity to take MDMA in a therapeutic setting as part of our Phase 1 study to investigate the effects of MDMA on healthy volunteers; this study is also designed to give therapists subjective experiences of what MDMA therapy is like.
We are anticipating that we will need more therapist teams in approximately three years, if and when we start our Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. If interested please contact Berra Yazar-Klosinski, Ph.D. at: .(JavaScript must be enabled to view this email address)
This is one of many great media pieces that arose from the Psychedelic Science in the 21st Century conference. This television news piece features interviews with Steven Ross, M.D. from the NYU psilocybin/cancer research team and CNN health correspondent Sanjay Gupta, M.D.
This television news article features short interviews with Rick Doblin and Michael Mithoefer, and coverage of the Psychedelic Science in 21st Century conference.
Jordanian MDMA/PTSD Research Team Visited U.S. for Training
From April 7-12, 2010, our Jordanian MDMA/PTSD team, led by Nasser Shuriquie, M.D., participated in a six-day therapist-training program conducted by the Mithoefers in Charleston, SC. The Jordanian team consisted of Tayseer Shawash, Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social worker Rodina Abubaker. The training included a review of our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was viewing videos from our first U.S. MDMA/PTSD study. Now that the team has participated in the non-drug training, each team member has the option to experience MDMA by participating in our Phase 1 study of the psychological effects of MDMA administered in a therapeutic setting to healthy volunteers.
On April 13, the Jordanian team traveled from Charleston, SC, to San Jose, CA, to attend our conference, Psychedelic Science in the 21st Century, and a post-conference workshop led by Stan Grof, M.D.
The Jordanian MDMA/PTSD study that MAPS is sponsoring has been approved by the Jordan IRB, and will soon be submitted to the Jordanian FDA. A team of five Jordanians from Al-Rashid Hospital in Amman will be coming to the United States from April 6th to 12th for an MDMA/PTSD therapist-training session, which will be held in Charleston, South Carolina and taught by Michael Mithoefer M.D. and Annie Mithoefer B.S.N. MAPS Executive Director Rick Doblin will be there on the first day of their arrival to welcome them all to the U.S., to express his appreciation for their coming to learn about MDMA, and to let them know how important their project is to MAPS. After the MDMA/PTSD therapist-training seminar, the five Jordanians from the Al-Rashid Hospital will travel to San Jose, California to participate in our Psychedelic Science in the 21st Century conference.
MAPS Continues Protocol Development and Planning of Spanish MDMA/PTSD Study
In Spain, MAPS is in the protocol development stage for a study being conducted by Jose Carlos Bouso, Ph.D., Jordo Riba, Ph.D., and Manel Barbanoj M.D. Weve agreed upon the protocol design with this team of researchers, and were now in the process of elaborating it into a full protocol for submission to their Hospitals Institutional Review Board, and then the Swiss Ministry of Health.
Once approved, this study will mark our overcoming the political suppression of our early MDMA/PTSD study in Spain. Jose Carloss MAPS-sponsored study in Madrid had been the worlds first MDMA/PTSD pilot study, started in 2000 and shut down in 2002 by the Madrid Anti-Drug authorities for political reasons. Weve posted more information about the history of our early MDMA/PTSD study in Spain, as well as a paper by Jose Carlos Bouso, reporting on the results that we were able to obtain.
This study will be the only one of our pilot studies that uses an active placebo thats not MDMA. In this study, well be testing d-amphetamine as the active placebo. Were also going to be intensely focusing on evaluating videotapes of the first several therapy sessions using our adherence criteria for our revised treatment manual. All of our MDMA/PTSD studies now will start with a more intensive review of the videotapes of the first several sessions by raters to quantify therapist adherence to the therapeutic method. Over time, this should help us to make our training of therapists more effective, which will make our treatment itself more effective.
Monitoring Visit Conducted on Swiss MDMA and LSD Studies
In late February, MAPS Clinical Operations Manager Amy Emerson, Deputy Director Valerie Mojeiko, and MAPS new clinical research specialist Berra Yazar Ph.D., conducted a monitoring visit in Switzerland. They worked with Peter Oehen M.D. on the Swiss MDMA/PTSD study, which has completed treating all 12 patients, to help prepare the data for reporting to Swiss Medic and the FDA, and also for writing an article for submission to a scientific journal.
This same team also paid a monitoring visit to Peter Gasser M.D.s MAPS-sponsored Swiss LSD/end-of-life study. The monitoring visit revealed that its more difficult than we had originally anticipated to work with people who are close to dying, because their underlying disease process affects their health and their anxiety, as well as their ability to come to the psychotherapy sessions on a schedule.
Swiss LSD researcher Peter Gasser had a teleconference with Rick Doblin, Ph.D., MAPS Research and Information Specialist Ilsa Jerome, Ph.D., and MAPS Clinical Research Associate Berra Yazar, Ph.D. They discussed ways to align the windows during which certain procedures should be taking place with the diminished abilities to keep to a schedule of the actual patient population that they are working with.
MDMA/PTSD Study in Israel Paused; Prospect of Revised Israeli Study Being Investigated
On March 26, 2010, we closed our Israeli MDMA/PTSD study to new subjects in order to provide more training to the therapeutic teams and to our independent rater, to improve our data collection processes, and to make several improvements to the protocol. There were no Serious Adverse Events (SAEs) and all patients had been treated without evidence of harm. We have conducted preliminary analysis of the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond. Rick will visit Israel in October to discuss procedures for restarting the study with Principle Investigator Moshe Kotler, M.D. Though recruitment had been slow, an official at the Israeli Defense Forces indicated a willingness to refer soldiers with war-related PTSD once we restart the study. We have learned from the Israeli study that we need to provide all of our therapist teams with enhanced training about MDMA-assisted psychotherapy, protocol adherence, and data collection, prior to a study’s initiation. We also have learned that we need a single, dedicated research coordinator for each site.
Swiss MDMA/PTSD Study Completes Active Treatment Phase
Our Swiss MDMA/PTSD study has now completed active treatment of all 12 subjects and has obtained data from the two-month follow-up. The long-term follow-up (12 months post-treatment) is still underway, and will not be completed until January 2011.
The results were promising, approaching significance but only reaching the .1 level. The underlying reduction in PTSD symptoms was larger than the reductions obtained in the Zoloft and Paxil studies, which led to their approval by the FDA for the treatment of PTSD. If this study had been somewhat larger with more subjects, the results we obtained would become significant.
MAPS Clinical Plan for End-of-Phase 2 Meeting with the U.S. FDA to Develop MDMA as a Prescription Medicine for PTSD
On Monday, March 22, MAPS received final approval from our Institutional Review Board (IRB) to move forward with our new MDMA/PTSD study. Michael Mithoefer, M.D. and Annie Mithoefer, BSN will conduct this new study in Charleston, South Carolina. They both ran the previous MAPS-sponsored US MDMA/PTSD study, which successfully demonstrated both safety and efficacy in treating treatment-resistant PTSD patients with MDMA-assisted psychotherapy and produced statistically and clinically significant findings. A scientific paper about the results is currently being evaluated for publication by a journal.
In the Mithoefers previous study of 21 people suffering from treatment-resistant PTSD, only two of the subjects were military veterans, and all but three of the subjects were women who were survivors of sexual assault or childhood sexual abuse. This new study will be conducted entirely with U.S. war veterans with PTSD. This study will help us determine if our treatment can be applied to people with PTSD from different causes or if our treatment itself needs to be modified to match the cause of the PTSD. Unlike the Mithoefers first study, which only had two groups (inactive placebo and full-dose MDMA), this study will compare three doses of MDMA—30 mg, 75 mg, and 125 mg, in an effort to enhance the double-blind. Most importantly, we will be testing what may become the protocol design that will be used in our large-scale, multi-site Phase 3 studies.
Because the Mithoefers previous study was the first study of its kind, we needed to establish a baseline of potential side effects of psychotherapy alone in people with PTSD who were treated with a placebo. People who received nothing but a placebo still reported side effects, so it was important that we have a pure placebo control, otherwise any of these side effects could be attributed to the MDMA. The rightful criticism of our first study, and the primary critique of the data so far, has been that it wasnt effectively double-blind because the subjects could easily tell if they were given the active drug or a placebo. That criticism will be addressed in the Mithoefers new study, and an active placebo of low-dose MDMA is being used in our other studies abroad—in Israel, Switzerland, Canada, Spain, and Jordan.
The Mithoefers new study will be a methodological response to the primary critique of our first study. In addition to our research in the United States, MAPS is currently engaged in MDMA/PTSD studies in several other countries around the world—Switzerland, Israel, and soon Canada, Jordan, and Spain. All of these studies are intended to prepare us for an End-of-Phase 2 meeting with the FDA, the purpose of which is to come to agreement with the FDA on the design of the large-scale Phase 3 studies that we want to conduct. At the meeting, we will review our data, and explain the methodological and statistical considerations in our proposed design of a large-scale, multi-site, Phase 3 safety and efficacy trial. Once weve come to an agreement on the design of our Phase 3 studies, if we get good results and show safety and efficacy, then the FDA will approve our application to market MDMA for PTSD patients.
The Mithoefers new study in veterans has been approved by both the FDA and the IRB, so now were waiting for the DEA to facilitate the licensing and transfer of the MDMA so we can begin this study. Michael and Annie Mithoefer will be giving a presentation about their work at the upcoming MAPS-sponsored Psychedelic Science conference in San Jose next month, and their workshop about MDMA and PTSD is already almost filled to capacity.
Update on Canadian MDMA/PTSD and Ayahuasca Studies and the Formation of MAPS Canada
There is good news from our friends north of the U.S. border. We have obtained approval in Canada for our MDMA/PTSD study from both Health Canada (in March 2009) and a Canadian Institutional Review Board (in May 2009). However, when Principal Investigator Ingrid Pacey, M.D. applied for a license to import the MDMA, she was told that theres a Canadian law which states that, because MDMA is a controlled substance, we cannot start the study without affiliation with a Canadian institution. In the United States, with Michael Mithoefer M.D.s study, we were fortunately able to proceed without an institutional affiliation other than MAPS.
On March 6, 2010, Dr. Pacey informed Health Canada in writing that we had obtained institutional affiliation with the Center for Addiction Research (CARBC) in British Columbia, associated with the University of Victoria. MAPS is currently waiting on Health Canada for their approval of our institutional affiliation, and for the licensing of Dr. Pacey and our pharmacist, so that we can import the MDMA from Switzerland for the study and finally begin.
MAPS is currently forming a new non-profit corporation in Canada—MAPS Canada—that will allow Canadians to give tax-deductible donations that help to fund MAPS-sponsored psychedelic research. MAPS currently has an association with Tides Canada, which acts as MAPS Canadian fiscal sponsor until weve established MAPS Canada. It will be more efficient when were able to have our own organizational tax deductible status in Canada, just like we do in the U.S. So far, the Board of Directors for MAPS Canada consists of Mark Haden, Philippe Lucas, Kirk Tousaw, Robert Barnhart, Valerie Mojeiko, and Rick Doblin, Ph.D.. Were seeking one additional Canadian so that the Board will be majority Canadian.
The formation of this new organizational branch of MAPS grew out of the successful fund-raising event that MAPS had in Vancouver, British Columbia on October 24, 2009. MAPS Canada will be involved with both helping to support the MDMA/PTSD study in Vancouver, and also an ayahuasca study in the treatment of addiction, being conducted by Philippe Lucas.
This will be our first Ayahuasca study, which will be using natural plant extractions. We will explore whether Ayahuasca administered within a spiritual context can be helpful in treating people who have problems with addiction. Philippe Lucas, who is leading the study, will be speaking about this research at the Psychedelic Science in the 21st Century conference. In fact, there will be an entire track of presentations about Ayahuasca at the conference, with talks by Philippe Lucas, Stephen Beyer, and many others.
MAPS currently owns approximately 17 grams of MDMA. We are having the supply of MDMA reexamined for quality assurance. The analysis is intended to make sure that the MDMA has not degraded over time. We will be dividing the 17 grams among several new studies that we are starting. We will have to order new MDMA in the near future for future studies.
Canadian Study Still on Hold, Waiting for Institutional Affiliation
Our MDMA/PTSD study in Canada is still on hold as we seek affiliation with an institution. Unlike our U.S. Study, which was conducted in the private offices of our principal investigator, Health Canada is requiring that our research be conducted at an institution. This has been a large disappointment for us, and an unforeseen hurdle. We had been under the impression for months that the only remaining item to take care of in order to start the study was obtaining a license to import MDMA from our supplier in Switzerland.
Jordanian Insurance Agency Paid $6,800 to Insure MDMA Study
We have paid $6,800 to a Jordanian insurance agency in order to insure our planned MDMA/PTSD study in Jordan. All of the documents for the Jordanian study can be found on this MDMA webpage in the “MDMA/PTSD Jordan Study” section.
The final session in our Swiss MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) took place on Friday, January 8, 2010. The twelfth and final subject received MDMA in the stage two open label portion of the trial, which means that he had previously received a placebo dose. Two months from this last session will be the final data gathering point in this study. One year from now will be the final date point in the long-term follow of this research.
We are pleased to report that just like our U.S. pilot study there was an excellent safety record. There is no evidence of any harm caused to any of the subjects by administering research grade MDMA in a therapeutic setting. Preliminary data analysis suggests that the research will have statistically significant results in reduction of PTSD symptoms in the subject population.
MAPS colleague Jose Carlos Bouso, Ph.D. Candidate, previous principal investigator of an MDMA/PTSD study in Spain, did not receive a 200,000 Euro government grant he had applied for last year. Jose had hoped to utilize the government grant to conduct a new study of MDMA-assisted psychotherapy for the treatment of PTSD.
In light of the absence of the grant, MAPS Executive Director Rick Doblin, Ph.D. had met with MAPS clinical research team to conceptualize sponsoring and designing a study in Spain for Jose to lead. The basic concept is that MAPS will fund the study for two subjects and then evaluate whether the research team is properly adhering with the protocol, data-gathering, and therapeutic method before funding additional participants. This concept is to insure that we spend our donated research funds on successful, well-managed projects.
MDMA Therapist Training Protocol Approved by IRB (Psychological Effects of MDMA in Healthy Volunteers)
Our Institutional Review Board (IRB) has approved our protocol designed as a Phase 1 study of the psychological effects of MDMA in healthy volunteers. To view all of the documents that have entailed the approval process on this webpage look in the “MDMA/PTSD Training Protocol for Researchers/Phase 1 Psychological Effects Study” section.
MDMA/PTSD Veteran of War Protocol Submitted to FDA
We have submitted the protocol (part 1, part 2, part 3) for our planned study of MDMA-assisted psychotherapy for the treatment of veterans of war with chronic posttraumatic stress disorder (PTSD) to the FDA. All of the documents that were submitted can be found on this “MDMA webpage in the MDMA/PTSD U.S. Study (Veterans of War)” section.
Preliminary Documents for Jordanian MDMA/PTSD Study Submitted for Review to Clinical Research Organization
Several templates for our planned study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) have been submitted for review to Clinquest JO, a Jordanian Clinical Research Organization. These documents include, the protocol, the protocol synopsis, the case report forms (CRF), and the principal investigators CV. All of the documents for the Jordanian study can be found on this MDMA webpage in the “MDMA/PTSD Jordan Study” section.
MDMA-Therapist Training Protocol Resubmitted to IRB
After our first therapist training protocol (cleared by the FDA as a Phase 1 study of MDMAs psychological effects on healthy subjects) was initially deferred by the institutional review board (IRB), we resubmitted the protocol to the IRB and addressed the IRBs concerns. The resubmission includes a cover letter, a deferral response, an amended informed consent form, and an amended protocol. The submission was accompanied by letters of support from University of West Georgia Psychology Professor Daniel A. Helminiak, Ph.D., and Johns Hopkins researcher William Richards, Ph.D. and a joint letter from Johns Hopkins research team Mathew Johnson, Ph.D., William Richards, Ph.D., and Roland Griffiths, Ph.D.
Next version MDMA/PTSD Treatment Manual to be edited by Sherry Falsetti, Ph.D.
We are very pleased to have contracted Psychologist Sherry Falsetti, Ph.D. to edit MAPS MDMA/PTSD treatment manual and to create instruments to measure a therapists compliance with the manuals techniques. An important part of the MDMA-assisted psychotherapy drug development process is to assess whether therapists are administering the therapy in a uniform manner consistent with the treatment manual. Sherry brings to the position years of experience from the field of psychology and medicine working with PTSD. She has prior experience developing treatment manuals and creating compliance measures.
Spanish MDMA Team Denied Grant New Ideas Underway for MAPS Research in European Union
Unfortunately, a several hundred thousand euro grant that MAPS colleague and Spanish Researcher Jose Carlos Bouso, Ph.D. Candidate applied for to conduct an MDMA/PTSD study in Spain was rejected. MAPS will now pursue other avenues to conduct additional MDMA/PTSD research within the European Union. One of the ideas that we plan to implement will be to have future studies use an open label dosing regimen for the first two subjects. This means that the first two subjects in a study will receive MDMA, rather than MDMA or placebo. MAPS will use this as a chance to monitor the research teams adherence to the protocol guidelines.
Jordanian MDMA/PTSD Study Selects Insurance Provider—Protocol is Able to be Submitted to IRB
Our study in Jordan is able to move another step forward now that we have reached an agreement with a Jordanian insurance agency. Now that the study is insured we can submit the protocol to the Jordanian institutional review board (IRB). We have also reached an agreement with Principal Investigator Nasser Shuriquie, M.D. that the subjects enrolled in the study will be treatment resistant. This means that subjects will have to have previously attempted talk and drug therapy to treat their PTSD without success.
Health Canada Places Major Hurdle in Front of MDMA/PTSD Study
After over a year of planning and preparations to conduct an MDMA/PTSD study in Vancouver, Health Canada placed a major hurdle on the study. For the past several months, we have been under the impression that obtaining a permit to import the MDMA to Canada was the only thing standing in the way of starting the study. Unfortunately we have now been told that our study needs to be conducted in conjunction with a Canadian institution, and will likely have to take place at that institution. We had previously planned for the study to take place at the private office of Principal Investigator Ingrid Pacey, M.D. We are now working to figure out the best means of affiliating Ingrid with an institution and what impact this will have on our projected budget for this study.
MAPS Starts Sister Organization in Canada MAPS Canada!
MAPS has partnered with a few Canadian Citizens to create MAPS Canada an official Canadian non-profit and sister organization to MAPS. MAPS Canada is being created to allow Canadian Citizens to make tax-deductible donations directly to MAPS-related projects (currently MAPS has a partnership with Tides Canada for Canadian Citizens to make donations to MAPS, call our office for details). MAPS Canada will provide the thriving Canadian psychedelic community an outlet to fund more psychedelic research projects in Canada.
The Board of Directors is likely to consist of Rick Doblin, Ph.D., Valerie Mojeiko, B.A., and Robert Barnhart of the United States and Mark Haden and Phillipe Lucas from Canada. We are approaching other Canadians to join the Board so Canadians will compose the majority of the Board. The legal documentation is underway for this project.
We had an exciting fundraiser in Vancouver, British Colombia, Canada, where we raised over $10,000 for our planned Canadian MDMA/PTSD study. The benefit dinner was attended by several prominent figures in the Canadian drug policy reform movement, including former Vancouver Mayor Philip Owen, architect of Vancouvers four-pillar drug strategy Donald MacPherson, Vancouver Island City Council Member Phillipe Lucas, Drug Policy and Health Expert Mark Haden, and numerous others. MAPS is grateful to all those who attended and offered financial support!
Also while in Vancouver, MAPS Deputy Director Valerie Mojeiko conducted a second pre-study visit with Principal Investigators Ingrid Pacey, M.D. and Andrew Feldmar, M.A., and study assistant Amanda Walker.
Progress Report: Jordan and Israel MDMA/PTSD Research
On September 30, we submitted our draft protocol, informed consent, and Case Report Forms for our Jordanian MDMA/PTSD research to Principal Investigator Nasser Shuriquie, M.D. and his Jordanian research team, and to Clinquest JO, a Jordanian Contract Research Organization (CRO). We have decided to hire Clinquest JO to monitor the study in order to limit the amount of travel and resources that our U.S. monitoring team would have to expend to travel frequently to Jordan. Furthermore, Clinquest JO helped to establish the Jordanian FDA, are culturally situated to Jordan, and speak Arabic. We are impressed with their quality of work and will be pleased to work with them. Dr. Shuriquie introduced Kamila Novak, Ph.D. of Clinquest JO to MAPS Executive Director Rick Doblin Ph.D. when Rick was in Jordan on August 13, 2009.
On October 20, Rick and Michael Mithoefer, M.D. will go to Amman, Jordan to make a presentation about the research agenda to representatives of the Jordanian FDA, Dr. Shuriquie, Shuriquies co-therapist and others who may be involved in the study. Clinquest JO will bring several clinical research staff from Egypt to hear the presentation. MAPS is excited to be venturing through the doorway to the Arabic research world.
From October 18-23, Michael and Rick will attend the conference “Future Directions in PTSD: Prevention, Diagnosis and Treatment,” put on by the Institute for Advanced Studies at the Hebrew University of Jerusalem. Michael will present a poster on MAPS MDMA/PTSD pilot study at the conference. Michael and Rick will also meet with Efrat Yasur, founder of Transcom Global, an Israeli CRO. MAPS is hiring Transcom Global to monitor our Israeli MDMA/PTSD study.
In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects.
One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use.
MAPS Next U.S. MDMA/PTSD Study in Veterans Protocol Development Proceeds
Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Rick’s home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies—our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter.
View As Single Entry > October 2, 2009 Clinical Psychology Review "PDF File" by Judith Cukor, Josh Spitalnick, JoAnn Difede, Albert Rizzo, and Barbara O. Rothbaum.
This scientific, peer-reviewed paper has a section on MDMA. The authors quote an article from Rick Doblin, Ph.D. published in 2002 which was about MAPS' MDMA/PTSD Clinical Plan. They also quote Andy Parrott about MDMA's therapeutic potential, even though he has mostly written about the risks of MDMA.
Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDAs goals and MAPS goals. Now that we have the FDAs “may proceed” letter, we will be seeking approval from an Institutional Review Board (IRB).
We will be measuring the psychological effects of MDMA on “healthy normals” as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS). As a crossover study, subjects will get placebo on one occasion and MDMA on the other.
The FDAs “may proceed letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams.
US MDMA/PTSD Pilot Study Manuscript Rejected by Journal
We learned a few weeks ago that the Archives of General Psychiatry rejected our manuscript about MAPS flagship U.S. MDMA/PTSD pilot study. While we are very disappointed that the paper was rejected, we knew that it would be a long shot since this is the leading journal in the field of psychiatry and it has a conservative reputation. While some of the reviewers comments were quite insightful, other comments about MDMAs safety and the study design were simply mistaken. We are in the process of taking the insightful comments into consideration and rewriting the paper for submission to a new journal.
Canadian MDMA/PTSD study: Application to Import MDMA Submitted
We are in the final stages of getting our Canadian MDMA/PTSD study up and running. At the beginning of this month, Colin Holyk from Kerrisdale Pharmacy went to the Royal Canadian Mounted Police (RCMP) to be fingerprinted and have a criminal records background check as part of the process to become licensed to import MDMA into Canada. He has now applied to Health Canada for the license. We do not know how long it will take Health Canada to process his application, but we hope it will not be more than a month. After the pharmacist receives his license to import, we will obtain a specific import and export permit to have the roughly 7 grams of MDMA shipped to Vancouver from Switzerland. MAPS clinical research team is currently preparing documents for a pre-initiation site visit to take place on Thursday October 22.
The popular British Columbian Globe and Mail newspaper ran an article about MAPS planned MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) study, to take place in Vancouver, BC. The article titled, "Landmark B.C. study lets trauma suffers find relief with ecstasy" was written by Frances Bula, who presented a concise overview of the study to Canadian readers. As a result of this article, Ingrid Pacey, M.D. the Principal Investigator of the study, received a deluge of media inquiries and even discussed the study on Canadian National TV.
MAPS Executive Director Rick Doblin Meets with Israeli MDMA/PTSD Team
On August 12, 2009, MAPS Executive Director Rick Doblin, Ph.D. met with Moshe Kotler, M.D., Principal Investigator of our Israeli MDMA/PTSD study. The two of them discussed the progress of the study and other administrative matters.
On August 24, Rick met with lead psychiatrist Sergio Marchevsky, M.D., and co-therapist Tali Nachoni, M.D. of the MAPS-sponsored Israeli MDMA/PTSD research team. They discussed the status of the fourth subject being treated in the study. Sergio reported to Rick that he felt more comfortable conducting MDMA-assisted psychotherapy after the therapist training seminar that took place in Austria this past June. Rick and Sergio further discussed plans to accelerate enrollment of subjects into the study, which is designed for 12 subjects.
While meeting with Sergio, Rick noticed a poster on the wall announcing an international scientific conference on PTSD to take place in Jerusalem in late October. Rick and MAPS lead researcher Michael Mithoefer, M.D., are now planning to attend that conference, at which Michael will present a poster about the results of our US MDMA/PTSD study.
MAPS Executive Director Rick Doblin Ph.D. visited Amman, Jordan to further explore MAPS planned Jordanian MDMA/PTSD study. Principal Investigator Dr. Nasser Shuriquie, who had been working for the Royal Jordanian Medical Services at the Jordanian Military Hospital in Amman, has taken a new position as the medical director of Al-Rashid Hospital, the first and largest psychiatric hospital in Jordan. Rick visited with Nasser at Al-Rashid and met with the hospital administrator Dr. Rifat Dadawi Al-Masri. After discussions and a tour of the facilities, Rick concluded that Al-Rashid Hospital would be an excellent place to conduct our study.
While in Jordan, Rick was introduced by Nasser to representatives of Clinquest JO, a clinical research organization that assists pharmaceutical companies with conducting clinical studies in accordance with Jordanian and international standards of clinical research. The representatives are General Manager Maha Tutunji, M.D. and Managing Director Kamilla Novak, M.D. It is likely that MAPS will hire Clinquest to conduct data and study monitoring and manage Jordanian regulatory affairs. This will make conducting the study in Jordan more economical and convenient. The next steps for the Jordanian study are to finalize the protocol design elements for budgeting and submission to regulatory authorities in Jordan.
MAPS lead researcher Michael Mithoefer M.D. and Rick are planning a visit to Jordan on October 20, to speak to Nasser and associates about the results of our US study and our treatment method. This visit is timed so Michael and Rick can also attend an international scientific conference on PTSD taking place in Israel.
Second Productive Teleconference with the U.S. FDA about MDMA Therapist Training Protocol
MAPS Researchers Michael Mithoefer, M.D., Ilsa Jerome, Ph.D., Amy Emerson, Valerie Mojeiko, and Rick Doblin Ph.D. had a second teleconference about our MDMA-therapist training protocol with officials in the FDAs Division of Psychiatric Products. The FDA requested that we add additional psychiatric measures for pre-and post-MDMA administration and that we design the study with a double-blind, placebo-controlled methodology. The alterations to the protocol will more rigorously examine the psychological effects of MDMA on healthy volunteers. We will be permitted to limit subjects to the therapists in our training program who will conduct Phase 2 and Phase 3 MDMA/PTSD studies. Our research team is in the process of modifying the protocol according to the FDAs requests and will be submitting a new version within the next week. We expect to obtain approval from FDA upon our next submission and will then submit the protocol to our Institutional Review Board.
We submitted to FDA a protocol that would allow therapist from our MDMA/PTSD research teams to take MDMA in a clinical-therapeutic setting. We believe that it will benefit therapist who will be working with patients undergoing difficult emotional therapy to have a subjective understanding of an MDMA experience. The only way such an experience can be legally obtained is through FDA approval of a protocol for that purpose.
There is a precedent for our current protocol from the 1970s. Dr. Stanislav Grofs team at Spring Grove Hospital had FDA permission to administer LSD to mental health professionals involved in LSD research. Over 100 medical professionals received LSD in those training sessions, including doctors, therapists, counselors, nurses and attendants. These LSD sessions helped the mental health workers apply a therapeutic approach to patients undergoing LSD psychotherapy and when consulting with patients who had had LSD experiences. We submitted letters from two participants of that program to FDA, including one from John Hopkins researcher William Richards, PhD.
MDMA Data Analysis Nearly Ready for FDA Submission
On May 29, 2009, we will submit a preliminary dataset to FDA containing basic safety information from our US MDMA-assisted psychotherapy pilot study. Over the past several months MAPS Clinical Research Associate Valerie Mojeiko has been working diligently with a team of consultants from the pharmaceutical industry to prepare this preliminary data set, and to develop a streamlined collection of standard operating procedures to use in future data sets. This submission to FDA is the first of several data reports from our first pilot study and will provide the scientific justification for future protocols that we will submit to FDA.
MDMA/PTSD Paper Completed and Sent for Friendly Review
MAPS is pleased to share that after months of work, our research team has completed a scientific paper that reports the remarkable results from our US MDMA/PTSD pilot study. Dr Michael Mithoefer, Annie Mithoefer, BSN, Ilsa Jerome, PhD, Mark Wagner, PhD, and MAPS President Rick Doblin, PhD, with assistance from statistician Yvonne Michel PhD, spent tremendous effort preparing the paper for submission to a peer-reviewed journal. We have now sent out the paper to several friendly reviewers for informal critique. We will incorporate the feedback we get from these reviewers and then submit the paper to a peer-reviewed scientific journal. This is a major milestone for MAPS and the legitimacy of psychedelic psychotherapy. When the paper is published in a peer-reviewed journal, MDMA-assisted psychotherapy will gain credibility among the scientific community and subsequently the general population. We have not yet released the paper to our readership, but keep checking back on our monthly email update to read about the results of this historic study.
IRB Services, the Canadian IRB that we are working with, has approved the changes to our MDMA/PTSD protocol that were made by Health Canada. MAPS Canadian MDMA-assisted psychotherapy PTSD study is now at the stage of seeking to import the research-grade MDMA into Canada. MDMA has never been legally imported to Canada before, so the process is a little slow. MAPS is working with a pharmacist who has applied for the license to import and we hope the approval will take place swiftly but we have no idea how long this process will actually take. When the license to import has been obtained, we can go forward with obtaining the specific import/export permits to ship the MDMA from the manufacturer in Switzerland to the pharmacist in Canada. Once the MDMA arrives in Canada, we can start enrolling subjects.
On Friday May 8, Valerie Mojeiko and Josh Sonstroem of MAPS Clinical Research Team, went to Vancouver to conduct a pre-study site visit. They met with co-therapists Ingrid Pacey, MD and Andrew Feldmar, PhD along with other site staff. This visit was necessary to ensure that data will be collected in manners compliant with FDA and Health Canada guidelines and that procedures will follow the protocol and IRB rules.
We are seeking a research assistant to help with this study 10-20 hours per week who lives in Vancouver and has prior research experience. Please view our job posting for more information.
Research Monitoring Team Completes Visits Around the World:
Over the past several weeks, MAPS clinical research team members Valerie Mojeiko, Director of Operations and Clinical Research Associate, and Joshua Sonstroem, Information and Technology Specialist and Accountant, visited MAPS research sites around the globe. Visits such as these are conducted periodically to ensure that each research team is conducting their research in accordance with US Food and Drug Administration (FDA) guidelines so that the data can ultimately be presented to the FDA as well as to national regulatory agencies and the European Medicines Agency (EMEA).
MAPS-Sponsored MDMA/PTSD Co-Therapists will Travel to MAPS Training Seminar in Austria, June 25 July 1, 2009:
MAPS has finalized plans and chosen a time and location for our first five-day MDMA/PTSD therapist training retreat for MAPS-sponsored researchers. The event will take place at the end of June in the Austrian mountains, where its off-season, reasonably priced, and more-or-less centrally located for therapist teams and MAPS staff coming together from the US, Canada, Switzerland, Spain, Israel, and Jordan.
Michael Mithoefer, MD and Annie Mithoefer, BSN, the co-therapist team from MAPS successfully completed U.S. MDMA/PTSD pilot study, will share techniques and results with the other therapists. June May Ruse, PhD, will present the principles in our treatment manual, which she is developing with feedback from our research teams.
The therapeutic outcomes in our US study were remarkable. In order to increase the chances that other co-therapist teams can replicate these results in MAPS other studies, Michael and Annie will present videotapes of their sessions and lead discussions about lessons theyve learned. The Swiss and Israeli co-therapist teams, who have treated some subjects but havent completed their studies yet, will also lead presentations about their results and methods. We will also discuss cultural differences, research methodology, and other treatments for PTSD and their similarities and differences from MDMA-assisted psychotherapy. We will have time for a breathwork session and opportunities for informal sharing. MAPS staff will be creating podcasts and writing blogs from the training seminar to keep our members and other interested parties informed of the valuable information that comes from it.
This private retreat will also serve to inform MAPS 2010 conference, which is open to medical professionals, MAPS members and the general public.
Canadian MDMA/PTSD Study Gets Green Light from Health Canada:
On March 17, Health Canada issued a No Objection Letter for MAPS’ Canadian MDMA/PTSD study. This means that the Canadian protocol and the MDMA that will be used in that study (from Switzerland) have been completely approved by Health Canada. On April 2, Dr. Ingrid Pacey applied for her Section 56 exemption, equivalent to a DEA Schedule 1 license. This license will permit her to possess and handle MDMA for the study. Once she has obtained her Section 56 Exemption, probably within the next month, MAPS can proceed to acquire the necessary import/export permits for shipment of the MDMA from Switzerland to Canada. MAPS monitoring team has scheduled their first pre-study visit to discuss logistics with the team on May 9. If all goes smoothly, we anticipate starting the study within the next 2-3 months.
A study that originated with MAPS, but that is now funded and managed independent of MAPS has had several important updates. The project offers MDMA-assisted psychotherapy and non-drug psychotherapy for advanced-stage cancer patients who are experiencing anxiety and other end-of-life issues not adequately treated by traditional means. The study had only been able to recruit from patients of the oncology service at the Lahey Clinic of Burlington, MA. Study candidates now just need to reside within a 100-mile radius of Boston and have an oncologist that the researchers can also work with. Moreover, the study now has a "Stage 2," so that 100% of participants have the opportunity to be part of the experiment employing the dose range of MDMA being evaluated as a treatment-level dose. To learn more about this study, either if you are curious or if you or someone you know may be interested in volunteering, see: http://clinicaltrials.partners.org/trials.aspx?tId=2284
Threshold Foundation Donates $8400, SAePT Donates 5000 to MDMA/PTSD Research:
Ashawna Hailey, on MAPS’ Board of Directors, presented information about our MDMA/PTSD research to a Threshold Foundation meeting. The Threshold Foundation is a group of philanthropists who meet together to pool resources and discuss their charitable giving. Ashawna made a presentation that highlighted our MDMA/PTSD research as a tool to help treat veterans of war. We wish to thank Ashawna for her speech and we extend our gratitude to the members of Threshold Foundation for their $8400 donation.
At their annual meeting on April 3, the Swiss Association for Psycholytic Therapy (SAePT) voted to donate 5000 Euros to the Swiss MDMA/PTSD study being conducted by Dr. Peter Oehen. We’re grateful for this contribution and the international collaboration between MAPS and SAePT, whose members include both Dr. Oehen and Dr. Gasser.
MAPS sent a payment of $20,000 to our Swiss MDMA/PTSD study, conducted by Principal Investigator Peter Oehen, MD, and his co-therapist Verena Widmer, RN. The study has enrolled 10 subjects, with 2 subjects still in the treatment process and two more to be enrolled.
MAPS Clinical research team members Valerie Mojeiko and Joshua Sonstroem are currently out “in the field” meeting with MAPS researchers around the world on a several week- monitoring trip. Valerie currently writes from Switzerland where they have just finished a visit with our MDMA/PTSD therapy site under the direction of psychiatrist Peter Oehen, MD and are currently working with psychiatrist Peter Gasser, MD at our LSD/end-of-life anxiety study.
“I am amazed at how many regulations there are and how difficult it is to conduct this type of research accordingly,” said Valerie, “Only with careful attention to detail are we able to succeed in keeping up with the regulations—the researchers in Switzerland have put much effort into this endeavor.” These visits to the research sites not only keep our research compliant with International Council on Harmonization/Good Clinical Practice (international ethical and scientific quality standard for pharmaceutical research) (ICH/GCP) guidelines, but also serve as a way to communicate between research teams and identify training or resource needs and other opportunities. “It is great to see the data firsthand and to hear stories from the researchers of the people who were helped by this therapy—Im glad to be a part of this research,” said Valerie.
MAPS US MDMA/PTSD researchers, including Michael Mithoefer MD, Annie Mithoefer BSN, Mark Wagner PhD, Ilsa Jerome PhD, and Rick Doblin PhD, are preparing a paper about our U.S. pilot study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder, which has obtained impressive results The first draft of the paper is close to being sent out to friendly reviewers for initial scrutiny. We will submit the paper to a scientific journal after we respond to the critiques from colleagues and experts. The team is working diligently on the paper to ensure that we provide the eventual reviewers with a compelling submission. MAPS is very excited about the paper; now that we have run the data analysis our research results are really impressive.
Several weeks ago, the Israeli therapists successfully treated a patient who had suffered from PTSD for over 40 years, since the Six-Day War in 1967. On his second MDMA session, the gentleman became acutely aware of fears he was still harboring within him since the war. He requested to leave the treatment room for a walk outside on the hospital grounds. The therapists escorted him outside as he had a breakthrough catharsis leading to dramatic healing. Ironically, planes were flying overhead on the way to bomb Gaza.
With so much new trauma being created, it may seem underwhelming to speak of treating only 12 subjects each in our Israeli and proposed Jordanian studies. Yet if successful, these pilot projects will lead to larger-scale studies. Furthermore, as Charles Mackay, author of Extraordinary Popular Delusions and the Madness of Crowds (published in 1841), observed, “Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.”
The MAPS team is honored and humbled to help someone who has suffered for so long. We hope that in the near future MDMA-assisted psychotherapy will be available legally to all who suffer from PTSD. We believe that in the future, our successes in the laboratory will translate into a more peaceful world.
Rick shared, “in the midst of war, we are developing the technologies of peace and healing.”
On January 16, Health Canada first responded to our Canadian MDMA/PTSD protocol design. They accepted almost all elements of the protocol but had some items they wanted changed. We also asked for a change in the kind of previous treatments for PTSD the subjects will be required to have tried and failed.
On January 20, we submitted our replies, accepting some changes and making our best argument for why it was important to include people who were free from substance abuse histories for the last 6 months rather than for the last 12 months, as Health Canada had suggested. In addition, we asked to be able to include subjects who failed on other psychotherapy and either tried and failed, or refused medication. Health Canada had suggested including only subjects who had failed on other psychotherapy, and had tried and failed to obtain relief from medication - excluding subjects who refused to try medication.
On February 3, we heard from Health Canada that our responses had been accepted and that our protocol design had been fully approved (Hooray!). This shows yet again that it is possible to negotiate with regulatory agencies that put science first.
On January 12, we heard from Health Canada’s chemistry reviewers. We’ve been gathering our replies ever since, which included obtaining a new analysis of the heavy metals and residue on ignition of the MDMA. In addition, Health Canada had a series of questions about the capsules, the lactose filler, and the bottles in which the capsules will be stored.
On February 2, Professor Rudolph Brenneisen from Switzerland provided MAPS with documents regarding the chemical make-up of the MDMA that will be imported to Canada from Switzerland. Ironically, the last bit of information we need to gather is the batch number of the lactose!
We expect to submit the required chemistry information in the next few days. Once the protocol is approved, we can start the process of obtaining the import/export permits for the MDMA from Switzerland, and can then start the study itself.
Flagship US MDMA/PTSD Study Final Monitoring Visit:
On January 20-22, MAPS’ clinical research monitoring team, Valerie Mojeiko and Josh Sonstroem, went to Charleston, South Carolina to conduct a closeout visit for MAPS’ flagship US MDMA/PTSD study. The data from this study is now ready to be submitted to FDA.
With this ending also comes the beginning of the “long-term follow up” extension to this study. During this extension, subjects who were enrolled in the original study will be retested on primary outcome variables one year or more after completion. In the initial study, the last measurement of PTSD severity was taken two months after the last experimental session. Since this study took over four years to conduct, some of the data from the long-term follow-up will be from subjects who were treated over four years ago. The value of the long-term follow-up study will be substantially enhanced as a result of the extra length of time since treatment for most of the subjects. MAPS is pleased to have the help of volunteers Scott Martin MD and Mili Ballard to coordinate this long-term follow-up study.
MAPS’ International MDMA/PTSD Research Progresses into the New Year.
Our Swiss and Israeli MDMA/PTSD studies are continuing to recruit subjects. Our Swiss study has only a few subjects still to recruit while our Israeli study has more than half remaining to be recruited. Sadly, the current war in Israel is creating many more people with PTSD.
For our proposed Jordanian MDMA/PTSD study, we’re in the process of having our informed consent form translated into Arabic for review by the Jordanian IRB. We’re also making progress toward obtaining the necessary insurance to conduct a study in Jordan.
On December 18, all the documents for our Canadian study of MDMA-assisted psychotherapy in the treatment of people with Posttraumatic Stress Disorder (PTSD) were submitted to Health Canada (Canada’s version of the FDA). We’ve already obtained approval of our protocol and informed consent from a Canadian Institutional Review Board. We should receive a reply from Health Canada within 30 days of our submission.
This is going to be a study with 12 subjects, similar in design to the recently completed US MDMA/PTSD study. Our main purpose for this particular study is to see if we can replicate the results of the US study. The budget for this study is $250,000, all of which remains to be raised.
MAPS Releases Year-End MDMA Literature Review: As part of our ongoing clinical research responsibilities, MAPS reviews all of the MDMA- related articles published in scientific peer-reviewed journals to determine whether we need to modify our risk/benefit analysis for our clinical studies. We have now completed our review of the scientific literature published between December 2007 and November 2008 and submitted the review to the Institutional Review Board (IRB) that oversees our US MDMA/PTSD study. Nothing in the review changes our risk/benefit analysis regarding our research in human subjects. This review—along with all previous reviews—are compiled by MAPS Research Specialist Ilsa Jerome, and are posted on the MAPS website at: www.maps.org/mdma/protocol/litreview.html
Newly Revised MDMA/PTSD Treatment Manual Now Online: MAPS Researchers Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, have created a revised version of MAPS MDMA/PTSD treatment manual. The new version of the manual builds on a previous manual from 2005, and includes lessons learned from our recently completed US MDMA/PTSD pilot study. The team of researchers reviewed many hours of videotapes of the therapy sessions with the aim of finding clear examples of the key elements of the therapeutic method. The manual will be continually revised as we identify best practices and gather data to link methods to outcomes. The manual, will also be used to develop measurement tools for identifying key elements of the therapeutic method.
The treatment manual, selected excerpts of the videotapes, and the measurement scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan.
A family foundation that wishes to remain anonymous donated $50,000 to MAPS for our US MDMA/PTSD research. The foundation had generously supported our US MDMA/PTSD study during the early stages of the research – giving substantial donations that played a crucial role in launching this project.
In addition, long-time MAPS supporter Tim Butcher (profiled in MAPS Bulletin article), is donating $17,000 to our US MDMA/PTSD study, with an initial donation of $5000 and $1,000 a month for the next year.
MAPS Researcher Michael Mithoefer, MD expressed his appreciation to these donors and noted, “Because MDMA can’t be patented these studies are not going to be funded by for-profit pharmaceutical companies. So far we have not been able to get government funding, and I don’t expect that to change in the foreseeable future. Contributions like yours are making it possible for us to complete the analysis and dissemination of our results and to now move forward with development of a training program, new protocols and teams of therapists and other researchers to perform a multi-center study. We are continually encouraged and deeply touched by the level of support MAPS is receiving for this work. The fact that this research can be accomplished by a small non-profit organization supported by a community of people who recognize the healing potential of MDMA and the importance of rational government policy based on science is quite extraordinary. This effort has already made a huge difference in the lives of the people with severe PTSD who participated in the study. I especially want to communicate that fact to you because you are playing a significant role in making it possible.”
MDMA/PTSD Study With War Veterans In The Planning Stage:
The European Medicines Agency has recently issued guidelines for sponsors interested in developing drugs to treat PTSD. The PTSD guidelines suggest that research be conducted in subgroups of people with PTSD, grouped according to the cause of their PTSD, for example, sexual assault or war-related PTSD. The purpose of such research is to identify if PTSD that is caused by a different type of trauma (i.e. sexual assault, war) responds to a specific treatment with similar or different success rates. If the treatment appears to have similar efficacy across subgroups, then people with PTSD from different causes can be enrolled in the same Phase 3 study but if the treatment is different, the Phase 3 studies should each be in a homogenous group of subjects by cause of PTSD.
As a result of the EMEA guidelines, MAPS, Michael Mithoefer MD, and Annie Mithoefer BSN will soon start the design and approval process for a new study investigating subjects whose PTSD is a result of war trauma. This study will include seven veterans, four women and three men, so that we can also gather some preliminary information on possible gender differences in response to MDMA-assisted psychotherapy.
Canadian IRB Gives Conditional Approval To MDMA/PTSD Protocol:
On Friday, November 7 the Canadian Institutional Review Board (IRB) granted conditional approval for our MDMA/PTSD protocol. The conditions are relatively easy to meet. We must have resuscitation equipment at the research clinic, confirm that study staff will possess previous practical experience with psychological distress, especially with respect to psychedelic drugs, and add a tool for the assessment of subjects’ suicidal risk (e.g., suicidal ideation) to provide a more structured evaluation. We are now selecting a preferred measure for assessing suicide risk. We are also now preparing documents to be submitted to Health Canada (Canada’s version of the FDA).
The IRB met on Wednesday, November 5 to review our replies to changes previously requested by the IRB. The IRB reviewed our responses and approved them. We replied to issues related to the open label stage of the protocol, the age of enrollment, and prior substance abuse history of subjects. The IRB agreed that we can retain the open label stage 2 portion of the protocol—the portion of the protocol in which everyone who was randomized to placebo in Stage 1 receives open label MDMA in the Stage 2. The inclusion of an open-label Stage 2 in our protocol has multiple purposes: 1) The therapist can better learn the contribution that MDMA itself plays in MDMA-assisted psychotherapy by treating patients who initially received placebo (psychotherapy without a full dose of MDMA 2) It is scientifically valuable since subjects who receive placebo initially act as their own controls; 3) It helps with recruitment and retention of subjects, since subjects know that by participating in the study they will eventually get the opportunity to receive MDMA-assisted psychotherapy
We reached a compromise agreement with the IRB on the age of enrollment and prior substance abuse history. Subjects must be 21 years old to enter the treatment and cannot have abused drugs during the six months leading up the treatment. We also shortened the length of the informed consent form, as requested. Our success with the Canadian IRB is an important milestone in our march toward the globalization of MDMA/PTSD research.
The fortieth edition Journal of Psychoactive Drugs published an article “MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder” by José Carlos Bouso PhD candidate, Rick Doblin PhD, Magí Farré MD PhD, Miguel Ángel Alcázar PhD, and Gregorio Gómez-Jarabo PhD. This article reports on the MAPS-sponsored MDMA-assisted psychotherapy study in Spain that was prematurely shut down by the Spanish government. The abstract of the article is as follows:
“The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented [in the article]. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.”
From October 6-10, 2008, Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, worked on the MDMA/PTSD treatment manual. This was their second week working together in person, with a third week anticipated in December or January. They have reviewed many hours of videotapes of therapy sessions from Michael and Annie’s recently completed US MDMA/PTSD pilot study, with the aim of finding clear examples of the key elements of the therapeutic method. They intend to develop scales of approximately ten key elements of the therapeutic method. These scales would then be used by raters to evaluate researchers/therapists’ adherence to our specific therapeutic method.
The treatment manual, selected excerpts of the videotapes, and the scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS’ Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan.
On October 7, 2008, MAPS sent a draft of a protocol for a MAPS-sponsored MDMA/PSTD pilot study to Royal Jordanian Military psychiatrist Nasser Shuriquie. Dr Shuriquie needs to show the protocol to other medical officials to gauge whether there is sufficient support to justify submitting a final draft of the protocol to a Jordanian Ethics Committee and the Jordanian Ministry of Health. This version of our protocol differs from other pilot studies in several ways. It begins with a three-subject open label run-in in which both the subjects and the therapists know that MDMA is being administered. In this way, the therapist gets a chance to practice our therapeutic technique and become familiar with the therapeutic process before administering MDMA or placebo to other subjects in the context of a placebo-controlled, randomized, double-blind study. We believe that it is important for the therapist to get a chance to become comfortable with the procedure prior to starting a controlled study. The remainder of the protocol is a nine-person study, where six subjects receive three sessions of full-dose MDMA, 125 mg followed one-and-a-half to two-and-a-half hours later by 62.5 mg. Three subjects would receive active placebo, in this case 40 mg followed 1.5-2.5 hours later by 20 mg. Our Swiss, Israeli and Canadian MDMA/PTSD pilot studies are using 25 mg as the active placebo while our US study used an inactive placebo.
On September 17, 2008, French psychiatrists Olivier Chambon and Fred Rosenfeld met with Patrick Lemoine MD in Lyon, France to discuss possibilities of starting a MAPS-sponsored MDMA/PTSD pilot study at a clinic where they work and that Dr. Lemoine directs. MAPS President Rick Doblin PhD and Director of Operations Valerie Mojeiko spoke in Paris in March 2008 at a conference about hallucinations in an attempt to catalyze MDMA/PTSD research [Link to article in current MAPS Bulletin on page 17]. On June, 28 2008, Valerie and Josh Sonstroem, MAPS’ Clinical Research Associates, conducted a site visit at the clinic where Drs. Chambon and Rosenfeld work.
After meeting with Drs. Chambon and Rosenfeld, Dr. Lemoine was intrigued but raised some concerns about MDMA neurotoxicity and cardiotoxicity. We sent detailed scientific information about those risks and await news as to whether we can move to the next stage of the project, which would be to develop a protocol that would be submitted to an Ethics Committee and the French Ministry of Health
The Institutional Review Board that is reviewing our Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted. We were delighted to receive this letter since it is clear now that the study itself will be approved. The IRB has some issues of concern that need a further exchange of information before being resolved.
The issues of concern relate to the open-label stage 2 portion of the protocol, the age of enrollment, and prior substance-abuse history of subjects. In addition, the Canadian IRB stated that our informed consent form was too long and detailed for subjects to fully comprehend and needed to be significantly shortened. This is in stark contrast to our United States IRB, which wanted an exhaustive informed consent form. The US form was so long that we instituted a non-graded quiz at the end to make sure that the subjects understood the nature of the risks of MDMA-assisted psychotherapy and the key elements of the study design.
We are gathering letters of support for the Canadian protocol from various experts, and will respond soon to the IRB’s concerns. Once the IRB approves a final version of the protocol and informed consent, we will then submit it to Health Canada – Canada’s version of the FDA. We hope to have this study fully approved and ready to begin in early 2009.
The budget for this study is $150,000, all of which remains to be raised.
The Sunday Baltimore Sun published an editorial ("Tuning In, Not Out") supporting research into the therapeutic potential of psychedelics. The editorial mentions the MAPS-supported research into MDMA-assisted psychotherapy in people with PTSD and ends by stating, "Instead of banning drugs that are perceived as bad simply because of their recreational use, scientists should be encouraged to pursue legitimate study - lest we miss out on a valuable medicinal tool."
The Sunday Times (London) recently published "Ecstasy is the Key to Treating PTSD," an in-depth piece on MDMA-assisted psychotherapy in people with PTSD, focusing on Dr. Mithoefer's MAPS-supported study and featuring quotes from MAPS president Rick Doblin and British psychiatrist Ben Sessa.
The list of articles and information on potential risks of MDMA now includes a report of estimated risk of MDMA in people with hepatitis C. While there is nothing in the medical literature on the topic, this report draws on information about MDMA, heptatitis C, and drugs used to treat it.
This letter by Krebs and Johansen commenting on and questioning the findings of the prospective study of cognitive function in ecstasy users is now published in the Archives of General Psychiatry. The letter addresses issues relating to the nature of the test score differences, the existence of long-term retest effects, participant durg use history and effects of anxiety arising from stereotype threat. Schilt and colleagues’ reply appears alongside the letter. They respond to questions concerning retest learning effects and re-analyze data with respect to drug use history. Krebs and Johansen are conducting an examination of psychological defense mechanisms in experimental sessions from Mithoefer’s randomized, placebo-controlled study of MDMA-assisted psychotherapy in people with PTSD.
View As Single Entry > November 30, 2007 Science Daily "Methamphetamine is not MDMA" .
An excellent article about studies on the effects of methamphetamine, not MDMA, describes findings in rats, not people.
Sessa and Nutt have recently published an editorial in the Journal of Psychopharmacology, "MDMA, politics and medical research: Have we thrown the baby out with the bathwater?", speaking out against the effects of politics and regulation on medical research with MDMA and in favor of more basic and medical research. In their editorial, Sessa and Nutt discuss the costs to the research enterprise imposed by regulation of MDMA, and proposes at least three avenues of further research. The piece is provocative and uneven, but makes for encouraging reading for supporters of MDMA psychotherapy research.
Washington Post magazine published an article (MAPS PDF Permalink) featured as the cover story about MAPS’ and Dr. Michael Mithoefer’s MDMA-PTSD research entitled "Peace Drug". This article is overall positive with one minor mistake--the idea of MDMA being prescribed only by specially trained therapists in psychedelic clinics is attributed to Dr. Michael Mithoefer when it should have been attributed to Rick Doblin Ph.D.’s dissertation. This article is unique as it is the first time that a reporter has been allowed to interview a research participant from this historic study. You can read the comments about this article here.
MAPS communications director Jag Davies conducted a podcast interview (mp3) with Dr. Michael Mithoefer, in which Dr. Mithoefer discusses the details of his study, his working relationship with wife and co-therapist Annie Mithoefer, and his musings on the psychological mechanisms involved in MDMA-assisted psychotherapy.
Sixteen out of twenty subjects have completed the double-blind protocol in Dr. Michael Mithoefer’s flagship MAPS-sponsored FDA Phase 2 study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD). Three new subjects have been enrolled, two of which are close to completion of the first stage of the protocol. One of these new subjects is a US military veteran whose trauma occurred during combat in Iraq.
Last month, MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, also a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The FDA has accepted our request, which we have just submitted to our institutional review board (IRB) for final review.
American Medical News published a feature article entitled "Altered Perceptions: Good Outcomes from 'Club Drugs'"? MAPS President Rick Doblin, PhD, and researchers Michael Mithoefer, MD, John Halpern, MD, and Charles Grob, MD, are quoted. American Medical News is a weekly newspaper for physicians published by the American Medical Association that is ciculated to over 230,000 physicians and health policy regulators.
MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The request to include a subject who is not a treatment-failure is due to the sad fact that this veteran, like several others with whom we have spoken, has been diagnosed with PTSD but has never been offered treatment by the military. We expect to hear from FDA in a few weeks. Michael Mithoefer, MD, and Annie Mithoefer, BSN, have enrolled 18 out of 20 subjects in their MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic PTSD. Another two potential subjects are currently in the screening process. The completion of MAPS’ flagship FDA Phase 2 clinical research study is now in sight.
No cause for alarm: Despite claims to the contrary, the recently published meta-analysis of studies of memory in ecstasy users does not demonstrate that memory is impaired even after a few doses of ecstasy. Here are our conclusions reached after reviewing the paper and correspondence with one of the study authors.
Yesterday, June 26, the 17th subject out of 20 completed the first experimental session in Dr. Michael Mithoefer’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post traumatic stress disorder (PTSD). We are still actively seeking to enroll in the study at least two US veterans with PTSD from the Iraq or Afghanistan wars.
This Phase II clinical study is the first-ever FDA-approved human study evaluating MDMA’s therapeutic applications. Efficacy data is extremely promising so far, making a strong case for continuing research into FDA Phase III studies.
News coverage of a soon-to-be published research report in the journal Human Psychopharmacology vary in depth and accuracy, with some claiming "Even Low ecstasy use harms memory," or Taking Ecstasy Once can Damage Memory", while others provide more details suggesting that this is not the case. The research in question is a meta-analysis of previous research studies. Read initial comments and reflections on the news coverage and research report13.
On June 3, MAPS-sponsored researchers Michael Mithoefer, MD, Annie Mithoefer, RN, Peter Oehen, MD, and Verena Widmer, RN, presented on MDMA-assisted psychotherapy research at the European Conference on Traumatic Stress in Croatia. Also present at the conference was Swiss researcher Dr. Franz Vollenweider, who is conducting a physiological study of the subjects in the Swiss MDMA/PTSD study, measuring markers for PTSD before and after treatment. MAPS’ MDMA/PTSD research now has preliminary data to share with PTSD researchers around the world.
The Netherlands XTC Toxicity (NeXT) research team has published yet one more prospective report of ecstasy users and non-users. In contrast to their earlier efforts, this report on attention and memory claims to have found differences between the two groups, with non-users performing better on verbal memory tests. However, the report contains problems both with the analysis and interpretation of the data.
We have learned that the data being generated from the Swiss and Israeli MAPS-sponsored studies will be accepted by the US FDA.
Although these protocols do not need to be approved by the FDA to be conducted in their home countries (they have already been approved by their home country’s regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS’ Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. The data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.
To learn more about the MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war- and terrorism-related PTSD, the protocol is posted on the MAPS Web site.
To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the protocol is also posted on the MAPS Web site.
Dr. Michael and Annie Mithoefer, the co-therapists for MAPS’ landmark US MDMA/PTSD study, were in Norway recently attending a workshop by Dr. Edna Foa, an internationally-recognized expert in the treatment of PTSD. The workshop was organized by Pal-Orjan Johansen, a Ph.D. candidate at the Trondheim Psychotherapy Research Program, Department of Psychology, The Norwegian University of Science and Technology, and Teri Krebs, B.S., Program in Neuroscience, Boston University.
While in Norway, Dr. Michael and Annie Mithoefer were also able to work with Pal and Teri, who are conducting a MAPS-sponsored study reviewing audio and video recordings and transcripts of subjects in the Mithoefer’s MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy.
Dr. Michael and Annie Mithoefer were also able to discuss with Pal and Teri their MAPS-sponsored project using the internet to search for reports of people with Asperger’s (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available.
Drs. Mithoefer, Peter Oehen and Franz Vollenweider, will be presenting their MDMA/PTSD work at the European Conference on Traumatic Stress in Croatia next month.
The Second Prospective Study of Ecstasy Users: No Support for Changes in Brain Activity, Associative Memory or Selective Attention. By Ilsa Jerome, Ph.D.
The MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war-and terrorism-related posttraumatic stress disorder (PTSD) has full government approval and is now in the subject recruitment stage. The study will be conducted at Beer Yakhov Mental Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces. The therapeutic team has been expanded and will now include Sergio Marchevsky, M.D., in addition to Rakefet Rodrigez, M.D., and Rael Strous, M.D.
Time Magazine's annual "What's Next" issue ran a brief story entitled "Taking a trip for your mental health," highlighting MAPS-sponsored MDMA, psilocybin, and ketamine research.
An encouraging advancement is that we may be close to enrolling the final five subjects needed to complete Dr. Mithoefer’s study. We’ve focused more attention on recruitment with ads on various psychedelic-related websites and websites for PTSD support groups and currently have more than five subjects going through the screening process. Two of these potential subjects are Iraq War veterans. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies.
After several years of effort, three rejections, and an appeal, the Institutional Review Board (IRB) for Dr. Michael Mithoefer’s flagship MAPS-sponsored US MDMA/PTSD study approved an amendment to the study’s protocol. The IRB decided that it will not object to subjects speaking with the media and/or documentary filmmakers following completion of each subject’s participation in the study. The IRB originally insisted that patients not speak with the media even after the entire study is complete. After years of careful consideration, the IRB has now determined that it has no jurisdiction to control subjects’ decisions about whether or not to speak to the media. Now that the media policy has been resolved, we are ready to move forward with our 12-month follow-up evaluations, which the IRB has previously approved.
Dr. Peter Oehen’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD) has been making swift progress. Last Thursday, March 8, the second subject in Dr. Oehen’s study underwent the second experimental treatment session. The third subject will undergo the first experimental session later this week, and the fourth and 5th subjects have already been recruited.
View As Single Entry > March 6, 2007 "External Source" by .
Peter Jennings' special ABC report entitled Ecstasy Rising is available for viewing. This groundbreaking documentary discusses MDMA's cultural history, its use as a therapeutic tool, the government's criminalization and exaggeration of its risks, and MAPS' recent success with MDMA-assisted psychotherapy research. Regarding this clip we would like to give SPECIAL thanks to Nathan for ripping this footage and hosting it onsite Many gracious THANX...!
MAPS has committed $5,300 to Dr. Franz Vollenweider at the Psychiatric University Hospital in Zurich to co-sponsor a secondary study that will gather data for physiological assessments of subjects in Dr. Oehen’s MDMA/PTSD study. The additional study will use several different measures to assess the psychophysiology of PTSD by using EEG/ERP and other biological measures such as heart rate variability (HRV) and pre-pulse inhibition (PPI). These parameters will be measured before and after the MDMA-assisted psychotherapy to allow researchers to evaluate changes in various areas of the brain and body. We expect that this additional neurophysiological and biological data will document the efficacy of MDMA-assisted psychotherapy. The amendment to Dr. Oehen’s protocol to include Dr. Vollenweider’s research was previously approved by Dr. Oehen’s Ethics Committee (IRB) in September 2006.
For more on this study, see Dr. Oehen’s article in the Fall 2006 MAPS Bulletin.
The UK’s Sky News published a short article describing Dr. Peter Oehen’s MAPS -sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD).
Swiss Radio International's Swissinfo published a brief original article describing Dr. Peter Oehen's ongoing MAPS-sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder.
The Data Safety Review Board (DSMB) for Dr. Michael Mithoefer’s MAPS-sponsored FDA Phase 2 pilot study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) met in late January for its final review, now that 15 out of 20 subjects have completed the experimental treatment. The DSMB recommended that the study continue without modification. Ironically, the DSMB’s only safety concern was that those subjects who received the placebo might see a substantial increase in PTSD symptoms after tapering off of psychiatric medications. The DSMB is comprised of an M.D., a Psy.D. and a Pharm.D. not otherwise involved in the study. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. We’re already looking beyond the next five subjects and the completion of this initial study, to future research protocols.
Slate published a positive description of MAPS' MDMA drug development efforts in a front page article entitled "What a Long, Strange Trip It's Been: Ecstasy, the New Prescription Drug?"
MAPS has donated $3000 to Pal-Orjan Johansen and Terri Krebs for a project that will seek to use the internet to search for reports of people with Asperger’s (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available.
MAPS also awarded another grant of $6000 to Pal-Orjan Johansen and Terri Krebs to expand their work reviewing transcripts of subjects in MAPS-sponsored MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy.
From January 3-6, 2007, MAPS’ clinical research team (Amy Emerson, Valerie Mojeiko, and Josh Sonstroem) was in Charleston, SC, conducting a monitoring inspection of Dr. Michael Mithoefer’s MAPS-sponsored IRB-, DEA-, and US FDA-approved MDMA/PTSD study. On January 5, the 15th subject participated in her third and final experimental MDMA-assisted psychotherapy session. On January 6, MAPS President Rick Doblin visited Charleston to meet with Dr. Michael and Annie Mithoefer and MAPS’ clinical research team to review the data, which looks very promising. An additional $125,000 will be required to complete this study.
In response to the sensationalistic and inaccurate recent news coverage of prospective Ecstasy user studies by Dutch researcher Dr. Maartje M. de Win, MAPS President Rick Doblin, Ph.D. wrote this open letter to Dr. de Win voicing his concerns, and MAPS Clinical Research Associate Ilsa Jerome, Ph.D., wrote a special report evaluating the media's claims and how they relate (or not) to the actual data.
While in Thailand to testify in a medical MDMA trial, MAPS President Rick Doblin took the opportunity to do an interview with The Nation, Thailand's largest English-language daily newspaper. In the interview, Doblin speculates on the possibility of conducting MDMA/PTSD research with tsunami victims and discusses MAPS' international psychedelic research agenda.
Dr. Peter Oehen conducted the second experimental MDMA-assisted psychotherapy session with the second subject in his ongoing MAPS-sponsored MDMA-assisted therapy pilot study for subjects with treatment-resistant post-traumatic stress disorder (PTSD). According to Dr. Oehen, the subject delved into some challenging content, but the long-term results appear to be quite positive. “She was confronted very hard with anxiety, negative emotions related to the sexual abuse and especially her isolation and avoidance of closeness,” said Dr. Oehen. “It was hard work for her in the following days but since then she has made substantial progress”. Therapist reports confirm that the subject “confronted very hard with anxiety and with negative emotions related to their tramua - especially isolation and avoidance of closeness.” This was followed by “hard work for the subject during the following days but since then they have made substantial progress.”
The MDMA arrived on-site today at Harvard’s McLean Hospital for Dr. John Halpern’s MAPS-initiated study evaluating MDMA-assisted psychotherapy for subjects with advanced-stage cancer suffering from end-of-life anxiety disorders. MAPS has withdrawn from direct sponsorship of this study, but will still have access to the data generated by Dr. Halpern, as will any other organization that requests it.
The MAPS clinical research monitoring team arrives in Israel today for the Site Initiation visit for the MAPS-sponsored MDMA/PTSD pilot study at Beer Yakhov Mental Health Center in Tel Aviv, Israel, under the direction of Principal Investigator Moshe Kotler, former chief psychiatrist of the Israeli Defense Forces. The study will focus on individuals suffering from war-related PTSD.
The MAPS clincial monitoring team consists of MAPS President Rick Doblin, Ph.D., Clinical Research Associate Valerie Mojeiko, and volunteer clinical research expert Amy Emerson. Their job is to help the researchers prepare the study to fit the strict guidelines necessary for the data generated to be eligible for consideration by the FDA and the European Medicines Agency.
On October 25, Doblin and Lester Grinspoon, M.D., will join Israeli and Palestinian drug policy experts in Jerusalem to talk at the first Arab-Israeli Joint Conference on Peace and Drug Policy, sponsored by the Ale-Yarok (“Green-Leaf”) Party. The conference will focus on issues related to the cultural impacts of marijuana, its regulation, and its medical uses and research. While in Israel, MAPS staffers Rick Doblin and Valerie Mojeiko will also be conducting a “Psychedelic Emergency Services” training seminar for a team of volunteers organizing a rave near the Dead Sea.
Dr. Michael Mithoefer treated the 13th subject with a third MDMA-assisted psychotherapy session today in his MAPS-sponsored FDA Phase II pilot study of MDMA-assisted psychotherapy for individuals with treatment-resistant post-traumatic stress disorder (PTSD). The 16th patient out of 20 was also just screened and admitted to the study earlier this week.
Dr. Peter Oehen’s MAPS-sponsored MDMA/PTSD protocol has full government approval and the first subject began the screening process last week. The Ethics Committee (the Swiss IRB equivalent, which previously approved Dr. Oehen’s MDMA/PTSD protocol) met on September 7 to review an addendum to the protocol, and we just learned today, September 12, that the IRB has granted approval, meaning that the study can now officially be initiated! The addendum is for an associated study by Dr. Franz Vollenweider, University of Zurich, that will examine subjects before and after treatment with MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several physiological factors that have been associated with PTSD (startle response, heart rate reactivity) as well as various EEG parameters to see if the MDMA-assisted psychotherapy results in any changes in these measures. The first applicant for the study will be administered baseline CAPS and PDS tomorrow, and, now that we have full approval, we hope to report shortly that the first subject has been treated with MDMA-assisted psychotherapy.
The Norwegian Research Council website recently posted “Ecstasy: Historien Starter” (article in PDF format) (English translation “Ecstasy; The History Begins”), an article by Pål-Ørjan Johansen that discusses the scheduling history, the research controversies, and new research into the therapeutic potential of MDMA.
In their “Newsdesk” section, the journal Lancet Neurology published “Hallucinogen Research Inspires Neurotheology,” a report on developments in research with psychedelic compounds, such as ketamine or psilocybin. The piece contains comments from Roland Griffiths, John Halpern and Deborah Mash.
The Israeli Import Permit and the Swiss Export Permit have now been approved. On Thursday, August 3rd, in the midst of war, about 5 grams of MDMA arrived in Israel for MAPS’ MDMA/PTSD study, imported into Israel from Switzerland. This study has full government approval and will be initiated in Fall 2006.
Dr. Michael and Annie Mithoefer treated the 13th subject with the second experimental MDMA/placebo session in their MAPS-sponsored MDMA/PTSD trial today. Dr. Mithoefer described it as “impressive.”
Dr. Michael Mithoefer initiated the first experimental MDMA-assisted psychotherapy session with the 13th subject out of 20 in his MAPS-sponsored FDA Phase II pilot study. This subject was the first to receive supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA’s therapeutic effectiveness, a change recently approved by Dr. Mithoefer’s Istitutional Review Board (IRB), the Food and Drug Administration (FDA), and the Data Safety Monitoring Board (DSMB). The supplemental dose did not seem to intensify the already strongly therapeutic experience but it did prolong the period of maximum therapeutic effect for at least 90 minutes. This appeared to be very useful. We were also happy to see that, as expected, there was no problem with vital signs.
Switzerland’s FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen’s MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen’s study will take place shortly thereafter.
Approval from SwissMedic of the source of the MDMA for the Swiss MDMA/PTSD study will now enable MAPS to move forward with the export of MDMA from Switzerland to Israel. The import/export of the MDMA is the last regulatory step in the initiation of Dr. Moshe Kotler’s MAPS-sponsored MDMA/PTSD research at Beer Yaakov Mental Health Center in Tel Aviv, in subjects with war and terrorism-related PTSD.
Dr. Michael Mithoefer has received Institutional Review Board (IRB) approval for several key changes that FDA had recently approved to his MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. The changes include (1) adding a third experimental session to the two that are currently included in the protocol to test whether a third session adds significantly to the therapeutic process, (2) providing supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA’s therapeutic effectiveness, and (3) doing without an ER doctor on standby in the next room since Dr. Mithoefer has become a board-certified ER doctor as well as a board-certified psychiatrist. Now that the Data Safety Monitoring Board (DSMB), FDA, and IRB have all approved these changes to our protocol, they will be implemented for the study’s remaining eight subjects.
The Boston Globe published "A Good Death", an article that discussess the resurgence of interest in studying MDMA and psychedelic drugs to help people with cancer deal with anxiety and pain. The piece describes research MAPS helped design and locate funding for that will look at the potential therapeutic benefits of MDMA in people who are anxious as a result of advanced stage cancer. The latest MAPS Bulletin contains an article about the woman described in this article who used MDMA to treat cancer-related pain and anxiety. A PDF of the this piece is now available.
A recently published editorial in the Lancet supports research into the potential therapeutic benefits of psychedelic drugs and calls for a new legal structure that makes this research easier and less burdensome to conduct. The Lancet editorial was likely inspired by a commentary published in the British Journal of Psychiatry. This editorial was then covered by the British newspaper, the Guardian.
In some fantastic news, philanthropist Peter Lewis has agreed to donate $250,000 directly to Harvard Medical School-affiliated McLean Hospital to fund the costs of Dr. John Halpern’s study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer.
Dr. Halpern’s MDMA/cancer anxiety study is already fully approved by the FDA, DEA, two Institutional Review Boards (IRB’s, at Lahey Clinic and McLean Hospital) and the Massachusetts Dept. of Public Health. Now that the study is fully funded, Dr. Halpern is preparing to initiate the study and hopes to enroll the first subject within the next several months.
As we reported in the last email update, MAPS has withdrawn from direct sponsorship of this study. The McLean Hospital administration felt that MAPS long-term advocacy for MDMA psychotherapy research and general opposition to Prohibition would cause the results of the study to be challenged as biased if MAPS were to sponsor the study and they did not want McLean Hospital to be involved in a study funded by MAPS. Therefore, we decided that it would be best for MAPS to offer to withdraw from further direct financial sponsorship of Dr. Halperns research so that the study, which many people labored so long to start, could proceed. Sacrifices sometimes need to be made. In this case, we decided that the benefits of the study moving forward substantially outweigh MAPS’ withdrawal from direct sponsorship. MAPS will still have access to the data generated by Dr. Halpern, as will any other organization that requests it.
The DEA has, after over one year, issued a license for Dr. John Halpern’s study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. The final regulatory approval has thus been obtained. Additional approvals have already been received from two Institutional Review Boards (IRB-McLean and Lahey Hospitals) as well as the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health. MAPS has donated over $94,000 to McLean Hospital over the last five years in an effort to initiate the evaluation of MDMA-assisted psychotherapy. One fruit of this support has been Dr. Halpern’s $1.8 million grant from the National Institute on Drug Abuse (NIDA) for a methodologically state-of-the art study started with MAPS funding of the neurocognitive consequences of the use of Ecstasy. Now that the MDMA/cancer anxiety study is fully approved, MAPS is withdrawing from any further financial sponsorship. MAPS, independent of McLean and Dr. Halpern, still hopes to assist with seeking donors interested in now donating directly to McLean Hospital. We believe that this financial distance from MAPS, and more so the rigor of the methodological design of the study itself, will enable the results of the study to be viewed by skeptics as more objective. If the results of the pilot study are promising, MAPS will again explore options for the support of research at McLean Hospital.
MAPS’ Data Safety Monitoring Board (DSMB) met to review records for the six new subjects who have enrolled since their last meeting in Dr. Michael Mithoefer’s study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. With data from a total of eleven subjects before them, the DSMB reported that they did not have any concerns about the safety of the study, and recommended that it continue without modification. The DSMB is comprised of an M.D., a Psy.D., and a Pharm.D. not otherwise involved in the study. Dr. Mithoefer has successfully treated 11 out of an eventual 20 subjects, and is currently treating the twelfth. The DSMB also reviewed and approved three protocol changes that Dr. Mithoefer and MAPS will initially submit to FDA and then, if approved, to our Institutional Review Board (IRB). Dr. Mithoefer is seeking permission to: 1) Increase the number of MDMA experimental sessions from two to three, to evaluate whether this extra session will enable subjects to make more therapeutic progress. 2) Administer supplemental doses of 1/2 the initial dose of MDMA 2 to 2 1/2 hours after the initial dose, in order to prolong the relatively short plateau of MDMA’s full therapeutic effectiveness. 3) Since Dr. Mithoefer has recently renewed his Board certification in ER medicine, we have asked to do without the additional Board-certified ER doctor sitting in the next room. In comparison, Dr. Peter Oehen’s study in Switzerland has been designed and approved for three MDMA experimental sessions and the use of supplemental doses. Dr. Kotler’s study in Israel has been designed and approved with supplemental dosing but just two MDMA experimental sessions.
The 25.01.06 article, "Mental scars of Iraq conflict participants exposed" by Kim Sengupta, reported that the US military was giving soldiers fighting the Iraq war "Ecstasy tablets to help free them of flashbacks and recurring nightmares," after the FDA "authorised the issuing of the MDMA drug to Iraq veterans after successful initial research carried out at a facility in South Carolina." This is not quite accurate. Its true that the initial MDMA research in South Carolina is generating very promising results, and the FDA did authorize the expansion of the research to include soldiers. However, no soldiers have yet been treated and the initial study has not been completed. Much larger studies will be needed before MDMA is ever a prescription medication. Research with MDMA for war and terrorism-related posttraumatic stress disorder (PTSD) has been approved in Israel and MDMA/PTSD research is soon to be approved in Switzerland. If approved as a treatment, MDMA will never be issued as tablets directly to soldiers or other patients. MDMA is not a standard pharmacological treatment. MDMA is intended to be used under direct supervision of a therapist as part of MDMA-assisted psychotherapy.
Rick Doblin, Ph.D.
President, MAPS (http://www.maps.org)
MAPS is the non-profit organization that is sponsoring
the research into MDMA-assisted psychotherapy
An article in the New Zealand Herald about posttraumatic stress disorder (PTSD) in veterans mentions the use of MDMA for PTSD but makes some incorrect claimsA letter to the editor from Rick Doblin corrects the mistakes. This article demonstrates that there is a widely perceived need for more effective treatments for PTSD and that the MDMA research is increasingly accepted as a necessary and not very controversial effort.
MAPS received word from Dr. Peter Oehen, Principal Investigator of the Swiss MDMA/PTSD pilot study cosponsored by MAPS and the Swiss Association for Psycholytic Therapy, that the final written approval from the ethic committee arrived today. Dr. Oehen will now submit the protocol and the other documents to Swissmedic, for a review process that we expect will take a month or two.
An article in the Washington Post, "A Political Debate On Stress Disorder," by Shankar Vedantam, reports that in 2004 the US Veterans Affairs Department spent $4.3 billion on PTSD benefit payments to a total of 215,871 veterans. If the results of the second half of our MDMA/PTSD study are as promising as the results of the first half, we will have data suggesting that it would be financially wise for the VA to fund the entire $5 million cost of MAPS' Phase III studies to evaluate whether MDMA-assisted psychotherapy for PTSD should become approved by the FDA as a legally-available treatment for PTSD.
Dr. Michael Mithoefer, Principal Investigator of the MAPS-sponsored MDMA/PTSD psychotherapy study in Charleston, South Carolina, filed an Annual Status Report with his Institutional Review Board (IRB). There have been no drug-related Serious Adverse Events (SAEs) and the results on treatment efficacy are promising.
MAPS received word that the Israeli Ministry of Health has approved our MDMA/PTSD pilot study!! One condition was that the Israeli Anti-Drug Authority write a letter formally indicating support for the protocol, which the Israeli Anti-Drug Authority has done. Now we need to bring the Israeli therapeutic team to the US to observe an MDMA/PTSD session conducted by Dr. Michael and Annie Mithoefer and we need to bring MAPS Clinical Research Monitoring Team to Israel, to set up the Case Report Forms and the Standard Operating Procedures (SOPs). Plus we need to arrange to export MDMA to Israel for the study. Once these steps have all been accomplished, the study itself can begin enrolling subjects. We’re anticipating that the study can begin in March 2006.
The Good Drugs Guide Radio show, out of England, broadcast a show entitled,"The State of Ecstasy." The show is described as follows, "It's ten years since the death of Leah Betts, a teenager who died after taking a single tablet of ecstasy, also known as MDMA. Her tragic death triggered a huge backlash against the drug here in the UK. Even so, 700,000 people still take E every week in this country. So what have we learnt about ecstasy in the last decade? Do the stories of terrible comedowns, brains like swiss cheese, and instant death have any credibility? Could MDMA really become a prescription drug? And has the music got any better? We find out. Guests include Dr Julie Holland, author of Ecstasy The Complete Guide, Rick Doblin, president of www.maps.org, and Mike Linnell of drug charity Lifeline. The show also uses clips from the excellent ABC documentary, Ecstasy Rising."
Dr. Michael Mithoefer received the disappointing news that the National Institute of Mental Health (NIMH) has rejected our grant application seeking $125,000 over two years for the development of a treatment manual for the use of MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD). MAPS’ grant application was not scored (it was considered in the bottom half of all applications). This rejection isn’t really surprising since the last time NIMH gave a grant for anything to do with psychedelic psychotherapy was over 30 years ago, with all NIMH intramural psychedelic psychotherapy research stopping in 1967. MAPS invested $2,768 in the NIMH grant application, but the money is not wasted. We have gained a better understanding of what it will take to complete the treatment manual that we have already begun to develop and we now can say that we have indeed tried to obtain funding from NIMH. Maybe once we complete the initial pilot study, we can submit the results to NIMH and try again to obtain support. It has been reported that in 2004, the Veterans Affairs Department (VA) spent $4.3 billion on PTSD disability payments! In 2006, the VA requested $2.2 billion for mental health services. Once we have completed our initial pilot study, we may have a better chance of obtaining some federal funding for MDMA/PTSD research.
The Daily Texan, the newspaper of the University of Texas at Austin, published a letter about, "The harms of MDMA" that presented misleading information about MAPS' MDMA research projects. The letter critiqued a previous column entitled, "Debunking drug folklore," MAPS President Rick Doblin replied to correct the record. While taking time to write to a student newspaper may not at first glance represent a wise use of MAPS staff time, in the age of Google, even student letters can be read by a large number of people, especially when the topic is discussed repeatedly in the student newspaper. Indeed, the Daily Texan also published a more reasonable letter, "The harm of Ecstacy, II." While MAPS concentrates on scientific research, our educational mission is also of major importance.
An article in the UCLA Daily Bruin discusses animal rights protesters objecting to a proposed study in primates, "Making Connections: MDMA Research on the Mechanisms of Affiliation and Trust." The article mentions that this research was submitted for funding to MAPS, by Anthropology Professor Alan Page Fiske, who is quoted as saying, "The biggest problems we have in the world are people not trusting each other and not feeling a solidarity (and) feeling distant," Fiske said. "If we could understand the basis of compassion and caring, that's about the most important thing human and biological sciences could do." A MAPS Bulletin article about Prof. Fiske's research can be found here. At present, there is no funding for the study.
Briefly stated, MAPS has not funded animal research for about ten years but is not categorically opposed to doing so if the research is of sufficient importance. MAPS considers Prof. Fiske's proposed research to be sufficiently important to be worthy of being conducted but the information it would generate isn't essential for MAPS' program of research intended to develop MDMA into an FDA-approved prescription medication. MAPS' top priority is our human studies into the therapeutic use of MDMA. These studies require substantial resources so our intention is to conduct further research in animals only when required by FDA.
A DEA Field Investigator came to McLean Hospital to test the alarms on the safes at the Pharmacy, where the roughly 4 grams of MDMA will be stored for the MAPS-sponsored MDMA/cancer anxiety study. Everything seemed to be in order and the DEA investigator stated that his report should get processed within one month. We’re cautiously optimistic we’ll have the final approvals before the end of 2005.
Dr.med. Peter Oehen submits an MDMA/PTSD protocol for review to a Swiss ethics committee, for a pilot study co-sponsored by MAPS and the Swiss Association for Psycholytic Therapy (SAePT). This study will involve three experimental sessions instead of two and will use supplemental dosing 2 1/2 hours after the initial dose.
View As Single Entry > September 13, 2005 The following letter was addressed to Laura Huxley from the mother of a woman who died of cancer. Read about Laura Huxley's life with husband Aldous Huxley in her book This Timeless Moment.
View As Single Entry > August 2, 2005 News-Medical.net "Sotnikova et al. 2005 on MDMA and Parkinsons" .
Ironically, after NIDA-funded researchers Drs. McCann and Ricaurte claimed that MDMA damaged dopamine neurons and could cause Parkinson's disease, a claim that they later had to retract, new research conducted at Duke University Medical Center has shown that MDMA is the most effective of 60 drugs tested in reversing the symptoms of Parkinson's disease! This research was discussed in an article in News-Medical.Net; note also a brief commentary on this and other related research into MDMA as an anti-Parkinson's disease treatment.
The 10th subject had her 2nd experimental session, which went well. Once she completes her final follow-up evaluation in about two months, we will have completed half of Stage 1 of the study. We’ll then conduct a preliminary data analysis and submit it to MAPS’ Data Safety Monitoring Board (DSMB) for review. There have been no Serious Adverse Events (SAEs) during the first half of our study and the outcome data looks promising.
Stage 2 is for those subjects who received placebo and wish to reenroll in the study to receive MDMA “open-label.” The second subject in Stage 2 is scheduled to receive her second MDMA session on Monday, August 1. This session will also be used as a training session for Drs. Halpern and Naidoo from Harvard Medical School. They have the subject’s permission to observe in order to help them prepare to conduct their MAPS-sponsored study of MDMA in subjects with anxiety associated with advanced-stage cancer. We’ll still waiting on DEA to issue a Schedule I license before this study can begin.
Australia’s Herald Sun publishes “Pill poison,” an article about the proliferation of of ecstasy dealing, consumption, and adulteration in the nation’s most populated region. The link also includes and editorial from the Herald Sun demanding that the community take responsibility for the nation’s drug problems.
Austrailia’s United Press runs “Dealers lacing ecstasy with other drugs,” reporting on the widespread adulteration of ecstasy tablets throughout the country.
The IRB approved the requested changes, conditional to accepting changes in the consent documents. Dr. Mithoefer accepted all changes the IRB recommended. Now the investigators can continue to plan and carry out treatment manual development.
A letter from the National Institute of Mental Health (NIMH) arrived at MAPS today, saying that our grant application, “Treatment Manual Development for MDMA-Assisted Therapy,” has been received and assigned to a Scientific Review Group (SRG). The initial peer review should be completed by the end of November 2005, with funding decisions made in January 2006 after the meeting of the appropriate National Advisory Group. MAPS’ grant application can be found at: http://www.maps.org/mdma/ptsd_study/grant0605/
Michael Mithoefer submitted proposed changes to the MDMA/PTSD, including provisions for videotaping all psychotherapy sessions, a step needed for developing a treatment manual for MDMA-assisted psychotherapy in people with PTSD, as needed to carry out the work proposed in the grant application submitted to NIMH.
UK News site Guardian Unlimited ran this story about Alexander Shulgin, his history as a pharmacologist, and the repercussions of his 1965 synthesis of MDMA.
The study protocol for the MDMA/PTSD study to take place in Israel was reviewed and approved by the Beer Yaakov Medical Center ethics committee (IRB). The study has now been sent to the Israeli national ethics committee. If it is approved by the national ethics committe, it will then be reviewed by the Ministry of Health.
The CQ (Congressional Quarterly) Weekly published an excellent cover story by Tim Starks, entitled "New Prescriptions for War Trauma." The article interviews Dr. Michael Mithoefer and discusses the MAPS-sponsored study of MDMA-assisted psychotherapy in the treatment of PTSD.
Online Publication Nursing Spectrum puts forth an article discussing the Harvard study of MDMA psychotherapy for treatment of anxiety associated with terminal cancer. Author Lisette Hilton quotes Dr. John Halpern that "the benefits of this therapy would have greater application for nurses who tend to dying patients on a daily basis than for the physicians who prescribe the therapy."
Psychology Today offers two articles about psychedelic research constraints in the United States, one from 2005 and the other from 1994. Compare what 11 years can do!
Join Together, a drug abuse prevention organization, ran a news summary regarding the recent St. Petersburg Times article on the MDMA research MAPS sponsors.
Canadian newspaper Northern Life ran an article in the online "police beat" section by Jason Thompson in which Dr. Stephen Kish of the Northern Ontario School of Medicine, among others, discuss problems and potential of MDMA use.
Rick Doblin appears on Joe Scarborough’s MSNBC Segment to talk about the MDMA therapy studies. Watch the video (permalink) or read the transcript of the interview by clicking the title above.
View As Single Entry > May 11, 2005 "WAV File" by .
Dr. Meg Jordan, Global Medicine Hunter, puts out a podcast about MAPS' research into the use of MDMA in the treatment of postraumatic stress disorder (PTSD) in Iraq War vets, and about her work with the therapeutic use of MDMA in the late 1970s!
The International edition of Newsweek published "A Psychedelic Cure", a piece similar to the a piece published last week in the domestic edition, but with greater discussion of proposed studies of MDMA-assisted psychotherapy in Spain and Israel.
The St. Petersburg Times ran a front page article, "Party pill gets tryout in therapy" written by Janet Zink, offering reporting on MAPS' mission of decriminizaling the use of MDMA for therapeutic purposes.
"The changing economics of Ecstasy is leading a rising number of youths to turn to cheaper, more available drugs. Among them: addictive prescription painkillers such as OxyContin and Vicodin, inhalants such as paint thinner, and methamphetamines. Two recent surveys said OxyContin and Vicodin had passed Ecstasy in popularity among teens."
"And this is considered progress!" comments Rick Doblin, MAPS President.
The LA Times published, "Ecstasy's Good Side", reporting on MDMA/cancer anxiety study to be conducted by John Halpern MD, and discussed related studies (such as the study of psilocybin in people with cancer-related anxiety conducted by Charles Grob MD, and the ongoing study of MDMA in people with PTSD. Note that the article erroneously reports on the location of the last study, which is at the offices of Michael Mithoefer MD, and not at the Medical University of South Carolina.
The largest Israeli newspaper, Yediot Ahronot, published a favorable article about MAPS' Israeli conference, which took place the day before, and the use of MDMA-assisted psychotherapy in treating posttraumatic stress disorder (PTSD). The article was accompanied by an incredible graphic of a drowning man holding on to a life preserver that was actually an Ecstasy pill with a smiling face.
MAPS sponsored a very successful conference in Israel on research with MDMA, ibogaine and marijuana for the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and representatives from the Israeli Anti-Drug Authority. The conference was intended to educate Israeli regulators and researchers about MAPS’ proposed MDMA/PTSD pilot study that we’re trying to sponsor in Israel, under the direction of Dr. Moshe Kotler, Chair, Department of Psychiatry, Tel Aviv University, Sackler School of Medicine. After the conference, Dr. Kotler said that he was ready to submit our draft protocol to the ethics committee for review.
Two articles in a newspaper in Ibiza (El Mundo), "An association which supports drug research auctions off a week "of dancing" in Eivissa on the Internet", and "Eivissa's 'raves' have made this tourist destination mythic" discuss MAPS' ebay auction of, among other things, a week at a "villa in Ibiza" and report on MAPS' agenda.
Today the Drug Enforcement Administration will visit Dr. John Halpern of Harvard Medical School’s McLean Hospital as a routine procedure before issuing his Schedule I license. Once Dr. Halpern has received his license, the MAPS-funded study of MDMA-assisted psychotherapy for anxiety in advanced cancer patients can begin.
The Scientist published "Renewed Faith in Ecstasy", a brief article on the recent history and progress of MDMA research, and featuring quotes from Rick Doblin.
View As Single Entry > March 8, 2005 "External Source" by .
The NPR show, To the Point, hosted by Warren Olney, discussed Dr. Michael Mithoefer's MAPS-sponsored MDMA/PTSD study and FDA's newly approved expansion of the study to include subjects with war-related PTSD. Guests include Dr. Andrew Pomeranz (PTSD therapist), Dr. Michael Mithoefer, Rick Doblin, Ph.D. and Robert Dupont, Ph.D. (first Director of the National Institute on Drug Abuse). The story runs from 23:35-50:52.
BBC On-Line published an article describing recently published findings that ecstasy use was associated with increased self-reported symptoms of depression, but only in people who have a certain form of the serotonin transporter gene. You can also read a commentary on the paper.
New Scientist published a lengthy and extensive overview of current and planned research into the medical or psychiatric benefits of psychedelic substances, including MDMA, psilocybin, LSD, ketamine and ibogaine, and covernig a wide array of MAPS-supported and Heffter Institute supported studies.. The article contains a history of medical research with psychedelics.
The Boston Globe published a lengthy piece on the MDMA/cancer anxiety study that will take place at Harvard University's McLean Hospital. The piece features quotes from Halpern and from Rick Doblin.
National Public Radio (NPR)'s "All Things Considered" aired an interview of John Halpern, who spoke about the MDMA/cancer anxiety study. You can hear a recording of the interview on the NPR website or you can read the transcripts of the interview
The German newspaper Der Spiegel published a report on the recent expansion of the MDMA/PTSD study to include people with combat-related PTPSD that is even more muddled than the report from the Guardian, above. Not only does this report suggest that a new investigation is underway, but that the US military is involved in this study. As already noted, there is no new study specifically studying MDMA-assisted therapy in people with combat-related PTSD, and the military has not been involved in any step of this research so far.
The Guardian published an extensive discussion of current and planned research into the therapeutic uses of MDMA and psychedelic drugs. The article quotes John Halpern, Rick Doblin and Michael Mithoefer, and covers a surprising breadth of current and planned research in this area.
Today Michael and Ann Mithoefer performed the first experimental (MDMA or placebo) session for the sixth participant enrolled in the study of MDMA-assisted psychotherapy in people with PTSD. If all goes well, the next experimental session will occur in three to five weeks.
The UCLA newspaper the Daily Bruin featured a report on Charles Grob's research on psilocybin in people with cancer experiencing anxiety relating to their illness. The piece quoted Grob and Dr. John Halpern, the principal investigator of the MAPS-sponsored study of MDMA in people with cancer-related anxiety.
January 30, 2005. The New York Times Sunday Magazine published a profile of psychedelic chemist, Sasha Shulgin, that highlighted the approval of MDMA research at Harvard sponsored by MAPS (though MAPS was not mentioned). The article includes a quote from Dr. Steve Hyman, Harvard Provost and ex-Director of the National Institute of Mental Health, saying that he is skeptical whether MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer will actually prove beneficial but that he thinks the research should go forward. The ghost of Timothy Leary has now definitely be laid to rest at Harvard. Now it's up to us to prove what we have been saying for decades, that MDMA and other psychedelics have remarkable healing potentials. As the saying goes, "Beware what you wish for." The challenge of proving the safety and efficacy of psychedelic psychotherapy is formidable, but definitely a goal worth the decades of prior and future work.
Psychiatry News (a publication of the American Psychiatric Association) reported on the proposed MDMA/cancer anxiety study, with quotes from principal investigator John Halpern MD.
The Boston Globe published an article contrasting FDA approval of MAPS' study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer with DEA rejection of Prof. Lyle Craker's MAPS-sponsored application for a license to establish a facility to produce marijuana for federally-approved research.
The Week in Review section of the Sunday New York Times had a thoughtful but rather snide and inaccurate article on the research into the use of MDMA and psilocybin in the treatment of anxiety associated with advanced cancer.
Prof. Mark Kleiman criticizes a NYTimes article on the use of psychedelics in treating anxiety in subjects with advanced-stage cancer. He notes the flawed central assumption of the article which is that "all "drugs" are alike, and that "drugs" have the property of dulling perception and cognition, making people less present to what is happening to them."
Dr. John Halpern submitted his application today to DEA for a Schedule I license, the final regulatory approval required before we can begin the MDMA/cancer anxiety study. Dr. Halpern has already received his State Schedule I license.
Dr. John Halpern is the guest on C-SPAN's Washington Journal for a live, half-hour national call-in show focused on Dr. Halpern's MAPS-sponsored study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer.
The Boston Herald published a short piece describing the MDMA /cancer anxiety study, quoting primary investigator John Halpern and MAPS President Rick Doblin.
MAPS donated $26,616 to McLean Hospital, Harvard University, for Dr. John Halpern’s MAPS-sponsored study of the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. This represents the first payment in what we expect will total $250,000 for this study. The approval of this study by McLean Hospital (where the MDMA-assisted psychotherapy will take place), the Lahey Clinic (where the patients receive primary care for their cancer), and the FDA, represents a triumph of hope over fear, hope for the too-long obstructed promise of MDMA-assisted psychotherapy v. fear of the risks of MDMA exaggerated by anti-drug crusaders and scientists for their own ends. At a time when the US government has placed all its eggs in the fear basket (war, terrorism, “drugs”, financial ruin of Social Security, gay marriage, etc., etc.), the remarkably widespread media reporting of FDA’s approval of psychedelic research again at Harvard after 40 years shows that people are eager for balance, for hopeful news. It’s now clear that the American public would welcome whatever help can be provided in facing directly life’s final challenge, to die gracefully and in peace, even if such help comes from a previously demonized and criminalized substance also used by young people seeking pleasure.
The Harvard Crimson reported on the MDMA/cancer anxiety study that will be taking place at McLean Hospital. Principal Investigator John Halpern MD is quoted, as well as MAPS President Rick Doblin PhD. The on-line version of this article has a link to a letter written by Timothy Leary and Richard Alpert (Ram Dass) and published in the Crimson in 1962.
An amazing editorial, Examining Ecstasy, about FDA approval of MAPS' MDMA/cancer anxiety study, was published today in the Ottawa Citizen. MAPS' Harvard study is considered restrained and Charles Grob is chastised for speaking of potential spiritual benefits!
An article in The Australian reports on the FDA approval of MAPS' MDMA/cancer anxiety study and quotes Australian Medical Association Queensland public health committee chairwoman Jeanette Tait as saying, "The medical community would look askance at this type of trial, except that it is being conducted by such a respected body," she said. "As it is such a fairly substantial body doing the trial, especially with FDA approval, I think the results will be very interesting. There's so much to be wary about illicit drugs and their use." Dr. Tait's comments reaffirm the value of MAPS' efforts to conduct MDMA psychotherapy research at Harvard, since the research is being taken more seriously as a result of where it is being conducted.
Excellent Washington Post article by Rick Weiss about FDA approval of MDMA/cancer anxiety research and general renewal of research into the therapeutic potential of MDMA and psychedelic compounds. [ Also see scans of the article. ]
The AP Wire Service published a report on the recent FDA approval of the MDMA/cancer anxiety study, with quotes from principal investigator John Halpern MD.
A fateful step has been taken. Today, MAPS submitted Dr. John Halpern’s MDMA/cancer anxiety protocol and associated documents to the FDA. FDA should receive the protocol Monday, November 22 and will then have 30 days from that point to review it. FDA will either approve the protocol or place it on clinical hold pending resolution of any issues FDA felt it appropriate to raise. If approved by FDA, the last remaining major hurdle before the study can start will be Dr. Halpern’s need to obtain a DEA Schedule 1 license to dispense the MDMA to be used in the study. After FDA approval has taken place, we feel that DEA will most likely issue the license sooner rather than later, probably voluntarily. DEA cooperation will be due to the compelling nature of this study, the amount of existing interest and support, the very low risk of diversion since there are no “take-home” doses, and, most importantly, the regulatory limits on the factors that DEA can use to evaluate applications for Schedule I licenses to conduct FDA-approved research. If fully approved, this study will become the first psychedelic research to take place at Harvard since 1965. A new era will then have begun in earnest 21st Century psychedelic research!
At the request of our Institutional Review Board (IRB), MAPS has established a Data Safety Monitoring Board (DSMB) that works for MAPS reviewing the data from Dr. Mithoefer’s MDMA/PTSD study on an ongoing basis. The DSMB met today to review the charts from the first five subjects who have completed their final follow-up evaluation. which takes place two months after the second experimental session. The DSMB concluded that “We did not see any significant adverse events that caused us any concerns about the safety of this study.” They recommended that “the study continue without modification.” The next scheduled meeting of the DSMB will take place after the next five subjects (the 6th-10th) have completed their final follow-up evaluations. The DSMB will also meet if there is a serious adverse event.
The McLean IRB approved the shortened informed consent form for the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer.
The Lahey Clinic Institutional Review Board (IRB) met this evening to review the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer, to be directed by co-investigators Dr. John Halpern, Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel. This protocol has to be reviewed and approved by both the IRB at McLean, where the psychotherapy and experimental sessions will take place, and by the IRB at Lahey Clinic, where Dr. Shuster works and from where the subjects will be recruited.
After the protocol was introduced by Dr. Shuster, Rick Doblin, Ph.D. and Dr. Halpern responded for about 30 minutes to a series of thoughtful and important questions from members of the IRB. The protocol and second, short informed consent form (covering just the initial screening process at Lahey) were then…approved! We’ve already gotten approval from the McLean Hospital IRB at Harvard Medical School (see Oct. 27, 2004 entry), so now it’s on to the FDA. We expect to submit the documents to FDA within the next week to ten days. FDA must, by regulation, respond in some manner within 30 days.
Harvard Medical School’s McLean Hospital Institutional Review Board (IRB) met to review the MAPS-sponsored pilot study designed to explore the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer, to be directed by co-investigators Dr. John Halpern, Dr. Todd Shuster, Dr. Umadevi Naidoo, and Dr. Arthur Siegel. The protocol was…approved! The only conditions were that that the approval was subject to FDA and DEA approval, and we were requested to shorten (!) the informed consent form.
As a result of a FOIA request made earlier this year, MAPS now has information on National Institute on Drug Abuse (NIDA) funding awarded to Dr. George Ricaurte and Dr. Una McCann in 2003 for the study of MDMA (Ecstasy) neurotoxicity and functional consequences of Ecstasy use. The pair of Johns Hopkins researchers were awarded over $1.8 million dollars during 2003. This brings their total government funding to more than $16.4 million since 1989.
View As Single Entry > October 8, 2004 Boston Phoenix "This is your Brain on Drugs" by Mike Miliard.
The October 8-14 Boston Phoenix features an interview with MAPS' president Rick Doblin Ph.D. that discusses, among other things, ongoing research into the therapeutic effects of MDMA, psilocybin, and marijuana.
The Salt Lake City Weekly published a piece on Ecstasy & Therapy. The piece includes interviews with two therapists practicing "underground" MDMA-assisted therapy, and an interview with Rick Doblin Ph.D., president of MAPS.
Wired published a piece charting the progress of research into the therapeutic uses of psychedelic drugs, including the ongoing studies of MDMA-assisted psychotherapy in people with PTSD, psilocybin in people with OCD, and psilocybin in cancer patient with anxiety, as well as planned studies into MDMA-assisted therapy in people with anxiety associated with advanced stage cancer, and psilocybin and LSD in people with cluster headaches.
View As Single Entry > September 14, 2004 Movement Disorders "Three Letters: Ecstasy and Parkinsonism" by Multiple.
The journal Movement Disorders has recently published two letters in response to a report of http://www.maps.org/sys/w3pb.pl?mode=search&c_pkey=20631&displayformat=allinfo&type=citation" target = new>parkinsonism in a former ecstasy user, and include a reply from the authors of the case report. The two letters include a letter authored by MAPS' Lisa Jerome and Rick Doblin and MDMA/PTSD study principal investigator Michael Mithoefer, and a report of a transient dystonia appearing after Ecstasy use. In their reply to both letters, the authors acknowledge the likely rarity of movement disorders associated with Ecstasy use, but fail to discuss the lack of evidence for a relationship between Ecstasy use and movement disorders.
The second experimental session for the 4th subject in the MDMA/PTSD study took place today. The session went very well. The next Data Safety Monitoring Board (DSMB) meeting will take place after the 5th subject has completed the final follow-up testing, two months after that subject’s 2nd experimental session.
Dr. John Halpern submitted a lengthy response to the questions that we were asked to address by the IRB reviewing the MDMA/cancer anxiety study. Now we wait until the IRB meeting at the end of August to see if there are more questions. We’re feeling hopeful about an eventual resolution of all the issues.
Medicine Hope for Psychedelic Drugs, an article from BBC News (UK Web), by Arran Frood, discussed psychedelic psychotherapy research supported by Heffter Research Institute and MAPS. This article is mostly based on an interview with Dr. Charles Grob and leaves the impression that it's about time that research into the therapeutic uses of psychedelics has resumed.
MAPS’ Data Safety Monitoring Board (DSMB) for the MDMA/PTSD study met today to review the data on the first five subjects who participated in at least one experimental session. The DSMB was comfortable with the data, and has recommended that the study continue as designed, without any modification.
The third subject in the MDMA/PTSD study participated in the second (and final) experimental session. The experimental sessions have all been scheduled on Fridays, which is working out to be a convenient time and gives subjects the weekend to rest and reflect.
The Charleston, South Carolina Post and Courier published an article about the MDMA/PTSD study. While the article overemphasizes the supposed dangers of MDMA, it does at least give the impression that MDMA may indeed have therapeutic potential. Dr. Mithoefer has written a letter to the editor clarifying some misleading statements made in the Post and Courier article. The Post and Courier also published another article on the history of psychedelic research.
On August 8, the Post and Courier printed the following correction: "A story on Page 1A of Wednesday's editions of The Post and Courier incorrectly stated that Dr. Michael C. Mithoefer was administering Ecstasy to "patients." The story should have made it clear that the drug was being given to research subjects. The federally approved research program is unrelated to Mithoefer's private practice and patients. Dr. Mithoefer also notes that the story would have more appropriately drawn a distinction between dangerous recreational use of Ecstasy and controlled clinical studies if it had noted other studies, including three US studies approved by the FDA, that found "no serious adverse events" and "no evidence of neurotoxicity" in tests administered under medical supervision."
The McLean IRB meet on Wednesday to review the MDMA/cancer anxiety study. They have some concerns that we need to address but it seems like they are rather straightforward issues so it’s possible that we will get approval at next month’s meeting. If so, then we will start seeking the rest of the approvals (from an IRB at the Lahey clinic where the oncologist works and where the subjects will come from, FDA and DEA).
A front page article in the Sunday Baltimore Sun discussed MAPS' MDMA psychotherapy research in a favorable light, illustrated with a photo of Rick Doblin. Of special note is the conclusion, in which Dr. George Ricaurte says that MDMA may one day find a place as an accepted medication. On July 29, the Sun published a clarification to the article.
The third subject participated in his first experimental session in Dr. Mithoefers’ MAPS-sponsored MDMA/PTSD study, without any adverse side effects. Several additional subjects are also scheduled to participate in their first experimental sessions during this month.
MAPS’ effort to start research at Harvard into the use of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced cancer began a new phase today, as Dr. John Halpern submitted a draft of the protocol to the McLean Hospital Institutional Review Board (IRB) for preliminary review. We anticipate several months of review and discussion before we will be able to determine if the protocol will be accepted. If so, the study then moves to the Lahey Clinic IRB for further review (Dr. Todd Shuster, oncologist co-investigator, works at Lahey Clinic and will refer subjects to participate in the study), and then on to the FDA. We’re hoping that this study will be the vehicle to restart psychedelic research at Harvard again, for the first time since 1965!
Dr. John Halpern of Harvard Medical School’s McLean Hospital submitted a protocol for review to the McLean Institutional Review Board (IRB) for a MAPS-sponsored study of MDMA in the treatment of anxiety in advanced stage cancer patients. After years of laying the groundwork for this study, and months of protocol development, we have now formally begun the effort to open a new area of research for MDMA and to restart psychedelic research at Harvard for the first time since 1965. If the McLean IRB approves the study, the protocol will then go to the IRB at Lahey Clinic, where oncologist and co-investigator Dr. Todd Shuster works and from where the subjects will be referred into the study, and then on to FDA. We anticipate that this study will take three to six months to become fully approved and hope to start treating the first subjects in late 2004 or early 2005.
Before MDMA was criminalized in 1985, several psychiatrists and therapists worked with cancer patients with MDMA with positive results in terms of reduced anxiety and pain. In the 1960s and early 1970s, LSD was also used successfully in the psychotherapeutic treatment of cancer patients. MAPS work to resume this line of research at Harvard represents an extremely important effort to start a new era of psychedelic research, at a culturally symbolic place where many people think psychedelic research went off the track, evidenced by Timothy Leary and Richard Alpert (Ram Dass) being kicked out of Harvard in 1963. After almost 40 years in the proverbial wilderness, its time for psychedelic research to return to Harvard!
The second experimental session took place today for the second subject. (Due to scheduling complications, the first subject’s second session is scheduled for next week.) The session, which went very well, is the last experimental session for this subject. She will receive some additional non-drug psychotherapy and a final follow-up evaluation two months from now.
Nature publishes a lengthy article and
editorial about MDMA psychotherapy research. The articles, about which Rick Doblin has written a lengthy commentary, are supportive of MAPS' research efforts. Alex Gamma wrote a letter to the editor responding to claims of insufficient knowledge of extent of risks in human trials made in the piece and providing greater detail on a human trial of MDMA described in the article.
Rick Doblin met in Jerusalem with Dr. Miki Reiter, Israeli Ministry of Health, about MAPS’ proposed Israeli MDMA/PTSD pilot study in subjects with war and terrorism-related PTSD. Dr. Reiter is supportive of the project and welcomed MAPS offer to donate $75,000 to fund the pilot study.
An Israeli dentist who survived a suicide bombing in a Jerusalem cafe in March 2002 that killed about 11 people met in person with Rick Doblin in Jerusalem. The dentist contacted MAPS last week after searching the internet for pages about MDMA and PTSD. The dentist, who has permanent hearing loss but wasn’t otherwise seriously wounded, developed PTSD after the bombing. After treatment with psychotherapy and SSRIs that was only moderately helpful, he discovered on his own that MDMA was of major benefit to him. He contacted MAPS since he felt it was a shame that MDMA had been available to him only illicitly and at risk to his professional license. After a long discussion, he surprised Rick by mentioning that the place he had chosen for their meeting was the same cafe in which the bombing had taken place. He has written a report, which is followed by additional comments from Rick.
Rick Doblin met in New York City with Israeli psychiatrist Dr. Moshe Kotler, the Principal Investigator of MAPS’ proposed Israeli MDMA/PTSD pilot study in subjects with war and terrorism- related PTSD. Now that the US study is fully approved, Dr. Kotler feels the time is right to move forward with the protocol design and approval process for the Israeli pilot study. Dr. Kotler used to be the chief psychiatrist for the Israeli Defense Forces (IDF).
The second subject participated in her first experimental session (MDMA or placebo). Each subject will receive two experimental sessions, two to three weeks apart, in additional to about 8 non-drug psychotherapy sessions. This study is now well underway and is moving forward steadily.
This is the 61st anniversary of the world’s first planned LSD experience. On Monday, April 19, 1943, at 4:20 PM, Albert Hofmann ingested 250 micrograms of LSD and neither he nor the world was ever the same again. Albert was trying to determine if an odd experience he had on Friday, April 16, 1943, was related to the LSD that he was synthesizing. Turns out, it was!
Historic Days! The first experimental session in MAPS’ MDMA/PTSD study took place today. Both the subject and the experimental team guessed that the substance that was administered was MDMA instead of the placebo. In any case, the session was remarkably therapeutic and seemed to represent a breakthrough for the subject. Sixty-one years ago, on April 16, 1943, the world’s first LSD experience took place due Dr. Albert Hofmann’s accidental ingestion of some of the chemical that he was synthesizing. The date of the first experimental session in the MDMA/PTSD study was set several weeks ago. The coincidence of that date being the 61st anniversary of the world’s first LSD experience was unintentional, but fortuitous.
MAPS
issues a report based on documents obtained through Freedom
of Information Act (FOIA) requests showing that from 1989-2002,
Drs. Ricaurte and McCann received federal grants totaling over $14.6
million dollars for MDMA and MDMA-related research. (A FOIA request
for 2003 data has been submitted.) This is a rather amazing amount
of money and suggests that Drs. Ricaurte and McCann had some powerful
incentives to exaggerate the risks of MDMA. This also speaks volumes
about our society’s warped priorities in that not a single penny
of federal money has been awarded to explore any of the therapeutic
uses of MDMA. This is an imbalance that MAPS hopes to rectify over
the coming years.
In
an article in Talon News (bringing the conservative message to America),
the fundamentalist drug warrior, Rep, Mark Souder, Chairman of the
House Government Reform Subcommittee on Criminal Justice, Drug Policy,
and Human Resources and author of the infamous law that denies educational
loans to students with a prior drug conviction, has strongly criticized
Peter Jennings’s Ecstasy Rising documentary. Rep. Souder’s criticisms
of Peter Jennings’ "lack of a moral compass" demonstrate yet again
that the Drug War is a holy, moral crusade where facts are subjugated
to ideology.
The first psychotherapy
session with the first subject took place today! In addition, a
second subject passed the screening process and has qualified for
the study. This study is definitely underway, full speed ahead.
A new
study of MDMA self-administration in monkeys found MDMA to be
far less toxic than assumed from previous studies. Study findings
suggest that when monkeys take doses of MDMA similar to those used
by Ecstasy-using humans, there are no signs of harm to serotonin
or dopamine cells. Study findings also suggest that monkeys, like
humans, may slowly lose interest in taking MDMA over time, and that
this change of heart is not a sign of brain toxicity.
A DEA-licensed pharmacist, a Randomization Monitor, and Dr. Mithoefer are creating the MDMA and placebo capsules
today for use in the MDMA/PTSD study. The process is being filmed
by a camera crew from ABC for use in a feature story about the MDMA/PTSD
study to be aired on World News Tonight at 6:30PM EST on April 1.
Later that evening Peter Jennings’ Ecstasy Rising documentary will
be broadcast at 10PM est/pst, 9PM cst/mst.
IRB approval was extended another six months,
to September 15, 2004, or until the first Data Safety Monitoring
Board (DSMB) report is available. Approval is conditional upon review
of the data on an ongoing basis by the DSMB. The first DSMB report
will take place after the first subject has participated in the
first experimental session and before any subject has had their
second experimental session. This first DSMB meeting will most likely
take place in late April or early May. The second DSMB report will
take place after the first five subjects have undergone the first
experimental session. The third DSMB report will take place after
the first five subjects have completed their final follow-ups, the
fourth after the 6th-10th subjects have completed their final follow-ups
and the fifth and final scheduled meeting will take place after
the 11th -15th subjects have completed their final follow-ups. Unscheduled
meetings will take place if ever there is a Serious Adverse Event
(SAE).
Spanish MDMA/PTSD Study Investigator Analyses Prospects for Restarting Spanish MDMA/PTSD Study
On March 15, 2004, the lead investigator for MAPS’ concluded Spanish study of MDMA-assisted psychotherapy for PTSD, Jose Carlos Bouso, PhD, submitted this political analysis:
Now that the progressive party won the national elections, I think drug policies will hopefully change for the better. The disappointing part of the story is that in the regional elections in the State of Madrid that took place last October, the conservative party won again which makes it difficult to restart the study since they are the same politicians who stopped it. Since all the hospitals in the State of Madrid belong to the government of the State of Madrid, it will be quite difficult to restart the study. But I will try anyway.
Since last Thursday all the media are talking about PTSD and now it seems clear that we need better therapeutic approaches. This is the argument, besides the beginning of the US MDMA/PTSD project, that I will use when I start again to ask for permits from the politicians in the State of Madrid. I am not optimistic, but I will try. It is sad, because last October if the progressive party had won, I am sure the study would have been restarted by now. So, though we have now have a new general government, it doesn’t have relevance to restarting the study.
MDMA arrives! Today the tiny amount of
MDMA required for the MDMA/PTSD study (4 grams) arrived, shipped
with all the appropriate DEA forms and procedures. Patients are
being scheduled for screening to see if they meet the inclusion
and exclusion criteria. This study is now fully underway. The tentative
date for the first experimental session is April 16, completely
coincidentally the same date that, in 1943, Albert Hofmann first
accidentally discovered the psychedelic properties of LSD.
Spanish MDMA/PTSD Study Investigator Appears on Spanish Television Debate
On March 12. 2004, Jose Carlos Bouso, PhD, participated in a televissd debate about drug policy. Here is his report:
Neither the Director of the Spanish Antidrug Agency nor the Director of the Madrid Antidrug Agency attended the debate. They delegated their participation in some of their employees. The debate was attended by:
A representative of the Spanish Antidrug Agency
A representative of the Madrid Antidrug Agency
A representative of an Association that works rehabilitating drug abusers
A social worker
A psychiatrist on the Universidad Complutense of Madrid
And me.
The debate was well. It was focused on the problems associated with recreational drugs, above all, cannabis, which it seems is the new “dark beast” to the Spanish authorities. I had to clarify some misconceptions regarding cannabis toxicity, but as time was passing by, the issue of MDMA/PTSD research was being forgotten by the moderator. I used the last minutes of my intervention to talk about the MDMA/PTSD research projects that was/are being developed both in Spain and US. I said that the Spanish project was stopped for political reasons and that the US just approved a similar project. Though it was quite difficult to talk about PTSD/MDMA research because the interest of the debate was focused on other issues, I was able to dedicate a couple of minutes to that. I am quite satisfied with my interventions and I hope that it could serve to transmit to the public opinion another way of understanding forbidden drugs, which includes an understanding of their therapeutic potential.
The TV debate will be released in 2 weeks, but not on important TV channels, but I hope that it could still reach a wide number of people in Spain. On the other hand, during these sad days all the media are talking about PTSD. I hope the upcoming Nature article will serve to call the attention of the Spanish media to MDMA/PTSD research.
Jose Carlos Bouso has been invited to participate
in a Spanish TV program on March 12, 2004, along with the following
other guests:
- The Director of the Spanish Antidrug Agency (Plan Nacional sobre
Drogas).
- The Director of the Madrid Antidrug Agency.
- The President of the Help Against Drug Addiction Foundation (FAD,
Fundacion de Ayuda Contra la Drogadiccion), the most important private
organization "against" drugs in Spain.
- One famous Spanish sociologist expert in drug abuse.
Jose Carlos has an excellent opportunity to raise the issue of
the willingness of supporters of the Drug War to suppress science
and ignore the welfare of PTSD patients in order to support Drug
War propaganda.
Spanish MDMA/PTSD Study Investigator Invited to Appear on Spanish Television Show
On March 4, 2004, the lead investigator for our Spanish study of MDMA-assisted psychotherapy for PTSD, Jose Carlos Bouso, PhD, was invited to participate in a Spanish TV program on March 12, 2004, along with the following other guests:
The Director of the Spanish Antidrug Agency (Plan Nacional sobre Drogas)
The Director of the Madrid Antidrug Agency
The President of the Help Against Drug Addiction Foundation (FAD, Fundacion de Ayuda Contra la Drogadiccion), the most important private organization “against” drugs in Spain
One famous Spanish sociologist expert in drug abuse
Bouso has an excellent opportunity to raise the issue of the willingness of supporters of the Drug War to suppress science and ignore the welfare of PTSD patients in order to support Drug War propaganda.
DEA
Accedes to Ecstasy Test by Kristen Philipkoski, Wired News.
This article contains a remarkable quote from George Ricaurte giving
qualified support for the MDMA/PTSD study.
The Israeli newspaper, Maariv, published
an article
about the approval of the MDMA/PTSD study, entitled "United
States Approves Ecstasy to Treat Trauma: The FDA says the party
drug will be used to treat people who have been sexually assaulted"
by Alex Doron.
One of most important national Spanish
newspapers (El Mundo) published an
article regarding the final approval of the US MDMA/PTSD study
in its Science section. The article is quite favorable and also
tells that the MAPS-sponsored Spanish MDMA/PTSD study was shutdown
for political reasons. We will continue to struggle to reopen the
Spanish MDMA/PTSD study.
CNN
Show: American Morning, 7 AM. Dr. Drew Pinsky thinking too reductionistically_
about the use of MDMA for the treatment of PTSD, "...it’s quite
legitimate...I think the idea that it creates a psychological effect
may be somewhat naive, the idea that somehow people are more open
to looking at the narrative around their trauma because of the sort
of subjective effects of the drug, that, to me, is kind of naive
because it’s so biologically powerful. It’s almost like looking
at electric shock therapy again."
Major Spanish Newspaper Announces New MAPS MDMA/PTSD Study
On February 26, 2004, one of most important national Spanish newspapers (El Mundo) published an article (PDF) about the final approval of MAPS’ US MDMA/PTSD study in its Science section. The article is quite favorable and also tells that the MAPS-sponsored Spanish MDMA/PTSD study was shutdown for political reasons. We will continue to struggle to reopen the Spanish MDMA/PTSD study.
MAPS donated $11,000 to McLean Hospital,
Harvard Medical School, for Dr. Halpern’s work on the protocol design
and approval process for a study of MDMA-assisted psychotherapy
in subjects with anxiety as a result of end-stage cancer, with outcome
measures to evaluate anxiety, pain and quality of life. MAPS has
previously donated $15,000 to McLean for this study on June 2003.
We plan to submit the protocol to the McLean IRB before the end
of Summer 2004.
Ecstasy
Agonistes A retracted study on a controversial substance raises
questions about the reliability of government-sponsored research
on drugs, By Thomas Bartlett, Chronicle of Higher Education
The Chronicle of Higher Education’s February 25, 2004 colloquy
live email chat with Rick Doblin is available in the Chronicle
archive.
Inching closer! Dr. Mithoefer spoke
with Dr. Belinda Hayes at DEA headquarters. She indicated that DEA
has received a fax of the document they need from FDA but not the
hard copy which they need to issue the license. She says the person
at FDA claimed to have mailed it 2 weeks ago. She said it should
only be a matter of days once they get the document before they
get it "entered into the system" and then issue the license.
Dr. Mithoefer received a call from DEA
indicating they have not received the official reply from FDA yet
in response to their request for a consultation. However, they know
that FDA recommended that he be given a Schedule I license and as
soon as DEA receives the official reply, they "will be issuing"
his Schedule I license. This is the first time we have heard from
the DEA that Dr. Mithoefer will receive his license and the study
will be able to move forward.
Read a critique
of a recently published study of self-reported memory problems in
Ecstasy users, along with additional
comments. You can also view the
full text of the report in PDF format.
MAPS received a call from FDA reporting
that DEA’s request for a consultation about Dr. Mithoefer’s qualifications
to conduct research has finally arrived at FDA. Furthermore, FDA’s
recommendation has already been sent back to DEA. We are inching
ever closer.
According to the Code of Federal Regulations [section 304(a) of
the Act (21 U.S.C. 824(a))], DEA must issue Schedule I licenses
to researchers with FDA-approved protocols within 10 days of DEA
receiving a recommendation from FDA that an applicant is qualified
to do the research, unless the applicant can be denied on any of
the grounds specified in section 304 (a) and has either 1) lied
on the application, 2) been convicted of a drug felony, or 3) no
longer has State registration to administer controlled substances.
Since none of these criteria apply, we may be quite close to being
able to start this study.
However, there could be some delays caused by the uncertain amount
of time between when FDA sends its recommendation to DEA and when
DEA acknowledges receiving it, with interagency mail notoriously
slow. MAPS will now work to expedite this process however we are
able.
Dr. Michael Mithoefer has been flown
to New York City and is being interviewed today for the upcoming
prime-time Ecstasy documentary being created by Peter Jennings’
documentary team. We’re encouraged that a large national audience
will learn of our efforts to conduct MDMA psychotherapy research.
The documentary will probably be aired in late February or March.
We’re still waiting on DEA to issue Dr.
Mithoefer his Schedule I license. DEA claims it is waiting to hear
from FDA regarding a requested consultation about Dr. Mithoefer’s
qualifications to conduct research. We’ve inquired at FDA to determine
whether DEA’s request for consultation has actually arrived yet
and, if so, when FDA will reply. We expect to hear back from FDA
shortly. According to the Code of Federal Regulations, DEA must
issue a Schedule I license for FDA-approved research within 10 days
of receiving favorable recommendation from FDA unless the applicant
has lied on his application, has had a drug-related felony conviction,
or no longer licensed by the State. Since Dr. Mithoefer cannot be
refused his license on any of these grounds, we’re cautiously optimistic
we will be able to start the study shortly after FDA responds to
DEA’s request for consultation.
MAPS submits a Freedom of Information
Act (FOIA) request to FDA seeking copies of all correspondence between
FDA and either the DEA, the Office of National Drug Control Policy,
or the Partnership for a Drug-Free America, regarding the MDMA/PTSD
protocol. We’d like to see what, if anything, these organizations
have been communicating to FDA regarding this study.
Dr. Mithoefer learned today that on
December 11, 2003, the South Carolina DEA office submitted its recommendation
to DEA headquarters that it give Dr. Mithoefer his Schedule I license
for the MDMA/PTSD study. DEA headquarters told Dr. Mithoefer last
week that it is still waiting to receive a recommendation from FDA’s
Controlled Substances Staff but we have no information as to whether
the FDA has actually received DEA’s request for a consultation.
Step by step we move closer to starting....
A recent media
report appeared, making some unduly alarming claims about MDMA
and "DNA mutations." However, the claims turn out to be false. Read
a
commentary on the research and what it actually meant. You can
also read the full
text (PDF) of the original research report.
This article reports that Ricaurte’s mislabeling error "came to
light when a student attempted to replicate the study and then made
an official complaint when permission to publish the new findings
was denied." In order to verify if this was accurate, Rick Doblin
called the Johns Hopkins press office and was informed that Dr.
Ricaurte says that there is no substance whatsoever to this allegation.
MAPS
sent a letter today to NIDA Director Nora Volkow, Ph.D., responding
to a November 18, 2003 letter
from Dr. Volkow to Rick Doblin. This exchange of letters was
part of a package of material that MAPS sent today to members of
NIDA’s National Advisory Council on Drug Abuse (NACDA) requesting
that NACDA recommend to NIDA that it release information about the
MDMA research of Dr. Ricaurte.
Dr. Volkow indicated in her thoughtful but careful letter that
she didn’t think it was necessary for NIDA to proactively release
the information about the MDMA research of Dr. Ricaurte that MAPS
requested and noted that MAPS will obtain some information as a
result of its Freedom of Information Act (FOIA) request. In reply,
Rick Doblin noted that, " NIDA should be forthcoming with the information
requested. To do otherwise leaves the impression that NIDA is not
actively and aggressively trying to clear up this disturbing episode
that has damaged the credibility of NIDA’s educational efforts regarding
the risks of MDMA and other illegal drugs."
The British newspaper The Guardianpublished
a positive article today about MAPS’ progress towards final
approval of our MDMA/PTSD study. Later today, BBC Scotland will
interview me about the MDMA/PTSD study during its drive-time rush
hour show. BBC World News just called about doing an interview that
it will send out tonight to stations all over the place, and BBC
London called for its Five Live national show. Also, the youth station
in Dublin, Ireland (Spin1038) will conduct an interview. Just the
struggle to obtain permission for the study is presenting us with
some good opportunities to do public education about MDMA.
MAPS’ MDMA/PTSD research team
met in Charleston, South Carolina to review the forms and procedures
that will be used to conduct the study. The meeting went extremely
well. Amy and Todd, the clinical research monitors who are volunteering
to help us implement pharmaceutical-level monitoring and checks
and balances, were impressively professional. This study will be
conducted with a level of formality and oversight that MAPS is implementing
for the first time but that will become standard on all our MDMA
research projects.
Dr. Mithoefer receives his Schedule
I research registration (R1) from South Carolina’s Department
of Health and Environmental Control (DHEC). Dr. Mithoefer is still
waiting on his DEA Schedule I license, which is all we need to get
started with the study.
DEA Inspection goes very well.
Several DEA agents inspected Dr. Mithoefer’s facility today as part
of DEA’s review of his application for a Schedule I license to handle
the 3.5 grams of MDMA needed for the entire study. The inspectors
focused on issues of diversion control and checked out the safe,
the alarm system and the forms and procedures that will be used
to track all of the MDMA and placebo capsules. The DEA agents were
interested in helping Dr. Mithoefer understand and follow their
rules and were quite reasonable. Dr. Mithoefer was told he will
probably receive his license in several weeks to several months.
Protocol Improvements Recommended by IRBs.
Though MAPS’ long series of interactions with multiple IRBs was
often frustrating, several improvements have been incorporated into
the protocol design as a result of recommendations/requirements
made by various of the IRBs.
MAPS has prepared a document
listing these improvements, with the primary ones consisting
of having patients remain overnight in the treatment facility which
will be staffed by an RN, having data periodically reviewed by an
independent Data Safety Monitoring Board (DSMB), requiring subjects
to take a quiz after reading the informed consent form to make sure
the primary risks were understood, and requiring a minimum score
on the questionnaire assessing the severity of PTSD that reflects
a "moderate" severity.
MAPS sends a
letter to all members of the National Institute on Drug
Abuse’s National Advisory Council on Drug Abuse, requesting that
it recommend that NIDA release all the information about Dr. Ricaurte’s
research that MAPS has requested in its Freedom of Information Act
(FOIA) request. (also in Word
format)
Promising news from DEA. DEA has
now scheduled an inspection of Dr. Mithoefer’s facility on October
28, by agents from both the regional DEA office and the South Carolina
Bureau of Drug Control. This is a routine step in the processing
of a Schedule I license. It’s encouraging to see that DEA is finally
moving forward with its responsibilities, now that IRB approval
for the protocol has been obtained.
An article
by Kelly Morris, entitled Concern over research reawakens
ecstasy neurotoxicity debate is published in the journal
Lancet: Neurology Vol 2, November 2003
Nature publishes a short news story (PDF
and HTML)
on the MAPS sponsored MDMA/PTSD study. Nature 425, 552 (09 October
2003)
MAPS has a few comments
on the article.
Could MDMA help people with Parkinson’s
disease ? A
recently published study in marmosets suggests that MDMA can
reduce side effects of some medicatios used in the treatment of
PD.
MAPS responds
to Ricaurte et al.’s retraction letter.
MAPS addresses the evidence that Ricaurte et al. cite in their retraction
letter in which they fail to give up the ghost and make a feeble
attempt to claim that MDMA could, after all, actually cause dopaminergic
neurotoxicity and Parkinson’s Disease.
MAPS Submits FOIA Request to NIDA.
MAPS receives a confirmation
letter from NIDA’s Freedom of Information Act (FOIA) staff that
it has received our request for specific information about the studies
that Drs. Ricaurte et al. conducted with genuine MDMA that failed
to find dopaminergic neurotoxicity, and about the studies that were
conducted with the mislabeled bottles of MDMA and methamphetamine.
The letter seems to indicate that there is a good chance that NIDA
will release most or all of the information we requested, but that
remains to be seen.
Triumph. The
Institutional Review Board (IRB) reviewing Dr. Mithoefer’s MDMA/PTSD
protocol made its final decision -- and approved the study! This
is a historic moment for MAPS and for MDMA research. The approval
marks the end of a three-month process with this IRB, and a 22-month
IRB process overall. Dr. Mithoefer and MAPS have been struggling
to obtain IRB approval since November 2001, when the FDA approved
the study.
This is the eighth IRB to which we’ve tried to submit the protocol.
Five refused to accept it for review (after varying periods of consideration),
one approved it then revoked that approval for political reasons,
and another finally tabled the review, after spending months formally
reviewing the study before making it clear, through unreasonable
demands, that the committee did not want to approve it. Along the
way, we also established a MAPS IRB, but fortunately, we didn’t
need to use it.
The last remaining step before we can begin the study is for Dr.
Mithoefer to obtain a DEA Schedule I license. DEA received Dr. Mithoefer’s
application more than 15 months ago. We hope to receive a license
somewhat quickly now that IRB approval has been obtained, but you
can never tell with DEA. After Dr. Mithoefer does obtain a Schedule
I license, we can finally begin the study of MDMA-assisted psychotherapy
in subjects with chronic Posttraumatic Stress Disorder (PTSD).
MAPS sends
a letter
to NIDA Director Nora Volkow noting the many unanswered questions
in the Ricaurte et al. retraction and requesting the release of
additional information. MAPS states that the credibility of NIDA
is at stake. These sentiments are also expressed in a powerful editorial
just released by the scientific journal, Nature.
Spanish Medical Journal Publishes MDMA Psychotherapy Article
On September 13, 2003, the Spanish medical journal Medicina Clínica published Jose Carlos Bouso’s letter to the editor (PDF, page 3) entitled “MDMA (‘ecstasy’) psychotherapy research.” The letter has been translated into English. A letter by Dr. Fernando Caudevilla Galligo objecting to the political pressures that shut down Bouso’s MDMA/PTSD study was also published.
Amazing Retraction! Dr. George Ricaurte
retracted his paper published in Science on Sept. 27, 2002. He originally
claimed that MDMA caused severe dopaminergic neurotoxicity in primates
injected with a common recreational dose regimen of MDMA, and suggested
that Ecstasy users could develop Parkinson’s. Dr. Ricaurte now reports
that his research team administered methamphetamine instead of MDMA
to his monkeys, a mistake which came to light after he failed to
replicate his findings after the oral administration of MDMA of
even higher doses of MDMA to additional monkeys. Dr. Ricaurte’s
claims were challenged by MAPS in an exchange of letters in Science
in June 6, 2003. Those letters, and a series of media articles about
today’s retraction can be found here.
George Ricaurte, Ph.D.’s retraction
of his paper "Severe dopaminergic neurotoxicity in primates
after a common recreational dose regimen of methylenedioxymethamphetamine
(MDMA)" is published in Science
For the last several months, another independent
Institutional Review Board (IRB) has been reviewing Dr. Michael
Mithoefer’s MAPS -sponsored MDMA/PTSD protocol. Today, we submitted
our response to another series of questions and a revised protocol
and informed consent form. We anticipate hearing from the IRB in
several weeks. MAPS had considered forming its own IRB and had written
a set of required standard operating procedures and obtained commitments
from a group of illustrious people to serve on the MAPS IRB. However,
before launching the MAPS IRB, we decided to try one more time with
an Independent IRB. So far, this IRB has restored our faith in the
IRB review process since the review is being based on the scientific
merits of the design.
If MAPS does obtain IRB approval, the final step in the approval
process will be for Dr. Mithoefer, the Principal Investigator, to
obtain a DEA Schedule I license to handle a total of 3 grams of
MDMA for administration to all the subjects in the study (12 subjects
will each receive a dose of 125 mgs on two occasions, three to five
weeks apart, with another 8 subjects will receive placebo on two
occasions, also three to five weeks apart). While DEA has held up
Dr. Mithoefer’s application for a Schedule I license for MDMA for
over a year, and has previously indicated that it might refuse to
approve Dr. Mithoefer’s license on the grounds that it considered
the study not to be in the public interest, we have more recently
gotten the impression that DEA will indeed approve the license once
IRB approval for the protocol has been obtained. A legal analysis
submitted to DEA by MAPS President Rick Doblin has been helpful
in that it showed that the Controlled Substances Act (CSA) was written
by a Congress that was suspicious the DEA would seek to block medical
research into Schedule I drugs, which has indeed turned out to be
the case. Fortunately, the CSA does not permit the DEA to take the
vague category of public interest into account when it reviews applications
for Schedule I licenses for FDA-approved research but is restricted
to using a much more limited set of criteria relating exclusively
to whether the physician can be trusted to administer the drugs
to the research subjects and not divert any to non-medical uses.
While nothing can be predicted with certainty, it seems that MAPS’
17-year struggle to start MDMA psychotherapy research (MAPS was
founded in 1986) may finally be successful within the next several
months. Time will tell...
Drs. Mithoefer, Jerome and Doblin have written
a reply to the Ricaurte
et al. letter published in Science on June 6, 2003. We have submitted
our reply to Drs. Ricaurte and McCann and indicated that we would
be happy to post their response to the MAPS website if they want
to continue this debate. Read more.
MAPS donated $15,046.25 to McLean Hospital,
affiliated with Harvard Medical School. The donation is to enable
Dr. John Halpern to develop a protocol for the use of MDMA-assisted
psychotherapy in the treatment of anxiety and depression in end-stage
cancer patients, and for work related to obtaining approval for
the study from the McLean Institutional Review Board (IRB) and the
FDA. The donation will support a portion of Dr. Halpern’s time from
now until the end of December 2003.
If this project is approved, it will represent the first psychedelic
research at Harvard since 1965 and will signal the beginning of
the post-Leary era.
Letters in Science. An exchange of letters
about MDMA dopaminergic neurotoxicity between the MAPS MDMA/PTSD
team and the NIDA-funded research team of Ricaurte et al. appeared
in the journal Science, June 6, 2003, Vol. 300, p. 1503-4. MAPS
has already submitted to Science a request for a correction to a
misleading statement in the Ricaurte et al. letter, in which only
one of the primates was claimed to have died from the doses of MDMA
administered, as compared to two primates reported to have died
in the initial paper. For details, see MAPS’ discussion
of the Ricaurte et al. study.
MAPS is in the process of preparing a response to the Ricaurte
et al. letter for the MAPS website and Forum. In brief, Ricaurte
et al. state that dopaminergic deficits will only be found in binge
users, but then discount all the studies in heavy MDMA users that
found no dopaminergic changes by saying that they contained no or
only a few binge users. This raises the obvious question of just
how "common" is this binge use pattern, since they allege in the
title of their paper that the doses they administered to the primates
represented a "common recreational dose regimen." Ricaurte conclude
their letter by saying that "we remain of the opinion that there
are not sufficient data to conclude that clinical MDMA research
can be conducted without running the risk of monoaminergic brain
neural injury." First, it’s impossible to ever prove that there
is no risk. Nevertheless, by Ricaurte et al.’s own admission that
binge use isn’t even the same as heavy use, it is possible to conclude
that there is no evidence that the clinical use of MDMA will in
any way cause dopaminergic neurotoxicity or lead to Parkinson’s.
Note also that Ricaurte et al. conclude with a general statement
about both serotonergic and dopaminergic risk, and dismiss as being
unpublished evidence from Dr. Franz Vollenweider’s PET scan study
that showed no evidence of serotonin changes in MDMA-naive subjects
administered doses of MDMA in the therapeutic range.
Spanish MDMA/PTSD Researcher’s Letter to the Editor Accepted by Medicina Clínica
On May 28, 2003, José Carlos Bouso, PhD, learned that a Letter to the Editor that he wrote to the Spanish Medical Journal Medicina Clínica (Clinical Medicine), was accepted for publication. The letter was in response to an article in the April issue, “Ecstasy: a review of scientific literature about MDMA by Dr. Fernando Caudevilla,” which mentioned MDMA psychotherapy. The original Spanish article can be downloaded here (PDF), and the letter has also been translated into English. MAPS and José Carlos Bouso will continue our efforts to restart the Spanish MDMA/PTSD study and hope that it will eventually be permitted to resume.
Spanish Magazine Uncovers Political Pressure Behind Spanish MDMA Study Closure
On April 28, 2003, a lengthy article in the prominent Spanish magazine Interviu reported on the controversy surrounding the Spanish MDMA/PTSD study and brought to light the fact that the Madrid Anti-Drug Authority actively pressured the Hospital to shut down the study. The article can be seen in the original format in Spanish, and has also been translated into English.
Yet Another Dead End. The new IRB informed
MAPS today that it has decided not to accept the protocol for review.
MAPS was clearly told in writing a month ago that this IRB would
accept the protocol for review. Now, after we spent all the staff
time to prepare and submit the necessary documents and yet another
month has gone by, that decision is reversed. We were told that
the IRB believes that "the local IRB has to take responsibility."
However, there is no local IRB, since the project is not affiliated
with any local institution. A fear of liability was also mentioned.
This is also rather puzzling since MAPS has been able to arrange
for an insurance policy for several million dollars that would indemnify
the IRB from lawsuits, in the extremely unlikely event that a subject
in the study would choose to sue the IRB.
Proposing to research a potentially beneficial use of one of the
most demonized drugs in America, and around the world, could be
considered a fool’s mission. But it’s not, it’s just extraordinarily
difficult and extraordinarily important. After all, MDMA-assisted
psychotherapy really can promote healing in a unique manner unlike
any other prescription medicine. A moment of despair is now in order,
after which MAPS will select a new strategy for moving forward with
this project.
Yet Another New Start. A new IRB has reviewed
the documents from the first two IRBs that led to dead-ends and
agreed to review the protocol. Documents were submitted, with feedback
expected in a month or so.
A Decision to Let the Review Stay Tabled.
Two weeks have passed without MAPS receiving an estimate for the
costs of consultants from the IRC-IRB. In any case, MAPS has decided
to let the review remain tabled, not to pay for consultants, and
start over with another IRB. We didn’t immediately inform the IRC-IRB
since we expected to hear any day about the costs of the consultants,
at which time we planned to explain our decision. The proverbial
straw that broke the camels back was that the IRB indicated that
even though a majority of its members agreed that MAPS has offered
persuasive arguments against the use of a CRO and the multi-site
design, the panel will not withdraw those suggestions unless and
until an unanimous decision is reached after a report from consultants
on seemingly unrelated matters. After waiting until March 25 without
being informed of the costs of the consultants, over a month after
MAPS requested in writing that these costs be provided, MAPS sent
a letter to the IRC-IRB saying that we were withdrawing the application.
MAPS then learned that the staff person at the IRC-IRB with whom
MAPS has primarily interacted has left the IRC-IRB for reasons unrelated
to our protocol.
No Decision Unless Unanimous, and After Consultation.The IRC-IRB sends a letter indicating
that it needs to receive the advice of consultants before making
a decision on the issues of the CRO and the multi-site study. While
the IRC-IRB does indicate that a majority of the members of the
panel find MAPS’ arguments that a CRO is not needed to be "compelling"
and that a majority are willing to consider abandoning the request
for a multi-site study, we are told that no decision will be made
unless it is unanimous, which MAPS is claimed to have previously
agreed to though this was never mentioned before and is not standard
practice.
A Request for A Decision. MAPS phones
the IRC-IRB and requests that the panel make a definite decision
on whether it would require MAPS to hire a CRO and/or move to a
multi-site design, neither of which MAPS is willing to do, before
MAPS decides whether to pay for consultants which the letter from
the IRC-IRB seems to indicate would be focused on issues unrelated
to the need for a CRO and a multi-site study.
IRB Review Tabled.The IRB informed
MAPS that it cannot proceed with its review until it obtains the
advice of two "qualified, objective psychiatric consultants," with
fees for the consultants required to be paid by MAPS. An estimate
of costs will be submitted to MAPS for approval prior to the IRB’s
engaging the services of these consultants.
More Documents. MAPS submitted a document
detailing our standardized procedures for responding to "agitated
subjects, or those with suicidal ideation associated with study
procedures." We also submitted a document
discussing the $175,000 bid that we received from a Contract Research
Organization (CRO) for monitoring the study, along with information
about the volunteer who would monitor the study for MAPS who had
the exact same credentials as the person who would be assigned by
the CRO.
An Exhaustive and Exhausting Reply.
MAPS submitted a twelve page basic
reply (which included in a bit of comic relief a required menu
of the snack foods and drinks that we would offer to subjects on
the MDMA therapy days and our plans for handling the issue of food-related
allergies), and assorted other documents including
a letter from the researcher
conducting the screening and outcome measures explaining that
he had never met Dr. Mithoefer in person and had no particular
interest in MDMA
an eight page informed consent
form for the friend/partner who would pick up the subject
after the MDMA session
a release form for sharing
of subject’s personal medical information
a wallet card for subjects showing
there had participated in a legal MDMA research project in case
they were drug tested for any reason in the several days after
the experimental sessions during which time they might test positive
for MDMA or amphetamines, and
A Rapid Response. MAPS submitted a six
page response focusing just on
the issues of the Contract Research Organization and the multi-site
study requirements, to be following up within a week or so with
a more detailed discussion of these and other issues raised by the
IRC-IRB.
An Astonishingly Depressing Response.
After the extensive discussions and good feelings of the January
28, 2003 in-person meeting, at which we seemingly discussed all
the outstanding issues, the totally surprising reply
sent by the IRC-IRB came with several scientifically misguided new
demands. One of these (hiring a Contract Research Organization to
take over the conduct of the study to avoid "unconscious bias")
was unusual, exorbitantly expensive and unnecessary since the study
was already a placebo-controlled, double-blind pilot study, with
blinded, independent raters. Another (redesigning the study into
a multi-site study with two different therapeutic teams) would probably
not even be approved by the FDA since single-site studies to standardize
the intervention precede multi-site studies. The IRC-IRB response,
which included quite a few other requirements, indicated a profound
misunderstanding by the IRC-IRB of the generally-accepted scientific
research process and communicated that the IRC-IRB was deeply fearful
of approving this protocol.
Though I (Rick Doblin) am by nature happy and optimistic (which
some friends of mine have teasingly referred to as evidence of MDMA
brain damage), the IRC-IRB response resulted in two days of a dark
depressive funk, the likes of which I haven’t felt for almost 30
years, back when I was working through early difficult LSD experiences.
The resolution of the depression came with the decision to throw
myself into responding in detail to the IRC-IRB letter, in the hopes
that a clearer presentation on our part of the qualifications of
our research team members, the logic behind our protocol design
choices, and a willingness to give the IRC-IRB whatever information
it asked for, would result in a return to generally-accepted scientific
research principles.
A Productive Dialogue. The January 28
meeting with the new IRB, at which Dr. Michael Mithoefer and Rick
Doblin, Ph.D. appeared in person, involved a series of thoughtful
questions about protocol design, risk assessment, confidentiality
procedures and the nature of PTSD and currently available treatments.
The meeting was characterized by mutual respect. We expect to receive
a written report outlining the IRB’s decisions within the next several
weeks.
Substantive Reply to IRB. MAPS submitted
a series of documents today to the IRC-IRB, in response to their
initial comments about the protocol which MAPS received on January
6. These documents represent a very substantial amount of staff
time on MAPS’ part and include a twenty page primary response letter, a five page protocol
summary, a two page plan for external
evaluation, a two page phone script
for the initial screening calls from potential volunteers, and a
sixty page updated review of
the MDMA literature published since our initial review was completed.
Dr. Michael Mithoefer and Rick Doblin will meet in person with
the IRB review panel on January 28 to discuss the issues under consideration.
History Lesson for the DEA. MAPS submitted
a letter to DEA from Rick Doblin concerning Dr. Michael Mithoefer’s
July 2002 application for a Schedule I license to possess the MDMA
that will be used in the MDMA/PTSD study. DEA has indicated that
it has safety concerns that need to be addressed before it will
issue the license. However, DEA is only legally charged with diversion
control (preventing drugs approved for medical use to be diverted
to non-medical uses) and has no legal mandate to review safety concerns,
which are the responsibility of the FDA. In 1994, DEA tried to use
similar arguments to justify its delay in issuing a Schedule I license
to Dr. Donald Abrams for his FDA-approved marijuana/AIDS wasting
study. Fortunately, FDA Commissioner Dr. David Kessler protested
to Dr. Lee Brown, Director, Office of National Drug Control Policy
(the Drug Czar), who wrote a letter to DEA Administrator Tom Constantine
reminding him that DEA has no authority to review scientific matters.
Dr. Brown told DEA that established lines of responsibility and
authority should be respected and that national policy was to permit
research with Schedule I drugs. MAPS’ letter reminds DEA of this
history and urges it to respect the national interest in facilitating,
and not obstructing, important research into new treatments for
PTSD.
Renewed hope. Today, MAPS received the
initial set of comments of the
IRC-IRB. My initial impression is that we will eventually be able
to get some protocol approved, but that we might need to limit enrollment
to more severe PTSD patients who have failed on psychotherapeutic
treatments as well as an SSRI, and are 21 or older.
We have been requested by the new IRB to provide a substantial
amount of additional information. We hope to submit our response
within several weeks for the next review, which Dr. Michael Mithoefer
and I will probably attend on either January 28 or February 4. Despite
the additional work that is ahead of us, it’s a profound relief
that the new IRB is willing to approach this issue based on the
science.
A New Start. MAPS submitted the MDMA/PTSD
protocol for review to the Independent Review Consulting Institutional
Review Board (IRC-IRB), with the protocol to be discussed by the
review board on January 2, 2003. Officials at the IRC-IRB have read
the entire correspondence between MAPS and the Western IRB and have
indicated that they will carefully review the protocol on its merits
without bias due to the controversial nature of MDMA-assisted psychotherapy
research. This IRB has a reputation for being rigorous but fair,
a set of characteristics that inspires confidence.
A Shameful Conclusion. On November 20,
after the Western IRB decided not to review MAPS’ MDMA/PTSD protocol,
Rick Doblin spoke to James Baldwin, Ph.D., Executive Director of
the Western IRB. Dr. Baldwin informed Rick that he was not authorized
to speak about what motivated the Western IRB to decide not to engage
in a dialogue about the rationale for WIRB’s decision to revoke
approval, to refuse to continue to review the protocol, and to refund
MAPS’ fee. Instead, Dr. Baldwin suggested that for more information,
Rick should contact Mr. Ron Warren, Senior Vice President of the
Western IRB. After Rick Doblin made repeated attempts over several
weeks to speak with Mr. Warren, his secretary finally informed Rick
Doblin on December 10 that he was unwilling to speak and had nothing
to add to the letter. So it ends, with a shameful silence.
MDMA/PTSD Research in Israel. MAPS sent
a draft of the MDMA/PTSD pilot study that MAPS is seeking to sponsor
in Israel to Dr. Moshe Kotler and Dr. Jorge Gleser, Israeli Ministry
of Health, for their review. MAPS’ conference on MDMA/PTSD research,
held at Beer Yakov Mental Health Center near Tel Aviv on November
14 for members of the Israeli Ministry of Health, the Israeli Society
of Addiction Medicine, and the Israeli Anti-Drug Authority, was
very well received. The conference and the proposed pilot study
were discussed in a positive article mentioned on the front page
of Maariv, Israel’s second largest newspaper. The protocol design
meeting, held at Beer Yakov on Nov. 17, was also productive, with
the draft protocol submitted today reflecting design choices made
at that meeting.
Pathetic News. Ron Warren, Senior Vice
President of the Western IRB, wrote a letter to Dr. Michael Mithoefer,
reporting the outcome of the November 19 meeting of the WIRB’s Executive
Policy Committee. The WIRB letter was two short sentences, "The
Western Institutional Review Board, Inc. (WIRB) has made the decision
not to provide institutional review board services for the Multidisciplinary
Association for Psychedelic Studies (MAPS). Please find enclosed
a refund of your previously paid fees, along with the material you
submitted for IRB review."
The WIRB retreated from its supposed
scientific rationale for revoking approval for MAPS’ MDMA/PTSD study,
as described in its September 6, 2002 letter and critiqued in MAPS’
October 10 letter, and fell back on no rationale whatsoever. The
WIRB has shown itself to be scientifically out of its depth and
lacking of sufficient integrity to acknowledge its mistakes and
refocus on a rational, data-based, risk/benefit analysis of MAPS’
MDMA/PTSD protocol.
Most importantly, MAPS will very soon
start the process of submitting the protocol to another IRB for
review.
MAPS submitted a short
letter to the Western IRB’s Executive Policy Committee, in advance
of its November 19 meeting at which it will discuss its review of
MAPS’ MDMA/PTSD protocol. The letter discussed MAPS’ Israeli MDMA/PTSD
project, briefly reviewed US government and international treaty
policies regarding research with Schedule I drugs, and reported
that MAPS had submitted unpublished data to FDA about MDMA and heart
valve tissue, data which the WIRB cited as partial justification
for revoking approval which neither MAPS nor FDA had seen.
A Surprising New Issue. After reviewing
MAPS’ letter, Dr. James Baldwin of the WIRB informed Rick Doblin
that the October 30 meeting was canceled, but not for the reasons
MAPS had hoped. Dr. James Baldwin said that the meeting was "premature"
because the WIRB now needed to convene its Executive Policy Committee
(EPC) to discuss whether the WIRB should be involved with research
with Schedule I drugs. The next EPC meeting is scheduled for November
19. The WIRB is no longer reviewing the protocol based on the science
but on non-scientific, internal policy issues, not a very encouraging
development.
A Comprehensive, Strong Response. MAPS
submitted a lengthy written response
to the WIRB letter, along with 14 letters of information and support
from MDMA scientists around the world. MAPS’ letter addressed every
point raised in the WIRB letter and was so solid that we thought
perhaps the WIRB would conclude that the October 30 meeting was
not necessary.
A Glimmer of Hope. Rick Doblin speaks
with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin
apologized for the tone of the WIRB letter and seemed to view favorably
MAPS’ arguments. He was informed that the one scientist whom the
WIRB letter claimed was against the study was actually in favor
of the study (subject to two conditions that MAPS could easily agree
with), that the second scientist cited in the WIRB letter was strongly
in favor of the study, and that the third scientist was probably
not fully informed about the details of the protocol and was neither
opposed to or in favor of the study. Dr. Baldwin tentatively scheduled
a meeting between Rick Doblin and Michael Mithoefer and the WIRB
for October 30, in Olympia, Washington.
Outrageous News. Dr. George Ricaurte
publishes an
article in Science reporting on primate data that he claims
suggests that even one night’s recreational use of Ecstasy can lead
to Parkinson’s. This government-funded research, which ignored the
high mortality rate of the test animals and directly contradictory
human data, is a classic example of risk amplification and the demonization
of illegal drugs. MAPS obtained a copy of this article before publication
and responded by sending out our first
press release ever. MAPS’ critique was favorably
reported in articles in the New York Times and Washington Post
and elsewhere. MAPS has also written a letter
to the editor of Science.
John Mendelson, M.D., Associate Professor at University California San Francisco, commented on Michael Mithoefer, M.D.s proposed MDMA study. Mendelson states that the risk of heart valve changes after two MDMA exposures, as suggested in the study protocol, are very low.
Terrible News. The Western IRB, which
approved the MDMA/PTSD protocol on July 10, informed us by letter
that approval was withdrawn. The revocation was based on secondhand
reports of conversations (not on data!) that a WIRB staff person
had with three MDMA researchers. The WIRB letter was written in
a surprisingly insulting manner and contained numerous mistakes.
MAPS was not informed that the protocol was being reevaluated and
did not have an opportunity to respond to the reports by the WIRB
staff person, who didn’t like the fact that the WIRB had approved
the protocol.
Tremendous news. On July 10, we received
word that the Institutional Review Board (IRB) had approved MAPS’
MDMA/PTSD study! We can now definitely say that the US study will
take place. Dr. Michael Mithoefer still needs to obtain his DEA
Schedule 1 license, which should take about 4-6 weeks, but this
is just a matter of time
There is now an excellent chance that the Israeli Ministry of
Health will approve an Israeli MDMA/PTSD study. Michael and I are
tentatively planning to go there in late Sept. or early Oct. for
a one-day seminar organized by the Ministry to discuss the latest
findings in MDMA research, and protocol design options for the Israeli
study.
Here are the financial implications:
We still need to raise an additional $60,000 for the US MDMA/PTSD
study and another $60,000 for the Israeli study. MAPS is also seeking
$10,000 for our National Institute of Mental Health (NIMH) grant
application for support for the development of a treatment manual
that describes in detail hw MDMA-assisted psychotherapy for PTSD
should be conducted and provides specific ways to evaluate whether
the therapy technique itself is being delivered appropriately. We
are also seeking $20,000 for our ongoing MDMA literature review.
Any help or suggestions would be greatly appreciated.
FDA gives final approval to conduct the
treatment sessions in Dr. Michael Mithoefer’s office, with a "crash
cart" and an Emergency Room doctor and nurse in the next room in
case they are needed.
Conference call with Dr. Mithoefer, Rick
Doblin and FDA officials, in which we come to tentative agreement
to conduct the study in Dr. Mithoefer’s office, as long as we hire
both an ER doctor and nurse to sit in the room.
Request submitted to FDA to change the
location of the treatment sessions from the Medical University of
South Carolina (MUSC) to Dr. Mithoefer’s office. We propose renting
a "crash cart" and hiring an emergency room nurse to be on site
in the room next to the treatment room for the first five hours
of each session, in case Dr. Michael Mithoefer and Annie Mithoefer,
R.N. need help responding to an adverse event.
The fourth patient in the Spain MDMA/PTSD
dose-response study was treated on November 28, 2001. We have now
completed the 50 mgs dose group (3 patients received 50 mgs and
1 received a placebo). The next dose level is 75 mgs (5 patients
will receive 75 mgs and 2 will receive a placebo).
It’s my pleasure
to report some excellent news. About 10 AM, Friday, November 2,
FDA contacted me to say that MAPS’ MDMA/PTSD protocol was approved.
This approval marks the culmination of 16 years of efforts to obtain
permission from FDA for MDMA-assisted psychotherapy research, since
MDMA was criminalized in 1985. This approval also marks the beginning
of what I hope will be a $5 million, 5-year project to develop MDMA
into a prescription medicine.
On Wednesday, Dr. Michael Mithoefer,
the principal investigator, and I had a conference call with FDA
during which we discussed various design issues. The conference
call was calm, serious and respectful. We agreed to make several
design changes, mainly closer monitoring of blood pressure and omitting
the opportunity for placebo subjects who still met inclusion criteria
for PTSD at the final evaluation to enroll in an open label extension
study during which they would receive MDMA. We argued against several
other possible changes, mainly the idea that patients should be
required to have had prior experience with MDMA. On Thursday, I
faxed an addendum specifying the changes we had agreed upon and
the places where the protocol needed to be changed. Last night,
I saw on CNN that anthrax was discovered in the FDA mailroom at
Rockville, where the FDA officials reviewing the protocol work.
Today, FDA officials were still at work and informed me that the
protocol was approved without the need for any additional changes.
Of course, we still need to obtain
Institutional Review Board approval from the Medical University
of South Carolina. This should take several additional months.
I’ve already let the Israeli Ministry
of Health know that the FDA approved the study. According to Dr.
Moshe Kotler, the principal investigator of the proposed Israeli
MDMA/PTSD protocol, FDA approval was need for an MDMA/PTSD study
before he would feel comfortable submitting a protocol to the Ministry.
The subjects in the ongoing Spain MDMA/PTSD study are women survivors
of sexual assault with chronic PTSD. The subjects in the FDA-approved
study are women and men survivors of criminal assault with chronic
PTSD. The Israeli study will hopefully include subjects whose PTSD
was the result of war and terrorism.
The formal approval letter from FDA
will arrive next week. -- Rick Doblin, Ph.D.
MAPS submitted
to the FDA today the protocol for Dr. Michael Mithoefer and Dr.
Mark Wagner’s MAPS-supported pilot study into the use of MDMA-assisted
psychotherapy in the treatment of patients who have experienced
criminal victimization and as a result have suffered from chronic,
treatment-resistance posttraumatic stress disorder (PTSD). The submission
of this protocol to FDA marks a major milestone in the history of
MAPS, and hopefully in the history of MDMA research. FDA has 30
days to respond to the protocol. We fully expect FDA eventually
to approve the study in some form.
(Faster download - without
individual case reports from Phase 1 study; longer
version - with individual case reports from Phase 1 study)
As part of its submission to FDA of a protocol
designed to study the use of MDMA in the treatment of PTSD, MAPS’
commissioned an extensive review
of the scientific literature on MDMA. This literature review was
developed under the direction of Matt Baggott with Ilsa Jerome,
Ph.D., and is now being made available to regulatory agencies, other
researchers and the public. The literature review will be updated
on a regular basis as new research is published.
A draft of the MDMA/PTSD
protocol that MAPS has been working for 2 years to develop, with
Dr. Michael Mithoefer and Mark Wagner, Ph.D., at the Medical University
of South Carolina, has now been posted to the web. The protocol
will submitted to FDA shortly after NIDA’s scientific meeting on
MDMA, held at the National Institutes of Health campus in Bethesda,
MD, on July 19-20. If and when it becomes approved in some form,
this protocol will be the first FDA-approved study of the therapeutic
use of MDMA since MDMA was placed in Schedule 1 in 1985.
The US Sentencing Commission held an open
hearing concerning its proposal to increase penalties on MDMA. Testimony
about MDMA opposing the increase was presented by Rick
Doblin, Ph.D., David Nichols,
Ph.D., Charles Grob, M.D.,
Julie Holland, M.D. and
Richard Glen Boire, Esq.
Testimony about legal issues by opponents of the increase was presented
by Ed Mallet, Executive Director of the National Association of
Criminal Defense Lawyers (NACDL), Julie Stewart, Executive Director
of Families Against Mandatory Minimums (FAMM), and Bill McColl,
Legislative Director of The Lindesmith Center/ Drug Policy Foundation
(TLC/DPF). The testimony had little effect and the Sentencing Commission
recommended substantial increases in penalties. MDMA is now, dose
for dose, punished more heavily than heroin.
Judge Diane Murphy, Chair of the
U.S. Sentencing Commission, explained the rationale
behind the Commission’s recommendation during a hearing of the Senate
Caucus on International Drug Control on March 21, 2001. (See also
visual presentation)
MAPS convened a protocol design meeting
in San Francisco to discuss the details of a protocol evaluating
the use of MDMA-assisted psychotherapy in the treatment of Post-Traumatic
Stress Disorder (PTSD). The meeting included. among others, the
principle investigator and therapists of the South Carolina team
(Dr. Michael Mithoefer and Annie Mithoefer, RN), the MAPS team that
has for the last year and a half been reviewing the MDMA literature
for submission to FDA (Matt Baggott, Ilsa Jerome), the team that
has been creating the MDMA bibliography of all scientific papers
on MDMA published in peer-reviewed journals (from erowid.org), and
scientific consultants including Dr. Charles Grob, Dr. George Greer,
and Dr. Dave Nichols. The meeting was quite productive, with the
protocol expected to be submitted to FDA in April 2001.
Rick
Doblin outlines MAPS’ strategy for the development of the therapeutic
use of MDMA into an FDA-approved prescription medicine, at the State
of Ecstasy conference in San Francisco, sponsored by the Lindesmith
Center- Drug Policy Foundation. Additional
transcripts of other speakers have been helpfully archived by
an anti-drug group.
The first patient was treated in the
MAPS-supported MDMA/PTSD study being conducted in Madrid, Spain,
under the director of José Carlos Bouso, Ph.D. candidate. José
Carlos and Marcela Ot’alora were the co-therapists. The four hour
session went very well and the patient seemed to have gotten to
a deeper, more therapeutic level. Of course, we won’t know for some
time whether the patient received a dose of 50 mgs or a placebo!
What we do know is that study is off to a great start. Read
more about this study, including the protocol
and informed consent form.
A Journal of the American Medical Association
(JAMA) letter reports on the DanceSafe/MAPS
pill testing program (the letter says people paid for their own
testing but that was a mistake. MAPS paid for most of the testing
of these pills).
A discussion about "Raves, Ecstasy and
Youth" was held at the Shadow Convention 2000 in Los Angeles. A
celebrity panel of MDMA researchers, experts and psychonauts was
assembled by the Lindesmith Center/Drug Policy Foundation; video
and audio coverage of this unique event can be found at the Shadow
Conventions 2000 website.
May 5-6, 2000. The California Association of Toxicologists
held a conference in North Hollywood, California, the first day
of which was devoted to drugs that are commonly found at raves.
Read summary and comments by Earth
and Richard
G. Boire.
New York Lindesmith Center.Hear
in RealAudioMDMA (’Ecstasy’) Research: When Science and
Politics Collide. Sound quality is excellent except for the
first few minutes, so be patient. Speakers: Julie Holland, MD, attending
psychiatrist, Bellevue Hospital Psychiatric Emergency Room and faculty,
NYU School of Medicine; John P. Morgan, MD, professor of pharmacology,
City College of New York; and Rick Doblin, president, MAPS) and
Ph.D. candidate, Kennedy School of Government, Harvard University,
assessed scientific and political efforts to conduct MDMA research
in the US and abroad. See also the transcript
of Holland’s talk.
A pilot study of MDMA therapy in
the treatment of PTSD has been approved and will be the first formal
therapy study with MDMA ever conducted. (Read
current update. MAPS has pledged $54,000 for this study; we
have raised $23,000 and are seeking additional contributions.
Researchers Present MDMA Research Results at Israeli MAPS MDMA Symposium
On September 1, 1999, Jordi Camí, MD, PhD, Magi Farré, MD, PhD, and José Carlos Bouso, PhD presented their Phase 1 clinical study of MDMA-assisted psychotherapy for PTSD at the MAPS MDMA symposium in Israel.
teleconference
with the FDA concerning MDMA psychotherapy research to treat anxiety,
depression and pain in cancer patients, the FDA indicates a willingness
to approve a "proof of principle" study.
The Observer (UK) "
Many gracious THANX...!
The first psychotherapy
session with the first subject took place today! In addition, a
second subject passed the screening process and has qualified for
the study. This study is definitely underway, full speed ahead. 
