Showing 25 of 490 total entries. View the full timeline of all MAPS MDMA/PTSD projects.

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January 16, 2012

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.

 

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January 8, 2012

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.

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December 25, 2011

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.

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December 9, 2011

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.

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December 3, 2011

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).

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December 2, 2011

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.

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December 1, 2011

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.

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October 24, 2011

New MDMA/PTSD Training Videos Under Development

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.

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October 21, 2011

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.

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October 18, 2011

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.

The lead investigator for this study, Ingrid Pacey, M.D., will speak on the MDMA-Assisted Psychotherapy for PTSD Research Panel at our 25th anniversary conference this December.

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.

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October 15, 2011

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).

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October 14, 2011

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.

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October 12, 2011

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.

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September 20, 2011

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.

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September 14, 2011

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.

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August 10, 2011

First Five Veterans Treated in US MDMA/PTSD Study

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.

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July 30, 2011

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.

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July 24, 2011

Israeli MDMA/PTSD Study Initiated

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.

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July 15, 2011

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.”

Read the rest of Lyvers’ commentary. The July 2011 issue of Addiction also included letters about the Harvard study from Andrew C. Parrott of Swansea University, John E. Fisk and colleagues of the University of Central Lancashire, and Jacqui Rodgers of Newcastle University, as well as a reply from Dr. Halpern.

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July 14, 2011

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.

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July 6, 2011

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).

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June 9, 2011

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.

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June 9, 2011

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.

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June 9, 2011

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.

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June 1, 2011

Data Finalized for Swiss MDMA/PTSD Study

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.

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A Randomized Triple-Blind, Phase 2 Pilot Study Comparing 3 Different Doses of MDMA in Conjunction with Manualized Psychotherapy in 16 Veterans with Chronic Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N.
Location: Charleston, SC (USA)

This pilot Phase 2 study will examine the safety and efficacy of MDMA-assisted psychotherapy in 16 veterans with war-related PTSD. We are seeking equal numbers of male and female subjects. This protocol is randomized, triple-blind, and placebo-controlled. All subjects will receive weekly non-drug psychotherapy and three experimental day-long therapy sessions, scheduled three to five weeks apart. We will test three different doses of MDMA to determine whether this design will result in a successful blind, with subjects, therapists and the independent rater being uncertain about which subject received which dose. Eight subjects will receive a full 125 mg dose followed by a 62.5 mg supplemental dose; four subjects will receive an active dose of 75 mg followed by a supplemental 37.5 mg dose; and four subjects will receive an active placebo dose of 30 mg followed by a supplemental 15 mg dose. According to European Medicines Agency (EMEA) Guidelines for the development of medicines for PTSD, it is important to conduct clinical trials in homogenous populations. The findings of this study in veterans with war-related trauma will be compared to the findings from our first MDMA/PTSD pilot study, which consisted primarily of women survivors of sexual abuse and assault. Previous studies suggest that war-related PTSD may be more prevalent and harder to cure than PTSD caused by other types of trauma, and our study may help to compare the effect of trauma etiology on treatment efficacy (see references).

We are currently seeking research participants for this study. Please visit our participate in research page for more information.

Download the protocol for this study.

We still need to raise approximately $175,000 out of the $595,000 needed for this study. Please consider donating today to make sure this study is completed.

View the timeline for this study.

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On December 23, 2009, we submitted our Investigational New Drug (IND) application to the FDA.

• MDMA/PTSD in U.S. War Veterans Protocol submitted to the FDA on December 23, 2009
• Submission Letter to FDA
• IND form 1571
• Principal Investigator form 1572
• Investigator's Brochure
• Original Protocol Part 1, Part 2, Part 3
• Curriculum vitae of Principal Investigator
• Curriculum vitae of Co-Investigator
• Curriculum vitae of Co-Investigator
• Template Informed Consent
• Draft Case Report Forms

On February 1, 2010, our FDA IND application was approved with no changes required.

On April 1, 2010, the FDA accepted the first amendment to our Veterans of War Protocol.

• Cover letter to the FDA
• IRB Approval Letter
• Summary of Changes
• FDA Forms

On August 27, 2010, the Drug Enforcement Administration (DEA) informed Clinical Investigator Michael Mithoefer, M.D., that it had approved his Schedule 1 license.

On August 31, 2010, we submitted the second amendment to our protocol to the IRB.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)
Principal Investigator: Michael Mithoefer, M.D., with co-therapist Ann Mithoefer, B.S.N.
Location: Charleston, SC (USA)

MAPS’ flagship Phase 2 pilot study is the first-ever protocol evaluating MDMA’s therapeutic applications in clinical trials conducted under an FDA IND. Like all of MAPS’ psychedelic-assisted psychotherapy studies, the protocol is randomized, double-blind and placebo-controlled. All twenty-one subjects with treatment-resistant PTSD, as a result of sexual abuse, crime, or war, have completed the experimental treatment. The study was completed in September 2008 with remarkably promising results.

On July 19, 2010, the results of this study were published in the Journal of Psychopharmacology. Our paper was the journal's most downloaded article in 2010.

On July 27, 2010, data collection was completed for the long-term follow-up to this study. We 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. The data is currently being analyzed and Dr. Mithoefer and colleagues will write a new paper for submission to a scientific journal in January 2012.

• Dr. Mithoefer's MAPS-sponsored MDMA/PTSD protocol

• The study has cost $1.2 Million; all of which has been raised.

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Relapse Study

An Open-Label Proof-of-Principle Study Testing the Use of an Additional MDMA-Assisted Psychotherapy Session in People who Relapsed after Participating in a Phase 2 Clinical Trial of MDMA-Assisted Psychotherapy to Treat Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Clinical Investigator: Michael Mithoefer, M.D.
Location: Charleston, SC

This study 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. 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.

This study has full approval from an Institutional Review Board (IRB), the U.S. Food and Drug Administration (FDA), and the U.S. Drug Enforcement Administration (DEA), and is now being initiated.

• MDMA/PTSD Relapse Study Protocol

This study is expected to cost $31,000, all of which remains to be raised.

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD) Intern Study

The next phase (Phase 3) of our clinical development plan for MDMA-assisted psychotherapy for PTSD will require many more male/female co-therapist teams than are currently available. Finding a cost-effective and sustainable way to recruit effective therapists is therefore a top priority.

In this pilot study, we will investigate the effectiveness of MDMA-assisted psychotherapy for PTSD when one member of the standard male/female co-therapist team is a healthcare intern (being trained in therapy, social work, or nursing). The other member of the team will be a professional therapist trained in our treatment method. As interns work for free in exchange for fulfilling required training hours under professional supervision, this approach would reduce costs and train the next generation of psychedelic therapists.

Principal Investigator: Marcela Otalora, M.A.
Location: Boulder, CO

Subjects will be U.S. veterans with PTSD, mostly from Iraq, Aghanistan, or Vietnam, along with survivors of childhood sexual abuse, assault, rape, and others.

This study is still in the protocol development stage.

This study is expected to cost $250,000, of which $150,000 remains to be raised.

View the timeline for this study.

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Australian Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study will evaluate the safety and effectiveness of MDMA-assisted psychotherapy in 12 subjects with chronic, treatment-resistant PTSD. It will compare the effectiveness of two dosages of MDMA in combination with psychotherapy: 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 other studies and helping us to determine whether two or three sessions is more efficient for use in our Phase 3 studies.

Principal Investigators:Dr. Stuart Saker, MBBS, and Fiona MacKenzie, MPsych(Clinical)
Location: In or near Sydney, Australia

This study is still in the protocol development stage.

View the timeline for this study.

This study has not yet been budgeted. We anticipate costs in the range of $250,000, of which MAPS has pledged $50,000 if the Australian research team raises $150,000.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Ingrid Pacey, MD and Andrew Feldmar, PhD
Location: Vancouver, BC (Canada)

This study has full approval from an Institutional Review Board (IRB) and from Health Canada. Data will also be submitted to the U.S. FDA. Psychiatrist Ingrid Pacey, M.D., a distinguished Holotropic Breathwork facilitator and psychologist Andrew Feldmar, Ph.D. will be the co-therapists leading the study. We are currently working to obtain an import permit to import the MDMA into Canada from a pharmacologist in Switzerland. The study will begin enrollment after the import permit is obtained and an amended protocol is approved by the IRB.

Canadian MDMA/PTSD pilot study protocol

The study will cost $290,000; $279,000 of which remains to be raised.

View the timeline for this study.

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Israeli Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

This study has the approval of the Israeli Ministry of Health and Ethics Committee, and will be initiated pending clearance by the US FDA.

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 ethics committee approved the protocol.

A revised protocol incorporating several changes to the study has been approved by the Israeli ethics committe. After reviewing the revised protocol, the ethics committee forwarded it to the Israeli Ministry of Health, which approved the study on June 1, 2011. The MDMA to be used in the study was previously imported for our earlier Israeli MDMA/PTSD study, so once the FDA has given its final approval we will have the initiation visit and start the study. We anticipate that it will be several months before we are able to begin treating subjects.

We closed our first Israeli MDMA/PTSD study on March 26, 2010, 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 reviewed the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond.

An official at the Israeli Defense Forces has indicated a willingness to refer soldiers with war-related PTSD once the new protocol clears the review process, which will help facilitate recruitment for the study.

New Israeli MDMA/PTSD Pilot Study Protocol (revised February 14, 2011)

View the timeline for this study.

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MDMA-Assisted Psychotherapy in the Treatment of Posttraumatic Stress Disorder (PTSD)

Principal Investigator: Nasser Shuriquie, M.D. and TBD
Location: Amman, Jordan

This study is currently awaiting approval from the Jordanian Food and Drug Administration (JFDA). It will be conducted under the direction of psychiatrist Nasser Shuriquie, M.D., in Amman, Jordan. We have approval from the IRB at Al-Rashid Hospital and are expecting the JFDA to notify us that the study may proceed by the end of April 2011. We hope to enroll Iraqi refugees living in Jordan who have PTSD, along with other Jordanians suffering from PTSD.

• The study will cost $136,000; of which we still need $51,000.

Current versions of study documents are below:

• Revised protocol (PDF)
• Revised One Page Protocol Synopsis (PDF)
• Case Report Forms (PDF)
• Curriculum Vitae of Principle Investigator (PDF)

View the timeline for this study.

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Spanish Study of MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (Concluded)

Started in 2000, this study was the world's first clinical trial to evaluate the safety and effectiveness of MDMA-assisted psychotherapy. This dose-response study, in 29 women with chronic, treatment-resistant PTSD caused by rape or childhood sexual abuse, was designed to compare the effectiveness of five dosages of MDMA in combination with psychotherapy: 50 mg, 75 mg, 100 mg, 125 mg, 150 mg. Six of the 29 subjects were treated before pressure from the Madrid Anti-Drug Authority led to the revocation of permission to use the study site. As of May 13, 2002, when the study was shut down for political reasons, we had completed treating four patients in the 50 mg dose group (three patients received 50 mg and one received a placebo), and two people in the 75 mg dose group (one patient received 75 mg and one received a placebo)

Principal Investigator: José Carlos Bouso, PhD
Location: Madrid, Spain

• Study Protocol (PDF)
• Informed Consent Form (PDF)
• Peer-Reviewed Paper on Study Results (PDF)

May 11, 1999: Study protocol approved by the Research Committee of the Hospital Psiquiátrico de Madrid
July 16, 1999: Study protocol approved by the Ethics Committee of the Hospital Universitario La Paz
February 7, 2000: Study approved by the Spanish Agency for Medicines and Health Products
March 2002: Spanish anti-Ecstasy campaign
May 13, 2002: Hospital Psiquiåtrico de Madrid revokes permission to use facilities
May 23, 2002: Study concluded

View the complete timeline for this study.

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Principal Investigator: Peter Oehen, MD, with co-therapist Verena Widmer, RN
Location: Solothurn, Switzerland

All data gathering has been completed and the results are being written up for publication. All 12 subjects with treatment-resistant PTSD have undergone the experimental treatment. The final subject's last visit took place on January 8, 2010. The final analysis was completed in January 2011, after the last measurements for the one-year, long-term follow-up phase of the study were collected from the final subject. We anticipate that the results will be submitted for publication in Spring 2012.

Our Swiss MDMA/PTSD pilot study had full approval from an Ethics Committee (Swiss IRB equivalent) and SwissMedic (FDA equivalent). The protocol had also been submitted to, and accepted by, the FDA under MAPS’ Investigational New Drug (IND) application for MDMA. The study is a part of MAPS’ clinical plan to develop MDMA into a prescription medicine approved by both the FDA and the European Medicines’ Agency (EMEA).

Swiss MDMA/PTSD pilot study protocol

The study will cost $260,000; $5,000 is still needed.

View the timeline for this study.

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Psychological effects of MDMA administration in normal volunteers training to conduct MDMA-assisted psychotherapy research

Principal Investigators: Michael Mithoefer, M.D. and Ann Mithoefer, B.S.N.
Location: Charleston, SC

This Therapist Training/ Phase 1 psychological effects protocol is a placebo-controlled, double-blind, randomized, cross-over study that allows MAPS to administer a single MDMA-assisted psychotherapy session to therapists as part of their training to conduct MAPS' MDMA/PTSD studies, while also conducting a series of evaluations of the psychological effects of MDMA administered to healthy volunteers in a therapeutic context.

This protocol is based in part on a precedent from the 1970s: Dr. Albert Kurland's LSD research team at Spring Grove Hospital in Maryland had FDA permission to administer LSD to help train nurses, attendants and others working with patients in clinical studies, and to mental health professionals (doctors, therapists, counselors, priests, rabbis) to help them better understand patients or congregants who had experienced LSD. Over 100 people received LSD in those training sessions. MAPS submitted letters to FDA from one of the researchers conducting that program, Johns Hopkins researcher William Richards, Ph.D., and from Daniel Helminiak, Ph.D., Ph.D., LPC, a participant in that program. Below you will find a partial list of documents that MAPS has submitted for this study. The list is not comprehensive because the IRB requested that we not include any proprietary documents and information.

On October 3, 2009, MAPS received a letter from the US FDA allowing the study to proceed. On December 21, 2009, we received IRB approval. On August 9, 2010, Dr. Mithoefer received his Schedule 1 license from the DEA to administer MDMA in this study.

Therapist Training Protocol/Phase 1 Psychological Effects: Amendment 2 approved by IRB 12/21/09 (PDF)

This study will cost $85,000, all of which remains to be raised.

Study Timeline

FDA IND application on June 22, 2009

• Submission Letter to FDA (PDF)
• IND form 1571 (PDF)
• IND form 1571 (PDF)
• Investigator's Brochure (PDF)
• Original Protocol (PDF)

FDA Submission of Amendment 1 on September 16, 2009

• Protocol Amendment 1 (PDF)
• MT-1 FDA approval letter (PDF)

IRB submission of Amendment 1 study materials on October 15, 2009

• Submission Letter to IRB (PDF)
• Principal Investigator Form 1572 (PDF)
• Protocol Amendment 1 (PDF)
• Principal Investigator CV (PDF)
• Co-Investigator CV (PDF)
• Investigator Medical License (PDF)
• MP-1 Preliminary Data (PDF)
• Study Rules (PDF)
• Subject Wallet Card (PDF)
• SUDS test (PDF)
• Interpersonal Closeness Test (PDF)
• IRB correspondence (PDF)

The IRB deferred approval of the study on October 26, 2009




We amended the study and re-submitted to the IRB on December 2, 2009

• IRB Submission Letter (PDF)
• MAPS Response to Deferral (PDF)
• Principal Investigator Form 1572 (PDF)
• Helminiak Letter of Support (PDF)
• Johnson Letter of Support (PDF)
• Richards Letter of Support (PDF)
• Protocol Amendment 2 (PDF)
• Case Report Forms (PDF)
• Template Therapy Manual (PDF)
• Johnson et. al. 2008 (PDF)
• IRB questions about study (PDF)
• IRB correspondence on December 14, 2009 (PDF)
• IRB conditional approval on December 16, 2009 (PDF)
• IRB correspondence on December 17, 2009 (PDF)
• IRB correspondence on December 21, 2009 (PDF)

The IRB officially approved the study on December 30, 2009

We submitted Amendment 2 for FDA Approval on December 30, 2009

• FDA Submission Letter (PDF)

This study has been fully approved.

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MDMA-Assisted Psychotherapy in the Treatment of Anxiety Secondary to Advanced Stage Cancer

Sponsor/Principal Investigator: John Halpern, M.D.
Location: McLean Hospital, Harvard Medical School, Belmont, MA (USA)

Dr. Halpern is the Sponsor/Investigator. In his FDA IND application, he cross-referenced MAPS’ IND for MDMA and MAPS will have full access to the data generated from his study. MAPS conducted the design and protocol approval process for this study through a direct gift to McLean Hospital. This study of twelve subjects was also being conducted under US FDA IND and has received IRB approval and DEA registration.

One subject completed the experimental treatment. A second subject participated in the first of two experimental sessions before dropping out due to a decision to resume chemotherapy, which required them to drop out since the study was only for people who were receiving only palliative treatments. No additional subjects were enrolled and the study was closed due to enrollment challenges.

Protocol submitted to FDA on November 26, 2004 (in HTML or PDF format)

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Treatment Manual for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder

Authors: June M. Ruse, Psy.D., Michael C. Mithoefer, M.D., Lisa Jerome, Ph.D., Rick Doblin, Ph.D., Elizabeth Gibson, M.S.

This detailed manual provides therapists conducting MAPS-sponsored MDMA/PTSD studies with standardized methods. MAPS uses this manual to train therapists and evaluate therapist adherence to the described approach.

Draft of Treatment Manual (PDF) describing MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD), revised November 30, 2011.

Draft of Adherence and Competence Protocol for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD), revised August 19, 2011.

MAPS has also prepared a concept paper that summarizes the rationale, goals, methods, and requirements of our MDMA-assisted psychotherapy research program.

Grant Concept Paper for MDMA-Assisted Psychotherapy for Posttraumatic Stress Disorder (PTSD) Research Program, February 22, 2011.

The project has cost $50,000; $40,000 is still needed.

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Outcome Study of Psychological Defense Mechanisms During MDMA-Assisted Psychotherapy for Treatment of PTSD

Principal Investigators: Pal-Orjan Johansen, Ph.D. (cand) and Teri Krebs

Norwegian University of Science and Technology, Trondheim (Norway)

This study analyzes audio and video recordings of therapy sessions from the ongoing MDMA-assisted psychotherapy studies in the treatment of subjects with PTSD. The objective of this study is to provide empirical evidence on how MDMA influences defense mechanisms in the context of psychotherapy, to understand how MDMA might facilitate the therapeutic process, and to inform the development of a standardized treatment manual for MDMA-assisted psychotherapy.

The study has cost $15,000, with the remainder fully funded.

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September 7, 2010 Here is the most recent version of MAPS’ MDMA Investigator’s Brochure

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Scientific Literature Reviews

MAPS’ comprehensive review of the scientific literature on MDMA Periodic updated reviews of the literature for August/September 2001-January 2003, for 2003-March 2004 (HTML and PDF versions), March 2004-January 2005 (HTML and PDF versions), and a significantly reformatted version covering research up through December 2007 (PDF) Monthly updates of MDMA-related literature MAPS MDMA bibliography with abstracts and PDFs, including a "What’s New" section A review by Alex Gamma, Ph.D. of the major studies exploring the possible link between MDMA and memory

Ricaurte MDMA Research Controversy

Rick Doblin has written a paper discussing how the risks of MDMA neurotoxicity have been exaggerated by government officials and government-funded scientists in a manner that has been used to support prohibitionist policies. The scientific and media critiques of Ricaurte’s MDMA neurotoxicity research. Ricaurte’s July 2003 NIDA Grant Progress Report, obtained 1/26/04 by MAPS through Freedom of Information Act (FOIA) request. Ricaurte explains how he determined he administered methamphetamine instead of MDMA to primates and describes research with genuine MDMA that didn’t cause dopamine reductions. MAPS’ comments on these documents can be found here. Information on grant funding awarded to Dr. George Ricaurte and Dr. Una McCann from 1989 to 2003.

Government Hearings and Conferences

The legal record from DEA’s 1984-1988 MDMA scheduling hearings Testimony by Rick Doblin, Ph.D. and others before US Sentencing Commission hearing on MDMA, 3/19/01 Why MDMA Should Not Have Been Made Illegal by Marsha Rosenbaum and Rick Doblin Meeting agenda and video archives for "MDMA/Ecstasy Research: Advances, Challenges, Future Directions" - NIDA-sponsored conference, July 19-20, 2001.

Media Reports

Merck’s official history of MDMA: Journal article and media report Historical Articles about MDMA 1984-1993 MAPS in the Media Archive: 2000-current

A MAPS History of MDMA

MDMA was synthesized in 1912 and patented in Germany by Merck in 1914 but was not the subject of human research at that time. In the 1950s it was briefly researched by the U.S. Government as part of the CIA’s and the Army’s chemical warfare investigations. It was forgotten until the middle 1970s when it was rediscovered by the psychedelic therapy community and began to be used as an adjunct to psychotherapy by psychiatrists and therapists who were familiar with the field of psychedelic psychotherapy. MAPS published a book, The Secret Chief, about the leader of this therapy community. In the early 1980s, the drug began to be used non-medically, particularly in Texas, under the name Ecstasy. Both the non-medical and therapeutic use of MDMA were made illegal in 1985 despite the Drug Enforcement Administration Administrative Law Judge Francis Young’s recommendation that physicians be permitted to continue to administer it to their patients. Rick Doblin, Alise Agar and Debby Harlow helped coordinate the pro-MDMA contingent in the DEA lawsuit. For an excellent history of the early use of MDMA, see Pursuit of Ecstasy by Beck and Rosenbaum. In 1986, with the goal of developing MDMA’s therapeutic potential through FDA-approved protocols, Rick Doblin founded MAPS as a non-profit research and educational organization with the mission to act as a psychedelic and medical marijuana pharmaceutical company. MAPS immediately opened a Drug Master File for MDMA with data gathered from the standard preclinical animal toxicity studies required by FDA . Subsequently, five different applications for permission to conduct human research with MDMA were submitted to FDA between 1986 to 1988, to the Neuropharmacologic Drug Products Division directed by Dr. Paul Leber. All five applications were rejected. Three protocols for double-blind controlled trials were from researchers at, respectively, Harvard Medical School, UC San Francisco Medical School, and U. of New Mexico Medical School, and were all rejected. Two applications submitted by individual physicians were for single case studies, one for a terminal cancer patient who had been successfully treated for pain with MDMA-assisted psychotherapy prior to the criminalization of MDMA and the other for a unipolar depression patient for whom all available treatments had been attempted without success. Both of these single-patient INDs were also rejected. The FDA based its rationale for rejecting all protocols and single case studies on the hypothetical risk of functional consequences of potential neurotoxicity from MDMA. MDMA research claimed that the rejection of all efforts to conduct FDA-approved MDMA research was based not on rational risk/benefit assessments but on an underlying cultural prejudice against medical research with drugs that were criminalized and on one or more FDA officials’ personal opposition to human research with psychedelics. Since FDA Review Divisions are sometimes described as operating like fiefdoms under the control of their Directors, proponents felt profoundly stymied. Proponents claimed that concerns about MDMA neurotoxicity, which numerous studies had failed to link with functional or behavioral consequence and which in any case had not been clearly demonstrated to occur at all at therapeutic does levels, were reminiscent of scientific research in the 1960s that claimed to prove that LSD damaged chromosomes. These reports were effective in generating public disapproval of LSD and in hindering research but were later determined to have no clinically significant effect. MAPS continued to fund animal toxicity studies at Stanford (1986-1988) and human safety studies at Stanford and Johns Hopkins (1988-1991). In 1992, FDA reviewed a MAPS-supported protocol submitted by Dr. Charles Grob, then at UC Irvine, for a study of the use of MDMA in the treatment of pain, anxiety and depression in cancer patients. FDA’s Drug Abuse Advisory Committee recommended that the cancer patient study be postponed and that a Phase 1 dose-response safety study be conducted first. The protocol was redesigned, with FDA giving final approval for the Phase 1 safety study on November 5, 1992. The safety study was completed in 1995. Data from the safety study revealed no unusual risks and indicated that MDMA could be safely administered within a clinical research context. Dr. Grob submitted the first draft of the protocol for the study of cancer patients in 1997. Negotiations with FDA moved very slowly, due to initial FDA decisions to put MDMA psychotherapy research on a slow track to nowhere. However, FDA opposition eventually lessened as MAPS and Dr. Grob persisted in our efforts to obtain permission for research into the use of MDMA-assisted psychotherapy in cancer patients. A July 24, 1999 teleconference with the FDA concerning MDMA psychotherapy research to treat anxiety, depression and pain in cancer patients went very well, with the FDA indicating a willingness to approve "proof of principle" study. Unfortunately, Dr. Grob’s other work-related responsibilities made it difficult for him to find the time to work on the approval process for this research project. On March 18, 2000, Rick Doblin and Michael Mithoefer met at an ayahuasca conference in San Francisco, sponsored by Ralph Metzner, and begin talking about conducting MDMA psychotherapy research in the US. This marks the beginning of their effort to study subjects with chronic posttraumatic stress disorder. On November 9, 2000, the first subject is treated in Jose Carlos Bouso’s MAPS-sponsored MDMA/PTSD study in Madrid, Spain. On May 13, 2002, the Spain MDMA/PTSD study gets shut down due to political pressure, after six subjects have been enrolled in the study without any persisting adverse effects. Dr. Grob subsequently decided to focus on the use of psilocybin, instead of MDMA, in cancer patients, on the accurate theory that psilocybin research would be less controversial than MDMA research. In June 2003, MAPS starts formally working with Dr. John Halpern, McLean Hospital, Harvard Medical School, on the design of a study administering MDMA-assisted psychotherapy to end-stage cancer patients. Late in 2003, Dr. Grob managed to obtain approval for his psilocybin/cancer patient study.

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PTSD MDMA and PTSD from a suicide bomber MDMA and PTSD from parent's suicide MDMA and trauma from sexual assault MDMA therapy and PTSD from sexual abuse MDMA and PTSD in a WWII Veteran MDMA and PTSD from violent sexual abuse Meditation and PTSD MDMA combined with meditation for PTSD from childhood trauma MDMA and meditation Cancer and Life-Threatening Illness MDMA and anxiety associated with advanced colon cancer MDMA for a couple dealing with anxiety associated with advanced renal cancer (Part 2/Part 3) MDMA for a father and daughter dealing with anxiety associated with pancreatic cancer MDMA for pain caused by cancer MDMA for coming to terms with life-threatening illness Bipolar Disorder MDMA for trauma and bipolar disorder Couples Therapy MDMA for relationships Chronic Pain Daily low-dose MDMA for chronic pain MDMA for chronic back pain Eating Disorders MDMA for anorexia and bulimia MDMA for eating disorders related to sexual trauma Family Relationships MDMA for father-son relationships MDMA for cancer and father-daughter relationships MDMA for family relationships Parkinson's Disease MDMA for Parkinson's disease. (See Dr. David Nichols'critical commentary) Rheumatoid Arthritis MDMA for rheumatoid arthritis Spiritual, Emotional, and Other Therapeutic Accounts Through the Gateway of the Heart by Raplh Metzner, Ph.D., a classic collection of over 50 personal accounts of MDMA for therapy and personal growth MDMA for psychosis MDMA as a more effective adjunct to therapy than ECT or other drugs MDMA for fear and depression MDMA and ovarian cysts MDMA in neuromuscular therapy MDMA for emotional and physical pain in the elderly MDMA as an adjunct to therapeutic bodywork MDMA and Trichototillomania, Tourette's Syndrome, and Cerebral Palsy

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MDMA Research Around the World Conference on the Clinical Utility of MDMA and MDE (1999) Updates on the Progress of Dr. Grob’s Studies and Protocol Ecstasy (MDMA) mimics the post-orgasmic state by Torsten Passie Structuring Psychotherapy Sessions with MDMA in a Research Context A Review of Clinical Issues in MDMA-Assisted Psychotherapy Ethical caring in psychedelic work The Nature of the MDMA Experience and Its Role in Healing, Psychotherapy, and Spiritual Practice A Family’s Perspective on the Use of MDMA MAPS MDMA Analysis Project A Psychospiritual Context for the Therapeutic Use of Psychedelics Spiritual Uses of MDMA in Traditional Religion Diary of a Subject in the Johns Hopkins MDMA Study MDMA research: more than I bargained for... MDMA Patentability and Orphan Drug Designation The great entactogen - empathogen debate In Memory of Nicholas Saunders Critique of Heffernan Ecstasy/Memory Study by Harry Sumnall (3/28/01) Therapeutic MDMA (Ecstasy) & The Federal Government: A Cloudy Past and a Hopeful Future by Donald David Lewis, a Harvard Law School paper for Prof. Peter Barton Hutt’s Food and Drug Law Class, Winter/Spring 2000. (Word Format)

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DanceSafe and the Ecstasy Harm Reduction Project: MDMA Page Ecstasy.org - Nicholas Saunder’s Site Erowid MDMA Vault Using Psychedelics Wisely May 22, 1986 DEA Ruling on MDMA Scheduling

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