MAPS' MDMA/PTSD Study updates sorted by site/location:
MDMA Research Timeline
MP-1
April 16, 2012
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. 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. 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.
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.
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.
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. 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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
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.
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?"
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.
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. 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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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’ 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 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.
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. 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.
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.
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?"
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.”
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.
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.
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
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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. 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. 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.
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.
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.
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.
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.
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.
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.
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.
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)
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.”
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.
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.
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.
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?"
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.
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.
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.
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
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.
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.
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.
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.
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. 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. 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. 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.
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.
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.
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.
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.
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.
Miller-Mccune "