See below for news related to our Israeli study of MDMA-assisted psychotherapy for PTSD.
MP-9
February 1, 2012
Israel: Independent Rater Training Completed
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.
Slate "