On February 2 and February 7, 2017, the eighth and ninth of 10 participants completed their 12-month follow-up interviews in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. The seventh participant completed their 12-month follow-up interview on December 8, 2016. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more...
Israel News Timeline
On November 10 and November 28, 2016, the fifth and sixth of 10 participants completed their 12-month follow-up interviews in ourIsraeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more...
On October 21, 2016, the fourth of 10 participants completed their 12-month follow-up interview in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study has treated 10 subjects with chronic, treatment-resistant PTSD from any cause. Learn more…
On January 13, 2016, the tenth and final subject received their first treatment in our Israeli Phase 2 study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat 10 subjects with chronic, treatment-resistant PTSD from any cause. Once the final treatments and evaluations are complete, we will gather data for inclusion in an international meta-analysis of the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD.
On December 10, 2015, the ninth participant was treated in our Israeli study of MDMA-assisted psychotherapy for PTSD. The tenth and final participant was enrolled on December 16. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat 10 subjects with chronic, treatment-resistant PTSD from any cause. “We are in the final stages of the Phase 2 research in Israel, having worked over the last few years with a variety of participants, their stories, feelings, body experiences, and the traumas that these reflect,” reports co-therapist Keren Tzarfaty, Ph.D. “As these intense processes unfold and old layers melt, we have been witnessing new seeds of healing and growth, love and hope, seeds of wholeness.” Once the final treatments and evaluations are complete, we will gather the data for inclusion in an international meta-analysis of the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. olled on December 16. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat 10 subjects with chronic, treatment-resistant PTSD from any cause. “We are in the final stages of the Phase 2 research in Israel, having worked over the last few years with a variety of participants, their stories, feelings, body experiences, and the traumas that these reflect,” reports co-therapist Keren Tzarfaty, Ph.D. “As these intense processes unfold and old layers melt, we have been witnessing new seeds of healing and growth, love and hope, seeds of wholeness.” Once the final treatments and evaluations are complete, we will gather the data for inclusion in an international meta-analysis of the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD.
On November 4, 2015, the ninth subject was enrolled in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat up to 10 subjects with chronic, treatment-resistant PTSD from any cause. We will close enrollment at the end of this month in order to gather the data for submission to the U.S. Food and Drug Administration as part of our End-of-Phase 2 meeting, in preparation for Phase 3.
On October 6, the eighth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat up to 10 subjects with chronic, treatment-resistant PTSD from any cause. The Israeli team is seeking to enroll the final two subjects prior to November 1, when we will close enrollment in order to gather the data for submission to the U.S. Food and Drug Administration as part of our End-of-Phase 2 meeting, in preparation for Phase 3. This study is actively seeking Israeli participants.
On September 4, 2015, the eighth subject was enrolled in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat up to 10 subjects with chronic, treatment-resistant PTSD from any cause. "The preliminary results are encouraging, and enrollment has picked up late in the study due to increased recruitment efforts," said Berra Yazar-Klosinski, Ph.D., MAPS Clinical Research Scientist. "This study is part of our efforts to reach participants where trauma is endemic." This study is actively seeking Israeli participants.
On July 14, 2015, the fifth subject was treated in our ongoing Israeli study of MDMA-assisted psychotherapy for PTSD. The seventh subject was enrolled on July 23. Led by Principal Investigator Moshe Kotler, M.D., this Phase 2 study will treat up to 10 subjects with chronic, treatment-resistant PTSD from any cause. "The entire clinical research team is pleased with the recent progress of our Israeli study, with four subjects enrolled in the last month," reports MAPS Clinical Research Scientist Berra Yazar-Klosinski, Ph.D. This study is actively seeking Israeli participants.
On May 13, 2014, the fourth subject was enrolled in our ongoing Israeli study of MDMA-assisted psychotherapy for 10 subjects with chronic, treatment-resistant PTSD. The subject prematurely reported last month as the fourth enrollment was not formally enrolled after the investigators determined the subject would not be appropriate for the study. This study is being conducted at the Beer Yaakov Mental Hospital in Israel and led by Principal Investigator Moshe Kotler, M.D.
- Ongoing study
- Location: Beer Yaakov, Israel
- Clinical Investigator: Moshe Kotler, M.D.
- Estimated study budget: $463,000
- Already raised: $39,000
- Needed to complete this study: $423,000
On July 19 and 31, 2013, trained raters completed their evaluations of the video recordings for the first two subjects in our ongoing Israeli study of MDMA-assisted psychotherapy for subjects with chronic, treatment-resistant PTSD. The purpose of these adherence ratings is to ensure that the therapist teams understand how to follow the therapeutic approach specified in our Treatment Manual before treating the rest of the subjects in the study. The potential third subject is now being screened.
On July 10, 2013, the second subject completed their last experimental treatment in our ongoing Israeli study of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. Data collected from this study will allow comparisons between the effects of different doses of MDMA on PTSD symptoms, and on symptoms of depression and sleep quality. Led by Clinical Investigator Moshe Kotler, M.D., at Beer Yaakov Mental Hospital, this study will treat 10 subjects with chronic, treatment-resistant PTSD.
On February 12, 2013, the first subject was enrolled in our new Israeli study of MDMA-assisted psychotherapy for PTSD. This study will enroll 10 subjects with chronic, treatment-resistant PTSD, some of whom will be referred by the Israeli Defence Forces. This study is taking place at Beer Ya'akov Mental Hospital, and is led by Principal Investigator Moshe Kotler, M.D.
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.
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.
With our Israeli study approved and our Jordanian study awaiting final government approval, we have been working hard to make our research tools accessible to clinical researchers in the Middle East. One of these tools is the Clinician Administered PTSD Scale (CAPS), which is the primary measure used by our researchers to determine the severity of PTSD symptoms before and after treatment. MAPS has now completed the translation of the CAPS into both Hebrew and Arabic, and we are working on back-translations which will verify the accuracy and consistency of the translations. By sharing these translations freely with the Veteran Administration's National Center for PTSD, and with researchers throughout Israel and the Arab world, MAPS is promoting the development of effective PTSD treatments by fostering collaborations between international research teams and across different cultures.
On June 1, 2011, Israel's Ministry of Health approved our Israeli study of MDMA-assisted psychotherapy for PTSD. This approval indicates that the Ministry was satisfied with our response to their April 28 request for additional information. Now that the study has the full approval of Israeli regulatory bodies, we have begun preparing to submit the protocol to the US FDA, which must prospectively approve the study before we can start enrolling subjects since it is being conducted under a US Investigational New Drug application. The study initiation will take place in approximately one month, during which time we will finalize the study insurance documents and contracts with the study site. Training materials containing the measures to be used in the study have been provided to the investigators and independent raters, and we continue working with clinical research organization Antaea Medical Services, Ltd., to prepare the remaining documents and forms.
On 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
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 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.
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.
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.
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.
In our Israeli MDMA/PTSD study, we've currently completed a preliminary analysis of the data. All five of the subjects enrolled to date have been treated without any evidence of harm. However, while there is some evidence of efficacy, its minimal. We've decided to close out this initial study and postpone new treatments until we have obtained adequate therapeutic training for members of our Israeli co-therapist team.
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.
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 President Rick Doblin PhD is delighted to share the success of a recent MDMA-assisted psychotherapy session in Israel. Rick was told a remarkable story during a check-in with the therapy team that is conducting our Israeli MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) study.
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.”
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.
MAPS sponsored a very successful conference in Israel on research with MDMA, ibogaine and marijuana for the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and representatives from the Israeli Anti-Drug Authority. The conference was intended to educate Israeli regulators and researchers about MAPS' proposed MDMA/PTSD pilot study that we're trying to sponsor in Israel, under the direction of Dr. Moshe Kotler, Chair, Department of Psychiatry, Tel Aviv University, Sackler School of Medicine. After the conference, Dr. Kotler said that he was ready to submit our draft protocol to the ethics committee for review.
An Israeli dentist who survived a suicide bombing in a Jerusalem cafe in March 2002 that killed about 11 people met in person with Rick Doblin in Jerusalem. The dentist contacted MAPS last week after searching the internet for pages about MDMA and PTSD. The dentist, who has permanent hearing loss but wasn't otherwise seriously wounded, developed PTSD after the bombing. After treatment with psychotherapy and SSRIs that was only moderately helpful, he discovered on his own that MDMA was of major benefit to him. He contacted MAPS since he felt it was a shame that MDMA had been available to him only illicitly and at risk to his professional license. After a long discussion, he surprised Rick by mentioning that the place he had chosen for their meeting was the same cafe in which the bombing had taken place. He has written a report, which is followed by additional comments from Rick.
Rick Doblin met in New York City with Israeli psychiatrist Dr. Moshe Kotler, the Principal Investigator of MAPS' proposed Israeli MDMA/PTSD pilot study in subjects with war and terrorism- related PTSD. Now that the US study is fully approved, Dr. Kotler feels the time is right to move forward with the protocol design and approval process for the Israeli pilot study. Dr. Kotler used to be the chief psychiatrist for the Israeli Defense Forces (IDF).
The Israeli newspaper, Maariv, published an article about the approval of the MDMA/PTSD study, entitled "United States Approves Ecstasy to Treat Trauma: The FDA says the party drug will be used to treat people who have been sexually assaulted" by Alex Doron.
MAPS sent a draft of the MDMA/PTSD pilot study that MAPS is seeking to sponsor in Israel to Dr. Moshe Kotler and Dr. Jorge Gleser, Israeli Ministry of Health, for their review. MAPS’ conference on MDMA/PTSD research, held at Beer Yakov Mental Health Center near Tel Aviv on November 14 for members of the Israeli Ministry of Health, the Israeli Society of Addiction Medicine, and the Israeli Anti-Drug Authority, was very well received. The conference and the proposed pilot study were discussed in a positive article mentioned on the front page of Maariv, Israel’s second largest newspaper. The protocol design meeting, held at Beer Yakov on Nov. 17, was also productive, with the draft protocol submitted today reflecting design choices made at that meeting.