Since 1998, MAPS has been engaged in an active and ongoing effort to sponsor a pilot study in Israel into the use of MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD). A report on MAPS’ 1999 international conference on clinical research with MDMA and MDE, held at the Dead Sea, can be found on the MAPS website at: http://www.maps.org/news-letters/v09n3/09309isr.html
On November 14, 2002, MAPS presented a seminar about MDMA/PTSD research at Beer Yakov Hospital near Tel-Aviv. Attending were officials from the Israeli Ministry of Health, Israeli Society of Addiction Medicine, and the Israeli Antidrug Authority. Organizing the event on the Israeli side was Dr. Jorge Gleser, Deputy Director, Mental Health Services, Director, Department for the Treatment of Substance Abuse, Israeli Ministry of Health. Costs of the seminar were covered by a donation to MAPS from Tim Butcher.
Speakers at the seminar were Dr. Michael Mithoefer, principal investigator for the MAPS-sponsored and FDA-approved MDMA/PTSD study (p. 4); June May Ruse, Ph.D., lead author of MAPS’ MDMA/PTSD treatment manual; Jose Carlos Bouso, Ph.D. candidate, principal investigator in the MAPS-sponsored MDMA/PTSD study in Spain (p.7); Peter Cohen, Ph.D., Director of the Centre for Drug Research (CEDRO) – Faculty of Social and Behavioral Sciences, Universiteit van Amsterdam (see http://www.cedro-uva.org), and myself. The seminar was favorably reported in Maariv, a major Israeli newspaper, (www.maps.org/media/maariv11.15.02.html). Dr. Cohen spent several days after the seminar in meetings with the Israeli Antidrug Authority, while I had an opportunity to meet with Antidrug Authority Director, General Haim Messing.
On November 17, MAPS organized a smaller protocol design meeting with several psychiatrists in the Ministry of Health including Dr. Moshe Kotler, the principal investigator of the Israeli MDMA/PTSD study; Dr. Rakefey Rodrigez, who is interested in working as a co-therapist on the project, and Dr. Gleser. Tentative agreement was reached on protocol design, with the research plan calling first for a small (N=4) non-blinded (“open label”) pilot study to be conducted in patients with war or terrorism-related PTSD. The purpose of this study would be to train treating therapists in conducting MDMA-assisted therapy and to gather initial information about MDMA-assisted psychotherapy in this population. If the open label study generates promising results, it will be followed by a randomized, double-blind, placebo-controlled investigation in a slightly larger sample of people (N=12) with war or terrorism-related PTSD. The placebo would be a very low dose of MDMA, as compared to a full dose. In both studies, treatment includes two extended MDMA-assisted therapy sessions within the context of a twelve-week course of psychotherapy.
The Israeli team has indicated that it will be ready to seek Ministry of Health approval for the Israeli pilot study as soon as the US MDMA/PTSD study is approved both by the FDA and an IRB. We’re hoping the Israeli study will be ready to start before the end of 2003.