http://www.maps.org/images/mapslogo-sm.gif http://www.maps.org/ 50 50 Psychedelic research news http://www.maps.org/ psychedelic research news en-us editor@maps.org webmaster@maps.org Wed, 15 Oct 2008 22:28:08 CST Journal of Psychoactive Drugs published an article “MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder” by José Carlos Bouso PhD candidate, Rick Doblin PhD, Magí Farré MD PhD, Miguel Ángel Alcázar PhD, and Gregorio Gómez-Jarabo PhD. This article reports on the MAPS-sponsored MDMA-assisted psychotherapy study in Spain that was prematurely shut down by the Spanish government. The abstract of the article is as follows:

“The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented [in the article]. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.” ]]> 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. ]]>
After meeting with Drs. Chambon and Rosenfeld, Dr. Lemoine was intrigued but raised some concerns about MDMA neurotoxicity and cardiotoxicity. We sent detailed scientific information about those risks and await news as to whether we can move to the next stage of the project, which would be to develop a protocol that would be submitted to an Ethics Committee and the French Ministry of Health]]> Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted (PDF) . 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. ]]>