Spring/Summer 2007 Vol. 17, No. 1 The Chrysalis Stage
MAPS IS ASSISTING RESEARCHERS to design, fund, and conduct the clinical trials necessary to develop MDMA-assisted psychotherapy into a recognized treatment for posttraumatic stress disorder (PTSD) and/or clinically diagnosed anxiety secondary to life-threatening illness. Currently, MAPS is sponsoring several Food and Drug Administration (FDA) Phase 2 studies of MDMA-assisted psychotherapy in people with PTSD and anxiety secondary to a life-threatening illness. Studies of MDMA-assisted psychotherapy in people with PTSD are taking place in the United States and Switzerland, with a study in Israel to be initiated this year, and a study of MDMA-assisted psychotherapy in people with anxiety associated with an illness is under way in the United States. If findings from these small pilot studies continue to be promising and indicate that MDMA-assisted therapy is safe and possibly efficacious, then MAPS must develop and conduct two large-scale multi-site Phase 3 studies if we wish to apply to FDA for approval and recognition of this treatment. Each of these studies will involve approximately eight teams of psychotherapists, and approximately 280 participants. Each therapeutic team will treat as many as 18 participants per year for two years. One Phase 3 study will be conducted throughout the United States and the other throughout Europe and Israel.
Such large studies will require training many mental health professionals to conduct MDMA-assisted therapy in people with PTSD in accordance with the treatment method developed by Michael Mithoefer, MD, and Annie Mithoefer, RN, as described in the treatment manual developed by Ruse et al. (2005).
The MAPS team is in the process of developing such a training program, to be led by Michael Mithoefer, principal investigator for the first study of MDMAassisted therapy for people with PTSD. The training program will provide therapists interested in conducting MAPSsponsored MDMA-assisted psychotherapy research with the experience, education, and information needed to perform this therapy.
Currently, under the training program we envision, we will enroll pairs of therapists in male-female co-therapist teams, matching MAPS’ treatment method for MDMA-assisted therapy, which requires a pair of therapists and strongly encourages the pair to consist of a man and a woman. Right now, the most likely design will have one or two teams of therapists-in-training visit Charleston, SC, on two separate occasions to meet with Michael and Annie for a four or five day training event. During this time, the trainees will each experience one session of MDMA-assisted therapy as the designated patient, with their partner as the therapist, and one session as the designated therapist, with the partner in the patient’s role.
The second visit to Charleston will be scheduled at least three months after the first so that the trainees have the time and opportunity to observe and learn not just about the MDMA experience itself but also how to integrate it into their daily lives.
The training program might involve bringing as many as 10 teams of therapists together for a week-long educational seminar about the use of MDMA-assisted psychotherapy for PTSD after they have all completed two training sessions, allowing for greater learning and sharing of experi-ences between teams. During this seminar, inner experiences would be catalyzed by holotropic breathwork rather than MDMA.
By creating this formal training program, therapists will be able to undergo two personal experiences with MDMA in a controlled, therapeutic setting. We’ll encourage therapists to work on their own issues so they can be as supportive as possible for their research subjects. The goal of the program is for trainees to understand how to collaborate with research participants in creating a set and setting that maximizes the effects of MDMA-assisted therapy and how to deal with emotional and physiological problems that might arise during treatment.
We are presently searching for measures to evaluate the effectiveness of the training program on the trainees. With this data, MAPS will then be able to select from among the training program participants those most likely to successfully conduct the Phase 3 multi-site studies evaluating the safety and efficacy of MDMA-assisted therapy.
Since MDMA is a controlled substance, the only way that MAPS can legally conduct a training program that includes trainees having personal experiences with MDMA is under the auspices of an FDA-approved clinical study. This is a situation for which we know of no precedent. In several months, MAPS will request a meeting with FDA staff to discuss the most appropriate contexts for moving forward.
1. Ruse J, Jerome L, Mithoefer M, Doblin R (2005). MDMA Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder (PTSD): A Treatment Manual Draft. MAPS