In preparation for Phase 3 trials starting Summer 2018, the MDMA Therapy Training Program is currently supporting 82 researchers in their final stage of training through our supervision program, a process of mentorship that will be an integral part of therapy training going forward. These Phase 3 therapy teams will provide MDMA-assisted psychotherapy for severe posttraumatic stress disorder (PTSD) at sites in the United States, Canada, and Israel. With the results from Phase 3 trials, MAPS will apply for a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), to make MDMA-assisted psychotherapy into a legal prescription medicine, anticipated to take place in 2021.
This month, Annie Mithofer, BSN, and Michael Mithoefer, M.D., led a weeklong in-person training in Northern California focused on MDMA-assisted psychotherapy, as part of the California Institute of Integral Studies (CIIS)’s Certificate for Psychedelic Therapies and Research Program. This fall, as MAPS prepares for a multi-site study of MDMA-assisted psychotherapy for PTSD in Europe, the MDMA Therapy Training Program will host a training in the Netherlands to prepare European Phase 3 researchers for this endeavor. In early November, Marcela Otalora will lead a training in Colombia for South American therapists.
In the coming year, MAPS plans to apply for a special FDA program called Expanded Access which allows the use of an investigational treatment outside of a clinical trial. The program is designed to address urgent and life-threatening conditions in patients who don’t currently have promising treatment options. You can learn more about Expanded Access on the FDA’s website.
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