MDMA Therapy Training Program: June 2018 Update

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.

If you would like to receive updates about the MDMA Therapy Training Program and Expanded Access plans, as well as learn about upcoming requirements for Expanded Access sites and providers, please sign up online for our training newsletter. Learn more…