MDMA Therapy Training Program: July 2018 Update

From June 24-30, 2018, Annie Mithoefer, B.S.N. and Michael Mithoefer, M.D., led a weeklong in-person training in Northern California focused on MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD), as part of the California Institute of Integral Studies’ (CIIS) Certificate for Psychedelic Therapies and Research Program (CPTR). Over 90 trainees with a wide range of professional backgrounds learned about the foundation of MAPS’ approach to MDMA-assisted psychotherapy, which involves a non-directive therapeutic orientation that supports participants’ inner healing ability to guide the treatment process.

In the coming year, MAPS plans to apply for a special U.S. Food and Drug Administration (FDA) program called Expanded Access, which allows the use of an investigational treatment outside of a clinical trial. The program’s purpose is to grant access to potentially beneficial investigational treatments for people facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. MAPS has had positive preliminary discussions about Expanded Access with both FDA and DEA. If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved as anticipated, new sites may obtain approval and undergo training to administer MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. The FDA’s website has more information on its Expanded Access program. Since Expanded Access is a U.S. FDA program, only sites in the U.S. and U.S. territories may participate. In the coming years, MAPS may be able to apply for similar programs abroad.

The MDMA Therapy Training Program, operated by the MAPS Public Benefit Corporation (MPBC), is currently updating our training website and creating an online application for potential Expanded Access sites and therapy providers, to be posted in late 2018. We do not yet have trainings scheduled. 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.

The MDMA Therapy Training Program is also currently supporting researchers in their final phase of training to work on Phase 3 clinical trials researching MDMA-assisted psychotherapy for PTSD. These 82 therapists are in the midst of our supervision program, which will be an integral part of our training program going forward. Phase 3 trials are starting Summer 2018 planned to start in the coming months, in the United States, Canada, and Israel. The results of the Phase 3 studies will support 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.

MAPS and MPBC are also excited to support the development of MDMA-assisted psychotherapy for PTSD research in Europe and South America. Several European countries will host Phase 3 sites; MPBC is hosting an invitation-only MDMA therapy training this fall to prepare European researchers for this endeavor. Approximately 60 therapists and researchers will attend a training in the Netherlands this fall, led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., to prepare potential sites to conduct Phase 3 trials in Europe. Another training is planned Colombia, South America in early November, led by Marcela Ot’alora, L.P.C., to prepare researchers in Columbia and Chile. The training program is not currently accepting applicants. Future international trainings will be planned as additional providers are needed. Learn more…