From July 16 – 19, 2018, MAPS-sponsored researchers Dr. Michael Mithoefer and Annie Mithoefer, BSN, Marcela Ot’alora, LPC, and Bruce Poulter, RN, together with MAPS Executive Director Rick Doblin, Ph.D., MPBC Executive Director Amy Emerson and MPBC Associate Director of Training and Supervision Shannon Carlin, M.A., participated in a four-day meeting in Boulder, CO., to further develop the training program for MAPS-sponsored MDMA researchers and potential Expanded Access sites. Work included adapting the program for a larger audience, planning refinements to the Treatment Manual, conducting a revision of the online training module (Part A), and building a standard format for in-person therapy trainings. The purpose of these adaptations is to prepare for the upcoming FDA Expanded Access program in 2019, which will involve a massive expansion of the number of people participating in these trainings.
MAPS and MPBC are excited to support the development of MDMA-assisted psychotherapy for PTSD research in Europe and South America. Approximately 60 therapists and researchers will attend a training in the Netherlands from September 27 – October 3, 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 in Colombia, South America is being planned for early November, led by Marcela Ot’alora, LPC to prepare researchers in Colombia and Chile.
In the coming year, MAPS will apply for a special FDA program called Expanded Access. 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.
If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved, which both FDA and DEA have indicated is almost certain, new sites in the U.S. may obtain approval and undergo training to administer open-label MDMA-assisted psychotherapy to eligible patients with treatment-resistant PTSD, under a MAPS protocol. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy with approval by regulatory agencies. In the coming years, MAPS may be able to apply for similar programs abroad. The FDA’s website has more information on its Expanded Access program.
Currently MPBC is updating its website, including web pages for the Therapy Training Program. We intend to have an online training application for eligible sites and providers later this year. Complete applications for potential sites to work on a U.S. FDA Expanded Access protocol for MDMA-assisted psychotherapy will be reviewed on an ongoing basis, starting late 2018 and continuing through the duration of the protocol, pending approval. Registration for the first training cohort will take place early 2019. Training events will take place starting March 2019, in locations across the U.S.
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