Expanded Access Training Update: April 2019

The MDMA Therapy Training Program has launched a series of trainings to prepare therapy providers to become eligible to work on a MAPS MDMA/PTSD protocol. In January 2019, MAPS PBC submitted an MDMA-assisted psychotherapy for PTSD protocol to the U.S. Food and Drug Administration (FDA) as part of an application to participate in the FDA Expanded Access (EA) program, which allows the which allows the wider use of an investigational treatment. The program’s purpose is to grant access to potentially beneficial investigational treatments for individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. If approved, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional sites to meet the requirements to provide this treatment to eligible patients under a MAPS protocol.

Qualified sites in the U.S. and U.S. Territories interested in being considered to participate in an MDMA PTSD Expanded Access protocol, pending approval, may now apply with MAPS PBC to assess eligibility and obtain the prerequisite training to administer MDMA-assisted psychotherapy for PTSD under a MAPS protocol. The basic requirements of a qualified site are 1) Treatment facility conducive to MDMA-assisted psychotherapy, 2) Therapy team, qualified and able to complete MDMA Therapy Training Program, and 3) Prescribing physician who can obtain a DEA Schedule I license for MDMA.

Site and Practitioner Application procedures are posted at maps.org/training. There are two layers of application: site questionnaire and MDMA therapy training application for therapy providers. Each site must submit one site questionnaire. Additionally, each therapy provider must submit an MDMA therapy training application for therapy providers. Only applicants affiliated with a qualifying site can be considered for training at this time. MAPS PBC will review applications on an ongoing basis, as they are received.

Applications remain open for the MDMA Therapy Training for Communities of Color event, taking place August 10-17, 2019, in Louisville, Kentucky, led by Marcela Ot’alora M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers. More details for both events, including exact location, schedule, line-up of guest presenters, scholarship and registration fees will be available as they are updated on our website. Scholarships will be available for therapy providers and community organizers of color through the generous contributions of Open Society Foundation and several other potential donations. Details on scholarship opportunities will be posted online as soon as they are available.

Additional Expanded Access training retreats in the U.S. will be announced via the training newsletter as they are scheduled. Unregistered applicants who have already applied for the training program will automatically be considered for these events. Please sign up for the newsletter to ensure updates. • Learn More