Expanded Access Training Update: February 2019

The MDMA Therapy Training Program has launched a new round of trainings in the U.S., with a special focus on sites interested in offering MDMA-assisted psychotherapy for PTSD in an Expanded Access (compassionate use) protocol, which MAPS Public Benefit Corporation (MAPS PBC) submitted to the FDA in January and is awaiting approval.

Interested and qualified sites may now apply with MAPS PBC to assess eligibility and obtain the required training to administer MDMA-assisted psychotherapy for PTSD under an approved 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 1 license for MDMA. Only sites in the U.S. and U.S. territories may participate in a U.S. FDA Expanded Access program. Over the coming years, as Phase 2 and Phase 3 clinical trials in Europe progress, and MDMA-assisted psychotherapy clinical research develops internationally, the MDMA Therapy Training Program plans to offer more training opportunities abroad.

To support the development of compassionate use internationally, on January 27 – February 1, 2019, the MDMA Therapy Training Program delivered an MDMA-assisted psychotherapy for PTSD training to 47 therapists, doctors, and counselors in Israel. The event was hosted by the community of Neve Shalom/Wahat al-Salam, “Oasis of Peace,” an intentional village co-founded by Israelis and Palestinians. The training was led by Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., and Israeli Phase 3 clinical investigators Keren Tzarfaty, Ph.D., M.F.T., and Ido Siemion, Ph.D. This training event prepared therapy providers to work on a compassionate use protocol in Israel, with approval by the Israeli Ministry of Health to treat 50 participants.

More information on therapy training requirements and application procedures for Expanded Access sites and therapy providers can be found on the MDMA Therapy Training Program webpage. Each site must submit one site questionnaire. Additionally, each therapy provider must submit an MDMA Therapy Training Program 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. Applicants can expect a response 3-6 weeks after submitting a complete application. Interested applicants should be familiar with the Treatment Manual, which describes the MDMA-assisted psychotherapy modality, before submitting an application.

Throughout this year and the coming years, the MDMA Therapy Training Program will host training retreats at various locations across the US. On May 4–11, 2019, Marcela Ota’lora, M.A., L.P.C., and Bruce Poulter, R.N., will lead a training event outside Fort Collins, Colorado. Additionally, the MDMA Therapy Training for Communities of Color, led by Marcela Ot’alora MA, L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers, will take place August 10-17 in Louisville, Kentucky. Additional training retreats, once scheduled, will be announced via the MDMA Therapy Training Newsletter. Please sign up online to receive updates. • Learn More