Currently, the MDMA Therapy Training Program is preparing for the launch of a series of Expanded Access training events in the US next year. In the coming weeks, the Multidisciplinary Association for Psychedelic Studies (MAPS) will apply for a special U.S. FDA program called Expanded Access (EA), which allows the use of an investigational treatment outside of a clinical trial. If the FDA agrees with the protocol design, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the U.S. to provide this treatment to eligible patients under a MAPS treatment protocol. The basic requirements of a qualified site are: 1) facility conducive to this treatment, 2) qualified and trained therapy team, 3) Medical Doctor who can obtain a DEA Schedule 1 license for MDMA. Sites must also gain Drug Enforcement Administration (DEA) approval to manage, store, and administer MDMA, a controlled substance. Since Expanded Access is a U.S. FDA program, only sites in the U.S. and U.S. territories may participate. International programs may become available in the future.
An online application for sites in the U.S. and U.S. territories that are interested in the MDMA PTSD Expanded Access protocol will be published early in the new year at maps.org. The MPBC Training and Supervision Department will review applications on an ongoing basis. The training department is developing a platform for therapists and sites to connect online in the interest of establishing clinics for Expanded Access.
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 and stay tuned for website updates and application material in the new year.
In January 2019, the MDMA Therapy Training Program will host a training event in Israel to prepare Israeli therapists to work on an Open Access protocol. Over the next year or two, as Phase 2 and 3 trials in Europe progress and additional protocols are developed and approved internationally, the MDMA Therapy Training Program will offer more training opportunities for international providers.
The MDMA Therapy Training Program is currently drafting a Code of Ethics for MDMA therapy providers, focusing on the professional guidelines for ethical therapeutic relationship. We are committed to reflecting internally on ethical care, to incorporating ethics as a foundation for our training curriculum, and collaborating with a growing network of psychedelic psychotherapy providers. When the Code of Ethics is finalized, it will be published online. Given the special ethical considerations of MDMA-assisted psychotherapy, as a psychedelic organization, we take seriously our commitment to safety.
MAPS recently received a grant from Open Society Foundation (OSF) to support an MDMA Therapy Training event for Communities of Color in August 2019 led by Marcela Ot’alora G, L.P.C., and Monnica Williams, Ph.D., with support from additional trainers. The purpose of this training is to ensure that MDMA therapy will be available to communities of color by training therapy providers of color in this modality, to expand enrollment of subjects to those with PTSD from racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. MAPS will continue to fundraise for this specific event, and to provide training opportunities for therapy providers who come from or work with marginalized communities. More information on this event, including date, time, and application information will be posted online in the coming weeks. If you would like to support MDMA Therapy Training opportunities for people of color, please consider making a donation. • Learn More
