Expanded Access Training Update

The MDMA Therapy Training Program is preparing to launch a series of trainings for therapy providers who will provide MDMA-assisted psychotherapy for PTSD under a MAPS-sponsored Expanded Access protocol, pending protocol approval. As of this week, Multidisciplinary Association for Psychedelic Studies (MAPS) has now submitted the Expanded Access protocol to the FDA for review. Expanded Access is a special FDA program 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 individuals or populations facing a serious or immediately life-threatening condition for which there is no satisfactory treatment currently available. The FDA’s website has more information on its Expanded Access program.

Pending approval, Expanded Access for MDMA-assisted psychotherapy for PTSD would allow additional qualified sites in the US 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.

An online application for sites in the US and US Territories that are interested in the MDMA PTSD Expanded Access protocol will be published within the next two weeks on maps.org and will be distributed through the training newsletter . For sites and therapists interested in working under a MAPS protocol (Expanded Access or otherwise), there are two layers of application: 1) Site Questionnaire, and 2) MDMA Therapy Training Application for Providers. Each site must submit one Site Questionnaire. Additionally, each therapy provider must submit an MDMA Therapy Training Application for Providers. Only applicants affiliated with a qualifying site can be considered for training to be eligible to work on Expanded Access or another MAPS protocol. Applications will be reviewed on a rolling basis, and several training cohorts of 60 trainees are anticipated to be enrolled in 2019, with training events at various locations in the US.

Since Expanded Access is a US FDA program, only sites in the US and US territories may participate. International programs may become available in the future. As one example, the MDMA Therapy Training Program will host a training event in Israel in January, as a collaboration with the Israeli Ministry of Health, to prepare Israeli therapists to work on an Open Access protocol.

One Expanded Access training event, scheduled in August 2019, will be an MDMA Therapy Training event for Communities of Color led by Marcela Ot’alora G, LPC, and Monnica Williams, PhD, 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 thinking about PTSD to include racial trauma, and to inform the ongoing development of culturally-informed curriculum within the MDMA Therapy Training Program. The Multidisciplinary Association for Psychedelic Studies (MAPS) recently received a grant from Open Society Foundation (OSF) to support this training, and 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. If you would like to support MDMA Therapy Training opportunities for people of color, please consider making a donation.

The MDMA Therapy Training program has also created an online portal for therapy providers and sites to network with each other, to connect in the hopes of building a site, or growing staff, to work on an Expanded Access MDMA PTSD protocol, pending FDA approval. This portal will be sent via the training newsletter within the next two weeks. If you are looking for more staff, an MD, or other needs, we hope that this platform will support you. Please sign up for the training newsletter to ensure updates. making a donation. • Learn More