In the coming year, MAPS plans to apply for a special U.S. Food and Drug Administration (FDA) program called Expanded Access (EA), which allows the use of an investigational medical product (one that has not yet been approved by the FDA) outside of a clinical trial. 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. The FDA’s website has more information on its Expanded Access program.
MAPS has already had positive preliminary discussions about Expanded Access with DEA on December 19, 2017, and with FDA on December 20, 2017. If Expanded Access for MDMA-assisted psychotherapy for PTSD is approved, new sites in the U.S. meeting the requirements 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 Expanded Access site applicants will have 1) a suitable facility to conduct MDMA-assisted psychotherapy and meet drug storage requirements, 2) qualified therapy team who have completed the MDMA PTSD Therapy Training Program, operated by MPBC, 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. As MAPS gets closer to application, the requirements will be better understood.
Currently MPBC is updating its website, including web pages for the Therapy Training Program and an online training application for eligible sites and providers. Completed 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.
We encourage each site, in choosing location and therapy teams, to consider diversity, inclusivity, and cultural and racial competence. One of the most robust ways to provide accessible care is to train therapists and practitioners from diverse backgrounds, including people of color and from the LGBTQ+ community. If you are a therapist from a marginalized community, we encourage you to reach out to us at firstname.lastname@example.org. The MDMA Therapy Training Program will also host a training event in 2019 specifically for therapy providers of color, led in part by Monnica Williams, PhD.
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. Learn more…