From September 26-October 3, 2018, Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., led a weeklong in-person training in the Netherlands focused on MDMA-assisted psychotherapy in the treatment of Posttraumatic Stress Disorder (PTSD). Sixty therapists and researchers representing fourteen countries learned about the foundation of MAPS’ approach to MDMA-assisted psychotherapy. Many of these trainees will provide MDMA-assisted psychotherapy to participants with PTSD under a MAPS protocol at several European sites starting in 2019. 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. Please sign up online for our training newsletter for updates.
As Phase 3 clinical trials begin in the U.S., Israel, and Canada, 82 therapy providers are now completing their final stage of training in clinical supervision, which will continue to be an integral part of the MDMA Therapy Training Program. The results of the Phase 3 studies will support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) to make MDMA-assisted psychotherapy into a legal prescription medicine anticipated to take place in 2021.
In November 2018, 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. 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. You can learn more about Expanded Access on the FDA’s website.
If approved, 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, starting as early as Spring 2019. 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. As MAPS gets closer to application, the requirements will be better understood.
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 late 2018 at maps.org. An additional application for each therapy provider affiliated with the site will also be posted; only applicants affiliated with a qualifying site can be considered for the Expanded Access training. The MPBC Training and Supervision Department will review applications on an ongoing basis; in 2019 approximately seven cohorts of 60 trainees will be enrolled.
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.Learn more…