MDMA Therapy Training Program: Update on Supervision Process and Expanded Access

The MDMA Therapy Training Program, operated by the MAPS Public Benefit Corporation (MPBC), is currently supporting the final segment of training for Phase 3 therapy teams, eighty-two researchers who will provide MDMA-assisted psychotherapy for severe posttraumatic stress disorder (PTSD) at sites across the United States and Canada. These trainees are in the midst of our supervision program, which will be an integral part of our training program going forward. We are also excited to prepare for a multi-site study of MDMA-assisted psychotherapy for PTSD in Europe. This fall in Europe, we will host a closed training to prepare European Phase 3 researchers for this endeavor.

We are working to prepare for MAPS’ anticipated application to Expanded Access. Expanded Access is an Food and Drug Administration (FDA) program that allows the use of an investigational drug outside of a clinical trial. The program is designed to address urgent and life-threatening conditions in patients who currently do not have promising treatment options.

If Expanded Access is approved, new sites meeting the requirements below can seek approval to be part of MPBC’s multi-center Expanded Access protocol, which will allow them to administer open-label MDMA-assisted psychotherapy for PTSD. Qualified applicants will have a team of therapy providers, a physician, and a facility suitable to conduct MDMA-assisted psychotherapy, with approval by regulatory agencies. You can learn more about Expanded Access on the FDA’s website.

Currently we’re working on updating the training program website, and hope to have an online training application for eligible Expanded Access sites and providers later this year. 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.

While our Phase 3 team is complete, and the MDMA Therapy Training Program is not accepting applications at this time. Learn more…