Expanded Access Training Update: March 2019

From March 3-10, 2019, 53 therapists, doctors, and counselors gathered in Asheville, North Carolina, to receive training from Annie Mithoefer, B.S.N., and Michael Mithoefer, M.D., on MDMA-assisted psychotherapy for PTSD. This six-and-a-half-day training retreat is the first in a new series of trainings to prepare therapy providers to work on an anticipated Expanded Access (“compassionate use”) protocol, submitted by MAPS PBC to the FDA in January and pending approval. The retreat offers training MAPS’ manualized approach to MDMA-assisted psychotherapy for PTSD: a non-directive orientation in which each participant’s inner healing intelligence guides the therapeutic process. As a benefit for this training effort, One World Brewing hosted a community event to raise funds for potential Expanded Access clinics in Asheville, NC, with over 400 attendees.

Trainees represented more than 16 potential Expanded Access sites across 13 states. Additional guests in attendance received training to prepare for Phase 3 protocols in Europe and Canada, for a pilot MAPS-sponsored study of MDMA in the treatment of eating disorders, and for an investigator-sponsored trial integrating cognitive processing therapy with MDMA as a treatment for PTSD.

In a sign of the growing acceptance of MDMA-assisted psychotherapy for PTSD, the trainees included three psychotherapists from the Bronx VA, a psychiatrist from the U.S. Army, and a police psychotherapist from a city near Boston, MA. MAPS subsidized the training of all of these therapists as part of our outreach to the VA, DoD and police.

Qualified sites interested in Expanded Access may now apply with MAPS PBC to assess eligibility and obtain the required training to administer MDMA-assisted psychotherapy for PTSD under an approved protocol. The basic requirements of a qualified site are 1) Treatment Facility conducive to MDMA-assisted psychotherapy, 2) Therapy Team, qualified and able to complete MDMA Therapy Training Program, and 3) Prescribing Physician who can obtain a DEA Schedule I license for MDMA. At this time, only sites in the U.S. and U.S. territories may participate in a U.S. FDA Expanded Access program. Over the coming years, as Phase 2 and Phase 3 clinical trials in Europe progress, and MDMA-assisted psychotherapy clinical research develops internationally, the MDMA Therapy Training Program plans to offer more training opportunities abroad. More information on therapy training requirements and application procedures for Expanded Access sites and therapy providers can be found on our website.

The MDMA Therapy Training Program takes seriously our obligation to participant safety and to reflecting internally to promote ethical growth in our programs. We are committed to providing quality and comprehensive training and supervision to support therapy providers in delivering ethical care within MAPS’ MDMA-assisted psychotherapy protocols. In service to this commitment, the MDMA Therapy Training Program has established the MAPS MDMA-Assisted Therapy Code of Ethics. This Code will be published in the MAPS Bulletin and posted online in the coming weeks. The Code will remain a living document to grow and adapt with the ongoing integration of feedback and evolution of needs over time.

The MDMA Therapy Training Program will host additional training retreats at various locations across the U.S. Marcela Ot’alora M.A., L.P.C., and Bruce Poulter, R.N., will lead a training event May 4-11, outside Fort Collins, Colorado. Additionally, the MDMA Therapy Training for Communities of Color, led by Marcela Ot’alora M.A., L.P.C., and Monnica Williams, Ph.D., A.B.P.P., with support from additional trainers, will take place August 10-17 in Louisville, Kentucky. Additional training retreats, once scheduled, will be announced via the MDMA Therapy Training Newsletter. To receive updates, please sign up online at maps.org/trainingLearn More