A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in U.S. Military Veterans with Chronic PTSD Timeline

Phase 2 Study at the Bronx, New York Veterans Affairs Medical Center

The Institutional Review Board (IRB) approved MAPS’ protocol for a Phase 2, open-label randomized controlled comparative study on the effectiveness of MDMA-assisted therapy in U.S. Veterans with chronic PTSD. Led by esteemed PTSD researcher Rachel Yehuda, Ph.D., Director at the Mental Health Patient Care Center, James J. Peters VA Medical Center, and Professor of Psychiatry and Neuroscience at the Icahn School of Medicine at Mount Sinai Hospital, the study is moving through the investigator-initiated research program of the U.S. Department of Veterans Affairs (VA). On August 25, 2020, the FDA agreed to proceed with the protocol.The study will enroll 60 veterans and will collect further information on whether there is a difference in two versus three sessions of MDMA-assisted psychotherapy for safety and therapeutic outcome. This study will also act as a training ground for VA clinicians and therapists on the MAPS modality, and will include blood collection samples for later analysis of hormones, molecules, and other biological markers that may be related to having or recovering from PTSD. Dr. Yehuda and her team plan to conduct this trial at the VA pending DEA approval.

A Phase 2, Open-Label, Randomized Comparative Effectiveness Study for MDMA-Assisted Psychotherapy in U.S. Military Veterans with Chronic PTSD

MAPS is delighted to report an important milestone towards a randomized clinical trial at the Veterans Affairs (VA) Administration, where so many of our nation's veterans are treated for PTSD. The Food & Drug Administration (FDA) has recently approved the first protocol submitted by MAPS in partnership with esteemed PTSD researcher Rachel Yehuda through the VA’s investigator-initiated research program. She and her team plan to conduct this trial at the VA pending institutional and regulatory approvals