FDA Places Open-Label, Multi-Site Research Study of the Safety and Psychological Effects of Manualized MDMA-Assisted Therapy in Healthy Volunteer Therapists (Study MT2) On Clinical Hold

On August 5, 2019, the U.S. Food and Drug Administration (FDA) placed Study MT2 on partial clinical hold, preventing the study from being initiated. FDA highlighted their reason for the hold and concerns in the Partial Clinical Hold. These related to the scientific merit of the study, the risk-benefit ratio for healthy therapist participants, as well as the credentials of clinical investigators responsible for facilitating MDMA-assisted therapy sessions, specifically requiring that the Lead Facilitator of our two-person co-facilitator team have an M.D., Ph.D., or equivalent degree and that an on-site physician should be mandated instead of an on-call physician.