The Data Safety Review Board (DSMB)

The Data Safety Review Board (DSMB) for Dr. Michael Mithoefer’s MAPS-sponsored FDA Phase 2 pilot study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) met in late January for its final review, now that 15 out of 20 subjects have completed the experimental treatment. The DSMB recommended that the study continue without modification. Ironically, the DSMB’s only safety concern was that those subjects who received the placebo might see a substantial increase in PTSD symptoms after tapering off of psychiatric medications. The DSMB is comprised of an M.D., a Psy.D. and a Pharm.D. not otherwise involved in the study. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. We’re already looking beyond the next five subjects and the completion of this initial study, to future research protocols.