MAPS’ Data Safety Monitoring Board (DSMB) met to review records for the six new subjects who have enrolled since their last meeting in Dr. Michael Mithoefer’s study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. With data from a total of eleven subjects before them, the DSMB reported that they did not have any concerns about the safety of the study, and recommended that it continue without modification. The DSMB is comprised of an M.D., a Psy.D., and a Pharm.D. not otherwise involved in the study. Dr. Mithoefer has successfully treated 11 out of an eventual 20 subjects, and is currently treating the twelfth. The DSMB also reviewed and approved three protocol changes that Dr. Mithoefer and MAPS will initially submit to FDA and then, if approved, to our Institutional Review Board (IRB). Dr. Mithoefer is seeking permission to: 1) Increase the number of MDMA experimental sessions from two to three, to evaluate whether this extra session will enable subjects to make more therapeutic progress. 2) Administer supplemental doses of 1/2 the initial dose of MDMA 2 to 2 1/2 hours after the initial dose, in order to prolong the relatively short plateau of MDMA’s full therapeutic effectiveness. 3) Since Dr. Mithoefer has recently renewed his Board certification in ER medicine, we have asked to do without the additional Board-certified ER doctor sitting in the next room. In comparison, Dr. Peter Oehen’s study in Switzerland has been designed and approved for three MDMA experimental sessions and the use of supplemental doses. Dr. Kotler’s study in Israel has been designed and approved with supplemental dosing but just two MDMA experimental sessions.
