MAPS submitted to the FDA today the protocol for Dr. Michael Mithoefer and Dr. Mark Wagner’s MAPS-supported pilot study into the use of MDMA-assisted psychotherapy in the treatment of patients who have experienced criminal victimization and as a result have suffered from chronic, treatment-resistance posttraumatic stress disorder (PTSD). The submission of this protocol to FDA marks a major milestone in the history of MAPS, and hopefully in the history of MDMA research. FDA has 30 days to respond to the protocol. We fully expect FDA eventually to approve the study in some form.
(Faster download – without individual case reports from Phase 1 study; longer version – with individual case reports from Phase 1 study)
