Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)

This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of MDMA-assisted therapy in participants diagnosed with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been identified and trained to work on the sponsor's planned Phase 3 studies will treat at least one open-label participant in this study. This study will compare the effects of three open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 100 mg or 125 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental half-dose (50 mg or 62.5 mg). Total amounts of MDMA to be administered per Experimental Session range from 100 mg to 187.5 mg. This \~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The primary outcome measure is the change in the Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS) for PTSD for the MAPS studies total scores from Baseline to Visit 19.