A Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder
This multi-site open-label study is a safety extension for Phase 3 participants who did not get treated due to the COVID-19 pandemic. The study will be conducted in up to N=100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized therapy in three monthly Experimental Sessions. 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 therapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) from Visit 3 to to Visit 16. This study will compare the effects of three manualized Experimental Sessions of therapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA, followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.