Overview

Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

Status:
Not yet recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
Summary
This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with posttraumatic stress disorder (PTSD). This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies
Treatments:
N-Methyl-3,4-methylenedioxyamphetamine