A Phase 1 Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA When Administered to Healthy Volunteers
The information gathered during this study helped us better understand the psychological effects produced by MDMA and how those effects can more effectively be used within a therapeutic context. Participants were healthy volunteers who had completed a program training them in conducting MDMA-assisted therapy. In this randomized, double blind study, participants received both placebo and MDMA during two separate sessions scheduled at least two days apart in a therapy setting. Study participants prepared for the experience with the investigators and underwent two day-long sessions, one with placebo and one with MDMA, with the second session happening two days after the first. Order of session was assigned randomly in a double-blind fashion. Participants completed psychological and safety measures and discussed their experience on the day after each session. Mood, psychological symptoms, and interpersonal closeness were measured before and after each session. The investigators followed up with participants again one and two months after the second experimental session, and participants completed a personality questionnaire two months after the second experimental session.
- Current Status: Fully Enrolled
- Clinicaltrials.gov Record
- Study Protocol
- Study Timeline