Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD
Status:
Completed
Trial end date:
2019-08-10
Target enrollment:
Participant gender:
Summary
This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of
3,4-methylenedioxymethamphetamine (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
therapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80
mg or 120 mg of MDMA compounded with lactose, followed 1.5 to 2 hours later by a supplemental
half-dose (40 mg or 60 mg). Total amounts of MDMA to be administered per Experimental Session
range from 80 mg to 180 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
Clinician Administered PTSD Scale for DSM 5 (CAPS-5) total severity scores from Baseline to
Primary Endpoint (Visit 19).
Phase:
Phase 2
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies