A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD
Status:
Recruiting
Trial end date:
2023-03-05
Target enrollment:
Participant gender:
Summary
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop
after a traumatic life experience that severely reduces quality of life. This multi-site,
double-blind, placebo-controlled, randomized Phase 3 study will assess the efficacy and
safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy compared to
psychotherapy with placebo in participants diagnosed with at least moderate PTSD. The study
will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a
flexible dose of 80 or 120 mg MDMA or placebo, followed by a supplemental half-dose of 40 or
60 mg MDMA or placebo, unless contraindicated, with manualized psychotherapy in three monthly
Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory
Sessions with the participant and therapists. During the Treatment Period, each Experimental
Session will be followed by three Integrative Sessions of non-drug psychotherapy.
Phase:
Phase 3
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies