A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)
Status:
Completed
Trial end date:
2020-08-21
Target enrollment:
Participant gender:
Summary
This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the
efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants
diagnosed with at least severe PTSD. The study will be conducted in up to N ≈ 100
participants. Participants will be randomized to receive a flexible dose of MDMA or placebo,
followed by a supplemental half-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 psychotherapy.
Phase:
Phase 3
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies