A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Status:
Enrolling by invitation
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
This multi-site open-label study assesses the efficacy and safety of
3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were
enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study
will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of
MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period
with manualized psychotherapy 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. The
Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and
Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit
16. This study will compare the effects of three manualized Experimental Sessions of
psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session
include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone
(mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40
or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg
to 180 mg.
Phase:
Phase 3
Details
Lead Sponsor:
Multidisciplinary Association for Psychedelic Studies