A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Posttraumatic Stress Disorder of Moderate or Greater Severity
This multi-site, double-blind, placebo-controlled, randomized Phase 3 study assessed the efficacy and safety of MDMA-assisted therapy versus therapy with placebo control in participants diagnosed with at least moderate PTSD. The study was conducted in N ≈ 100 participants. Participants were randomized into one of two groups (MDMA or placebo) in a 1:1 ratio. A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, was administered during the Treatment Period with manualized therapy in three monthly Experimental Sessions. This ~12-week Treatment Period was preceded by three Preparatory Sessions with the participant and therapists. Initial doses in each Experimental Session were 80 mg or 120 mg of MDMA, followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg, respectively). Total amounts of MDMA administered per Experimental Session ranged from 80 mg to 180 mg. Each Experimental Session was followed by three Integrative Sessions of non-drug therapy to help the participants process and understand their experiences during the Experimental Sessions.
- Current Status: Complete
- ClinicalTrials.gov Record
- Study Protocol
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Seeking Research Volunteers
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Seeking Research Volunteers
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MAPS and MAPS Public Benefit Corporation Announce Positive Result from Phase 3 Trial of MDMA-Assisted Therapy for PTSD
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: All Experimental Treatment Sessions Completed in First Trial, Enrollment Continues in Second Trial
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Currently Enrolling
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: All Sites Enroll a Participant
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 14 Sites Screening Participants
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Now Enrolling
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 13 Sites Screening Participants
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 10 Sites Screening Participants
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 9 Sites Screening Participants
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: Study Site Initiation in Tel Hashomer, Israel
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Israel Approves Compassionate Use of MDMA-Assisted Therapy for PTSD
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Phase 3 Trials of MDMA-Assisted Therapy for PTSD: 8 Sites Screening Participants
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Medical-Grade MDMA Arrives at Multiple Phase 3 Clinical Trial Sites
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Phase 3 Trials: Recruitment Opens for New Trials of MDMA-Assisted Therapy for PTSD
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Phase 3 Trials: Study Initiation Visits for 5 Sites Completed
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Phase 3 Trials: Participant Enrollment Begins This Summer
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Phase 3 Trials: MAPS Meets with European Medicines Agency (EMA)
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Phase 3 Program: MDMA-Assisted Therapy for PTSD