A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP2)
Public ClinicalTrials.gov record NCT04077437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least moderate PTSD. The main question it aims to answer is: Do three sessions of MDMA-assisted therapy reduce PTSD symptoms? Researchers will compare three sessions of MDMA-assisted therapy with an initial dose of 80 to 120 mg to three sessions of placebo with therapy. Participants will undergo three preparatory sessions without any study drug, followed by three MDMA-assisted therapy or placebo with therapy sessions. Each medication session will be followed by three integrative therapy sessions without study drug.
Study identification
- NCT ID
- NCT04077437
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2, 2020 (Actual)
- Primary completion
- Oct 30, 2022 (Actual)
- Completion
- Nov 2, 2022 (Actual)
- Last update posted
- Jun 6, 2025
2020 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New School Research | Los Angeles | California | 90004 | — |
| San Francisco Insight and Integration Center | San Francisco | California | 94122 | — |
| UCSF | San Francisco | California | 94122 | — |
| Aguazul Bluewater, Inc. | Boulder | Colorado | 80304 | — |
| Wholeness Center | Fort Collins | Colorado | 80525 | — |
| University of Connecticut | Farmington | Connecticut | 06030 | — |
| Ray Worthy Psychiatry LLC | New Orleans | Louisiana | 70123 | — |
| Trauma Research Foundation | Boston | Massachusetts | 02446 | — |
| New York University | New York | New York | 10016 | — |
| Nautilus Psychiatric Services | New York | New York | 11012 | — |
| Zen Therapeutic Solutions, LLC | Mt. Pleasant | South Carolina | 29464 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53705-2222 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04077437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 6, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04077437 live on ClinicalTrials.gov.