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A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)
NCT03537014 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe 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.
Conditions Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Therapy
- DRUG midomafetamine HCl
Study Locations (15)
California
- New School Research LLT — North Hollywood
- San Francisco Insight and Integration Center — San Francisco
- University of California San Francisco — San Francisco
Colorado
- Aguazul-Blue Water Inc. — Boulder
- Wholeness Center — Fort Collins
New York
- New York University — New York
- New York Private Practice — New York
Other
- Assaf Harofeh Research Fund — Be’er Ya‘aqov
- Sheba Fund for Health Services and Research — Tel Litwinsky
Louisiana
- Ray Worthy Psychiatry LLC — New Orleans
Massachusetts
- Trauma Research Foundation — Boston
South Carolina
- Zen Therapeutic Solutions, LLC — Mt. Pleasant
Wisconsin
- University of Wisconsin at Madison — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-11-21 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03537014
The ClinicalTrials.gov registry entry for NCT03537014 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lykos Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03537014 reports 15 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03537014 about?
NCT03537014 is a clinical study titled "A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)". The goal of this clinical trial is to learn if MDMA-assisted therapy is safe and effective in people with at least severe 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 ...
What is the current status of trial NCT03537014?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2018-11-21. Estimated completion is 2020-08-21.
What conditions does trial NCT03537014 study?
This clinical trial studies the following conditions: Posttraumatic Stress Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03537014?
The interventions under investigation include: Placebo (DRUG), Therapy (BEHAVIORAL), midomafetamine HCl (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03537014?
This trial is sponsored by Lykos Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03537014 being conducted?
This trial has 15 study locations across California, Colorado, Louisiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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