A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD
Public ClinicalTrials.gov record NCT04714359. 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 Multi-Site Open-Label Safety Extension Study of Manualized MDMA-Assisted Psychotherapy for the Treatment of Participants With Posttraumatic Stress Disorder
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 at reducing PTSD symptoms in people with PTSD who received placebo in a prior MDMA-assisted therapy study. The main question it aims to answer is: Do PTSD symptoms decrease in people who receive a flexible dose of MDMA (120 or 180 mg MDMA HCl) with therapy in three sessions? Participants will undergo three preparatory therapy sessions without any study drug, then three MDMA-assisted therapy sessions with a flexible dose of 80 or 120 mg, followed by three integrative therapy sessions without study drug after each MDMA-assisted therapy session.
Study identification
- NCT ID
- NCT04714359
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 87 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
- Mar 7, 2021
- Primary completion
- Oct 31, 2023
- Completion
- Nov 5, 2023
- Last update posted
- Jun 5, 2025
2021 – 2023
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New School Research | Los Angeles | California | 90004 | — |
| San Francisco Insight and Integration Center | San Francisco | California | 94114 | — |
| UCSF | San Francisco | California | 94122 | — |
| Aguazul-Blue Water Inc. | Boulder | Colorado | 80302 | — |
| Wholeness Center | Fort Collins | Colorado | 80525 | — |
| Ray Worthy Psychiatry | New Orleans | Louisiana | 70123 | — |
| Trauma Research Foundation | Boston | Massachusetts | 02446 | — |
| NYU | New York | New York | 10016 | — |
| New York Private Practice | 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04714359, 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 5, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04714359 live on ClinicalTrials.gov.