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NCT04264026 · ClinicalTrials.gov registry record · Phase 2
MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD
A Phase 2 study, sponsored by VA Loma Linda Health Care System.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04264026: Completed Phase 2 study, sponsored by VA Loma Linda Health Care System.
NCT04264026 is a Phase 2 study that has completed, run by VA Loma Linda Health Care System. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04264026, a Phase 2 study, has completed, sponsored by VA Loma Linda Health Care System.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy in three single-dose psychotherapy sessions in a hospital setting over the course of 12 weeks, along with preparatory and integration psychotherapy sessions in-between each active-dose session. The overall objective of this study is to evaluate the risks, benefits, and feasibility of MDMA used in conjunction with manualized psychotherapy, on reduction of symptoms, or remission of PTSD, as evaluated by standard clinical measures, in a VA Healthcare System. The primary outcome measure for the study is the Clinician-Administered PTSD Scale (CAPS-5), a semi-structured interview used in the majority of clinical trials for PTSD, which will be assessed at baseline, primary endpoint, and at the long-term 12-month follow-up visit. Secondary safety and efficacy measures will also be collected. The planned duration of this study is 1-3 years, with each active treatment period lasting approximately 12 weeks, along with a long-term follow-up 12 months after the last active-drug session.
Primary Outcome
The primary objective was amended in January 2024. The study will now aim to explore the feasibility of MDMA used in conjunction with manualized psychotherapy on reduction of symptoms, or remission of combat-related treatment resistant PTSD, as evaluated by standard clinical measures as a multiple case series.
Interventions
- DRUG 3,4-methylenedioxymethamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2025-05-01 |
| Phase | Phase 2 |
What the finished NCT04264026 record still lists
NCT04264026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which 3,4-methylenedioxymethamphetamine is the first listed.
NCT04264026 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04264026 about?
NCT04264026 is a clinical study titled "MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD". This will be a single-site, open-label phase 2 study designed to test the feasibility of administering MDMA in conjunction with psychotherapy for combat-related treatment-resistant PTSD in US military veterans currently enrolled in VA. MDMA will be given in conjunction with structured psychotherapy ...
What is the current status of trial NCT04264026?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-07-29. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT04264026?
The interventions under investigation include: 3,4-methylenedioxymethamphetamine (DRUG).
Who is sponsoring clinical trial NCT04264026?
This trial is sponsored by VA Loma Linda Health Care System, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04264026's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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