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NCT05961527 · ClinicalTrials.gov registry record · Phase 1
Group MDMA-therapy for Veterans With PTSD
A Phase 1 study, sponsored by Portland VA Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT05961527: Completed Phase 1 study, sponsored by Portland VA Research Foundation.
NCT05961527 is a Phase 1 study that has completed, run by Portland VA Research Foundation. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05961527, a Phase 1 study, has completed, sponsored by Portland VA Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.
Primary Outcome
The CAPS-5 is a semi-structured interview that assesses index history of DSM-5-defined traumatic event exposure, including the most distressing event, time since exposure, to produce a diagnostic score (presence vs. absence) and a PTSD Total Severity score. The CAPS-5 rates intrusion symptoms (intrusive thoughts or memories), avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress and dissociation. The total severity score is a sum of symptom freq
Interventions
- DRUG MDMA
- BEHAVIORAL Group Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-10-01 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 1 |
What the finished NCT05961527 record still lists
NCT05961527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which MDMA is the first listed.
NCT05961527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05961527 about?
NCT05961527 is a clinical study titled "Group MDMA-therapy for Veterans With PTSD". This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions...
What is the current status of trial NCT05961527?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-10-01. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT05961527?
The interventions under investigation include: MDMA (DRUG), Group Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05961527?
This trial is sponsored by Portland VA Research Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05961527's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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