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NCT07569159 · ClinicalTrials.gov registry record · Phase 2
MDMA Therapy in Veterans With PTSD
A Phase 2 study, sponsored by Sunstone Medical.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT07569159: Recruiting Phase 2 study, sponsored by Sunstone Medical.
NCT07569159 is a Phase 2 study that is actively recruiting participants, run by Sunstone Medical. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07569159, a Phase 2 study, is actively recruiting participants, sponsored by Sunstone Medical.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
Primary Outcome
To assess the safety and tolerability of individual and group MDMA-assisted therapy in adult veterans with PTSD using Incidence and occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from signing of ICF until the EOS Visit.
Interventions
- DRUG MDMA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2027-08 |
| Phase | Phase 2 |
What NCT07569159 shows while recruiting
NCT07569159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which MDMA is the first listed.
NCT07569159 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07569159 about?
NCT07569159 is a clinical study titled "MDMA Therapy in Veterans With PTSD". A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.
What is the current status of trial NCT07569159?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2026-06-30. Estimated completion is 2027-08.
What interventions are being tested in trial NCT07569159?
The interventions under investigation include: MDMA (DRUG).
Who is sponsoring clinical trial NCT07569159?
This trial is sponsored by Sunstone Medical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07569159's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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