MDMA Therapy for PTSD in Veterans
Official title: A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)
Run by Sunstone Medical · NCT07569159 · Data updated 2026-11-12
This phase 2 study tests a fixed 120 mg dose of MDMA, followed by a 60 mg supplemental dose, plus therapy, to see if it helps adults who are veterans with PTSD.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Sunstone Medical Academic / other |
| Locations | 1 site (Rockville, Maryland) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | April 1, 2027 |
| Study ends | August 2027 |
| Registry record updated | July 1, 2026 |
| Trial ID | NCT07569159 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are veterans aged 18 or older who can reliably attend visits, swallow pills, and complete the required assessments in English, with no disqualifying medical or psychiatric conditions.
✕Probably not a fit
Participants with significant cardiovascular disease, active psychosis, certain severe psychiatric conditions, or pregnancy may not benefit or could be at risk.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, single-center, open-label study evaluating the safety, tolerability, and potential efficacy of MDMA-assisted therapy for PTSD in veterans. The trial uses a fixed-dose regimen with an initial 120 mg MDMA dose and a supplementary 60 mg dose, delivered alongside psychotherapy. Participants are assessed through protocol-required tools and visits, in both individual and group therapy settings. Enrollment is limited to adults who can swallow pills, speak English, and provide informed consent, with various medical and psychiatric exclusions applied. The study is led by Sunstone Medical at Sunstone Therapies in Rockville, MD.
Why it matters
Potential benefit: If successful, the approach could offer a new therapeutic option for PTSD in veterans.
How similar studies have gone: Other early studies of MDMA-assisted therapy for PTSD have shown potential benefits but varying results, making this investigation important to establish efficacy and safety in a veteran population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans who are at least 18 years old * Are able to swallow pills * Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits. * Proficient in speaking and reading English. Exclusion Criteria: * Condition impairing oral intake or digestive absorption. * Unable to give adequate informed consent. * Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months * Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF) * A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders. * Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner. * Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.
Where it's running
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Sunstone Therapies
Rockville, Maryland, United States Recruiting
Study contacts
- Principal investigator: Manish Agarwal — Sunstone Medical, PC
- Study coordinator: Clinical Evaluation Team
- Email: clinical.specialists@sunstonetherapies.com
- Phone: (301) 750-3401
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.