NCT07569159 MDMA Therapy in Veterans With PTSD
| NCT ID | NCT07569159 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sunstone Medical |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2026-06-30 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Manish Agarwal
PRINCIPAL INVESTIGATOR
Sunstone Medical, PC
Frequently Asked Questions
Who can join the NCT07569159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07569159 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07569159 currently recruiting?
Yes, NCT07569159 is actively recruiting participants. Contact the research team at clinical.specialists@sunstonetherapies.com for enrollment information.
Where is the NCT07569159 trial being conducted?
This trial is being conducted at Rockville, United States.
Who is sponsoring the NCT07569159 clinical trial?
NCT07569159 is sponsored by Sunstone Medical. The principal investigator is Manish Agarwal at Sunstone Medical, PC. The trial plans to enroll 52 participants.