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RecruitingPhase 2

MDMA Therapy in Veterans With PTSD

NCT07569159 · Sunstone Medical

Recruiting
Status
Accepting participants
Phase 2
Phase
52
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Safety and Tolerability

    Measured over 15 months

  • C-SSRS

    Measured over 15 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
Sunstone TherapiesRockvilleMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07569159 on ClinicalTrials.gov →

Last updated in the registry 2026-07-01. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits