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CompletedPhase 1 / Phase 2

Group MDMA-therapy for Veterans With PTSD

NCT05961527 · Group-MVP · Portland VA Research Foundation, Inc

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
23
Target enrolment
1
Study sites
1 US states

What it is testing

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.

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

  • Change in CAPS-5 Total Severity Score

    Measured over Baseline - 3 months from first Experimental Session

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 to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Are at least 18 years old. * Are a U.S. Military Veteran * Are fluent in speaking and reading the predominantly used or recognized language of the study site. * Are able to swallow pills. * Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions. * Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable. * Must agree to inform the investigators within 48 hours of any medical conditions and procedures. * If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session. * Must not participate in any other interventional clinical trials during the duration of the study. * Must commit to medication dosing, therapy, and study procedures. * Have a current PTSD diagnosis at the time of screening. Exclusion Criteria: * Are not able to give adequate informed consent. * Have uncontrolled hypertension. * Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments. * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). * Have evidence or history of significant medical disorders. * Have symptomatic liver or biliary disease. * Have history of hyponatremia or hyperthermia. * Weigh less than 48 kilograms (kg). * Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control. * Are abusing illegal drugs or alcohol.

Where

1 study site

FacilityCityRegionCountry
Portland-Vancouver VAVancouverWashingtonUnited 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.

NCT05961527 on ClinicalTrials.gov →

Last updated in the registry 2025-06-12. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits