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RecruitingPhase 2

Dose Optimization of MDMA-Assisted Therapy for PTSD

NCT06418178 · DosOp · Bronx VA Medical Center

Recruiting
Status
Accepting participants
Phase 2
Phase
60
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.

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

  • PTSD Checklist for DSM-5 (PCL-5)

    Measured over From Baseline to Outcome Site Visit (up to ~27 weeks for participants who complete all five treatment cycles)

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: 1. Are a U.S. military veteran at least 18 years old. 2. Are able to provide written, informed consent. 3. Are able to swallow pills. 4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions. 5. Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable. 6. 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 contraceptive methods. 7. Must have a current PTSD diagnosis at screening and baseline. 8. Must not participate in any other interventional clinical trials for the duration of the study. 9. Must commit to medication dosing, therapy, and all study procedures. Exclusion Criteria: 1. Are not able to give adequate informed consent. 2. Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful. 3. Have uncontrolled hypertension. 4. Have evidence or history of significant medical or psychiatric disorders. 5. Have symptomatic liver disease. 6. Have history of hyponatremia or hyperthermia. 7. Weigh less than 48 kilograms (kg). 8. Unable or unwilling to safely taper off prohibited psychiatric medication. 9. Abusing illegal drugs or alcohol. 10. Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment. 11. Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.

Where

1 study site

FacilityCityRegionCountry
James J. Peters VA Medical CenterThe BronxNew YorkUnited 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.

NCT06418178 on ClinicalTrials.gov →

Last updated in the registry 2025-06-26. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in