Dose Optimization of MDMA-Assisted Therapy for PTSD

Recruiting now · Phase 2

Conditions studied: Posttraumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT06418178

Run by

Bronx VA Medical Center

People needed

60

Starts

2025-06-03

Expected to finish

2029-10-01

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are a U.S. military veteran at least 18 years old.
• Are able to provide written, informed consent.
• Are able to swallow pills.
• Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
• 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.
• 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.
• Must have a current PTSD diagnosis at screening and baseline.
• Must not participate in any other interventional clinical trials for the duration of the study.
• Must commit to medication dosing, therapy, and all study procedures.

You may not qualify if…

• Are not able to give adequate informed consent.
• Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.
• Have uncontrolled hypertension.
• Have evidence or history of significant medical or psychiatric disorders.
• Have symptomatic liver disease.
• Have history of hyponatremia or hyperthermia.
• Weigh less than 48 kilograms (kg).
• Unable or unwilling to safely taper off prohibited psychiatric medication.
• Abusing illegal drugs or alcohol.
• Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment.
• Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.

Where it is running

• James J. Peters VA Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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