Optimizing the number of MDMA-assisted therapy cycles for veterans with PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, within-subjects Phase 2 trial enrolls U.S. military veterans with PTSD to determine the optimal number of MDMA-assisted therapy cycles. All participants receive three preparatory psychotherapy sessions, then at least one cycle consisting of one approximately eight-hour MDMA session with a two-therapist team followed by three 90-minute integration sessions, and they may continue up to five cycles. After each cycle, the participant and therapy team decide whether to continue based on symptom change, tolerability, and participant burden. Blood samples will be banked for future biomarker analyses and the design allows evaluation of both clinical response and tolerability across multiple cycles.

Why it matters

Who can join: the full rules

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 it's running

• James J. Peters VA Medical Center
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Rachel Yehuda, PhD — James J. Peters VA Medical Center
• Study coordinator: Amy Lehrner, PhD
• Email: Amy.Lehrner@va.gov
• Phone: 718-584-9000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.