Who is eligible for clinical trial NCT06418178?

Participants must meet protocol criteria for Posttraumatic Stress Disorder. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06418178 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-06-23

Dose Optimization of MDMA-Assisted Therapy for PTSD (NCT06418178)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Bronx VA Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (12 items).

Location: James J. Peters VA Medical Center — The Bronx, New York

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

James J. Peters VA Medical Center — The Bronx, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗