Dose Optimization of MDMA-Assisted Therapy for PTSD
A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
Bronx VA Medical Center
60 participants
Jun 3, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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.
Exclusion Criteria11
- 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.
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Interventions
One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)
Standardized psychotherapy performed by therapy team
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06418178