Dose Optimization of MDMA-Assisted Therapy for PTSD

Eligibility 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.
• 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.