Dose Optimization of MDMA-Assisted Therapy for PTSD

Launched by BRONX VA MEDICAL CENTER · May 13, 2024

Keywords

ClinConnect Summary

This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in ...

Gender

ALL

Eligibility criteria

• 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.

Trial Officials