Dose Optimization of MDMA-Assisted Therapy for PTSD

Launched by BRONX VA MEDICAL CENTER · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how many sessions of MDMA-Assisted Therapy (MDMA-AT) are most helpful for U.S. military veterans who have Posttraumatic Stress Disorder (PTSD). Participants will take part in a series of therapy sessions that include one session with MDMA, followed by three sessions to help integrate what they learned during the MDMA session. Veterans between the ages of 18 and 74 who have been diagnosed with PTSD and can provide informed consent are eligible to join.

If you decide to participate, you can expect to go through different cycles of therapy, with each cycle consisting of both the MDMA session and follow-up sessions. During the study, you will have regular visits to discuss your progress, and your sessions will be recorded to help with research. It’s important to note that you cannot be part of another clinical trial while this study is ongoing, and there are some health conditions that would exclude you from participating. This trial aims to find out the best way to use MDMA in therapy to support veterans with PTSD, potentially helping many individuals who are struggling.

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.