MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted therapy in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-assisted therapy versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-assisted therapy for PTSD within the VA system.
Official Title
A Randomized Trial to Compare MDMA-assisted Therapy (MDMA-AT) Versus Cognitive Processing Therapy (CPT), a VA Standard-of-care Psychotherapy for PTSD, for the Treatment of Severe Posttraumatic Stress Disorder
Eligibility Criteria
- Participants are eligible to be included in the study only if all of the following criteria apply:
- 1. Are at least 18 years at the time of signing the informed consent.2. Are a U.S Military Veteran3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System4. Are fluent in speaking and reading in English5. Agree to have study visits audio and/or video recorded6. Able to identify appropriate support person(s) to stay with the participant on the evenings of the Experimental Sessions.7. Meet DSM-5 criteria for current severe PTSD with a symptom duration of at least 6 months.8. Have severe PTSD symptoms in the last month.9. Body weight of at least 48 kilograms (kg).10. Is not pregnant, planning to get pregnant, or breastfeeding11. Capable of giving signed informed consent
- Participants are excluded from the study if any of the following criteria apply:
- 1. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful2. Have current unstable medical illness3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment5. Have an active alcohol or substance use disorder6. Have current serious suicide risk7. Unable or unwilling to stop or safely taper off prohibited medications8. Have used Ecstasy more than 10 times within the last 10 years9. Currently enrolled in any clinical study10. Have a history of or current psychotic disorders, bipolar disorder type I, or severe personality disorders11. Lack social support, or lack a stable living situation12. Previous participation in a MAPS-sponsored MDMA clinical trial
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Sara Ellis
650-849-0161
View on ClinicalTrials.gov
