MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
Trial ID or NCT#
Status
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 Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT 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-aCPT for PTSD within the VA system.
Official Title
A Randomized Trial to Compare MDMA-assisted Cognitive Processing Therapy (aCPT) Versus a VA Standard-of-care CPT for the Treatment of Severe Posttraumatic Stress Disorder Among Veterans
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 consent2. 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. If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions7. Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months8. Have severe PTSD symptoms in the last month9. 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. Moderate or severe alcohol or cannabis use disorder within the last 12 months6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months7. Have current serious suicide risk8. Unable or unwilling to stop or safely taper off prohibited medications9. Have used MDMA (ecstasy) ever10. Currently enrolled in any clinical study11. Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features12. Lack social support, or lack a stable living situation
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Anna Donnelly
650-849-0161
View on ClinicalTrials.gov
