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
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.
‣ Participants are eligible to be included in the study only if all of the following criteria apply:
• Are at least 18 years at the time of signing the informed consent
• Are a U.S Military Veteran
• Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
• Are fluent in speaking and reading in English
• Agree to have study visits audio and/or video recorded
• If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions
• Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months
• Have severe PTSD symptoms in the last month
• Body weight of at least 48 kilograms (kg)
⁃ Is not pregnant, planning to get pregnant, or breastfeeding
⁃ Capable of giving signed informed consent