MDMA-assisted CPT vs. Cognitive Processing Therapy for Severe PTSD
Compares MDMA-assisted Cognitive Processing Therapy with standard CPT in veterans with severe PTSD.
This is an interventional study — the research team administers the treatment under a controlled, IRB-approved protocol. Participation never happens outside that protocol.
- Substance
- MDMA
- Status
- Recruiting now
- Conditions
- PTSD
- Who can join
- Veterans only
- Where
- Palo Alto, CA
- Run by
- Stanford / VA Palo Alto
- Registry ID
- NCT05837845 ↗
How to join this study
Call or email the study team directly. You do not go through Psychedelic Vets — we just make the door easier to find.
Contact details as published by the sponsor, last verified 2025-07. People move on — if this doesn't reach anyone, check ClinicalTrials.gov.
What taking part involves
This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (\~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed.
This arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a \~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed.
Who can join
Listed as the research team wrote them. This is not a decision about you — only the study team can say whether you are eligible, and the only way to find out is to ask them.
What the study is looking for
- 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 Veteran
- 3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
- 4. Are fluent in speaking and reading in English
- 5. Agree to have study visits audio and/or video recorded
- 6. If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions
- 7. Meet DSM-5 criteria for 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 breastfeeding
- 11. Capable of giving signed informed consent
What would rule you out
- 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 harmful
- 2. Have current unstable medical illness
- 3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- 4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- 5. Moderate or severe alcohol or cannabis use disorder within the last 12 months
- 6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
- 7. Have current serious suicide risk
- 8. Unable or unwilling to stop or safely taper off prohibited medications
- 9. Have used MDMA (ecstasy) ever
- 10. Currently enrolled in any clinical study
- 11. Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
- 12. Lack social support, or lack a stable living situation
You enroll directly with the research team through their own official page and IRB-approved consent process. Psychedelic Vets does not run this study or collect any of your health information.
Study data is sourced from ClinicalTrials.gov (U.S. National Library of Medicine) and verified university/nonprofit sources. This page is educational and is not medical advice or an endorsement. Details can change — always confirm on the official page above. ← Back to all studies
