MDMA-assisted therapy for veterans with severe PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) compared to standard Cognitive Processing Therapy (CPT) for veterans suffering from severe posttraumatic stress disorder (PTSD). Conducted in collaboration with the Veterans Affairs Palo Alto Health Care System and Stanford University, the study aims to assess clinical outcomes, implementation feasibility, and health economics of this innovative treatment approach. Participants will be randomly assigned to receive either MDMA-aCPT or CPT, with the goal of determining the potential benefits of MDMA in enhancing therapeutic outcomes for PTSD.

Why it matters

Who can join: the full rules

Inclusion 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 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

Exclusion Criteria:

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

Where it's running

• VA Palo Alto Health Care System / Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: Trisha Suppes, MD, PhD — VA Palo Alto Healthcare System / Stanford University
• Study coordinator: Anna Donnelly
• Email: exploratorytherapeuticslab@stanford.edu
• Phone: 650-849-0161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.