MDMA-assisted therapy for veterans with severe PTSD
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
This study is testing whether therapy combined with MDMA can help veterans with severe PTSD feel better compared to standard therapy alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Palo Alto Veterans Institute for Research Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05837845 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. military veterans aged 18 and older who are receiving services from specific VA healthcare systems and meet the criteria for severe PTSD.
Not a fit: Patients who do not meet the PTSD criteria or have contraindications to MDMA use may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for veterans suffering from severe PTSD.
How similar studies have performed: Previous studies have shown promising results for MDMA-assisted therapies in treating PTSD, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Palo Alto, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.