NCT05837845 MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
| NCT ID | NCT05837845 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Patricia Suppes |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-02-10 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Trisha Suppes, MD, PhD
PRINCIPAL INVESTIGATOR
VA Palo Alto Healthcare System / Stanford University
Frequently Asked Questions
Who can join the NCT05837845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05837845 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05837845 currently recruiting?
Yes, NCT05837845 is actively recruiting participants. Contact the research team at exploratorytherapeuticslab@stanford.edu for enrollment information.
Where is the NCT05837845 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT05837845 clinical trial?
NCT05837845 is sponsored by Patricia Suppes. The principal investigator is Trisha Suppes, MD, PhD at VA Palo Alto Healthcare System / Stanford University. The trial plans to enroll 30 participants.
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