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RecruitingPhase 2

MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder

NCT05837845 · Patricia Suppes

Recruiting
Status
Accepting participants
Phase 2
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score

    Measured over From Baseline to approximately 4 months post-baseline

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

1 study site

FacilityCityRegionCountry
VA Palo Alto Health Care System / Stanford UniversityPalo AltoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05837845 on ClinicalTrials.gov →

Last updated in the registry 2025-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in