MDMA-assisted Cognitive Processing Therapy for Veterans with PTSD

This study is looking at how well MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) works for U.S. Military Veterans with severe Posttraumatic Stress Disorder (PTSD). You would either receive MDMA-aCPT, which combines MDMA (a drug) with therapy sessions, or Cognitive Processing Therapy (CPT), a standard therapy for PTSD. The study wants to see if MDMA-aCPT helps reduce PTSD symptoms more effectively than CPT. Researchers will measure changes in your PTSD symptoms using a special scale (CAPS-5) over about four months. They also want to understand if MDMA-aCPT can be used within the VA system. This study is currently recruiting 30 participants and is open to Veterans receiving care at specific VA healthcare systems.

Study design
This is an interventional study comparing two different treatments for PTSD. It plans to enroll 30 participants.
What's involved
You would attend non-drug preparatory and integration sessions, and three experimental sessions where MDMA HCl is given with therapy. You would also receive 8-15 sessions of Cognitive Processing Therapy.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms will be measured from the start of the study to approximately 4 months after the baseline.

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NCT05837845

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Patricia Suppes
~30 participants
Updated 2025-07-31 on ClinicalTrials.gov
What's tested:MDMACognitive Processing TherapyMDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score
Measured over From Baseline to approximately 4 months post-baseline
PTSD
1 sites across 1 states
California1
  • Trisha Suppes, MD, PhD · PRINCIPAL_INVESTIGATOR · VA Palo Alto Healthcare System / Stanford University
  • Shannon Wiltsey Stirman, PhD · PRINCIPAL_INVESTIGATOR · VA Palo Alto Healthcare System / Stanford University

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  • Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity ScoreFrom Baseline to approximately 4 months post-baseline

    The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to 4 months post-baseline assessed by a blinded study staff rater. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.