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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- 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
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.