Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05837845

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

Led by Patricia Suppes · Updated on 2025-07-31

30

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

Sponsors

P

Patricia Suppes

Lead Sponsor

S

Stanford University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be at least 18 years old at the time of signing consent
  • Be a U.S. Military Veteran
  • Receive services from VA Palo Alto, VA San Francisco, or VA NorCal Healthcare Systems
  • Be fluent in English speaking and reading
  • Agree to have study visits audio and/or video recorded
  • If assigned to MDMA-aCPT, identify support person(s) to stay with participant on MDMA session evenings
  • Meet DSM-5 criteria for PTSD with symptoms lasting at least 6 months
  • Have severe PTSD symptoms in the last month
  • Weigh at least 48 kilograms
  • Not be pregnant, planning pregnancy, or breastfeeding
  • Be capable of giving signed informed consent
Not Eligible

You will not qualify if you...

  • History of medical conditions that make receiving sympathomimetic drugs harmful
  • Current unstable medical illness
  • Cardiac conditions such as uncontrolled hypertension or prolonged QTc interval
  • Received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks prior
  • Moderate or severe alcohol or cannabis use disorder in the last 12 months
  • Active illicit or prescription drug use disorder (other than cannabis) in last 12 months
  • Current serious suicide risk
  • Unable or unwilling to stop or safely taper prohibited medications
  • Previous use of MDMA (ecstasy)
  • Currently enrolled in another clinical study
  • Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
  • Lack of social support or stable living situation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Palo Alto Health Care System / Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

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Research Team

A

Anna Donnelly

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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