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

Description

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

PTSD

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Study Overview

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Study Details

Study overview

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.

A Randomized Trial to Compare MDMA-assisted Cognitive Processing Therapy (aCPT) Versus a VA Standard-of-care CPT for the Treatment of Severe Posttraumatic Stress Disorder Among Veterans

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

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

Palo Alto

VA Palo Alto Health Care System / Stanford University, Palo Alto, California, United States, 94304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Patricia Suppes,

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

Study Record Dates

2027-12