RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05837845

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are at least 18 years at the time of signing the informed consent
  2. 2. Are a U.S Military Veteran
  3. 3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System
  4. 4. Are fluent in speaking and reading in English
  5. 5. Agree to have study visits audio and/or video recorded
  6. 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. 7. Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months
  8. 8. Have severe PTSD symptoms in the last month
  9. 9. Body weight of at least 48 kilograms (kg)
  10. 10. Is not pregnant, planning to get pregnant, or breastfeeding
  11. 11. Capable of giving signed informed consent
  1. 1. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
  2. 2. Have current unstable medical illness
  3. 3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
  4. 4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
  5. 5. Moderate or severe alcohol or cannabis use disorder within the last 12 months
  6. 6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
  7. 7. Have current serious suicide risk
  8. 8. Unable or unwilling to stop or safely taper off prohibited medications
  9. 9. Have used MDMA (ecstasy) ever
  10. 10. Currently enrolled in any clinical study
  11. 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. 12. Lack social support, or lack a stable living situation

Contacts and Locations

Study Contact

Anna Donnelly
CONTACT
650-849-0161
exploratorytherapeuticslab@stanford.edu

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-02
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • MDMA-assisted Therapy
  • Cognitive Processing Therapy
  • Veterans
  • Posttraumatic stress disorder
  • Quality of Life

Additional Relevant MeSH Terms

  • PTSD