We are currently accepting patients for this trial.

View on clinicaltrials.gov: https://clinicaltrials.gov/study/NCT05837845

Stanford Investigator(s):

• Trisha Suppes, MD, PhD
• Shannon Wiltsey Stirman

Intervention(s):

• drug: MDMA
• behavioral: Cognitive Processing Therapy
• behavioral: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)

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.

Eligibility

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

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

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

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 - N/A

Genders Eligible for Study

ALL