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

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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 therapy in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-assisted therapy 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-assisted therapy for PTSD within the VA system.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Patricia Suppes
• Collaborators: Stanford University; Steven & Alexandra Cohen Foundation; VA Palo Alto Health Care System
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

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 fluent in speaking and reading in English

4. Agree to have study visits audio and/or video recorded

5. Able to identify appropriate support person(s) to stay with the participant on the evenings of the Experimental Sessions.

6. Meet DSM-5 criteria for current severe PTSD with a symptom duration of at least 6 months.

7. Have severe PTSD symptoms in the last month.

8. Body weight of at least 48 kilograms (kg).

9. Is not pregnant, planning to get pregnant, or breastfeeding

10. 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. Have an active alcohol or substance use disorder

6. Have current serious suicide risk

7. Unable or unwilling to stop or safely taper off prohibited medications

8. Have used Ecstasy more than 10 times within the last 10 years

9. Currently enrolled in any clinical study

10. Have a history of or current psychotic disorders, bipolar disorder type I, or severe personality disorders

11. Lack social support, or lack a stable living situation

12. Previous participation in a MAPS-sponsored MDMA clinical trial