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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Are at least 18 years at the time of signing the informed consent

• Are a U.S Military Veteran

• Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System

• Are fluent in speaking and reading in English

• Agree to have study visits audio and/or video recorded

• If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions

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

• Have severe PTSD symptoms in the last month

• Body weight of at least 48 kilograms (kg)

⁃ Is not pregnant, planning to get pregnant, or breastfeeding

⁃ Capable of giving signed informed consent

Locations
United States
California
VA Palo Alto Health Care System / Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Anna Donnelly
exploratorytherapeuticslab@stanford.edu
650-849-0161
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 30
Treatments
Experimental: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)
This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (\~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed.
Experimental: Cognitive processing therapy
This arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a \~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed.
Related Therapeutic Areas
Sponsors
Leads: Patricia Suppes
Collaborators: Stanford University, Steven & Alexandra Cohen Foundation, VA Palo Alto Health Care System

This content was sourced from clinicaltrials.gov