MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder
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
Patricia Suppes
30 participants
Feb 10, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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
Exclusion Criteria13
- Participants are excluded from the study if any of the following criteria apply:
- Have a history of any medical condition that could make receiving a sympathomimetic drug harmful
- Have current unstable medical illness
- Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions
- Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment
- Moderate or severe alcohol or cannabis use disorder within the last 12 months
- Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months
- Have current serious suicide risk
- Unable or unwilling to stop or safely taper off prohibited medications
- Have used MDMA (ecstasy) ever
- Currently enrolled in any clinical study
- Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features
- Lack social support, or lack a stable living situation
Interventions
Participants will receive a flexible divided-dose of MDMA HCl plus therapy at three Experimental Sessions, as well as non-drug Preparatory and Integration Sessions
Participants will receive 8-15 (average of 12) sessions of Cognitive Processing Therapy
Participants assigned to MDMA-aCPT will undergo a therapeutic approach administered by trained therapists. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. MDMA can elicit feelings of empathy, love, and deep appreciation, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one's emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05837845