A Phase 1/2 Open-Label Treatment Development Study of MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in which One Member Has Chronic Posttraumatic Stress Disorder (PTSD)
Cognitive-behavioural conjoint therapy (CBCT) for PTSD has been shown to improve PTSD, relationship adjustment, and the health and well-being of partners. MDMA may hold promise in catalyzing the effects of CBCT for PTSD, given the properties of MDMA and its ability to induce empathy and interpersonal openness.
This is a pilot open-label study exploring the safety, tolerability, and efficacy of CBCT integrated with MDMA-assisted therapy for the treatment of chronic PTSD. This study enrolled 6 couples consisting of one participant diagnosed with PTSD and one concerned significant other who did not have a current PTSD diagnosis, but who was experiencing problems associated with the psychosocial circumstances related to the PTSD participant’s diagnosis. There were two sessions in which both members of the couple were administered MDMA. There were significant improvements in clinician-assessed, patient-rated, and partner-rated PTSD symptoms, as well as patient depression, sleep, emotional regulation, and trauma-related beliefs. In addition, there were significant improvements in patient and partner-rated relationship adjustment and happiness. These results demonstrate that MDMA holds promise as a facilitator of CBCT to achieve more robust and broad effects on individual and relational functioning in those with PTSD and their partners.
- Current Status: Completed
- ClinicalTrials.gov Record
- Study Protocol
- Publication (2020)
- Case Study Publication (2019)
- Press Release
- Study Timeline
