This open-label, Phase II trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
The unique treatment approach involves two once-monthly experimental therapy sessions, combined with a divided dose of MDMA, supplemented by non-drug preparatory and integrative therapy. The primary outcome measure, the Timeline Follow-back, will be used to assess changes in alcohol use over time, while PTSD symptoms will also be evaluated. Additional data will be collected via neuroimaging and biomarkers to study brain changes before and after treatment.
Find the study design here.
Trial Details
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Sponsors & Collaborators
Brown UniversityBrown University, under the leadership of researcher Carolina Haass-Koffler, is actively involved in an innovative clinical trial studying the safety and preliminary effectiveness of MDMA-assisted therapy.