Condition: Post Traumatic Stress Disorder · Alcohol Use Disorder · Sponsor: VA Office of Research and Development
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The primary objective of the proposed project is to evaluate safety and clinical outcomes of MDMA-assisted therapy compared to identical psychotherapy with low dose ("active placebo") MDMA for the treatment of PTSD-AUD in military Veterans. The Primary Outcome measures, the Clinician Administered PTSD Scale (CAPS-5) and Inventory of Psychosocial Functioning (IPF), will evaluate changes in PTSD symptoms and psychosocial outcomes over time. Changes in drinking outcomes will also be evaluated (via the Timeline Followback, TLFB).
This description comes directly from the study's public registry record.
Erica M Eaton, PhD · (401) 273-7100 · Erica.Eaton@va.gov
Christy Capone, PhD · (401) 273-7100 · christy.capone@va.gov
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| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven, Connecticut, United States | Recruiting |
| Providence VA Medical Center, Providence, RI | Providence, Rhode Island, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07118839