Carolina L Haass-Koffler
The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.
The study will use a longitudinal design to conduct an open label pilot trial of MDMA-AT. The study will also collect neuroimaging and biomarker data to examine brain changes pre-post treatment. Eligible participants will complete an in-person baseline assessment, undergo optional imaging protocols (if participant agrees and is medically safe to do so), engage in MDMA-AT with clinicians trained by MAPS PBC, and complete assessments at the post-treatment follow-up For complete description of the investigational plan, please the attached Clinical Protocol.
Inclusion Criteria: 1. Are able to provide proof of veteran status. 2. Are fluent in speaking and reading English. 3. At Baseline, meet criteria for Alcohol Use Disorder as measured by the SCID-5. 4. Able to safely abstain from alcohol for at least 48 hours without requiring medical detox. 5. At Baseline meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months. 6. At Baseline, have a PCL-5 score of 33 or greater. 7. At Baseline, have a confirmed PTSD diagnosis per the CAPS-5 and a Total Severity Score of 28 or greater. 8. Are able to swallow pills. 9. Agree to have st…
medication and therapy combined
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