Condition: Alcohol Use Disorder · Alcohol Abuse · Substance Use Disorders · Sponsor: Spark Biomedical, Inc.
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.
This description comes directly from the study's public registry record.
Hyuntaek Oh, PhD · (713) 275-5019 · hyuntaek.oh@bcm.edu
Caroline Benner · (210) 624-8046 · clinicaltrials@sparkbiomedical.com
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| The Menninger Clinic | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07281261