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Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder (KSAW)
The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.
Details
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2025-08-01 |
| Completion | 2027-12 |
Conditions
- Alcohol Use Disorder
- Alcohol Withdrawal
- Ketosis
Interventions
- ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,
- magnetic resonance imaging session
- Placebo beverage
Primary outcomes
- Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention. — 4 days
Patients in alcohol withdrawal management receive benzodiazepines measured in milligrams to treat their alcohol withdrawal symptoms. The primary outcome of this study is to compare the group differences in the amounts of benzodiazepines given to subjects after receiving either a ketone supplement or placebo beverage after 4 days, while undergoing in-patient acute withdrawal management.
Countries
United States