Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
NCT06559995 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-15
Summary
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.
Conditions
- Alcohol Use Disorder
- Alcohol Withdrawal
- Ketosis
Interventions
- DIETARY_SUPPLEMENT
-
ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,
ketone supplement
- DIAGNOSTIC_TEST
-
magnetic resonance imaging session
1.5 hour magnetic resonance imaging session
- DIETARY_SUPPLEMENT
-
Placebo beverage
Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
Sponsors & Collaborators
-
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH - lead OTHER
Principal Investigators
-
Corinde Wiers, Ph.D. · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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