Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
University of Pennsylvania
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.
Description
This is a 4-day randomized double-blinded intervention study of 30 treatment seeking adults with alcohol use disorder, who are receiving alcohol detoxification treatment at the Hospital of the University of Pennsylvania, Cedar Detox Center. Within 24 hours of admission to the inpatient unit, participants will be consented and randomized to receive 3x daily of 12g of KS (n=15; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 4 days or placebo beverage (n=15). Benzodiazepines and other "comfort" medications will be administered daily following the HUP Ced…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to communicate English and provide written informed consent 2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD 3. Minimum 3-year history of heavy drinking (self-report). 4. Presence of alcohol withdrawal (DSM-5) Exclusion Criteria: 1. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures. 2. Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history a…
Interventions
- Dietary Supplementketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,
ketone supplement
- Diagnostic Testmagnetic resonance imaging session
1.5 hour magnetic resonance imaging session
- Dietary SupplementPlacebo 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.
Location
- Center for Studies of AddictionPhiladelphia, Pennsylvania