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Effects of Ketone Supplementation on Acute Alcohol Withdrawal Symptoms During Alcohol Withdrawal Management
The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.
This is a 5 day double-blinded, placebo-controlled intervention study of 50 treatment-seeking individuals with AUD, who are receiving detoxification treatment at Caron Treatment Center. Participants will be recruited for participation within 48 hours of admission to the inpatient unit. Participants will be consented and randomized to receive 10 g of ketone supplement three times daily (n=30; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 5 days or a placebo beverage (n=20). Benzodiazepines and other "comfort" medications will be administered daily following the Caron withdrawal management protocol, with additional benzodiazepines administered based on withdrawal symptoms, monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar). The CIWA-Ar is given three or more times per day clinically to determine patient withdrawal levels and adjust medication dosages. Total daily maximum CIWA-Ar scores, benzodiazepine dosage and other "comfort" medications will be analyzed with a repeated measures design, with a binary factor for intervention, factor of time, and intervention by time interaction. Daily mood and alcohol craving questions will assess differences between treatment groups.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States
Caron Treatment Center
Wernersville, Pennsylvania, United States
Start Date
March 11, 2024
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2027
Last Updated
March 25, 2025
50
ESTIMATED participants
Kenetik; Ketone Concentrate
DIETARY_SUPPLEMENT
Isocaloric dextrose placebo
DIETARY_SUPPLEMENT
Lead Sponsor
University of Pennsylvania
NCT05855668
NCT07071779
Data Source & Attribution
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