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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
50
Ketone Supplement
Drink that is taste and visually matched to Ketone supplement
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States
Caron Treatment Center
Wernersville, Pennsylvania, United States
Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).
To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg), while undergoing inpatient acute withdrawal management.
Time frame: 5 days
Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores).
To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores, range 0-67) while undergoing inpatient acute withdrawal management.
Time frame: 5 days
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