Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Phase 2

• Conditions: Ketosis; Alcohol Use Disorder; Alcohol Withdrawal; Alcohol Dependence
• Interventions: Dietary Supplement: Isocaloric dextrose placebo; Dietary Supplement: Kenetik; Ketone Concentrate

• Registration Number: NCT06173973
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-18
• Study Start: 2024-03-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
2. Willingness to provide signed, informed consent and commit to completing the procedures in the study

Exclusion Criteria

1. Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
2. Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
3. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
4. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Beverage	Isocaloric dextrose placebo	Matching Placebo drink three times daily for five days
Ketone Supplement	Kenetik; Ketone Concentrate	Ketone Supplement drink with 10 g ketones three times daily for five days.

Primary Outcome Measures

Name	Time	Method
Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).	5 days	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.

Secondary Outcome Measures

Name	Time	Method
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).	5 days	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.

Trial Locations

Locations (2)

University of Pennsylvania Center for Studies of Addiction; 🇺🇸 Philadelphia, Pennsylvania, United States

Caron Treatment Center; 🇺🇸 Wernersville, Pennsylvania, United States