Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Ketone Supplementation on Acute Alcohol Withdrawal Symptoms During Alcohol Withdrawal Management

Conditions
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Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketosis

Intervention / Treatment
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* Dietary Supplement: Kenetik; Ketone Concentrate
* Dietary Supplement: Isocaloric dextrose placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center Willingness to provide signed, informed consent and commit to completing the procedures in the study Exclusion Criteria: 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. Currently pregnant or lactating, based on urine pregnancy test and clinical exam. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Placebo controlled, Double blinded study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketone Supplement<br>Ketone Supplement drink with 10 g ketones three times daily for five days. | Dietary Supplement: Kenetik; Ketone Concentrate<br>* Ketone Supplement<br>* Other names: D-hydroxybutyric acid and R-1,3 butanediol;|
| Placebo Comparator: Placebo Beverage<br>Matching Placebo drink three times daily for five days | Dietary Supplement: Isocaloric dextrose placebo<br>* Drink that is taste and visually matched to Ketone supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketone Supplement, Ketosis