Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2027-12-31

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.

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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.

Conditions

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Alcohol Use Disorder Alcohol Withdrawal Alcohol Dependence Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Placebo controlled, Double blinded study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double blind

Study Groups

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Ketone Supplement

Ketone Supplement drink with 10 g ketones three times daily for five days.

Group Type ACTIVE_COMPARATOR

Kenetik; Ketone Concentrate

Intervention Type DIETARY_SUPPLEMENT

Ketone Supplement

Placebo Beverage

Matching Placebo drink three times daily for five days

Group Type PLACEBO_COMPARATOR

Isocaloric dextrose placebo

Intervention Type DIETARY_SUPPLEMENT

Drink that is taste and visually matched to Ketone supplement

Interventions

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Kenetik; Ketone Concentrate

Ketone Supplement

Intervention Type DIETARY_SUPPLEMENT

Isocaloric dextrose placebo

Drink that is taste and visually matched to Ketone supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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D-hydroxybutyric acid and R-1,3 butanediol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No