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Enrolling by Invitation

NCT Number: NCT06173973

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

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.

Enrolling by Invitation

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Pennsylvania Center for Studies of Addiction, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kenetik; Ketone Concentrate

Dietary Supplement

Ketone Supplement

Other names: D-hydroxybutyric acid and R-1,3 butanediol

Isocaloric dextrose placebo

Dietary Supplement

Drink that is taste and visually matched to Ketone supplement

Primary outcomes

  1. Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).

    Time frame: 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 outcomes

  1. 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).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 18, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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