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Enrolling by invitation NCT06173973

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Phase II / Phase III Interventional Alcohol Use Disorder Alcohol Withdrawal Alcohol Dependence Ketosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Kenetik; Ketone Concentrate, Isocaloric dextrose placebo.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Alcohol Withdrawal, Alcohol Dependence, Ketosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Dietary supplement Kenetik; Ketone Concentrate
    Ketone Supplement
  • Dietary supplement Isocaloric dextrose placebo
    Drink that is taste and visually matched to Ketone supplement

Primary outcome measures

  • Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg). [Time frame: 5 days]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • University of Pennsylvania Center for Studies of Addiction — Philadelphia
  • Caron Treatment Center — Wernersville

Identifiers

NCT: NCT06173973 · 854682

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗