Effects of Ketone Supplementation on Acute Alcohol Withdrawal

University of Pennsylvania

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Alcohol Withdrawal; Ketosis; Alcohol Use Disorder; Alcohol Dependence

Treatments: Dietary Supplement: Isocaloric dextrose placebo; Dietary Supplement: Kenetik; Ketone Concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06173973

854682

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 2 patient groups, including a placebo group

Ketone Supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Kenetik; Ketone Concentrate

Placebo Beverage

Placebo Comparator group

Description:

Matching Placebo drink three times daily for five days

Treatment:

Dietary Supplement: Isocaloric dextrose placebo