Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06173973
• Other study ID #: 854682
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: March 11, 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcohol Withdrawal
• Alcoholism
• Ketosis

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania Center for Studies of Addiction	Philadelphia	Pennsylvania
United States	Caron Treatment Center	Wernersville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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