Clinical trial NCT06173973: Effects of Ketone Supplementation on Acute Alcohol Withdrawal
Official title: Effects of Ketone Supplementation on Acute Alcohol Withdrawal Symptoms During Alcohol Withdrawal Management
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Alcohol Use Disorder
Alcohol Withdrawal
Alcohol Dependence
Ketosis
Keywords: Alcohol Use Disorder
Alcohol Withdrawal
Alcohol Dependence
Ketone Supplement
Ketosis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo controlled, Double blinded study
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).
timeFrame: 5 days
Secondary outcomes:
measure: 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).
timeFrame: 5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for Studies of Addiction
state: Pennsylvania
city: Wernersville
country: United States
facility: Caron Treatment Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Corinde E Wiers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: