Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
KSAW
2 other identifiers
interventional
30
1 country
1
Brief Summary
The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 15, 2025
September 1, 2025
2.3 years
July 29, 2024
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention.
Patients in alcohol withdrawal management receive benzodiazepines measured in milligrams to treat their alcohol withdrawal symptoms. The primary outcome of this study is to compare the group differences in the amounts of benzodiazepines given to subjects after receiving either a ketone supplement or placebo beverage after 4 days, while undergoing in-patient acute withdrawal management.
4 days
Secondary Outcomes (2)
To measure the group differences of BHB levels in millimoles, in subjects receiving ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
4 days
To measure the group differences of Gamma-Aminobutyric Acid levels in millimoles in subjects receiving a ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
4 days
Study Arms (2)
Ketone Supplement
EXPERIMENTALKetone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12g of ketones, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
Placebo Beverage
PLACEBO COMPARATORPlacebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
Interventions
ketone supplement
1.5 hour magnetic resonance imaging session
Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
Eligibility Criteria
You may qualify if:
- Able to communicate English and provide written informed consent
- Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
- Minimum 3-year history of heavy drinking (self-report).
- Presence of alcohol withdrawal (DSM-5)
You may not qualify if:
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
- Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam.
- Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
- Head trauma with loss of consciousness for more than 30 minutes,
- Pregnant or breast-feeding
- BMI greater than 35
- Self-reported claustrophobia
- Contraindications to MRI (e.g., metal in the body that cannot be removed).
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinde Wiers, Ph.D.
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double blinded
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2024
First Posted
August 19, 2024
Study Start
August 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
September 15, 2025
Record last verified: 2025-09