RecruitingPhase 2/3

Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder

United States30 participantsStarted 2025-08-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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).

What they're measuring

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.

Timeframe: 4 days

Trial details

NCT IDNCT06559995

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Timothy Pond, MPH

215-746-1959 timpond@pennmedicine.upenn.edu

View on ClinicalTrials.gov More Alcohol Use Disorder trials