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

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Alcohol Use Disorder, Alcohol Withdrawal, Ketosis

In brief

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.

Key facts

Study ID

NCT06559995

Run by

University of Pennsylvania

People needed

30

Starts

2025-08-01

Expected to finish

2027-12-01

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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