RecruitingPhase 2Phase 3NCT06559995

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


Sponsor

University of Pennsylvania

Enrollment

30 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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.

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Interventions

DIETARY_SUPPLEMENTketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,

ketone supplement

DIAGNOSTIC_TESTmagnetic resonance imaging session

1.5 hour magnetic resonance imaging session

DIETARY_SUPPLEMENTPlacebo beverage

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.


Locations(1)

Center for Studies of Addiction

Philadelphia, Pennsylvania, United States

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NCT06559995


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