Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 65Years
All Genders
NCT06559995

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

Led by University of Pennsylvania · Updated on 2025-09-15

30

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to communicate English and provide written informed consent
  • Meets current DSM-5 criteria for moderate or severe alcohol use disorder and seeking treatment
  • Minimum 3-year history of heavy drinking (self-report)
  • Presence of alcohol withdrawal according to DSM-5
Not Eligible

You will not qualify if you...

  • 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 affecting brain function or ketone supplement use (e.g., epilepsy, diabetes)
  • Clinically significant laboratory findings affecting brain function (e.g., HIV+)
  • Head trauma with loss of consciousness longer than 30 minutes
  • Pregnant or breast-feeding
  • Body mass index greater than 35
  • Self-reported claustrophobia
  • Contraindications to MRI (e.g., metal in the body that cannot be removed)
  • Current gastrointestinal, liver, or other significant physical disease interfering with ketone supplement intake
  • Significant withdrawal from other substances requiring medication management
  • Judged unsuitable for the study by the principal investigator or study physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for Studies of Addiction

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

T

Timothy Pond, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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