RECRUITING

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

Conditions

Alcohol Use Disorder Alcohol Withdrawal Ketosis Ketone Supplement

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-01

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06559995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Able to communicate English and provide written informed consent 2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD 3. Minimum 3-year history of heavy drinking (self-report). 4. Presence of alcohol withdrawal (DSM-5)	1. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures. 2. 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. 3. Clinically significant laboratory findings that could affect brain function (e.g., HIV+) 4. Head trauma with loss of consciousness for more than 30 minutes, 5. Pregnant or breast-feeding 6. BMI greater than 35 7. Self-reported claustrophobia 8. Contraindications to MRI (e.g., metal in the body that cannot be removed). 9. 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. 10. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan. 11. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Inclusion Criteria

Exclusion Criteria

1. Able to communicate English and provide written informed consent
2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
3. Minimum 3-year history of heavy drinking (self-report).
4. Presence of alcohol withdrawal (DSM-5)

1. Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
2. 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.
3. Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
4. Head trauma with loss of consciousness for more than 30 minutes,
5. Pregnant or breast-feeding
6. BMI greater than 35
7. Self-reported claustrophobia
8. Contraindications to MRI (e.g., metal in the body that cannot be removed).
9. 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.
10. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
11. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Contacts and Locations

Study Contact

Timothy Pond, MPH

CONTACT

215-746-1959

timpond@pennmedicine.upenn.edu

Principal Investigator

Corinde Wiers, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Corinde Wiers, Ph.D., PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Alcohol Use Disorder
Alcohol Withdrawal
ketosis
Ketone Supplement

Additional Relevant MeSH Terms

Alcohol Use Disorder
Alcohol Withdrawal
Ketosis