Recruiting
Phase 2
Phase 3

Ketone Supplement

Sponsor:

University of Pennsylvania

Code:

NCT06559995

Conditions

Alcohol Use Disorder

Alcohol Withdrawal

Ketosis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

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

magnetic resonance imaging session

Placebo beverage

Study Details

Brief 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.

Conditions

Alcohol Use Disorder

Alcohol Withdrawal

Ketosis

Study ID

NCT06559995

Start date

Aug 1, 2025

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion 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)

Exclusion Criteria:

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketone Supplement

Ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12g of ketones, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.

placebo comparator: Placebo 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.

Interventions

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

ketone supplement

magnetic resonance imaging session

1.5 hour magnetic resonance imaging session

Placebo 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.

Primary outcome measure

  • 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. [ Time Frame: 4 days ]

Central Contacts and Locations

Central contacts

Locations

Center for Studies of Addiction

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Corinde Wiers, Ph.D

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • Alcohol Use Disorder
  • Alcohol Withdrawal
  • ketosis
  • Ketone Supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-09-15.