Ketone Supplement for Alcohol Withdrawal

(KSAW Trial)

Overseen By Timothy Pond, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Pennsylvania

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 0

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Corinde Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults with moderate to severe alcohol use disorder who are undergoing a 4-day alcohol withdrawal treatment. It's being conducted at the Hospital of the University of Pennsylvania, Cedar Detox Center.

Inclusion Criteria

Minimum 3-year history of heavy drinking (self-report)

Able to communicate in English and provide written informed consent

Presence of alcohol withdrawal (DSM-5)

Exclusion Criteria

Pregnant or breast-feeding

BMI greater than 35

Contraindications to MRI (e.g., metal in the body that cannot be removed)

Treatment Details

Interventions

• Ketone Supplement

Trial Overview The study is testing if a ketone supplement can help with alcohol withdrawal symptoms compared to a placebo. Participants will also undergo an MRI session to see how their brain metabolism might be affected.

Participant Groups

Group I: Ketone Supplement Active Control 2 Interventions

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.

Group II: Placebo Beverage Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+