Kenotic for Alcoholism

(KABA Trial)

Overseen By Timothy Pond, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Pennsylvania

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET/CT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.

Research Team

Corinde Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for individuals with alcohol use disorder who are interested in how a nutritional ketone supplement might affect their brain function and drinking behavior. Participants will undergo scans and lab sessions involving alcohol consumption.

Inclusion Criteria

I am between 21 and 65 years old.

Not seeking treatment for AUD (self-report)

Able to provide written informed consent

Exclusion Criteria

I am claustrophobic.

Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year

Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history)

Treatment Details

Interventions

• Kenetik (Dietary Supplement)

Trial Overview The study tests the effects of Kenetik, a ketone supplement, versus a placebo on brain energy and response to alcohol. It involves MRI and PET/CT scans, plus controlled alcohol intake in a bar lab setting, with treatments given randomly.

Participant Groups

Group I: Alcohol beverage Experimental Treatment 2 Interventions

The alcoholic beverage will be created by using a standard dose of 0.5g/kg 0.43 g/kg for men and women respectively (50% vodka), calculated to achieve a BrAC of about 0.050%. The alcoholic beverage will be given once at bar lab 1 and again at bar lab 2.

Group II: Ketone Supplement, Kenetik Active Control 3 Interventions

Kenetik: Ketone Drink supplement containing D-beta-hydroxybutyric acid and R-1,3 butanediol. D-beta-hydroxybutyric acid (C4H8O3) and 1,3 butanediol (C4H10O2). We will give 25 g of ketones 3 times. Once at an MRI visit, once at an FDG PET/CT scan visit, and once at an alcohol bar lab visit.

Group III: Placebo Beverage Placebo Group 3 Interventions

Taste-matched placebo beverage is given 3 times. Once at an MRI visit, once at an FDG PET/CT scan visit, and once at an alcohol bar lab 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+