Recruiting
Phase 2
Phase 3

Kenetik

Sponsor:

University of Pennsylvania

Code:

NCT06807918

Conditions

Alcohol Use Disorder

Ketosis

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Kenetik

magnetic resonance imaging scan

Alcohol bar lab

Placebo beverage

Study Details

Brief summary:

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, 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%.

Conditions

Alcohol Use Disorder

Ketosis

Study ID

NCT06807918

Start date

Dec 1, 2026

Status verified date

Oct, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 21-65 years old
2. Able to provide written informed consent
3. Meets current DSM-5 criteria for mild to moderate (established using MINI)
4. Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)
5. Not seeking treatment for AUD (self-report)

Exclusion Criteria:

1. Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).
2. Use of psychoactive medications or medications that may affect study results (self-report, medical history).
3. 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.
4. Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).
5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).
6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, 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.
7. Clinically significant laboratory findings that could affect brain function (e.g., HIV+).
8. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
9. Pregnant or breast-feeding
10. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
11. BMI greater than 35.
12. Self-reported claustrophobia.
13. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Ketone Supplement, Kenetik

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, and once at an alcohol bar lab visit.

placebo comparator: Placebo Beverage

Taste-matched placebo beverage is given 3 times. Once at an MRI visit, and once at an alcohol bar lab visit.

experimental: Alcohol beverage

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.

Interventions

Kenetik

Drink a single dose of ketone supplement 25g, three times, randomly given at 1 of 2 MRI scan visits, and 1 of 2 alcohol bar lab visits.

magnetic resonance imaging scan

Each subject will undergo 2 research MRI scan evaluations of the brain (up to 90 min.). The MRI is FDA-approved 7.0T Magentom Prisma scanner (Siemens Medical Solutions USA, Inc., Malvern, PA) with an approved radiofrequency head coil.

Alcohol bar lab

Each subject will undergo 2 alcohol bar labs. Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%.

Placebo beverage

Drink a single dose of placebo beverage, that will look and taste the same as the ketone supplement. Subjects will receive the beverage three times, randomly given at 1 of 2 MRI scan visits, and 1 of 2 alcohol bar lab visits, opposite of the Kenetik beverage.

Primary outcome measure

  • To examine the effects of a single dose of KS compared to placebo on brain ketone energetics [ Time Frame: 90 minutes ]

Central Contacts and Locations

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

Oct 21, 2026

Last verified

Oct, 2026

Keywords

  • Alcohol Use Disorder
  • Ketosis
  • Ketone supplement
  • Magnetic Resonance Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-10-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.