Effects of a ketone supplement on brain power and drinking in alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, crossover study in adults with alcohol use disorder to test the immediate effects of Kenetik on brain activity and drinking behavior. Participants will undergo two MRI scans and two alcohol bar labs, receiving Kenetik at one visit and placebo at the other. Brain imaging will assess responses at rest and while viewing alcohol cues, and participants will consume alcohol during the bar labs to reach a breath alcohol concentration around 0.050%. The study uses blinded interventions and crossover design to compare effects within the same individuals.

Why it matters

Who can join: the full rules

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).

Where it's running

• Center for Studies of Addiction
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Corinde Wiers, Ph.D. — University of Pennsylvania
• Study coordinator: Timothy Pond, MPH
• Email: timpond@Pennmedicine.upenn.edu
• Phone: 215-746-1959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.