Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Pennsylvania
About 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%.
Eligibility criteria
Qualifiers
Age 21-65 years old
Able to provide written informed consent
Meets current DSM-5 criteria for mild to moderate (established using MINI)
Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)
Disqualifiers
Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).
Use of psychoactive medications or medications that may affect study results (self-report, medical history).
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).
Trial design
Treatments tested in this trial
- Kenetik
- magnetic resonance imaging scan
- fludeoxyglucose-18 positron emission tomography scan
- Alcohol bar lab
- Placebo beverage
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov