Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06807918
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Kenetik — DIETARY_SUPPLEMENT
    Drink a single dose of ketone supplement 25g, three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET/CT scan visits, and 1 of 2 alcohol bar lab visits.
  • magnetic resonance imaging scan — OTHER
    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.
  • fludeoxyglucose-18 positron emission tomography scan — OTHER
    Each subject will undergo 2 FDG PET/CT scans. FDG is a positron emitting radiopharmaceutical. In addition to the radioactive FDG tracer, a low-dose CT of the chest is typically performed with the FDG PET/CT for the purpose of anatomical registration and attenuation correction of PET images. There are no separate diagnostic CT scans performed as part of this study.
  • Alcohol bar lab — OTHER
    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 — OTHER
    Drink a single dose of placebo beverage, that will look and taste the same as the ketone supplement. Subjects will recieve the beverage three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET/CT scan visits, and 1 of 2 alcohol bar lab visits, opisite of the Kenetik beverage.

Study Details

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%.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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, once at an FDG PET/CT scan 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, once at an FDG PET/CT scan 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Studies of AddictionPhiladelphiaPennsylvania19104
Timothy Pond, MPH
[email protected]
215-746-1959
Corinde Wiers, Ph.D (PRINCIPAL_INVESTIGATOR)
Cindy Li, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Center for Studies of Addiction· Philadelphia, PA

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