Actively Recruiting
Ketone Ester Intervention in Alcohol Use Disorder
Led by University of Pennsylvania · Updated on 2026-02-09
20
Participants Needed
1
Research Sites
325 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research is to study how a nutritional ketone ester may effect brain function and alcohol consumption in regular alcohol users. The study will see how the brain responds, once after drinking the ketone ester and once after drinking a "placebo", which will look and taste the same as the ketone ester drink. Metabolic ketosis induced by a ketogenic diet has been previously shown to elevate brain ketone bodies and reduce alcohol withdrawal symptoms in humans with AUD, and reduce alcohol consumption in alcohol-dependent rats. The study investigates whether metabolic ketosis induced by a one-dose nutritional ketone ester (KE) reduces brain reactivity to alcohol cues (fMRI), alcohol craving and alcohol consumption in humans with AUD, and if KE elevates ketone bodies using proton spectroscopy. This study uses a double blind, random ordered, 2-way crossover design in n=20 non-treatment seeking AUD who come in on two separate testing days: on one testing day the participants consume KE ((R)-3-hydroxybutyl (R)-3-hydroxybutyrate), and on another testing day a drink with isocaloric dextrose (DEXT), after which participants are scanned for 1H-MRS and fMRI and complete an alcohol consumption paradigm each day after scanning.
CONDITIONS
Official Title
Ketone Ester Intervention in Alcohol Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years to 65 years old
- Willingness to provide signed, informed consent and complete all study procedures
- Meets DSM-5 criteria for Alcohol Use Disorder
- Average weekly alcohol consumption of at least 15 standard drinks over the past month
- Not currently seeking treatment for Alcohol Use Disorder
- Alcohol is the preferred drug of use
- Women of child-bearing potential must be non-lactating, use reliable birth control, and have a negative pregnancy test before study and MRI procedures
You will not qualify if you...
- Unable or unwilling to avoid psychoactive medications or other medications affecting study results within 24 hours before MRI
- Current major psychiatric disorder requiring hospitalization or daily medication over 4 weeks in the past year, excluding mild/moderate substance use or nicotine disorders
- Positive urine drug screen for opioids, cocaine, or amphetamines on study visits (one repeat allowed)
- Significant physical diseases or abnormalities affecting brain function, ketone ester use, or alcohol use (e.g., epilepsy, diabetes, liver or kidney disease, cardiomyopathy)
- History or current stroke or stroke-related spasticity
- History of seizures
- HIV positive status
- Head trauma with loss of consciousness over 30 minutes, skull fracture, intracranial bleeding, or abnormal MRI
- Presence of ferromagnetic objects contraindicating MRI, claustrophobia, or inability to lie flat for 2 hours
- Body mass index over 35, body girth over 52 inches, or head girth over 25 inches
- Vision problems uncorrectable by glasses
- Investigator judgment deeming participant unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Timothy S Pond, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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