Ketone Ester Intervention in Alcohol Use Disorder

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.

NCT Number	NCT04616781
Lead Sponsor	University of Pennsylvania Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol Drinking, Alcohol Use Disorder
Enrollment	20 participants
Start Date	2021-04-05
Primary Completion	2026-12 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-02-09