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RECRUITING
NCT04616781
PHASE2/PHASE3

Ketone Ester Intervention in Alcohol Use Disorder

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

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.

Official title: Effects of Ketone Ester on Brain Function and Alcohol Consumption in Alcohol Use Disorder

Key Details

Gender

All

Age Range

21 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-04-05

Completion Date

2027-07

Last Updated

2026-02-09

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"

nutritional ketone ester

DRUG

Isocaloric dextrose placebo

Drink indistinguishable from ketone ester

OTHER

Alcohol drinks

drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC.

Locations (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, United States