Ketone Ester Intervention in Alcohol Use Disorder

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.

Conditions

• Alcohol Drinking
• Alcohol Use Disorder

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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Corinde E Wiers, Ph.D. · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-04-05

Primary Completion

2026-12-31

Completion

2027-07-31

FDA Drug

Yes

Countries

• United States

Study Locations