RecruitingPhase 2Phase 3NCT04616781

Ketone Ester Intervention in Alcohol Use Disorder

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


Sponsor

University of Pennsylvania

Enrollment

20 participants

Start Date

Apr 5, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a ketone ester drink (a supplement that gives the brain an alternative energy source) can reduce cravings for alcohol and help people drink less, without requiring them to seek formal treatment for alcohol use disorder. **You may be eligible if...** - You are between 21 and 65 years old - You meet clinical criteria for alcohol use disorder (AUD) as defined by DSM-5 - You drink at least 15 standard alcoholic drinks per week on average - You identify alcohol as your preferred substance - You are not currently seeking treatment for your drinking - Women of childbearing age must use reliable contraception and have a negative pregnancy test **You may NOT be eligible if...** - You have uncontrolled diabetes - You are pregnant or breastfeeding - You have serious heart, liver, or other medical conditions - You are currently taking medications that would interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

nutritional ketone ester

DRUGIsocaloric dextrose placebo

Drink indistinguishable from ketone ester

OTHERAlcohol 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

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NCT04616781


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