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Ketone Ester for Alcoholism

Phase 2 & 3
Recruiting
Led By Corinde E Wiers, Ph.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 years to 65 years old
Be older than 18 years old
Must not have
History of seizures
Unwilling or unable to refrain from use, within 24 hours of MRI procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory drugs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours

Summary

This trial is testing the effects of a ketone ester on brain function and alcohol consumption in regular alcohol users.

Who is the study for?
This trial is for adults aged 21-65 with Alcohol Use Disorder (AUD) who consume at least 15 alcoholic drinks weekly and are not seeking treatment. Participants must be willing to use reliable birth control if applicable, have no major psychiatric disorders requiring hospitalization or daily medication, and cannot have conditions like epilepsy, diabetes, liver disease, or a history of severe head trauma.
What is being tested?
Researchers are testing whether a one-time dose of Ketone Ester can reduce brain reactivity to alcohol cues and craving in people with AUD using fMRI scans. The study compares the effects of Ketone Ester against an isocaloric dextrose placebo in a double-blind crossover design involving two separate test days.
What are the potential side effects?
While specific side effects are not listed for this trial, potential risks may include discomfort from consuming the ketone ester or placebo drink and reactions related to undergoing MRI scans such as claustrophobia or anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures.
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I can avoid taking certain medications like painkillers or antibiotics before an MRI.
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I've had a severe head injury with loss of consciousness, skull fracture, or bleeding.
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I am HIV positive.
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I have a major psychiatric disorder that needed hospitalization or daily medication for over 4 weeks in the past year.
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I have had a stroke or suffer from muscle stiffness due to a stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the effect of KE on alcohol craving
Determine the effect of KE on brain reactivity to alcohol cues
Determine the effects of ketone ester "R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (KE) on alcohol consumption
Secondary study objectives
Determine whether KE elevates brain ketone bodies using magnetic resonance spectroscopy
Determine whether ghrelin levels in blood covary with alcohol craving and consumption

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Ketone ester with alcohol consumptionActive Control2 Interventions
Drink a single dose of ketone ester 1.9 kcal/kg, complete 1 hour MRI scan, 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.
Group II: Isocaloric dextrose placebo drink with alcohol consumptionPlacebo Group2 Interventions
Drink a single dose of Isocaloric dextrose placebo drink, complete 1 hour MRI scan, 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,069 Previous Clinical Trials
42,713,452 Total Patients Enrolled
27 Trials studying Alcoholism
3,660 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
833 Previous Clinical Trials
1,082,530 Total Patients Enrolled
435 Trials studying Alcoholism
779,324 Patients Enrolled for Alcoholism
Corinde E Wiers, Ph.D.Principal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
70 Total Patients Enrolled
2 Trials studying Alcoholism
70 Patients Enrolled for Alcoholism
~1 spots leftby Jan 2025
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