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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,189 Total Patients Enrolled

26 Trials studying Alcoholism

3,630 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,377 Total Patients Enrolled

423 Trials studying Alcoholism

985,688 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are involved in this experiment?

"That is correct, the listing on clinicaltrials.gov notes that this research project is currently seeking subjects. This trial was first advertised on April 5th 2021 and has been updated as recently as July 18th 2022. The study needs 20 individuals from a single location."

Answered by AI

Are patients being actively recruited for this trial?

"Yes, the information on clinicaltrials.gov indicates that this trial is still looking for patients. The posting went up on 4/5/2021 and was last updated 7/18/2022. They are hoping to find 20 people total at 1 location."

Answered by AI

Could I potentially join this research project?

"This study is looking for 20 patients with a history of alcohol abuse. Candidates must meet the following criteria: Be between 21 and 65 years old, Meet DSM-5 criteria for AUD, Alcohol specified as the preferred drug (self-report), Willingness to provide signed, informed consent and commit to completing the procedures in the study, Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report), Participants not seeking treatment for their AUD (self-report), Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral o"

Answered by AI