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NCT04616781 · ClinicalTrials.gov registry record · Phase 2

Ketone Ester Intervention in Alcohol Use Disorder

A Phase 2 study of Alcohol Use Disorder and Alcohol Drinking, sponsored by University of Pennsylvania.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT04616781 is a Phase 2 study of Alcohol Use Disorder and Alcohol Drinking that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 20 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04616781, a Phase 2 study of Alcohol Use Disorder and Alcohol Drinking, is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study 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 Studied

Alcohol Use Disorder Alcohol Drinking

Interventions

  • DIETARY_SUPPLEMENT Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"
  • DRUG Isocaloric dextrose placebo
  • OTHER Alcohol drinks

Study Locations (1)

Pennsylvania

  • University of Pennsylvania Center for Studies of Addiction - Philadelphia

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2021-04-05
Est. Completion 2027-07
Phase Phase 2

Sponsor

University of Pennsylvania

1,423 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04616781

The ClinicalTrials.gov registry entry for NCT04616781 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" is the first listed.

NCT04616781 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04616781 about?

NCT04616781 is a clinical study titled "Ketone Ester Intervention in Alcohol Use Disorder". 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 ...

What is the current status of trial NCT04616781?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2021-04-05. Estimated completion is 2027-07.

What conditions does trial NCT04616781 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Alcohol Drinking.

What interventions are being tested in trial NCT04616781?

The interventions under investigation include: Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate" (DIETARY_SUPPLEMENT), Isocaloric dextrose placebo (DRUG), Alcohol drinks (OTHER).

Who is sponsoring clinical trial NCT04616781?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04616781 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.