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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: Recruiting Phase 2 study of Alcohol Use Disorder and Alcohol Drinking, sponsored by University of Pennsylvania.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Compare the number of alcoholic drinks consumed in a "bar lab" paradigm after KE versus the Placebo drink
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT04616781 shows while recruiting
NCT04616781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04616781's enrollment target sits among peer trials
20 165th of 184 higher than 15 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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