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RECRUITING Phase 2

Ketone Ester Intervention in Alcohol Use Disorder

NCT04616781 · View on ClinicalTrials.gov ↗

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.

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

1,457 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04616781 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04616781?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial