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Ketone Ester Intervention in Alcohol Use Disorder

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jan 2026 to Dec 2026 Completion date: Dec 2026 to Jul 2027v11 Show 1 more changeShow less
    • Completion date: Dec 2026 to Jul 2027
  2. Re-verified, no change to tracked fieldsv10
  3. Primary completion date: Jan 2025 to Jan 2026 Completion date: Sep 2025 to Dec 2026 · Site contact updatedv9 Show 2 more changesShow less
    • Completion date: Sep 2025 to Dec 2026
    • Site contact updated
  4. Primary completion date: Jan 2024 to Jan 2025 Completion date: Sep 2024 to Sep 2025 · Site contact updatedv8 Show 2 more changesShow less
    • Completion date: Sep 2024 to Sep 2025
    • Site contact updated
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria revisedv6 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv5
  3. Start date changed from estimate of Apr 2021 to Apr 5, 2021v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2021 to Apr 2021 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Feb 2021 to Apr 2021
    • Site details revised
  5. Start date: Dec 2020 to Feb 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04616781
Lead Sponsor University of Pennsylvania
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Drinking, Alcohol Use Disorder
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov