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Search / Trial NCT06173973

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Launched by UNIVERSITY OF PENNSYLVANIA · Dec 7, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Alcohol Use Disorder Alcohol Withdrawal Alcohol Dependence Ketone Supplement Ketosis

ClinConnect Summary

This is a 5 day double-blinded, placebo-controlled intervention study of 50 treatment-seeking individuals with AUD, who are receiving detoxification treatment at Caron Treatment Center. Participants will be recruited for participation within 48 hours of admission to the inpatient unit. Participants will be consented and randomized to receive 10 g of ketone supplement three times daily (n=30; 1,3-butanediol and D-hydroxybutyric acid from Kenetik, VitaNav Inc., Washington D.C.) for 5 days or a placebo beverage (n=20). Benzodiazepines and other "comfort" medications will be administered daily ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
  • 2. Willingness to provide signed, informed consent and commit to completing the procedures in the study
  • Exclusion Criteria:
  • 1. Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
  • 2. Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
  • 3. Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
  • 4. Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

Wernersville, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Corinde E Wiers, Ph.D.

Principal Investigator

University of Pennsylvania

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported