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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Wernersville, Pennsylvania, United States
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