Status:
ENROLLING_BY_INVITATION
Effects of Ketone Supplementation on Acute Alcohol Withdrawal
Lead Sponsor:
University of Pennsylvania
Conditions:
Alcohol Use Disorder
Alcohol Withdrawal
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdraw...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
Exclusion
- 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.
- Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
- Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
- Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06173973
Start Date
March 11 2024
End Date
December 1 2027
Last Update
March 25 2025
Active Locations (2)
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1
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
2
Caron Treatment Center
Wernersville, Pennsylvania, United States, 19565