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Ketone Supplement for Alcohol Withdrawal Syndrome (KSAW Trial)
Phase 2 & 3
Waitlist Available
Led By Corinde Wiers, Ph.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. Able to communicate English and provide written informed consent
2. Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 days
Awards & highlights
Summary
The goal of this clinical trial is to learn the effects of ketone supplement compared to placebo on alcohol withdrawal symptoms during a 4 day alcohol withdrawal management treatment in adults with moderate to severe alcohol use disorder at the Hospital of the University of Pennsylvania, Cedar Detox Center.
Who is the study for?
This trial is for adults with moderate to severe alcohol use disorder who are undergoing a 4-day alcohol withdrawal treatment. It's being conducted at the Hospital of the University of Pennsylvania, Cedar Detox Center.
What is being tested?
The study is testing if a ketone supplement can help with alcohol withdrawal symptoms compared to a placebo. Participants will also undergo an MRI session to see how their brain metabolism might be affected.
What are the potential side effects?
Potential side effects from the ketone supplement could include stomach discomfort, nausea, bad taste in mouth, and potential changes seen in MRI related to brain metabolism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Group changes in the total milligrams of benzodiazepines given to subjects during alcohol withdrawal management after receiving either ketone supplement or placebo beverage after 4 days of study intervention.
Secondary study objectives
To measure the group differences of BHB levels in millimoles, in subjects receiving ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
To measure the group differences of Gamma-Aminobutyric Acid levels in millimoles in subjects receiving a ketone supplement, Kenetik three times daily, versus a placebo beverage after 4 days of study intervention.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Ketone SupplementActive Control2 Interventions
Ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" (Kenetik: Ketone Drink, VitaNav Inc., Washington D.C.) 12g of ketones, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
Group II: Placebo BeveragePlacebo Group2 Interventions
Placebo beverage, visually matched, three times a day before meals, by mouth for 4 days plus 1 dose on day 5 for magnetic resonance imaging session visit.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,043 Previous Clinical Trials
42,889,597 Total Patients Enrolled
1 Trials studying Alcohol Withdrawal Syndrome
50 Patients Enrolled for Alcohol Withdrawal Syndrome
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
819 Previous Clinical Trials
1,160,621 Total Patients Enrolled
2 Trials studying Alcohol Withdrawal Syndrome
343 Patients Enrolled for Alcohol Withdrawal Syndrome
Corinde Wiers, Ph.D.Principal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
20 Total Patients Enrolled
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