Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559995
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KSAW
Brief 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
Detailed Description:
This is a 4-day randomized double-blinded intervention study of 30 treatment seeking adults with alcohol use disorder who are receiving alcohol detoxification treatment at the Hospital of the University of Pennsylvania Cedar Detox Center Within 24 hours of admission to the inpatient unit participants will be consented and randomized to receive 3x daily of 12g of KS n15 13-butanediol and D-hydroxybutyric acid from Kenetik VitaNav Inc Washington DC for 4 days or placebo beverage n15 Benzodiazepines and other comfort medications will be administered daily following the HUP Cedar withdrawal management protocol with benzodiazepines administered based on withdrawal symptoms monitored with the revised Clinical Institute Withdrawal Assessment for Alcohol The revised Clinical Institute Withdrawal Assessment for Alcohol is given three or more times a day clinically to determine patient withdrawal levels and adjust medication dosages Total daily maximum revised Clinical Institute Withdrawal Assessment for Alcohol scores benzodiazepine dosage and other comfort medications will be analyzed with a repeated measures design with a binary factor for intervention factor of time and intervention by time interaction Daily mood questions and alcohol craving questions will assess differences between treatment groups After 4 days of study intervention all participants will undergo an approximately 15-hr magnetic resonance imaging session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None