Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06559995
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones, — DIETARY_SUPPLEMENT
    ketone supplement
  • magnetic resonance imaging session — DIAGNOSTIC_TEST
    1.5 hour magnetic resonance imaging session
  • Placebo beverage — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ketone Supplement
    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.
  • Placebo Comparator: Placebo Beverage
    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.

Primary Outcome Measure

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. [ Time Frame: 4 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Studies of AddictionPhiladelphiaPennsylvania19104
Timothy Pond, MPH
[email protected]
215-746-1959
Corinde Wiers, Ph.D (PRINCIPAL_INVESTIGATOR)
Ravi Nanga, Ph.D. (SUB_INVESTIGATOR)
Henry Kranzler, MD (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Center for Studies of Addiction· Philadelphia, PA

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