Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
Able to communicate English and provide written informed consent
Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
Minimum 3-year history of heavy drinking (self-report).
Presence of alcohol withdrawal (DSM-5)
Disqualifiers
Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam.
Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
Head trauma with loss of consciousness for more than 30 minutes,
Trial design
Treatments tested in this trial
- ketone supplement "D-beta-hydroxybutryric acid and R-1,3 butanediol" 12g of ketones,
- magnetic resonance imaging session
- Placebo beverage
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov