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

ConditionsAlcohol Use DisorderAlcohol WithdrawalKetosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Ketone SupplementExperimental treatment 2 interventions
Group B: Placebo BeveragePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Patients in alcohol withdrawal management receive benzodiazepines measured in milligrams to treat their alcohol withdrawal symptoms. The primary outcome of this study is to compare the group differences in the amounts of benzodiazepines given to subjects after receiving either a ketone supplement or placebo beverage after 4 days, while undergoing in-patient acute withdrawal management.

Time frame
4 days

Secondary outcomes

1

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.

Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain BHB levels in millimoles after the 4 days of the study intervention.

Time frame
4 days
2

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.

Subjects will undergo a high-field strength, 7 Tesla 1H-MRS scan to measure brain Gamma-Aminobutyric Acid levels in millimoles after the 4 days of the study intervention.

Time frame
4 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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