NCT06173973

Brief Summary

The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
19mo left

Started Mar 2024

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Mar 2024Dec 2027

First Submitted

Initial submission to the registry

November 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

November 28, 2023

Last Update Submit

March 20, 2025

Conditions

Alcohol Use DisorderAlcohol WithdrawalAlcohol DependenceKetosis

Keywords

Alcohol Use DisorderAlcohol WithdrawalAlcohol DependenceKetone SupplementKetosis

Outcome Measures

Primary Outcomes (1)

  • Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg).

    To examine the effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on the need for benzodiazepines (daily use in mg), while undergoing inpatient acute withdrawal management.

    5 days

Secondary Outcomes (1)

  • Effects of ketone supplement Kenetik, three times daily (TID), versus placebo, on Clinical Institute Withdrawal Assessment Alcohol Scale Revised (CIWA-Ar) scores (daily maximum scores).

    5 days

Study Arms (2)

Ketone Supplement

ACTIVE COMPARATOR

Ketone Supplement drink with 10 g ketones three times daily for five days.

Dietary Supplement: Kenetik; Ketone Concentrate

Placebo Beverage

PLACEBO COMPARATOR

Matching Placebo drink three times daily for five days

Dietary Supplement: Isocaloric dextrose placebo

Interventions

Kenetik; Ketone ConcentrateDIETARY_SUPPLEMENT

Ketone Supplement

Also known as: D-hydroxybutyric acid and R-1,3 butanediol
Ketone Supplement
Isocaloric dextrose placeboDIETARY_SUPPLEMENT

Drink that is taste and visually matched to Ketone supplement

Placebo Beverage

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets current DSM-5 criteria for AUD and admitted for alcohol withdrawal management treatment at Caron Treatment Center
  • Willingness to provide signed, informed consent and commit to completing the procedures in the study

You may not qualify if:

  • Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
  • Currently pregnant or lactating, based on urine pregnancy test and clinical exam.
  • Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
  • Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

Caron Treatment Center

Wernersville, Pennsylvania, 19565, United States

Location

MeSH Terms

Conditions

AlcoholismKetosis

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Corinde E Wiers, Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Double blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Placebo controlled, Double blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 18, 2023

Study Start

March 11, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations

US(2)