Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers

NCT05551754 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 852002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single blinded, randomized trial to evaluate the immediate subjective and objective effects of alcohol after a dose ketone supplement compared to a placebo in 10 health volunteers. Subjects will complete 2 lab visits where they consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%. Participants will randomly receive ketone supplement at one lab and the placebo at the next lab.

Conditions

Alcohol Drinking

Keywords

Ketone Ester

Outcome Measures

Primary Outcomes (1)

• Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo

  Change in breath/blood alcohol levels (grams per 210 Liters of breath) in response to ketone supplement verse placebo

  4 hours

Secondary Outcomes (1)

• Acute effects of subjective reports of intoxication and alcohol craving in response to ketone supplement verse placebo after alcohol drinks.

  4 hours

Study Arms (2)

ketone supplement

ACTIVE COMPARATOR

Subjects will drink single dose of ketone supplement 25g

Dietary Supplement: Ketone Supplement; Other: Alcohol Beverage

Placebo beverage

PLACEBO COMPARATOR

Subjects will drink single dose of placebo beverage that will look and taste the same as ketone supplement.

Other: Alcohol Beverage

Interventions

Ketone Supplement DIETARY_SUPPLEMENT

Drink a single dose of ketone supplement 25g

Also known as: ketone supplement, D-hydroxybutyric acid and 1,3 butanediol

ketone supplement

Alcohol Beverage OTHER

Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%

Placebo beverage; ketone supplement

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willingness to provide signed, informed consent and commit to completing the alcohol lab studies.
• All subjects must report at least one occasion in the prior month of drinking at least 2 drinks on a single day.

You may not qualify if:

• Unwilling or unable to refrain from use, within 24 hours of alcohol lab procedures, psychoactive medications or medications that may affect study results.
• Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) (identified by clinical examination or the structured interview) that could interfere with study participation or make it hazardous for the subject.
• Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified)
• A baseline breath alcohol concentration of greater than 0.00% on study visit prior to alcohol tolerance test
• A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
• Currently suffering from or with a history of stroke and/or stroke related spasticity.
• Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical history).
• Weight greater than 225lbs (Need to cap amount of alcohol give based on weight to individuals).
• Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

1,3-butylene glycol; Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Corinde Wiers, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo controlled, randomized, crossover trial in 10 healthy volunteers

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 23, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)