Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers (NCT05551754) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers
United States10 participantsStarted 2022-10-20
Plain-language 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.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo
. Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).
. 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).