A Phase 2/3 interventional study of Kenetik and magnetic resonance imaging scan in Alcohol Use Disorder and Ketosis, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Pennsylvania · Phase 2/3, Interventional, and Basic science
This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.
The purpose of this research is to study how a nutritional ketone supplement, Kenetik may affect brain function and alcohol consumption in individuals with alcohol use disorder.
The study will use imaging to see how the brain responds to Kenetik versus a placebo beverage. The study will use magnetic resonance imaging (MRI) scans to study the brain. MRI scans use large magnets to create a magnetic field and radio waves to produce images of the brain. The study will test brain functions at rest and while viewing pictures of alcohol. Participants will be asked to complete 2 MRI scans. Participants will randomly receive the Kenetik at 1 MRI scan and at 1 PET scan and will receive the placebo at the other MRI scan visits.
The study will use two alcohol bar labs to study how Kenetik may affect alcohol consumption. Participants will randomly receive Kenetik on one of the visits, and the placebo beverage at the other visit. At each bar lab, Participants will be asked to drink alcohol beverages.
The study is double-blinded, which means that participants and the study staff running the study visits will not know at which visit participants will receive the Kenetik or placebo beverage.
Visit 1. Consent and Screening Visit (this will last \~4-5 hours)
Participants are asked not to eat or drink anything except water on the day of the screening session. A a meal will be proved during the visit. A breathalyzer test will be given to ensure that participants breath alcohol levels are 0.020 or lower and are sober and able to make a well-reasoned decision about whether or not to participate in the study.
The following will occur at the screening session, following signed consent:
After the screening visit, staff will call participants to confirm that the study is a good fit and schedule the rest of the study visits.
Visits 2 \& 3. Alcohol Bar Lab visits (approximately 5 hrs.) The following will occur on the day of the two bar lab visits for participants. Participants will not to eat or drink anything except water after midnight the day before and on the day of the lab visit.
4:30 PM BrAC 7, 3 questionnaires, Bar lab: second tray of 4 alcoholic mini-drinks.
5:00 PM BrAC 8 5:30 PM BrAC 9, and Study Intervention questionnaire 5:50 PM Meal, finger stick for BHB, and Glucose 6:00 PM BrAC 10, meet with study clinician and leaves by Lyft when BRAC is \<0.010% and Glucose returns to normal levels of > 70 mg/dl.
*Time in the above table may vary due to delays in start time of the lab visit.
Follow-up Visit (approximately 5 minutes): A follow-up phone call will occur the day after each lab visit and the following will occur:
Visit 4 \& 5. MRI Scan visits (approximately 2 hours)
On the day before the scan visits, participants will not drink any alcoholic beverages after 10 PM. Staff will provide participants with a snack after the scanning visit is complete.
On the day of the study visits the following will be done:
Participants will receive a brain 7-Tesla MRI scan (\~1.5 hours). An MRI is a type of scan that uses radio waves to take detailed pictures of the body. Participants lie on an MRI table where the technologist will place a receiver on the part of the body to be studied (brain). A blanket will be provided for comfort and earplugs since the MRI makes noises while it is scanning. Participants will still be able to hear some sound to ensure communication with the technologist and follow any direction given throughout the MRI scan. The technologist will slowly slide participants into the MRI magnet where radio waves will be transmitted.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 60 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Kenetik: Ketone Drink supplement containing D-beta-hydroxybutyric acid and R-1,3 butanediol. D-beta-hydroxybutyric acid (C4H8O3) and 1,3 butanediol (C4H10O2). We will give 25 g of ketones 3 times. Once at an MRI visit, and once at an alcohol bar lab visit.
Other: magnetic resonance imaging scan · Other: Alcohol bar lab
Taste-matched placebo beverage is given 3 times. Once at an MRI visit, and once at an alcohol bar lab visit.
Other: magnetic resonance imaging scan · Other: Alcohol bar lab
The alcoholic beverage will be created by using a standard dose of 0.5g/kg 0.43 g/kg for men and women respectively (50% vodka), calculated to achieve a BrAC of about 0.050%. The alcoholic beverage will be given once at bar lab 1 and again at bar lab 2.
Dietary Supplement: Kenetik · Other: Placebo beverage
Drug pages: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols
Drink a single dose of ketone supplement 25g, three times, randomly given at 1 of 2 MRI scan visits, and 1 of 2 alcohol bar lab visits.
Also known as: D-Beta-hydroxybutyric acid and R-1,3 butanediol, Ketone supplement
Each subject will undergo 2 research MRI scan evaluations of the brain (up to 90 min.). The MRI is FDA-approved 7.0T Magentom Prisma scanner (Siemens Medical Solutions USA, Inc., Malvern, PA) with an approved radiofrequency head coil.
Also known as: MRI scan
Each subject will undergo 2 alcohol bar labs. Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%.
Also known as: Alcoholic beverages
Drink a single dose of placebo beverage, that will look and taste the same as the ketone supplement. Subjects will receive the beverage three times, randomly given at 1 of 2 MRI scan visits, and 1 of 2 alcohol bar lab visits, opposite of the Kenetik beverage.
To examine the effects of a single dose of KS compared to placebo on brain ketone energetics
The primary outcome measure to be analyzed is a comparison of a single dose of KS versus placebo in AUD subjects in the amount of FDG uptake BHB (beta-hydroxybutyrate) (mmol/L) levels in the brain.
Time frame: 90 minutes
To determine the effects of KS compared to placebo on alcohol pharmacokinetics and subjective responses following an alcohol priming dose.
The outcome measure to be analyzed is a comparison of breath ethanol levels (grams/210liters of breath) in response to a priming dose of alcohol following administration of KS vs. placebo.
Time frame: 3 hours
To determine the effects of KS compared to placebo on alcohol consumption.
The outcome measure to be analyzed is a comparison of the number of alcohol drinks consumed during the bar lab, following the administration of KS vs. placebo.
Time frame: 2 hours
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: 3-Hydroxybutyric Acid · Butylene glycol · Butylene Glycols