Alcohol DrinkingPhase 2/3NCT05551754
Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers
A Phase 2/3 study testing Ketone Supplement and Alcohol Beverage in people with Alcohol Drinking, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking
- What is being tested?
- Ketone Supplement and Alcohol Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2022to Jul 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: Acute Effects of Ketone Supplementation on Subjective and Objective Responses to Alcohol in Healthy Volunteers
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.
Read the detailed description
The purpose of the study is to evaluate the immediate subjective and objective effects of alcohol after consuming a ketone supplement beverage, compared to a placebo beverage (an inactive substance). Participants will not know which lab they receive the ketone drink, however they will be asked to drink an alcohol beverage (based on weight), to bring breath alcohol concentration (BrAC) to about 0.050% at each lab visit.
The goal of the study is to see how measure subjective effects of alcohol, once after drinking the ketone supplement and once after drinking a placebo beverage. The study will use questionnaires, blood, and breath alcohol tests to see how subjects body and brain experience alcohol. The study is also interested in if the ketone supplement makes people want to drink alcohol more or less.
Consent and Screening Session (approximately 3 hrs)
The following will occur at the screening session, following signed consent:
- First, subjects will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The BrAC must be at 0.000% to complete this visit.
- Demographic information, such as date of birth, age, biological sex, marital status, education, race, and ethnicity will be collected.
- Subjects will be asked to provide current information about address and contact information to register them as a patient at the University of Pennsylvania, if they have not been a patient here before.
- Approximately 2 tablespoons of blood for standard laboratory tests will be drawn. It is possible that bloodwork will need to be repeated due to unforeseen events (abnormal findings or potential lab errors).
- Subject's will be asked to provide a urine sample for routine urinalysis, drug screen, and a pregnancy test in women who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height. Subject's will be asked to complete a questionnaire about current and past medical history and any medications currently taking.
- Study personnel will complete a brief psychiatric interview and ask about alcohol and cigarette use over the past 90 days.
Staff will confirm eligible within 5 business days after the screening visit, to schedule the rest of the study visits.
Lab visits (approximately 5 1/2 hrs) The following will occur on the day of the two lab visits as a participant.
- Subject's are asked to not eat or drink anything except water after midnight the day before and on the day of the lab visit. A light meal will be provided on the lab days, after staff takes a BrAC (must be 0.000% to continue), preforms a finger stick for blood glucose level (must be below 140), measures weight, and vital signs.
- Subjects will be asked to provide a urine sample to conduct a drug screen, and a pregnancy test (for woman able to become pregnant).
- Staff will review the current list medications and vitamins provided at the screening visit and ask if anything has changed?
- Subjects will be asked about alcohol and drug use history since the last visit.
- Approximately 1 hour after the light meal, subjects will be asked to drink the ketone supplement or placebo beverage.
- Approximately 30 minutes after drinking the beverage, subjects will be asked to drink an alcohol beverage based on weight in 15 minutes. Staff will record the BrAC, draw blood and ask subjects to complete questionnaire as listed in the below table.
- Staff will ask about any side effects that may occur throughout the lab procedures.
- During the lab day between study procedures, subjects may read books, magazines, or watch videos.
- After a snack, staff will check the final BrAC and ask again about any side effects. The second visit will be scheduled at least 2 days after the first visit and will follow the same procedures. Subjects may leave with a BrAC below 0.010.
Table of assessments on Lab Visits:
- Approximate study times • Procedure
- 10:30am • BrAC1, vital signs, urine sample
- 10:40am • light meal
- 11:00am • Review of medications currently taking, and review of alcohol and drug use since last visit
- 12:00pm • Ketone supplement or placebo drink
- 12:20pm • BrAC 2, and 3 questionnaires
- 12:30pm • Finger stick
- Alcohol administration
- 12:45pm • BrAC 3, and blood draw 1
- 1:00pm • BrAC 4, and 2 questionnaires
- 1:15pm • BrAC 5, and blood draw 2
- 1:30pm • BrAC 6, and 2 questionnaires
- 2:00pm • BrAC 7, Blood draw 3, and 3 questionnaires
- 2:30pm • BrAC 8
- 3:00pm • BrAC 9
- 3:30pm • BrAC 10, blood draw 4, and 3 questionnaires
- 3:50pm • Snack
- 4:00pm • Final BrAC end of 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:
- Staff will ask about any side effects that may have been experienced.
- Conditions
- Alcohol Drinking
- Being tested
- Ketone Supplement, Alcohol Beverage
- Keywords
- Ketone Ester
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone SupplementDietary supplement
Also called ketone supplement, D-hydroxybutyric acid and 1,3 butanediol
Drink a single dose of ketone supplement 25g
Alcohol BeverageOther
Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%
| Study group | Role | What they receive |
|---|---|---|
| ketone supplement | Active comparator | Subjects will drink single dose of ketone supplement 25g Receives: 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. Receives: Other: Alcohol Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Change in subjective effects are measured using the Drug Effects Questionnaire (DEQ): A 5-item scale assessing the extent to which participants (1) feel any DRUG EFFECTS, (2) feel HIGH, (3) LIKE the effects, (4) DISLIKE the effects, and (5) want MORE of the substance using a 100-mm visual analogue scale.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start20 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo controlled, randomized, crossover trial in 10 healthy volunteers
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corinde Wiers, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551754
- Sponsor's protocol ID
- 852002
- Status last verified
- Aug 2026
- First submitted
- 15 Sep 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Ketone Supplementation on Subjective and Objective Responses to Alcohol in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05551754
- Acronym / sponsor ID
- 852002
- Conditions
- Alcohol Drinking
- Keywords
- Ketone Ester
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the study is to evaluate the immediate subjective and objective effects of alcohol after consuming a ketone supplement beverage, compared to a placebo beverage (an inactive substance). Participants will not know which lab they receive the ketone drink, however they will be asked to drink an alcohol beverage (based on weight), to bring breath alcohol concentration (BrAC) to about 0.050% at each lab visit.
The goal of the study is to see how measure subjective effects of alcohol, once after drinking the ketone supplement and once after drinking a placebo beverage. The study will use questionnaires, blood, and breath alcohol tests to see how subjects body and brain experience alcohol. The study is also interested in if the ketone supplement makes people want to drink alcohol more or less.
Consent and Screening Session (approximately 3 hrs)
The following will occur at the screening session, following signed consent:
- First, subjects will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The BrAC must be at 0.000% to complete this visit.
- Demographic information, such as date of birth, age, biological sex, marital status, education, race, and ethnicity will be collected.
- Subjects will be asked to provide current information about address and contact information to register them as a patient at the University of Pennsylvania, if they have not been a patient here before.
- Approximately 2 tablespoons of blood for standard laboratory tests will be drawn. It is possible that bloodwork will need to be repeated due to unforeseen events (abnormal findings or potential lab errors).
- Subject's will be asked to provide a urine sample for routine urinalysis, drug screen, and a pregnancy test in women who are able to become pregnant.
- Study personnel will measure vital signs (blood pressure and pulse), weight, and height. Subject's will be asked to complete a questionnaire about current and past medical history and any medications currently taking.
- Study personnel will complete a brief psychiatric interview and ask about alcohol and cigarette use over the past 90 days.
Staff will confirm eligible within 5 business days after the screening visit, to schedule the rest of the study visits.
Lab visits (approximately 5 1/2 hrs) The following will occur on the day of the two lab visits as a participant.
- Subject's are asked to not eat or drink anything except water after midnight the day before and on the day of the lab visit. A light meal will be provided on the lab days, after staff takes a BrAC (must be 0.000% to continue), preforms a finger stick for blood glucose level (must be below 140), measures weight, and vital signs.
- Subjects will be asked to provide a urine sample to conduct a drug screen, and a pregnancy test (for woman able to become pregnant).
- Staff will review the current list medications and vitamins provided at the screening visit and ask if anything has changed?
- Subjects will be asked about alcohol and drug use history since the last visit.
- Approximately 1 hour after the light meal, subjects will be asked to drink the ketone supplement or placebo beverage.
- Approximately 30 minutes after drinking the beverage, subjects will be asked to drink an alcohol beverage based on weight in 15 minutes. Staff will record the BrAC, draw blood and ask subjects to complete questionnaire as listed in the below table.
- Staff will ask about any side effects that may occur throughout the lab procedures.
- During the lab day between study procedures, subjects may read books, magazines, or watch videos.
- After a snack, staff will check the final BrAC and ask again about any side effects. The second visit will be scheduled at least 2 days after the first visit and will follow the same procedures. Subjects may leave with a BrAC below 0.010.
Table of assessments on Lab Visits:
- Approximate study times • Procedure
- 10:30am • BrAC1, vital signs, urine sample
- 10:40am • light meal
- 11:00am • Review of medications currently taking, and review of alcohol and drug use since last visit
- 12:00pm • Ketone supplement or placebo drink
- 12:20pm • BrAC 2, and 3 questionnaires
- 12:30pm • Finger stick
- Alcohol administration
- 12:45pm • BrAC 3, and blood draw 1
- 1:00pm • BrAC 4, and 2 questionnaires
- 1:15pm • BrAC 5, and blood draw 2
- 1:30pm • BrAC 6, and 2 questionnaires
- 2:00pm • BrAC 7, Blood draw 3, and 3 questionnaires
- 2:30pm • BrAC 8
- 3:00pm • BrAC 9
- 3:30pm • BrAC 10, blood draw 4, and 3 questionnaires
- 3:50pm • Snack
- 4:00pm • Final BrAC end of 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:
- Staff will ask about any side effects that may have been experienced.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Placebo controlled, randomized, crossover trial in 10 healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| ketone supplement | Active comparator | Dietary Supplement: Ketone Supplement, Other: Alcohol BeverageSubjects will drink single dose of ketone supplement 25g |
| Placebo beverage | Placebo comparator | Other: Alcohol BeverageSubjects will drink single dose of placebo beverage that will look and taste the same as ketone supplement. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone SupplementAlso: ketone supplement, D-hydroxybutyric acid and 1,3 butanediolDrink a single dose of ketone supplement 25g | Dietary supplement | ketone supplement |
| Alcohol BeverageSubjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050% | Other | Placebo beverage, ketone supplement |
Primary outcome
Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo
Time frame: 4 hours
Change in breath/blood alcohol levels (grams per 210 Liters of breath) in response to ketone supplement verse placebo
1 secondary outcome
Acute effects of subjective reports of intoxication and alcohol craving in response to ketone supplement verse placebo after alcohol drinks.
Time frame: 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinde Wiers, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketone Supplement and Alcohol Beverage in people with Alcohol Drinking, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute effects of breath/blood alcohol levels in response to ketone supplement verse placebo (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.