An Early Phase 1 interventional study of Ethanol and Placebo in Alcohol Drinking, Drinking Behavior and Physiological Effects of Drugs, sponsored by University of Chicago. Completed at 1 site in United States. Open to male participants aged 21 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by University of Chicago · Early Phase 1, Interventional, and Basic science
To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's enrollment of 30 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.
Drug: Ethanol
Subjects will receive placebo of black cherry sugar-free jello.
Other: Placebo
The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. The 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.
The placebo comparator will be individual servings of back cheery sugar-free jello.
Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Time frame: At expected peak drug effect (30 min post drink administration)
| Milestone | Placebo First (0 g/kg), Then Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg) | Placebo (0 g/kg), Then Ethanol (0.8 g/kg), Then Ethanol (0.4 g/kg) | Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg), Then Placebo (0 g/kg) | Ethanol First (0.8 g/kg) Then Ethanol (0.4 g/kg), Then Placebo (0 g/kg) | Ethanol First (0.8 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.4 g/kg), | Ethanol First (0.4 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.8 g/kg), |
|---|---|---|---|---|---|---|
| Started | 6 | 5 | 3 | 6 | 6 | 4 |
| Sedative-like effects | 3 | 3 | 1 | 3 | 3 | 2 |
| Stimulant like effects | 3 | 2 | 2 | 3 | 3 | 2 |
| Completed | 6 | 5 | 3 | 6 | 6 | 4 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
| units on a scale | Placebo (Gelatin) | Ethanol (0.4 g/kg) | Ethanol (0.8 g/kg) |
|---|---|---|---|
| "Feel Drug" | 3.65 ± 15.9 | 45.5 ± 24.9 | 62.3 ± 20.3 |
| "Feel High" | 3.0 ± 15.9 | 33.7 ± 27.4 | 47.0 ± 32.8 |
| "Like Drug" | 10.0 ± 19.7 | 48.3 ± 22.7 | 60.9 ± 22.8 |
| "Want More" | 10.1 ± 23.6 | 39.6 ± 30.4 | 45.3 ± 31.2 |
Collected over Through study completion, an average of 5 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ethanol (0.4 g/kg) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Placebo (Gelatin Vehicle) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Ethanol (0.8 g/kg) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Customized(years) | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| >21 years of age | 15 | 15 | 30 |
| Sex: Female, Male(Participants) | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 8 | 8 | 16 |
| Race (NIH/OMB)(Participants) | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 11 | 11 | 22 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| United States | 15 | 15 | 30 |
| Education - High School Education(Participants) | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| Count of participants | 15 | 15 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Dec 2020, 19 months.
Results were first posted in Jan 2025, 4 years 1 month after primary completion.
Of 32 non-industry phase 1 interventional studies under Alcohol Drinking, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 49. This study's 19 months is below that.
Counting every sponsor, half of 34 studies reached it within 37 months; a quarter within 21 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ethanol