Alcohol Drinking, Central Nervous System Depression, Drinking Behavior, Physiological Effects of Drugs
Conditions
Brief summary
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.
Interventions
DRUGEthanol
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.
OTHERPlacebo
The placebo comparator will be individual servings of back cheery sugar-free jello.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 21-35 years old * 4-30 alcoholic drinks per week (as reported on PHQ or TLFB) * No 'flushing' reaction to alcohol * BMI 19-26 * High school education or greater, fluent in English * No night shift work * No current or past year Axis I psychiatric disorder including drug/alcohol dependence * No current psychopharmacological treatment * No lifetime ADHD or prescription for ADHD medication * No abnormal EKG, cardiovascular illness, high blood pressure * No medical condition or pharmacological treatment for which alcohol is contraindicated * Not pregnant, lactating, or planning to become pregnant * Smoke \<6 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | At expected peak drug effect (30 min post drink administration) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sedative-like Effects (All Study) Subjects that experienced more sedative like effects | 15 |
| Stimulant-like (All Study) Subjects that experienced more stimulant-like effects | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Sedative-like Effects (All Study) | Stimulant-like (All Study) | Total |
|---|---|---|---|
| Age, Customized >21 years of age | 15 years | 15 years | 30 years |
| Education - High School Education | 15 Participants | 15 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 30 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Gelatin) | 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 | Feel Drug | 3.65 units on a scale | Standard Deviation 15.9 |
| Placebo (Gelatin) | 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 | Feel High | 3.0 units on a scale | Standard Deviation 15.9 |
| Placebo (Gelatin) | 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 | Like Drug | 10.0 units on a scale | Standard Deviation 19.7 |
| Placebo (Gelatin) | 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 | Want More | 10.1 units on a scale | Standard Deviation 23.6 |
| Ethanol (0.4 g/kg) | 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 | Want More | 39.6 units on a scale | Standard Deviation 30.4 |
| Ethanol (0.4 g/kg) | 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 | Feel Drug | 45.5 units on a scale | Standard Deviation 24.9 |
| Ethanol (0.4 g/kg) | 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 | Like Drug | 48.3 units on a scale | Standard Deviation 22.7 |
| Ethanol (0.4 g/kg) | 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 | Feel High | 33.7 units on a scale | Standard Deviation 27.4 |
| Ethanol (0.8 g/kg) | 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 | Want More | 45.3 units on a scale | Standard Deviation 31.2 |
| Ethanol (0.8 g/kg) | 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 | Feel High | 47.0 units on a scale | Standard Deviation 32.8 |
| Ethanol (0.8 g/kg) | 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 | Like Drug | 60.9 units on a scale | Standard Deviation 22.8 |
| Ethanol (0.8 g/kg) | 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 | Feel Drug | 62.3 units on a scale | Standard Deviation 20.3 |
p-value: <0.05ANOVA