Alcohol Drinking, Binge Drinking, Central Nervous System Depressants, Drinking Behavior, Ethanol, Physiological Effects of Drugs, Substance-Related Disorders
Conditions
Brief summary
To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.
Interventions
DRUGEthanol
The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 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. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
OTHERPlacebo
The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* 21-29 years old * 7-30 alcoholic drinks per week (as reported on PHQ or TLFB) * At least one binge episode (4 for females/5 for males) per month * No 'flushing' reaction to alcohol * Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation) * 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 * No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stop Signal Task (SST) | Within an hour post-stimulation condition | The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ethanol Subjects will receive 4 color-coded beverages in green or blue cups, containing ethanol (0.2 g/kg per dose, total dose 0.8 g/kg).
Ethanol: The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 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. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water | 40 |
| Placebo (Juice) Subjects will receive 4 color-coded beverages in green or blue cups, containing placebo (Juice).
Placebo: The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Ethanol | Placebo (Juice) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 40 Participants | 80 Participants |
| Education - High School Education | 40 Participants | 40 Participants | 80 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 | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 22 Participants | 22 Participants | 44 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Stop Signal Task (SST)
The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.
Time frame: Within an hour post-stimulation condition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ethanol | Stop Signal Task (SST) | 255 milliseconds | Standard Deviation 463 |
| Placebo (Juice) | Stop Signal Task (SST) | 215 milliseconds | Standard Deviation 278 |