Chicago Social Drinking Project

Study Overview
=================
Brief Summary
-----------------
This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by: Examining subjective and objective response differences to alcohol and other common substances in a sample of young, adult social drinkers with varying consumption patterns. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.

Official Title
-----------------
Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: Ethanol
* Drug: Placebo
* Drug: Diphenhydramine
* Drug: Caffeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-65 Weigh between 110-210 lbs Drink alcohol at least once weekly with weekly binge drinking episodes Available to complete in-person screening and 2, 4 hour experimental sessions at the University of Chicago Available by phone, mail, or Internet for follow-up interviews for at least 2 years following sessions Exclusion Criteria: Current or past major medical or psychiatric disorders including alcohol and substance dependence

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beverage with Heavy Alcohol Dose<br>Beverage containing 0.8 g/kg alcohol | Drug: Ethanol<br>* Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol<br>* Other names: Everclear;|
| Experimental: Beverage with Low Alcohol Dose<br>Beverage containing 0.4 g/kg alcohol | Drug: Ethanol<br>* Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol<br>* Other names: Everclear;|
| Placebo Comparator: Beverage with No alcohol (Placebo)<br>Beverage containing 0.0 g/kg alcohol to act as placebo | Drug: Placebo<br>* Beverage containing 0.0 g/kg alcohol to act as placebo<br>|
| Experimental: Beverage with Diphenhydramine<br>Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl) | Drug: Diphenhydramine<br>* Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)<br>* Other names: Benadryl;|
| Experimental: Beverage with Caffeine<br>Beverage containing the equivalent of 1.5 times participant's average caffeine consumption | Drug: Caffeine<br>* Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers |  | Measured during 5 timepoints at each experimental session: 1) Pre-drink baseline, 2) +30 minutes, 3) +60 minutes, 4) +120 minutes, and 5) +180 minutes following the initiation of beverage consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use Behavior Reported During Follow-Up Interviews |  | Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session |