Chicago Social Drinking Project

Not Applicable

Active, not recruiting

• Conditions: Alcoholism
• Interventions: Drug: Placebo; Drug: Diphenhydramine; Drug: Ethanol; Drug: Caffeine

• Registration Number: NCT00961792
• Lead Sponsor: University of Chicago

Brief Summary

This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:

1. Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.

2. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.

3. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beverage with No alcohol (Placebo)	Placebo	Beverage containing 0.0 g/kg alcohol to act as placebo
Beverage with Diphenhydramine	Diphenhydramine	Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)
Beverage with Low Alcohol Dose	Ethanol	Beverage containing 0.4 g/kg alcohol
Beverage with Heavy Alcohol Dose	Ethanol	Beverage containing 0.8 g/kg alcohol
Beverage with Caffeine	Caffeine	Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Addictions Research Laboratory; 🇺🇸 Chicago, Illinois, United States