Chicago Social Drinking Project (CSDP)

The University of Chicago

Status: Active, not recruiting

Conditions: Alcoholism

Treatments: Drug: Caffeine; Drug: Placebo; Drug: Ethanol; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00961792

12119a

5R01AA013746 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 6 patient groups, including a placebo group

Beverage with Heavy Alcohol Dose

Experimental group

Description:

Beverage containing 0.8 g/kg alcohol

Treatment:

Drug: Ethanol

Beverage with Low Alcohol Dose

Experimental group

Description:

Beverage containing 0.4 g/kg alcohol

Treatment:

Drug: Ethanol

Beverage with No alcohol (Placebo)

Placebo Comparator group

Description:

Beverage containing 0.0 g/kg alcohol to act as placebo

Treatment:

Drug: Placebo

Beverage with Diphenhydramine

Experimental group

Description:

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

Treatment:

Drug: Diphenhydramine

Beverage with Caffeine

Experimental group

Description:

Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

Treatment:

Drug: Caffeine

Beverage in Natural Environment

No Intervention group

Description:

Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment