CSDP: Chicago Social Drinking Project

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT00961792
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
400
1
5
249
1.6

Study Details

Study Description

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 young, adult social drinkers 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Screening
Official Title:
Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults
Study Start Date :
Mar 1, 2004
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beverage with Heavy Alcohol Dose

Beverage containing 0.8 g/kg alcohol

Drug: Ethanol
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
Other Names:
  • Kool-Aid
  • Splenda
  • Everclear
  • Experimental: Beverage with Low Alcohol Dose

    Beverage containing 0.4 g/kg alcohol

    Drug: Ethanol
    Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
    Other Names:
  • Kool-Aid
  • Splenda
  • Everclear
  • Placebo Comparator: Beverage with No alcohol (Placebo)

    Beverage containing 0.0 g/kg alcohol to act as placebo

    Drug: Placebo
    Beverage containing 0.0 g/kg alcohol to act as placebo

    Experimental: Beverage with Diphenhydramine

    Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

    Drug: Diphenhydramine
    Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
    Other Names:
  • Benadryl
  • Experimental: Beverage with Caffeine

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

    Drug: Caffeine
    Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Addictions Research Laboratory Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    Investigators

    • Principal Investigator: Andrea C King, PhD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00961792
    Other Study ID Numbers:
    • 12119a
    • 5R01AA013746
    First Posted:
    Aug 19, 2009
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022