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Chicago Social Drinking Project (CSDP)

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ClinicalTrials.gov Identifier: NCT00961792
Recruitment Status : Active, not recruiting
First Posted : August 19, 2009
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of Chicago

Study Description
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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
Alcoholism Drug: Ethanol Drug: Placebo Drug: Diphenhydramine Drug: Caffeine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2004
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Subjective response to alcohol and other common substances utilizing mood questionnaires in social drinking young adults [ Time Frame: 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 [ Time Frame: Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21-29
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961792


Locations
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United States, Illinois
Clinical Addictions Research Laboratory
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Andrea C King, PhD University of Chicago
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00961792    
Other Study ID Numbers: 12119a
5R01AA013746 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Diphenhydramine
Promethazine
Ethanol
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
 Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents