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Chicago Social Drinking Project (CSDP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00961792
Recruitment Status : Active, not recruiting
First Posted : August 19, 2009
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
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 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

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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 : April 2021
Estimated Study Completion Date : July 2021


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




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 ]


Information from the National Library of Medicine

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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

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

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     History of Changes
Other Study ID Numbers: 12119a
5R01AA013746 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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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
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents