Chicago Social Drinking Project (CSDP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00961792
First received: August 11, 2009
Last updated: September 4, 2013
Last verified: February 2013
  Purpose

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 Intervention
Alcoholism
Drug: Ethanol
Drug: Placebo
Drug: Diphenhydramine
Drug: Caffeine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2004
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 29 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961792

Locations
United States, Illinois
Clinical Addictions Research Laboratory
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Andrea C King, PhD University of Chicago
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00961792     History of Changes
Other Study ID Numbers: 12119a, 5R01AA013746
Study First Received: August 11, 2009
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Diphenhydramine
Caffeine
Promethazine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics

ClinicalTrials.gov processed this record on July 24, 2014