- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961792
Chicago Social Drinking Project (CSDP)
April 3, 2026 updated by: University of Chicago
Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults
This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:
- Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.
- Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.
- Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Clinical Addictions Research Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Beverage with Heavy Alcohol Dose
Beverage containing 0.8 g/kg alcohol
|
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
Other Names:
|
|
Experimental: Beverage with Low Alcohol Dose
Beverage containing 0.4 g/kg alcohol
|
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
Other Names:
|
|
Placebo Comparator: Beverage with No alcohol (Placebo)
Beverage containing 0.0 g/kg alcohol to act as 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)
|
Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
Other Names:
|
|
Experimental: Beverage with Caffeine
Beverage containing the equivalent of 1.5 times participant's average caffeine consumption
|
Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake
|
|
No Intervention: Beverage in Natural Environment
Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers
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
|
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
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrea C King, PhD, University of Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- King AC, Byars JA. Alcohol-induced performance impairment in heavy episodic and light social drinkers. J Stud Alcohol. 2004 Jan;65(1):27-36. doi: 10.15288/jsa.2004.65.27.
- King AC, Houle T, de Wit H, Holdstock L, Schuster A. Biphasic alcohol response differs in heavy versus light drinkers. Alcohol Clin Exp Res. 2002 Jun;26(6):827-35.
- Rueger SY, McNamara PJ, King AC. Expanding the utility of the Biphasic Alcohol Effects Scale (BAES) and initial psychometric support for the Brief-BAES (B-BAES). Alcohol Clin Exp Res. 2009 May;33(5):916-24. doi: 10.1111/j.1530-0277.2009.00914.x. Epub 2009 Mar 11.
- Epstein AM, Sher TG, Young MA, King AC. Tobacco chippers show robust increases in smoking urge after alcohol consumption. Psychopharmacology (Berl). 2007 Feb;190(3):321-9. doi: 10.1007/s00213-006-0438-8. Epub 2006 Jun 28.
- Brumback T, Cao D, King A. Effects of alcohol on psychomotor performance and perceived impairment in heavy binge social drinkers. Drug Alcohol Depend. 2007 Nov 2;91(1):10-7. doi: 10.1016/j.drugalcdep.2007.04.013. Epub 2007 Jun 8.
- King A, Epstein A, Conrad M, McNamara P, Cao D. Sex differences in the relationship between alcohol-associated smoking urge and behavior: a pilot study. Am J Addict. 2008 Sep-Oct;17(5):347-53. doi: 10.1080/10550490802268140.
- King AC, Epstein AM. Alcohol dose-dependent increases in smoking urge in light smokers. Alcohol Clin Exp Res. 2005 Apr;29(4):547-52. doi: 10.1097/01.alc.0000158839.65251.fe.
- King A, Vena A, Hasin DS, deWit H, O'Connor SJ, Cao D. Subjective Responses to Alcohol in the Development and Maintenance of Alcohol Use Disorder. Am J Psychiatry. 2021 Jun;178(6):560-571. doi: 10.1176/appi.ajp.2020.20030247. Epub 2021 Jan 5.
- King AC, Cao D, deWit H, O'Connor SJ, Hasin DS. The role of alcohol response phenotypes in the risk for alcohol use disorder. BJPsych Open. 2019 Apr 22;5(3):e38. doi: 10.1192/bjo.2019.18.
- King AC, Hasin D, O'Connor SJ, McNamara PJ, Cao D. A Prospective 5-Year Re-examination of Alcohol Response in Heavy Drinkers Progressing in Alcohol Use Disorder. Biol Psychiatry. 2016 Mar 15;79(6):489-98. doi: 10.1016/j.biopsych.2015.05.007. Epub 2015 May 14.
- King AC, McNamara PJ, Hasin DS, Cao D. Alcohol challenge responses predict future alcohol use disorder symptoms: a 6-year prospective study. Biol Psychiatry. 2014 May 15;75(10):798-806. doi: 10.1016/j.biopsych.2013.08.001. Epub 2013 Oct 2.
- King AC, de Wit H, McNamara PJ, Cao D. Rewarding, stimulant, and sedative alcohol responses and relationship to future binge drinking. Arch Gen Psychiatry. 2011 Apr;68(4):389-99. doi: 10.1001/archgenpsychiatry.2011.26.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2004
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2027
Study Registration Dates
First Submitted
August 11, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimated)
August 19, 2009
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Substance-Related Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Alcoholism
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Hydrocarbons
- Hydrocarbons, Cyclic
- Alkaloids
- Hydrocarbons, Aromatic
- Amines
- Purinones
- Purines
- Benzene Derivatives
- Alcohols
- Ethylamines
- Benzhydryl Compounds
- Xanthines
- Caffeine
- Ethanol
- Diphenhydramine
- trichlorosucrose
Other Study ID Numbers
- 12119a
- 5R01AA013746 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.