Chicago Social Drinking Project (CSDP)

• ClinicalTrials.gov Identifier: NCT00961792
• Recruitment Status: Active, not recruiting
• First Posted: August 19, 2009
• Last Update Posted: April 17, 2019
• Sponsor: University of Chicago
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): University of Chicago

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
Alcoholism	Drug: Ethanol; Drug: Placebo; Drug: Diphenhydramine; Drug: Caffeine	Not Applicable

Study Design

• 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

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 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

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

• 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

Locations

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

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

More Information

Additional Information:

Study Website 

Publications of Results:

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. 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. 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.

Other 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.

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.

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

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.

• 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
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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