Chicago Social Drinking Project

NCT00961792 | Active Not Recruiting

• 2 other identifiers: 12119a5R01AA013746
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:

1. 1.Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.
2. 2.Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.
3. 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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers

  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 Outcomes (1)

• Substance Use Behavior Reported During Follow-Up Interviews

  Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session

Study Arms (6)

Beverage with Heavy Alcohol Dose

EXPERIMENTAL

Beverage containing 0.8 g/kg alcohol

Drug: Ethanol

Beverage with Low Alcohol Dose

EXPERIMENTAL

Beverage containing 0.4 g/kg alcohol

Drug: Ethanol

Beverage with No alcohol (Placebo)

PLACEBO COMPARATOR

Beverage containing 0.0 g/kg alcohol to act as placebo

Drug: Placebo

Beverage with Diphenhydramine

EXPERIMENTAL

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

Drug: Diphenhydramine

Beverage with Caffeine

EXPERIMENTAL

Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

Drug: Caffeine

Beverage in Natural Environment

NO INTERVENTION

Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment

Interventions

Ethanol DRUG

Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol

Also known as: Kool-Aid, Splenda, Everclear

Beverage with Heavy Alcohol Dose; Beverage with Low Alcohol Dose

Placebo DRUG

Beverage containing 0.0 g/kg alcohol to act as placebo

Beverage with No alcohol (Placebo)

Diphenhydramine DRUG

Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)

Also known as: Benadryl

Beverage with Diphenhydramine

Caffeine DRUG

Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake

Beverage with Caffeine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current or past major medical or psychiatric disorders including alcohol and substance dependence

Sponsors & Collaborators

• University of Chicago: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Clinical Addictions Research Laboratory

Chicago, Illinois, 60637, United States

Location

Related Publications (12)

• 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.

  PMID: 15000501 BACKGROUND

• 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.

  PMID: 12068251 BACKGROUND

• 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.

  PMID: 19320625 RESULT

• 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.

  PMID: 16804691 RESULT

• 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.

  PMID: 17560739 RESULT

• 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.

  PMID: 18770076 RESULT

• 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.

  PMID: 15834219 RESULT

• 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.

  PMID: 33397141 RESULT

• 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.

  PMID: 31685074 DERIVED

• 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.

  PMID: 26117308 DERIVED

• 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.

  PMID: 24094754 DERIVED

• 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.

  PMID: 21464363 DERIVED

Related Links

• Study Website

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol; trichlorosucrose; Diphenhydramine; Caffeine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrea C King, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 19, 2009
• Study Start: March 1, 2004
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)