Chicago Social Drinking Project

NCT ID: NCT00961792

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2026-10-31

Brief Summary

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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 adults 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.

Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Beverage with Heavy Alcohol Dose

Beverage containing 0.8 g/kg alcohol

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

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

Beverage with Low Alcohol Dose

Beverage containing 0.4 g/kg alcohol

Group Type EXPERIMENTAL

Ethanol

Intervention Type DRUG

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

Beverage with No alcohol (Placebo)

Beverage containing 0.0 g/kg alcohol to act as placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Beverage containing 0.0 g/kg alcohol to act as placebo

Beverage with Diphenhydramine

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

Group Type EXPERIMENTAL

Diphenhydramine

Intervention Type DRUG

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

Beverage with Caffeine

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

Group Type EXPERIMENTAL

Caffeine

Intervention Type DRUG

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

Beverage in Natural Environment

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ethanol

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

Intervention Type DRUG

Placebo

Beverage containing 0.0 g/kg alcohol to act as placebo

Intervention Type DRUG

Diphenhydramine

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

Intervention Type DRUG

Caffeine

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

Intervention Type DRUG

Other Intervention Names

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Kool-Aid Splenda Everclear Benadryl

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea C King, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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Clinical Addictions Research Laboratory

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15000501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12068251 (View on PubMed)

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.

Reference Type RESULT
PMID: 19320625 (View on PubMed)

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.

Reference Type RESULT
PMID: 16804691 (View on PubMed)

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.

Reference Type RESULT
PMID: 17560739 (View on PubMed)

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.

Reference Type RESULT
PMID: 18770076 (View on PubMed)

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.

Reference Type RESULT
PMID: 15834219 (View on PubMed)

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.

Reference Type RESULT
PMID: 33397141 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31685074 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26117308 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24094754 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21464363 (View on PubMed)

Related Links

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Other Identifiers

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5R01AA013746

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12119a

Identifier Type: -

Identifier Source: org_study_id

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