Clinical trial NCT00961792: Chicago Social Drinking Project
Official title: Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcoholism
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2009-08-19
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers
timeFrame: 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:
measure: Substance Use Behavior Reported During Follow-Up Interviews
timeFrame: Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Clinical Addictions Research Laboratory
state: Illinois
Study officials:
affiliation: University of Chicago
name: Andrea C King, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.