Brief Summary

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Official Title: "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:

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening
• Study Primary Completion Date: July 2016

Interventions Used in this Clinical Trial

• Drug: Ethanol
  • Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
• Drug: Placebo
  • Beverage containing 0.0 g/kg alcohol to act as placebo
• Drug: Diphenhydramine
  • Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
• Drug: Caffeine
  • Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Beverage with Heavy Alcohol Dose
  • Beverage containing 0.8 g/kg alcohol
• Experimental: Beverage with Low Alcohol Dose
  • Beverage containing 0.4 g/kg alcohol
• Placebo Comparator: Beverage with No alcohol (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)
• Experimental: Beverage with Caffeine
  • Beverage containing the equivalent of 1.5 times participant's average caffeine consumption

Outcome Measures for this Clinical Trial

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 29 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • University of Chicago
• Collaborator
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Provider of Information About this Clinical Study
  • Principal Investigator: Andrea King, Ph.D - University of Chicago
• Overall Official(s)
  • Andrea C King, PhD, Principal Investigator, University of Chicago

References

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.

Citations Reporting on 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. 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.

King AC, Epstein AM. Alcohol dose-dependent increases in smoking urge in light smokers. Alcohol Clin Exp Res. 2005 Apr;29(4):547-52.