Chicago Social Drinking Project

Alcoholism Clinical Trial

— CSDP  

Official title:

Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00961792
• Other study ID #: 12119a
• Secondary ID: 5R01AA013746
• Status: Recruiting
• Phase: N/A
• Start date: March 2004
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: ANDREA KING, PhD
• Phone: 7737026181
• Email: aking[@]bsdad.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Addictions Research Laboratory	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Study Website