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Chicago Social Drinking Project (CSDP)

Primary Purpose

Alcoholism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ethanol
Placebo
Diphenhydramine
Caffeine
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcoholism

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Addictions Research LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Beverage with Heavy Alcohol Dose

Beverage with Low Alcohol Dose

Beverage with No alcohol (Placebo)

Beverage with Diphenhydramine

Beverage with Caffeine

Arm Description

Beverage containing 0.8 g/kg alcohol

Beverage containing 0.4 g/kg alcohol

Beverage containing 0.0 g/kg alcohol to act as placebo

Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Substance Use Behavior Reported During Follow-Up Interviews

Full Information

First Posted
August 11, 2009
Last Updated
February 4, 2022
Sponsor
University of Chicago
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00961792
Brief Title
Chicago Social Drinking Project
Acronym
CSDP
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by: Examining subjective and objective response differences to alcohol and other common substances in a sample of young, adult social drinkers with varying consumption patterns. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beverage with Heavy Alcohol Dose
Arm Type
Experimental
Arm Description
Beverage containing 0.8 g/kg alcohol
Arm Title
Beverage with Low Alcohol Dose
Arm Type
Experimental
Arm Description
Beverage containing 0.4 g/kg alcohol
Arm Title
Beverage with No alcohol (Placebo)
Arm Type
Placebo Comparator
Arm Description
Beverage containing 0.0 g/kg alcohol to act as placebo
Arm Title
Beverage with Diphenhydramine
Arm Type
Experimental
Arm Description
Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)
Arm Title
Beverage with Caffeine
Arm Type
Experimental
Arm Description
Beverage containing the equivalent of 1.5 times participant's average caffeine consumption
Intervention Type
Drug
Intervention Name(s)
Ethanol
Other Intervention Name(s)
Kool-Aid, Splenda, Everclear
Intervention Description
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Beverage containing 0.0 g/kg alcohol to act as placebo
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Intervention Description
Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake
Primary Outcome Measure Information:
Title
Subjective response to alcohol and other common substances utilizing mood questionnaires in adult drinkers
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANDREA KING, PhD
Phone
7737026181
Email
aking@bsdad.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C King, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Addictions Research Laboratory
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea King, PhD
Phone
773-702-6181
Email
aking@yoda.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Andrea C King, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15000501
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.
Results Reference
background
PubMed Identifier
12068251
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.
Results Reference
background
PubMed Identifier
19320625
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.
Results Reference
result
PubMed Identifier
16804691
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.
Results Reference
result
PubMed Identifier
17560739
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.
Results Reference
result
PubMed Identifier
18770076
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.
Results Reference
result
PubMed Identifier
15834219
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.
Results Reference
result
PubMed Identifier
33397141
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.
Results Reference
result
PubMed Identifier
31685074
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.
Results Reference
derived
PubMed Identifier
26117308
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.
Results Reference
derived
PubMed Identifier
24094754
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.
Results Reference
derived
PubMed Identifier
21464363
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.
Results Reference
derived

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Chicago Social Drinking Project

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