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AzTrials

AlcoholismCSDPNCT00961792

Chicago Social Drinking Project

A study testing Ethanol, Diphenhydramine and Caffeine in people with Alcoholism, run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Alcoholism
What is being tested?
Ethanol, Diphenhydramine and Caffeine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
1 siteUnited States
Study dates
Mar 2004to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Current or past major medical or psychiatric disorders including alcohol and substance dependence

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Addictions Research Laboratory

    Chicago, Illinois, 60637

Other trials in United States

About this study

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 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.
Conditions
Alcoholism
Being tested
Ethanol, Placebo, Diphenhydramine, Caffeine
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EthanolDrug

    Also called Kool-Aid, Splenda, Everclear

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

  • PlaceboDrug

    Beverage containing 0.0 g/kg alcohol to act as placebo

  • DiphenhydramineDrug

    Also called Benadryl

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

  • CaffeineDrug

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

Study groups in NCT00961792
Study groupRoleWhat they receive
Beverage with Heavy Alcohol DoseExperimentalBeverage containing 0.8 g/kg alcohol
Receives: Drug: Ethanol
Beverage with Low Alcohol DoseExperimentalBeverage containing 0.4 g/kg alcohol
Receives: Drug: Ethanol
Beverage with No alcohol (Placebo)Placebo comparatorBeverage containing 0.0 g/kg alcohol to act as placebo
Receives: Drug: Placebo
Beverage with DiphenhydramineExperimentalBeverage containing 1.5 standard dose of Diphenhydramine (Benadryl)
Receives: Drug: Diphenhydramine
Beverage with CaffeineExperimentalBeverage containing the equivalent of 1.5 times participant's average caffeine consumption
Receives: Drug: Caffeine
Beverage in Natural EnvironmentNo interventionParticipant consumes alcohol containing beverages or non-alcohol beverages in natural environment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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 (1)

  1. Substance Use Behavior Reported During Follow-Up Interviews

    Measured: Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2009 (estimated)
  2. Study startMar 2004
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00961792
Sponsor's protocol ID
12119a
Other IDs
5R01AA013746
Acronym
CSDP
Status last verified
Apr 2026
First submitted
11 Aug 2009
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15000501

  • 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.

    PubMed 12068251

  • 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.

    PubMed 19320625

  • 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.

    PubMed 16804691

  • 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.

    PubMed 17560739

  • 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.

    PubMed 18770076

  • 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.

    PubMed 15834219

  • 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.

    PubMed 33397141

  • King AC, Nordgren RK, Cao D, Wellendorf CE, Fridberg DJ. Testing neurobiological models of reward/incentive sensitization in the continuation of alcohol use disorder (AUD) symptoms in young adults with AUD: A four-year longitudinal study. Neuropsychopharmacology. 2026 Oct 12. doi: 10.1038/s41386-026-02572-2. Online ahead of print.

    PubMed 42864386

  • 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.

    PubMed 31685074

  • 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.

    PubMed 26117308

  • 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.

    PubMed 24094754

  • 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.

    PubMed 21464363

Questions about this trial

What is this clinical trial studying?

A study testing Ethanol, Diphenhydramine and Caffeine in people with Alcoholism, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00961792, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

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