Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT00961792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2009-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chicago Social Drinking Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'C026285', 'term': 'trichlorosucrose'}, {'id': 'D004155', 'term': 'Diphenhydramine'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2009-08-11', 'studyFirstSubmitQcDate': '2009-08-18', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcoholism']}, 'referencesModule': {'references': [{'pmid': '15000501', 'type': 'BACKGROUND', '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.'}, {'pmid': '12068251', 'type': 'BACKGROUND', '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.'}, {'pmid': '19320625', 'type': 'RESULT', '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.'}, {'pmid': '16804691', 'type': 'RESULT', '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.'}, {'pmid': '17560739', 'type': 'RESULT', '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.'}, {'pmid': '18770076', 'type': 'RESULT', '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.'}, {'pmid': '15834219', 'type': 'RESULT', '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.'}, {'pmid': '33397141', 'type': 'RESULT', '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."}, {'pmid': '31685074', 'type': 'DERIVED', '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."}, {'pmid': '26117308', 'type': 'DERIVED', '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."}, {'pmid': '24094754', 'type': 'DERIVED', '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.'}, {'pmid': '21464363', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'https://socialdrinking.bsd.uchicago.edu/', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:\n\n1. Examining subjective and objective response differences to alcohol and other common substances in a sample of adults with varying consumption patterns.\n2. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.\n3. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-65\n* Weigh between 110-210 lbs\n* Drink alcohol at least once weekly with weekly "binge" drinking episodes\n* Available to complete in-person screening and 2, 4 hour experimental sessions at the University of Chicago\n* Available by phone, mail, or Internet for follow-up interviews for at least 2 years following sessions\n\nExclusion Criteria:\n\n* Current or past major medical or psychiatric disorders including alcohol and substance dependence'}, 'identificationModule': {'nctId': 'NCT00961792', 'acronym': 'CSDP', 'briefTitle': 'Chicago Social Drinking Project', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults', 'orgStudyIdInfo': {'id': '12119a'}, 'secondaryIdInfos': [{'id': '5R01AA013746', 'link': 'https://reporter.nih.gov/quickSearch/5R01AA013746', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beverage with Heavy Alcohol Dose', 'description': 'Beverage containing 0.8 g/kg alcohol', 'interventionNames': ['Drug: Ethanol']}, {'type': 'EXPERIMENTAL', 'label': 'Beverage with Low Alcohol Dose', 'description': 'Beverage containing 0.4 g/kg alcohol', 'interventionNames': ['Drug: Ethanol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Beverage with No alcohol (Placebo)', 'description': 'Beverage containing 0.0 g/kg alcohol to act as placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Beverage with Diphenhydramine', 'description': 'Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)', 'interventionNames': ['Drug: Diphenhydramine']}, {'type': 'EXPERIMENTAL', 'label': 'Beverage with Caffeine', 'description': "Beverage containing the equivalent of 1.5 times participant's average caffeine consumption", 'interventionNames': ['Drug: Caffeine']}, {'type': 'NO_INTERVENTION', 'label': 'Beverage in Natural Environment', 'description': 'Participant consumes alcohol containing beverages or non-alcohol beverages in natural environment'}], 'interventions': [{'name': 'Ethanol', 'type': 'DRUG', 'otherNames': ['Kool-Aid', 'Splenda', 'Everclear'], 'description': 'Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol', 'armGroupLabels': ['Beverage with Heavy Alcohol Dose', 'Beverage with Low Alcohol Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Beverage containing 0.0 g/kg alcohol to act as placebo', 'armGroupLabels': ['Beverage with No alcohol (Placebo)']}, {'name': 'Diphenhydramine', 'type': 'DRUG', 'otherNames': ['Benadryl'], 'description': 'Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)', 'armGroupLabels': ['Beverage with Diphenhydramine']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': "Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake", 'armGroupLabels': ['Beverage with Caffeine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Addictions Research Laboratory', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Andrea C King, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}