{"protocolSection":{"identificationModule":{"nctId":"NCT00580645","orgStudyIdInfo":{"id":"HIC0702002391"},"secondaryIdInfos":[{"id":"R01AA015596-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01AA015596-01"}],"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Do Treatments for Smoking Cessation Affect Alcohol Drinking?","officialTitle":"Do Treatments for Smoking Cessation Affect Alcohol Drinking?"},"statusModule":{"statusVerifiedDate":"2018-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-04","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-11","type":"ACTUAL"},"completionDateStruct":{"date":"2016-11","type":"ACTUAL"},"studyFirstSubmitDate":"2007-12-25","studyFirstSubmitQcDate":"2007-12-26","studyFirstPostDateStruct":{"date":"2007-12-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-11-20","resultsFirstSubmitQcDate":"2018-01-08","resultsFirstPostDateStruct":{"date":"2018-02-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-01-08","lastUpdatePostDateStruct":{"date":"2018-02-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Sherry McKee","investigatorTitle":"Associate Professor of Psychiatry","investigatorAffiliation":"Yale University"},"leadSponsor":{"name":"Yale University","class":"OTHER"},"collaborators":[{"name":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to examine the effect of smoking cessation medications on alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.\n\nFollowing 7 days of medication pre-treatment to achieve steady state levels, participants complete a laboratory session assessing alcohol self-administration behavior.\n\nStudy enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo."},"conditionsModule":{"conditions":["Alcohol Drinking"],"keywords":["alcohol","smoking cessation","varenicline","bupropion","smoking cessation medications"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":60,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"varenicline","type":"EXPERIMENTAL","description":"varenicline 1mg/day or 2mg/day","interventionNames":["Drug: varenicline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo Controlled","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"varenicline","description":"2mg/day or 1mg/day with 1-week medication lead-in period.","armGroupLabels":["varenicline"],"otherNames":["Chantix"]},{"type":"DRUG","name":"placebo","description":"placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Drinks Consumed","description":"number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session","timeFrame":"2 hour ad-lib drinking period, during the laboratory session (Day 8)"}],"secondaryOutcomes":[{"measure":"Alcohol Craving","description":"alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)","timeFrame":"during laboratory session (Day 8) at baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* 21 years old or older\n* Able to read and write in English\n* Smokers, non-daily smokers, and non-smokers\n* Heavy Drinkers and/or meet criteria for alcohol use disorders\n\nExclusion Criteria:\n\n* Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol\n* Significant hepatocellular injury\n* Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines\n* Women who are pregnant or nursing\n* Suicidal, homicidal, or evidence of severe mental illness\n* Prescription of any psychotropic drug in the 30 days prior to study enrollment\n* Blood donation within the past 8 weeks\n* Individuals who are seeking treatment for drinking or smoking or who have attempted to quit drinking or smoking within the past 3 months\n* Specific exclusions for administration of bupropion not specified above including: having taken monoamine inhibitors in the past six weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology\n* Known allergy to varenicline or taking H2blockers\n* Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study\n* Subjects likely to exhibit clinically significant alcohol withdrawal during the study","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Sherry A McKee, PhD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale Center for Clinical Investigation and Yale Behavioral Pharmacology Laboratory","city":"New Haven","state":"Connecticut","zip":"06519","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]},"referencesModule":{"references":[{"pmid":"29389170","type":"DERIVED","citation":"Roberts W, McKee SA. Effects of varenicline on cognitive performance in heavy drinkers: Dose-response effects and associations with drinking outcomes. Exp Clin Psychopharmacol. 2018 Feb;26(1):49-57. doi: 10.1037/pha0000161."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Placebo controlled\n\nplacebo: placebo"},{"id":"FG001","title":"1 mg/Day Varenicline","description":"1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."},{"id":"FG002","title":"2 mg/Day Varenicline","description":"2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Placebo controlled\n\nplacebo: placebo"},{"id":"BG001","title":"1 mg/Day Varenicline","description":"1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."},{"id":"BG002","title":"2 mg/Day Varenicline","description":"2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"60"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34.2","spread":"9.52"},{"groupId":"BG001","value":"33.35","spread":"8.51"},{"groupId":"BG002","value":"34.15","spread":"11.6"},{"groupId":"BG003","value":"33.90","spread":"9.80"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"41"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}]},{"title":"African American","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"17"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"36"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Drinks Consumed","description":"number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session","populationDescription":"number of drinks consumed during hour 1 and hour 2 of the 120 minute alcohol self-administration session","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"number of drinks","timeFrame":"2 hour ad-lib drinking period, during the laboratory session (Day 8)","groups":[{"id":"OG000","title":"Placebo","description":"Placebo controlled\n\nplacebo: placebo"},{"id":"OG001","title":"1 mg/Day Varenicline","description":"1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."},{"id":"OG002","title":"2 mg/Day Varenicline","description":"2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"20"}]}],"classes":[{"title":"hour 1","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"0.37"},{"groupId":"OG001","value":"2.05","spread":"0.32"},{"groupId":"OG002","value":"1.5","spread":"0.33"}]}]},{"title":"hour 2","categories":[{"measurements":[{"groupId":"OG000","value":"1.7","spread":"0.37"},{"groupId":"OG001","value":"2.05","spread":"0.37"},{"groupId":"OG002","value":"1.5","spread":"0.37"}]}]}]},{"type":"SECONDARY","title":"Alcohol Craving","description":"alcohol craving during the alcohol priming dose period using a visual analog scale of alcohol craving (1-100; higher scores = higher craving)","populationDescription":"n=19 in the 2mg/day varenicline group because 1 subject failed to respond on measure.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a visual analog scale","timeFrame":"during laboratory session (Day 8) at baseline","groups":[{"id":"OG000","title":"Placebo","description":"Placebo controlled\n\nplacebo: placebo"},{"id":"OG001","title":"1 mg/Day Varenicline","description":"1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."},{"id":"OG002","title":"2 mg/Day Varenicline","description":"2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"19"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37.24","spread":"5.32"},{"groupId":"OG001","value":"34.11","spread":"5.32"},{"groupId":"OG002","value":"24.04","spread":"5.33"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Titration period (8 days).","description":"All adverse events reported during 1 week medication period. Baseline reporting not controlled. Subjects were queried about the presence/absence of severity of common symptoms (\\>5% from placebo according to manufacturer) associated with varenicline. Adverse events assessed on Day 1, 2, 5, and Day 8.","eventGroups":[{"id":"EG000","title":"Placebo","description":"Placebo controlled\n\nplacebo: placebo","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":7,"otherNumAtRisk":20},{"id":"EG001","title":"1 mg/Day Varenicline","description":"1mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for days 1-5, followed by 0.5mg twice daily for days 6-7. 0.5mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":4,"otherNumAtRisk":20},{"id":"EG002","title":"2 mg/Day Varenicline","description":"2mg/day with 1-week medication lead-in period. The starting dose is 0.5 mg/day for Day 1 and 2, 0.5 mg twice daily for Days 3-5, and 1.0mg twice daily on Days 6-7. 1.0mg twice daily administered during laboratory session (day 8) and for 4 weeks after laboratory session.","deathsNumAffected":0,"deathsNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"otherNumAffected":5,"otherNumAtRisk":20}],"otherEvents":[{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":20},{"groupId":"EG002","numAffected":2,"numAtRisk":20}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":20},{"groupId":"EG002","numAffected":5,"numAtRisk":20}]},{"term":"Dry Mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":20},{"groupId":"EG002","numAffected":2,"numAtRisk":20}]},{"term":"Insomnia","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":20},{"groupId":"EG002","numAffected":5,"numAtRisk":20}]},{"term":"Flatulence","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":20},{"groupId":"EG002","numAffected":1,"numAtRisk":20}]},{"term":"Difficulty Breathing","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":20},{"groupId":"EG002","numAffected":1,"numAtRisk":20}]},{"term":"Shortness of Breath","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":20},{"groupId":"EG002","numAffected":1,"numAtRisk":20}]},{"term":"Tightness in Chest","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":20},{"groupId":"EG002","numAffected":0,"numAtRisk":20}]},{"term":"Abnormal Dreams","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":20},{"groupId":"EG002","numAffected":3,"numAtRisk":20}]},{"term":"Fast Heartbeat","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":20},{"groupId":"EG002","numAffected":3,"numAtRisk":20}]},{"term":"Suicidal Thoughts","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":20},{"groupId":"EG002","numAffected":0,"numAtRisk":20}]},{"term":"Erratic Behavior","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":20},{"groupId":"EG002","numAffected":0,"numAtRisk":20}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Sherry McKee PhD","organization":"Yale School of Medicine","email":"sherry.mckee@yale.edu","phone":"203-737-3529"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000428","term":"Alcohol Drinking"},{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D004327","term":"Drinking Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D015438","term":"Health Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068580","term":"Varenicline"}],"ancestors":[{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"}]}},"hasResults":true}