[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522026":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":56,"centralContacts":62,"locations":72,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":31,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":31,"enrollmentInfo":101,"targetDuration":31,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":31,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Yale University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"E-cigarettes","EXPERIMENTAL","Adults who smoke cigarettes will be randomized to receive e-cigarettes for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco\u002Funflavored available or tobacco\u002Funflavored only available, and nicotine concentration is either higher (5% e-cig) or lower (2.4% e-cig). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.",[13,14,15,16],"Behavioral: E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors","Behavioral: E-cigarette with 2.4% Nicotine with Tobacco Flavor Only","Behavioral: E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors","Behavioral: E-cigarette with 5% Nicotine with Tobacco Flavor Only",{"label":18,"type":10,"description":19,"interventionNames":20},"Nicotine Pouches","Adults who smoke cigarettes will be randomized to receive nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco\u002Funflavored available or tobacco\u002Funflavored only available, and nicotine concentration is either higher (6mg pouch) or lower (3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. They will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided.",[21,22,23,24],"Behavioral: Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors","Behavioral: Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only","Behavioral: Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors","Behavioral: Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only",[26,32,36,40,44,47,50,53],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"BEHAVIORAL","E-cigarette with 2.4% Nicotine with Menthol and Tobacco Flavors","Flavor availability is menthol and tobacco\u002Funflavored with lower nicotine concentration.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"E-cigarette with 2.4% Nicotine with Tobacco Flavor Only","Flavor availability is tobacco\u002Funflavored only with lower nicotine concentration.",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"E-cigarette with 5% Nicotine with Menthol and Tobacco Flavors","Flavor availability is menthol and tobacco\u002Funflavored with higher nicotine concentration.",[9],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"E-cigarette with 5% Nicotine with Tobacco Flavor Only","Flavor availability is tobacco\u002Funflavored only with higher nicotine concentration.",[9],{"type":27,"name":45,"description":29,"armGroupLabels":46,"otherNames":31},"Tobacco Pouches with 3mg Nicotine with Menthol and Tobacco Flavors",[18],{"type":27,"name":48,"description":34,"armGroupLabels":49,"otherNames":31},"Tobacco Pouches with 3mg Nicotine with Tobacco Flavor Only",[18],{"type":27,"name":51,"description":38,"armGroupLabels":52,"otherNames":31},"Tobacco Pouches with 6mg Nicotine with Menthol and Tobacco Flavors",[18],{"type":27,"name":54,"description":42,"armGroupLabels":55,"otherNames":31},"Tobacco Pouches with 6mg Nicotine with Tobacco Flavor Only",[18],[57,60],{"name":58,"affiliation":5,"role":59},"Lisa Fucito, PhD","PRINCIPAL_INVESTIGATOR",{"name":61,"affiliation":5,"role":59},"Krysten Bold, PhD",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":31,"email":67},"Lisa M. Fucito, PhD","CONTACT","203-200-1470","lisa.fucito@yale.edu",{"name":69,"role":65,"phone":70,"phoneExt":31,"email":71},"Krysten W Bold, PhD","203-974-7603","krysten.bold@yale.edu",[73],{"facility":5,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":31},"RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-72.92816,41.30815,{"lat":84,"lon":83},{"type":87,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[89],{"name":90,"class":91},"National Institute on Drug Abuse (NIDA)","NIH","100522026","effects-of-e-cigs-vs-pouches-on-cigarette-smoking-and-addiction-100522026",false,"NCT06077240","Effects of E-cigs vs Pouches on Cigarette Smoking and Addiction","Evaluating The Effects Of E-cigarettes Versus Oral Nicotine Pouches and Product Constituents (Menthol Flavor, Nicotine Concentration) On Adult Cigarette Smoking and Addiction","Inclusion Criteria:\n\n* 21+ years old\n* English literate\n* Currently smoking cigarettes, biochemically confirmed\n\nExclusion Criteria:\n\n* Currently using smoking cessation pharmacotherapies (NRT, bupropion, varenicline)\n* Currently pregnant or breastfeeding\n* Significant current medical or psychiatric condition\n* Known hypersensitivity to propylene glycol","ALL","21 Years",{"count":102,"type":103},256,"ESTIMATED","INTERVENTIONAL",[106],"NA","The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco\u002Funflavored available or tobacco\u002Funflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.",[109,110,111],"Smoking","Smoking Behaviors","Nicotine Dependence","2026-03-17",{"date":114,"type":115},"2026-03-19","ACTUAL",{"date":117,"type":115},"2024-08-20",{"date":119,"type":103},"2028-04-01",{"name":5,"class":6},1]