[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493324":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":76,"collaborators":31,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":31,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":31,"enrollmentInfo":88,"targetDuration":31,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":31,"overallStatus":54,"whyStopped":31,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Kansas Medical Center","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Varenicline and electronic cigarette","EXPERIMENTAL","At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive 1mg varenicline to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.",[13,14],"Drug: Varenicline Tartrate","Other: Electronic cigarette",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo and electronic cigarette","PLACEBO_COMPARATOR","At the end of the 6-week open label phase, dual users of cigarettes and e-cigarettes will receive placebo pills to take twice daily for 12 weeks. They will also receive an additional 12 weeks of the nicotine salt-based pod system e-cigarette.",[20,14],"Drug: Placebo",{"label":22,"type":6,"description":23,"interventionNames":24},"Open label electronic cigarette","All participants will receive an initial 6-week supply of the study electronic cigarette.",[14],[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Varenicline Tartrate","0.5 mg once daily for days 1-3, 0.5mg twice daily for days 4-7 and 1.0 mg twice daily from day 8 through week 12.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","One pill (white) once daily for days 1-3, one pill (white) twice daily for days 4-7 and one pill (blue) twice daily from day 8 through week 12.",[16],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Electronic cigarette","Nicotine salt pod based e-cigarette in 5% nicotine",[22,16,9],[41],{"name":42,"affiliation":43,"role":44},"Nicole Nollen, PhD","University of Kanas Medical Center","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Tricia Snow, MPH","CONTACT","816-398-8960","psnow@kumc.edu",[52,70],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Swope Health Central","RECRUITING","Kansas City","Missouri","64130","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-94.57857,39.09973,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":69,"phoneExt":31,"email":50},"Tricia Snow","816-599-5311",{"facility":5,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},{"type":61,"coordinates":72},[63,64],{"lat":64,"lon":63},[75],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},{"type":77,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100493324","phase-3-switching-to-e-cigarettes-in-smokers-not-interested-in-quitting-100493324",false,"NCT05703672","Switching to E-cigarettes in Smokers Not Interested in Quitting","4th Generation E-cigarettes: Reducing Harm and Quitting Combustible Cigarettes in Dual Users","Inclusion Criteria:\n\n* ≥ 21 years of age\n* Smoke \\>5 cigarettes per day\n* Smoked cigarettes for \\> 6 months\n* Verified smoker (CO \\> 5 ppm)\n* Functioning telephone\n* Interested in switching to EC\n* Willing to take varenicline and complete all study visits\n\nExclusion Criteria:\n\n* Interested in quitting smoking\n* Use of smoking cessation pharmacotherapy in the month prior to enrollment\n* Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes)\n* EC use on \\> 4 of the past 30 days\n* Uncontrolled hypertension: BP \\> 180 (systolic) or \\> 105 (diastolic)\n* Heart-related event in the past 30 days\n* Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation\n* Pregnant, contemplating getting pregnant, or breastfeeding\n* Plans to move from Kansas City metro area during the treatment and follow-up phase\n* Another household member enrolled in the study",true,"ALL","21 Years",{"count":89,"type":90},500,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in adult (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking.",[96],"Smoking Reduction","2025-12-24",{"date":99,"type":100},"2025-12-29","ACTUAL",{"date":102,"type":100},"2023-07-17",{"date":104,"type":90},"2027-02-28",{"name":5,"class":6},2]