[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07040566":3,"trial-entities:NCT07040566":103,"trial-summary:NCT07040566":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":46,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":65,"locations":68,"central_contacts":86,"overall_officials":95,"references":101,"see_also_links":102},"NCT07040566","2000038513","A Trial of Varenicline for E-cigarette Cessation","Investigating Efficacious E-Cigarette Interventions and Cessation Effects on Cancer-Related Biomarkers: A Randomized Trial of Varenicline in Adults","RECRUITING","2030-10-30","2025-12","2025-12-17","2025-10-14","Yale University","OTHER",true,"This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.","Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.\n\nThe primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.",[19,20,21],"E-cigarette Use","Vaping","Nicotine Dependence",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},326,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Varenicline 1mg BID","12 weeks following the standard titration of 1 mg, twice daily",[36],"Varenicline",{"type":32,"name":38,"description":39,"armGroupLabels":40},"Placebo","Matching placebo twice daily",[38],[42],{"measure":43,"description":44,"timeFrame":45},"Number of Participants Abstinent From E-cigarette Use at Week 12","7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use \\[and no use of any combusted tobacco product\\], not even a puff, biochemically verified by saliva cotinine","Week 12",[47],{"measure":48,"description":49,"timeFrame":50},"Number of Participants Abstinent From E-cigarette Use at Week 26","7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use \\[and no use of any combusted tobacco product\\], not even a puff, biochemically verified by saliva cotinine","Week 26","ALL","18 Years",null,false,{"inclusion":56,"exclusion":59,"raw_text":64},[57,58],"report daily use of an e-cigarette containing nicotine","live in Connecticut or South Carolina",[60,61,62,63],"regular use of other tobacco products besides e-cigarettes","medical contraindications for varenicline use","current treatment for tobacco cessation","lack proficiency in English","Inclusion Criteria:\n\n* report daily use of an e-cigarette containing nicotine\n* live in Connecticut or South Carolina\n\nExclusion Criteria:\n\n* regular use of other tobacco products besides e-cigarettes\n* medical contraindications for varenicline use\n* current treatment for tobacco cessation\n* lack proficiency in English",[66,67],"ADULT","OLDER_ADULT",[69,78],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Yale Cancer Center\u002FSmilow Cancer Hospital at Yale-New Haven","New Haven","Connecticut","06520","United States",{"lat":76,"lon":77},41.30815,-72.92816,{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":74,"geoPoint":83},"Hollings Cancer Center at MUSC (HCC)","Charleston","South Carolina","29425",{"lat":84,"lon":85},32.77632,-79.93275,[87,92],{"name":88,"role":89,"phone":90,"email":91},"Lisa Fucito, PhD","CONTACT","2032001470","lisa.fucito@yale.edu",{"name":93,"role":89,"email":94},"Michael Fatigate, PhD","Michael.fatigate@yale.edu",[96,98],{"name":88,"affiliation":13,"role":97},"PRINCIPAL_INVESTIGATOR",{"name":99,"affiliation":100,"role":97},"Benjamin Toll, PhD","Medical University of South Carolina",[],[],{"nct_id":4,"conditions":104,"biomarkers":105},[21],[],{"nct_id":4,"found":15,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is a randomized, placebo-controlled study, meaning participants are randomly assigned to receive either varenicline or a placebo. The study plans to enroll 326 participants.","completed","Varenicline for E-cigarette Cessation","This study is testing if a medication called varenicline (Chantix) can help people stop using e-cigarettes. You might be able to join if you are an adult, use e-cigarettes daily, and live in Connecticut or South Carolina. You cannot join if you use other tobacco products, have certain medical conditions, or are already getting treatment to quit tobacco. Participants will either receive varenicline or a placebo (an inactive pill that looks like the study drug) for 12 weeks, along with counseling. The main goal is to see how many people successfully quit e-cigarettes by week 12. The current status of this study is unclear.","There will be a final follow-up visit at week 26, which is 14 weeks after the treatment period ends.",104,"You would take varenicline or placebo for 12 weeks. You will also have research assessments every 3 weeks during treatment.","Not stated in the trial record.",[38],"v2"]