[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06118502":3,"trial-entities:NCT06118502":95,"trial-summary:NCT06118502":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":47,"secondary_outcomes":52,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":14,"eligibility_criteria":60,"std_ages":66,"locations":69,"central_contacts":83,"overall_officials":92,"references":93,"see_also_links":94},"NCT06118502","00128175","A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse","RECRUITING","2028-03-31","2026-08","2026-08-12","2024-03-25","Medical University of South Carolina","OTHER",true,"This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.\n\nAll visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.","Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.",[18,19,20],"Cigarette Smoking","Smoking Behaviors","Treatment",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},544,"ESTIMATED",[30,36,42],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Switching to a different medication","Participants will receive four weeks of the other FDA approved option, either varenicline or combination NRT, with instructions to try to quit again at week 4.",[35],"Adaptive Randomization 1",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Continued use of the same medication","Participants will receive four additional weeks of the same medication (varenicline or NRT) with instructions to try to quit again at week 4.",[40,41],"Non-Adaptive Randomization 1","Non-Adaptive Randomization 2",{"type":31,"name":43,"description":44,"armGroupLabels":45},"Switching to a harm reduction tobacco product","Participants will receive four weeks of e-cigarette products with instructions to switch completely at Week 8",[46],"Harm Reduction Randomization 2",[48],{"measure":49,"description":50,"timeFrame":51},"Non-responders after initial course of FDA-approved medication","7-day point prevalence abstinence at Week 8 among non-responders at Week 4","8 weeks",[53],{"measure":54,"description":55,"timeFrame":56},"Dependence and duration of longest quit attempt","7-day point prevalence abstinence at Week 12 among non-responders at Week 8.","12 weeks","ALL","21 Years",null,{"inclusion":61,"exclusion":63,"raw_text":65},[62],"Smokers who want to quit",[64],"Non-smokers","Inclusion Criteria:\n\n* Smokers who want to quit\n\nExclusion Criteria:\n\n* Non-smokers",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":12,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":80},"Charleston","South Carolina","29425","United States",[76],{"name":77,"role":78,"email":79},"William McCamy","CONTACT","mccamy@musc.edu",{"lat":81,"lon":82},32.77632,-79.93275,[84,88],{"name":85,"role":78,"phone":86,"email":87},"Tracy T Smith, PhD","8438725164","smithtra@musc.edu",{"name":89,"role":78,"phone":90,"email":91},"Matthew J Carpenter, PhD","8438762436","carpente@musc.edu",[],[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[18],[],{"nct_id":4,"found":14,"summary":99,"prompt_version":109},{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This interventional study plans to enroll 544 participants. It will test different approaches to help people quit smoking.","completed","Adaptive Treatment for Early Smoking Cessation Relapse","This study is looking for smokers who want to quit and have found it difficult to stop using medications. It aims to improve how treatment decisions are made for these individuals. You'll receive free products for 12 weeks, which could include nicotine replacement therapies (patches and lozenges), varenicline (a medication to help you quit smoking), or e-cigarettes (a harm reduction product). The specific treatment you receive will depend on how you respond to earlier treatments. The study will measure if you are still smoking after your initial medication course at 8 weeks. This study is currently unclear about its recruitment status, but plans to enroll 544 participants.","The study team will contact participants 6 months after the first study phone call to complete another survey.",107,"All visits and assessments will be remote. You will complete 8 surveys over six months.","All treatments will be provided free of charge for the first 12 weeks.",[],"v2"]