[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07419425":3,"trial-entities:NCT07419425":152,"trial-summary:NCT07419425":155},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":55,"secondary_outcomes":60,"sex":83,"minimum_age":84,"maximum_age":85,"healthy_volunteers":15,"eligibility_criteria":86,"std_ages":95,"locations":98,"central_contacts":141,"overall_officials":147,"references":150,"see_also_links":151},"NCT07419425","2025-1697","My Path to Quit Tobacco","Comparing Three Multicomponent Interventions to Help Adults Quit Smoking","RECRUITING","2030-01","2026-05","2026-07-23","2026-07-06","University of Wisconsin, Madison","OTHER",true,"The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.","Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.\n\nSecondary Objectives:\n\n* Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)\n* Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.\n* Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.",[19],"Smoking Cessation",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},1550,"ESTIMATED",[29,39,43,47,51],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":37},"DRUG","Nicotine patch","Patch dosing will be consistent with the package insert",[34,35,36],"Intensive Incentivized Intervention","Intensive Intervention","Standard Intervention",[38],"NicoDerm CQ",{"type":14,"name":40,"description":41,"armGroupLabels":42},"Quitline Counseling Phone Calls","4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD.",[36],{"type":14,"name":44,"description":45,"armGroupLabels":46},"Counseling Sessions","Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions",[34,35],{"type":14,"name":48,"description":49,"armGroupLabels":50},"Pathways to Freedom","Pathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt.",[34,35],{"type":14,"name":52,"description":53,"armGroupLabels":54},"Monetary Incentive","up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)",[34],[56],{"measure":57,"description":58,"timeFrame":59},"Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day","The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng\u002Fml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD","26 weeks post-TQD",[61,64,68,72,75,77,80],{"measure":62,"description":63,"timeFrame":59},"Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day","salivary cotinine using a cut-off of less than 10 ng\u002Fml to indicate abstinence from any nicotine product (combusted cigarettes, e-cigarettes, nicotine replacement therapy \\[NRT\\])",{"measure":65,"description":66,"timeFrame":67},"Treatment Satisfaction","Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.","8 weeks post-TQD",{"measure":69,"description":70,"timeFrame":71},"Cigarettes per day","Cigarettes per day based on the past 7 days.","baseline, 8 and 26 weeks post-TQD",{"measure":73,"description":74,"timeFrame":71},"Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)","Scores range from 0 to 100 where higher scores indicate better quality of life.",{"measure":76,"timeFrame":71},"Money spent on cigarettes per week",{"measure":78,"description":79,"timeFrame":71},"Smoking Cessation Self-efficacy using a single 10-point Likert scale","Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy.",{"measure":81,"description":82,"timeFrame":71},"Psychological Distress measured by the 6-item Kessler screener (K6)","Total range of scores is from 0-24 where higher scores mean decreased psychological distress.","ALL","21 Years",null,{"inclusion":87,"exclusion":92,"raw_text":94},[88,89,90,91],"self-identify as Black","smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days\u002Fweek)","motivated to quit smoking","willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.",[93],"currently taking bupropion for non-smoking cessation reasons","Inclusion Criteria:\n\n* self-identify as Black\n* smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days\u002Fweek)\n* motivated to quit smoking\n* willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.\n\nExclusion Criteria:\n\n* currently taking bupropion for non-smoking cessation reasons",[96,97],"ADULT","OLDER_ADULT",[99,109,117,125,133],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"geoPoint":106},"Arizona State University","NOT_YET_RECRUITING","Phoenix","Arizona","85004","United States",{"lat":107,"lon":108},33.44838,-112.07404,{"facility":110,"status":101,"city":111,"state":112,"zip":113,"country":105,"geoPoint":114},"Indiana University","Indianapolis","Indiana","46202",{"lat":115,"lon":116},39.76838,-86.15804,{"facility":118,"status":101,"city":119,"state":120,"zip":121,"country":105,"geoPoint":122},"University of Kansas Medical Center Research Institute, Inc","Kansas City","Kansas","66160",{"lat":123,"lon":124},39.11417,-94.62746,{"facility":126,"status":101,"city":127,"state":128,"zip":129,"country":105,"geoPoint":130},"Virginia Commonwealth University","Richmond","Virginia","23298",{"lat":131,"lon":132},37.55376,-77.46026,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":105,"geoPoint":138},"UW School of Medicine and Public Health","Milwaukee","Wisconsin","53233",{"lat":139,"lon":140},43.0389,-87.90647,[142],{"name":143,"role":144,"phone":145,"email":146},"Megan Piper, PhD","CONTACT","608-265-5472","mep@ctri.wisc.edu",[148],{"name":143,"affiliation":134,"role":149},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":153,"biomarkers":154},[19],[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This interventional study plans to enroll 1550 participants. It compares three different treatment approaches to help people quit smoking.","completed","My Path to Quit Tobacco: Smoking Cessation Study for Black Adults","This study, called \"My Path to Quit Tobacco,\" is looking for Black adults who smoke cigarettes and want to quit. It compares different ways to help people stop smoking. You might receive a nicotine patch, phone counseling sessions, or video group counseling sessions. Some participants will also watch a video called \"Pathways to Freedom\" that helps with coping skills and triggers. The study wants to see which approach is most effective at helping people quit smoking for good. To join, you must self-identify as Black, smoke at least one cigarette on four or more days a week, and be motivated to quit. The main goal is to see if participants can stay smoke-free for 26 weeks after their target quit day.","The study will check if you are smoke-free 26 weeks after your target quit day.",121,"You would participate in counseling sessions, which could be phone calls or video group sessions. You would also use a nicotine patch.","You may receive up to $50 for completing counseling sessions.",[31,44,48],"v2"]