[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685899":3,"trial-entities:NCT07685899":109,"trial-summary:NCT07685899":112},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":81,"locations":84,"central_contacts":99,"overall_officials":106,"references":107,"see_also_links":108},"NCT07685899","DA055779-2","Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial","NOT_YET_RECRUITING","2027-05-30","2026-06","2026-07-06","2026-08-20","University of Kansas Medical Center","OTHER",true,"Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem we will recruit 40 patients for a pilot 2-arm effectiveness trial. We will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.","Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.\n\nThe goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive \"CounsCM\" for engaging in five quitline calls and \"MedCM\" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.",[18],"Smoking Cessation",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},40,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Health Rewards","All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM).",[33],"CounsCM+MedCM",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Control","All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.",[35],[39,43,47],{"measure":40,"description":41,"timeFrame":42},"Feasibility outcomes","Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.","Week 3 to 12",{"measure":44,"description":45,"timeFrame":46},"Proportion of quitline calls completed","Completion of the five quitline calls according to Kansas quitline reports","Week 12",{"measure":48,"description":49,"timeFrame":46},"Proportion of varenicline pills taken","Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting",[51,54],{"measure":52,"description":53,"timeFrame":46},"Proportion of patients with biochemically verified smoking abstinence","Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng\u002Fml",{"measure":55,"description":56,"timeFrame":46},"Proportion of patients with self-reported smoking abstinence","Past 7 days self-reported smoking abstinence","ALL","18 Years",null,false,{"inclusion":62,"exclusion":75,"raw_text":80},[63,64,65,66,67,68,69,70,71,72,73,74],"Smoked in the past 30 days","Smoke at least 1 cigarette per day when they smoke","≥ 18 years old","Kansas resident","Speak\u002Fread English","Access to a mobile phone","Mobile phone receives text messages","No varenicline contraindications (no acute renal impairment)","Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)","Cognitively able to participate","Physically able to participate","Not pregnant\u002Fbreastfeeding",[76,77,78,79],"Medically ineligible for varenicline","Patient on smoking cessation medication within 2 weeks of admission date","Patient already talked to quitline in the past 2 weeks.","Patients participating in other quit smoking program or research study","Inclusion Criteria:\n\n* Smoked in the past 30 days\n* Smoke at least 1 cigarette per day when they smoke\n* ≥ 18 years old\n* Kansas resident\n* Speak\u002Fread English\n* Access to a mobile phone\n* Mobile phone receives text messages\n* No varenicline contraindications (no acute renal impairment)\n* Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)\n* Cognitively able to participate\n* Physically able to participate\n* Not pregnant\u002Fbreastfeeding\n\nExclusion Criteria:\n\n* Medically ineligible for varenicline\n* Patient on smoking cessation medication within 2 weeks of admission date\n* Patient already talked to quitline in the past 2 weeks.\n* Patients participating in other quit smoking program or research study",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":12,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"Kansas City","Kansas","66103","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Erica Cruvinel","CONTACT","913-526-0774","ecruvinel@kumc.edu",{"lat":97,"lon":98},39.11417,-94.62746,[100,102],{"name":92,"role":93,"phone":101,"email":95},"913-945-6966",{"name":103,"role":93,"phone":104,"email":105},"Vinita Devarasetty, MPH","913-617-1018","v210d808@kumc.edu",[],[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[18],[],{"nct_id":4,"found":14,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is a pilot interventional study with 40 participants. It is a randomized clinical trial, meaning participants will be assigned by chance to either the Health Rewards group or the Control group.","completed","Contingency Management for Smoking Cessation","This study is testing a new way to help people quit smoking by encouraging them to use a medication called varenicline and participate in counseling. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. Some participants will also receive \"Health Rewards\" (Contingency Management), which means they could earn financial incentives for taking their medication and attending counseling sessions. We are looking for 40 adults, aged 18 or older, who live in Kansas, smoke at least one cigarette a day, and can read English and use a mobile phone for text messages. The main goal is to see if this approach is practical and acceptable, and to measure how many quitline calls are completed and how much varenicline is taken over 12 weeks. The study status is currently unclear.","The study will measure outcomes at Week 3 and Week 12, focusing on the proportion of quitline calls completed and varenicline pills taken.",134,"Participants will receive 12 weeks of varenicline and referrals to a state tobacco quitline. The study will measure how many quitline calls are completed and how much varenicline is taken over 12 weeks.","Participants in the Health Rewards group will receive financial incentives for taking medication and attending counseling sessions. Payments will be automated and dispensed daily using a reloadable debit card.",[30],"v2"]