[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523626":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":57,"centralContacts":62,"locations":70,"responsibleParty":93,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":43,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":43,"enrollmentInfo":109,"targetDuration":43,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":43,"overallStatus":73,"whyStopped":43,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of Miami","OTHER",[8,14,20,24,28,33],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Group A: Tobacco Quit-line (TQL) Group","EXPERIMENTAL","Participants will be referred to the TQL and will be followed up for up to 12 months.",[13],"Behavioral: Tobacco Quit-line",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1 Group B: Brief Behavioral Counseling Group","Participants will receive one brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a referral to the TQL.\n\nFor the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply will be provided at the second follow-up.",[18,13,19],"Drug: Nicorette","Behavioral: Brief Behavioral Counseling",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 2 Group A: Second Tobacco Quit-line (TQL) Group","Participants from Group A who did not quit smoking at the 3-month follow-up may receive a second referral to the TQL and will be followed up for up to 12 months.",[13],{"label":25,"type":10,"description":26,"interventionNames":27},"Phase 2 Group B: Second Brief Behavioral Counseling Group","Participants from Group B who did not quit smoking at the 3-month follow-up may receive a second brief behavioral counseling session and two phone call follow-ups, then be followed up for 12 months. Besides the counseling session, they will be provided with Nicotine Replacement Therapy (NRT) and a second referral to the TQL.\n\nFor the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the second follow-up.",[18,13,19],{"label":29,"type":10,"description":30,"interventionNames":31},"Phase 2 Group A + C: TQL and Intensive Behavioral Counseling Group","Participants from Phase 1 Group A who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.\n\nFor the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.",[18,13,32],"Behavioral: Intensive Behavioral Counseling",{"label":34,"type":10,"description":35,"interventionNames":36},"Phase 2 Group B + C: Brief Counseling and Intensive Behavioral Counseling Group","Participants from Phase 1 Group B who did not quit smoking at the 3-month follow-up may receive four behavioral counseling sessions, two phone-call follow-ups, and Nicotine Replacement Therapy (NRT) and be followed up for 12 months.\n\nFor the NRT, participants will receive one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked), as well as 8 additional gums for a total of 168 gums during the first counseling session. This amount is enough for 3 weeks. An additional 3-week supply is provided at the fourth session.",[18,13,19,32],[38,44,49,53],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DRUG","Nicorette","Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed\n\nNRT will be distributed based on the treatment condition.",[15,29,34,25],null,{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":43},"BEHAVIORAL","Tobacco Quit-line","The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.",[9,15,29,21,34,25],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":43},"Brief Behavioral Counseling","The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the \"5A's\" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.",[15,34,25],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":43},"Intensive Behavioral Counseling","Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.",[29,34],[58],{"name":59,"affiliation":60,"role":61},"Taghrid Asfar, MD","tasfar@miami.edu","PRINCIPAL_INVESTIGATOR",[63,66],{"name":59,"role":64,"phone":65,"phoneExt":43,"email":60},"CONTACT","305-243-3826",{"name":67,"role":64,"phone":68,"phoneExt":43,"email":69},"Roxana de Dios Despaux, MPH","786-317-7927","rad317@miami.edu",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Don Soffer Clinical Research Center","RECRUITING","Miami","Florida","33136","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-80.19366,25.77427,{"lat":83,"lon":82},[86,88,92],{"name":87,"role":64,"phone":68,"phoneExt":43,"email":69},"Roxana De Dios Despaux, MPH",{"name":89,"role":64,"phone":90,"phoneExt":43,"email":91},"Daniela Avendano, MS","305-915-0061","dxa1356@miami.edu",{"name":59,"role":61,"phone":43,"phoneExt":43,"email":43},{"type":61,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Taghrid Asfar","Professor",[97],{"name":98,"class":99},"Florida Department of Health","OTHER_GOV","100523626","phase-4-smoking-cessation-program-in-the-construction-sector-100523626",false,"NCT06098144","Smoking Cessation Program in the Construction Sector","Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector","Inclusion Criteria:\n\nCompany leaders:\n\n* ≥ 18 years\n* Involved in decision making\n* Willing to participate in the implementation development and evaluation\n\nSafety Managers:\n\n\\- ≥ 18 years Self-identified as a safety manager or superintendent Have no plans to leave the company in the next year Speak either English or Spanish Non-cigarette smoker Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers\n\nConstruction Workers:\n\n* Be a construction worker\n* ≥ 18 years\n* Have smoked on average 5 or more cigarettes daily for the past year\n* Willing to make a serious quit attempt in the next 30 days\n* Willing to receive treatment from the Florida Tobacco Quitline.\n* Planning to stay in the company for the next 6 months\n* Own a telephone and plan to keep it active for the next 12 months\n\nExclusion Criteria:\n\nSafety Managers:\n\n\\- Current cigarette smoker","ALL","18 Years",{"count":110,"type":111},608,"ESTIMATED","INTERVENTIONAL",[114],"PHASE4","The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.",[117,118,119],"Smoking Cessation","Tobacco Use Cessation","Tobacco Smoking","2025-08-26",{"date":122,"type":123},"2025-09-03","ACTUAL",{"date":125,"type":123},"2024-04-10",{"date":127,"type":111},"2027-02-28",{"name":5,"class":6},1]