[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598752":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":43,"locations":52,"responsibleParty":69,"collaborators":29,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":29,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":29,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":98,"whyStopped":29,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Hawaii","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"NRT Gum Only","EXPERIMENTAL","Participants receive nicotine gum (2 mg) according to a 12-week FDA-approved tapering schedule. No counseling is provided.",[13],"Drug: Nicotine Polacrilex Gum (2 mg)",{"label":15,"type":10,"description":16,"interventionNames":17},"CBGT Only","Participants attend six weekly sessions of cognitive-behavioral group therapy (CBGT) for smoking cessation. No nicotine gum is provided.",[18],"Behavioral: Cognitive Behavioral Group Therapy (CBGT)",{"label":20,"type":10,"description":21,"interventionNames":22},"CBGT + NRT Gum","Participants receive both nicotine gum (2 mg, tapered over 12 weeks) and attend six weekly CBGT sessions for smoking cessation.",[13,18],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Nicotine Polacrilex Gum (2 mg)","Participants chew 2 mg nicotine gum according to a tapering 12-week schedule: Weeks 1-6: 1 piece every 1-2 hours; at least 9 pieces\u002Fday; Weeks 7-9: 1 piece every 2-4 hours; Weeks 10-12: 1 piece every 4-8 hours. Max 24 pieces\u002Fday. Gum is distributed every 2 weeks during study visits.\n\nArm(s) Used In:\n\nNRT Gum Only CBGT + NRT Gum",[20,9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"BEHAVIORAL","Cognitive Behavioral Group Therapy (CBGT)","Participants attend six sessions of group-based cognitive behavioral therapy focused on smoking cessation, over the 12-week study period. Sessions include education on cravings, relapse prevention, stress management, and self-efficacy building.\n\nArm(s) Used In:\n\nCBGT Only CBGT + NRT Gum",[20,15],[36,40],{"name":37,"affiliation":38,"role":39},"Crissy T Kawamoto","University of Hawai'i Cancer Center","STUDY_DIRECTOR",{"name":41,"affiliation":38,"role":42},"Pallav Pokhrel, PhD, MPH","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":29,"email":47},"CONTACT","808-441-7711","ppokhrel@cc.hawaii.edu",{"name":49,"role":45,"phone":50,"phoneExt":29,"email":51},"Yoko Takahashi, MD","8086926501","ytakahashi@cc.hawaii.edu",[53],{"facility":54,"status":29,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"University of Hawai'i","Honolulu","Hawaii","96813","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-157.85833,21.30694,{"lat":64,"lon":63},[67],{"name":41,"role":45,"phone":68,"phoneExt":29,"email":47},"8084417711",{"type":70,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100598752","quit-smoking-study-for-native-hawaiians-100598752",false,"NCT07075575","Quit-Smoking Study for Native Hawaiians","Smoking Cessation Among Native Hawaiians: A Test of Pharmacotherapies and Group-Based Counseling","Inclusion Criteria:\n\n* Self-identifies as full or part Native Hawaiian\n* Between the ages of 18 and 80 years, inclusive, at eligibility screening\n* Currently smoking ≥5 cigarettes per day (self-report) at eligibility screening\n* Has smoked more than 100 cigarettes in his\u002Fher lifetime (self-report)\n* Affiliated with one of three (3) designated public housing complexes at which the intervention will be delivered: Kalihi Valley Homes, Kuhio Park Terrace, Mayor Wright Housing\n* Willing to make a smoking cessation attempt the day after the first study visit (i.e., date of consent)\n* Willing to engage in use of nicotine replacement therapy gum (NRT gum) and\u002For smoking cessation-focused cognitive-behavioral group therapy (CBGT)\n* Participant must agree to not use any form of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking during the 12-week study period, except as specifically assigned to his or her study condition and distributed by the research team\n* Participant must agree to not use other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) during the 12-week study period\n* Participant must agree to not smoke or vape cannabis (i.e., marijuana) during the 12- week study period\n* Participant must agree to not use other illicit drugs, including prescription opioid medications, during the 12-week study period\n* Participant must be able to speak, read, and write English\n* Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing, or planning to become pregnant or breastfeed in the next three (3) months\n* Use of pharmacotherapy (i.e., prescription medication or any form of nicotine replacement therapy) to try to quit smoking in the 30 days prior to eligibility screening\n* Use of other tobacco or nicotine products (e.g., cigars, little cigars, electronic cigarettes, nicotine pouches) in the 30 days prior to eligibility screening\n* Use of smoked or vaped cannabis (i.e., marijuana) in the 30 days prior to eligibility screening\n* Use of other illicit drugs, including prescription opioid medications, in the 30 days prior to eligibility screening","ALL","18 Years","80 Years",{"count":82,"type":83},75,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling. Participants will be assigned to one of three groups: (1) nicotine gum only, (2) group counseling only, or (3) a combination of both. The study will take place at public housing sites on O'ahu. Researchers will check if these approaches-alone or in combination-can support people in successfully quitting smoking. The goal is to find out which method works best and is most acceptable in this community.",[89,90],"Tobacco Use Disorder","Smoking Cessation",[92,93,94,95,96,97],"Native Hawaiian","Smoking cessation","Nicotine replacement therapy","Nicotine gum","Cigarette Smoking","Tobacco Dependence","NOT_YET_RECRUITING","2026-03-29",{"date":101,"type":102},"2026-03-31","ACTUAL",{"date":104,"type":83},"2026-04-01",{"date":106,"type":83},"2028-04-01",{"name":5,"class":6},1]