{"protocolSection":{"identificationModule":{"nctId":"NCT03897439","orgStudyIdInfo":{"id":"Study0000142310"},"secondaryIdInfos":[{"id":"R01DA046576","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA046576"}],"organization":{"fullName":"University of Kansas Medical Center","class":"OTHER"},"briefTitle":"Individualizing Pharmacotherapy for African American Smokers","officialTitle":"Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community"},"statusModule":{"statusVerifiedDate":"2023-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-05-01","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2021-11-30","type":"ACTUAL"},"completionDateStruct":{"date":"2022-01-30","type":"ACTUAL"},"studyFirstSubmitDate":"2019-03-25","studyFirstSubmitQcDate":"2019-03-28","studyFirstPostDateStruct":{"date":"2019-04-01","type":"ACTUAL"},"resultsFirstSubmitDate":"2023-01-31","resultsFirstSubmitQcDate":"2023-03-07","resultsFirstPostDateStruct":{"date":"2023-04-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-03-07","lastUpdatePostDateStruct":{"date":"2023-04-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Nikki Nollen, PhD, MA","investigatorTitle":"Associate Professor","investigatorAffiliation":"University of Kansas Medical Center"},"leadSponsor":{"name":"University of Kansas Medical Center","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.","detailedDescription":"The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \\[varenicline (VAR), bupropion (BUP) plus NP, \\] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12."},"conditionsModule":{"conditions":["Smoking Cessation"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations \\[varenicline (VAR), bupropion (BUP) plus NP\\] based on verified smoking status at Weeks 2 and 6.\n\nAfrican American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":392,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Usual Care (UC)","type":"ACTIVE_COMPARATOR","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.","interventionNames":["Drug: Nicotine patch"]},{"label":"Optimized Care (OPT)","type":"EXPERIMENTAL","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.","interventionNames":["Drug: Nicotine patch","Drug: Varenicline Tartrate","Drug: Bupropion"]}],"interventions":[{"type":"DRUG","name":"Nicotine patch","description":"Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.","armGroupLabels":["Optimized Care (OPT)","Usual Care (UC)"],"otherNames":["Nicoderm"]},{"type":"DRUG","name":"Varenicline Tartrate","description":"VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.","armGroupLabels":["Optimized Care (OPT)"],"otherNames":["Chantix"]},{"type":"DRUG","name":"Bupropion","description":"BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.","armGroupLabels":["Optimized Care (OPT)"],"otherNames":["Zyban","Wellbutrin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 12","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.","timeFrame":"Week 12"}],"secondaryOutcomes":[{"measure":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 18","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers","timeFrame":"Week 18"},{"measure":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 26","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers","timeFrame":"Week 26"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Non-Hispanic African American\n* ≥ 18 years of age\n* Smoke 5-30 cigarettes per day (CPD)\n* Daily cigarette smoker\n* Smoked at current rate for \\> 6 months\n* Verified smoker (CO \\> 5 ppm)\n* Functioning telephone\n* Interested in quitting smoking\n* Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits\n\nExclusion Criteria:\n\n* Use of non-cigarette tobacco products in past 30 days\n* Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year\n* Use of pharmacotherapy in the month prior to enrollment\n* Pregnant, contemplating getting pregnant, or breastfeeding\n* Unstable housing (e.g., street, shelter)\n* Plans to move from Kansas City during the treatment and follow-up phase\n* Another household member enrolled in the study","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Nicole Nollen, PhD","affiliation":"University of Kansas Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Swope Health Central","city":"Kansas City","state":"Missouri","zip":"64130","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}}]},"referencesModule":{"references":[{"pmid":"39976595","type":"DERIVED","citation":"Lambart LM, Cox LS, Mayo MS, Brown AR, Leavens ELS, Ahluwalia JS, Nollen NL. Change in Cigarette, Other Tobacco Product, and Cannabis Use Among Individuals Who Used or Did Not Use Cannabis During a Smoking Cessation Trial. Nicotine Tob Res. 2025 Aug 22;27(9):1641-1646. doi: 10.1093/ntr/ntaf045."},{"pmid":"37338906","type":"DERIVED","citation":"Nollen NL, Ahluwalia JS, Mayo MS, Ellerbeck EF, Leavens ELS, Salzman G, Shanks D, Woodward J, Greiner KA, Cox LS. Multiple Pharmacotherapy Adaptations for Smoking Cessation Based on Treatment Response in Black Adults Who Smoke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317895. doi: 10.1001/jamanetworkopen.2023.17895."},{"pmid":"36387983","type":"DERIVED","citation":"Nollen NL, Cox LS, Mayo MS, Ellerbeck EF, Arnold MJ, Salzman G, Shanks D, Woodward J, Greiner KA, Ahluwalia JS. Protocol from a randomized clinical trial of multiple pharmacotherapy adaptations based on treatment response in African Americans who smoke. Contemp Clin Trials Commun. 2022 Nov 5;30:101032. doi: 10.1016/j.conctc.2022.101032. eCollection 2022 Dec."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Usual Care (UC)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"FG001","title":"Optimized Care (OPT)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.\n\nVarenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.\n\nBupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment."}],"periods":[{"title":"Randomization (Week 0)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"196"}]},{"type":"Started on Nicotine Patch","achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"196"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"196"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Optimization Point 1 (Week 2)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"9 participants were lost to follow-up between period 1 and 2","numSubjects":"187"},{"groupId":"FG001","comment":"9 participants were lost to follow-up between period 1 and period 2","numSubjects":"187"}]},{"type":"Stayed on Nicotine Patch","achievements":[{"groupId":"FG000","numSubjects":"187"},{"groupId":"FG001","numSubjects":"61"}]},{"type":"Adapted to VAR","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"126"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"187"},{"groupId":"FG001","numSubjects":"187"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Optimization Point 2 (Week 6)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"9 participants were lost to follow-up between period 2 and period 3.","numSubjects":"178"},{"groupId":"FG001","comment":"14 participants were lost to follow-up between period 2 and period 3.","numSubjects":"173"}]},{"type":"Stayed on Nicotine Patch","achievements":[{"groupId":"FG000","numSubjects":"178"},{"groupId":"FG001","numSubjects":"52"}]},{"type":"Stayed on VAR","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"Adapted to Varenicline","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"}]},{"type":"Adapted to BUP + Nicotine Patch","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"87"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"178"},{"groupId":"FG001","numSubjects":"173"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Primary Endpoint (Week 12)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"4 participants were lost to follow-up between period 3 and period 4.","numSubjects":"174"},{"groupId":"FG001","comment":"8 participants were lost to follow-up between period 3 and period 4.","numSubjects":"165"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"174"},{"groupId":"FG001","numSubjects":"165"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"End of Treatment (Week 18)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"4 participants were lost to follow-up between period 4 and period 5.","numSubjects":"170"},{"groupId":"FG001","comment":"2 participants were lost to follow-up between period 4 and period 5.","numSubjects":"163"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"170"},{"groupId":"FG001","numSubjects":"163"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"End of Study (Week 26)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"8 participants were lost to follow-up between period 5 and period 6.","numSubjects":"162"},{"groupId":"FG001","comment":"1 participant was lost to follow-up between period 5 and period 6.","numSubjects":"162"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"162"},{"groupId":"FG001","numSubjects":"162"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Usual Care","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"BG001","title":"Optimized Care","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"392"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53.0","spread":"11.5"},{"groupId":"BG001","value":"52.3","spread":"11.7"},{"groupId":"BG002","value":"52.6","spread":"11.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"110"},{"groupId":"BG001","value":"114"},{"groupId":"BG002","value":"224"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"168"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"392"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"392"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"196"},{"groupId":"BG002","value":"392"}]}]}]},{"title":"Cohabitation Status; Married/Living with partner","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"116"}]}]}]},{"title":"Employment Status; Not currently employed","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"124"},{"groupId":"BG002","value":"231"}]}]}]},{"title":"Education Level; some college or technical school","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"101"},{"groupId":"BG002","value":"187"}]}]}]},{"title":"Has Health Insurance","description":"Do you have health insurance that pays for most of your medical care (yes, no)?","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"124"},{"groupId":"BG002","value":"262"}]}]}]},{"title":"% with a Federal Poverty Level <=100%","description":"Federal poverty level is determined by a combination of total income and number of people in the household. Thresholds are defined annually by HHS.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"87"},{"groupId":"BG001","value":"99"},{"groupId":"BG002","value":"186"}]}]}]},{"title":"Housing; Own a home","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"65"}]}]}]},{"title":"Cigarettes per day in the past 7 days","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes per day","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13.3","spread":"7.3"},{"groupId":"BG001","value":"12.2","spread":"6.9"},{"groupId":"BG002","value":"12.8","spread":"7.1"}]}]}]},{"title":"Menthol smoker","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"172"},{"groupId":"BG001","value":"173"},{"groupId":"BG002","value":"345"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 12","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.","populationDescription":"Intent to treat with missing treated as smokers","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Usual Care (UC)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"OG001","title":"Optimized Care (OPT)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.\n\nVarenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.\n\nBupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"196"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"34"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 18","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 18 visit. This will evaluate the end-of-treatment efficacy of optimized pharmacotherapy for smoking cessation in African American smokers","populationDescription":"Intent to treat with missing treated as smokers","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 18","groups":[{"id":"OG000","title":"Usual Care (UC)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"OG001","title":"Optimized Care (OPT)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.\n\nVarenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.\n\nBupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"196"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Biochemically Verified Smoking Abstinence at Week 26","description":"Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 26 visit. This will evaluate the long-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers","populationDescription":"Intent to treat with missing treated as smokers.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 26","groups":[{"id":"OG000","title":"Usual Care (UC)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment."},{"id":"OG001","title":"Optimized Care (OPT)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.\n\nVarenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.\n\nBupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"196"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"24"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse event data was collected through Week 18.","description":"Adverse event data was collected at each follow-up timepoint with a series of global side effect questions and a prompt to report an adverse events. Events are reported by group, overall (OPT, UC) , and not per intervention within group (e.g., optimized care: NP, optimized care: VAR, optimized care: BUP + NP) because many participants in OPT received all interventions and it is not possible to separate the adverse events they experienced during each of the interventions they received.","eventGroups":[{"id":"EG000","title":"Usual Care (UC)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.","deathsNumAffected":0,"deathsNumAtRisk":196,"seriousNumAffected":0,"seriousNumAtRisk":196,"otherNumAffected":25,"otherNumAtRisk":196},{"id":"EG001","title":"Optimized Care (OPT)","description":"196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.\n\nNicotine patch: Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.\n\nVarenicline Tartrate: VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.\n\nBupropion: BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.","deathsNumAffected":0,"deathsNumAtRisk":196,"seriousNumAffected":0,"seriousNumAtRisk":196,"otherNumAffected":19,"otherNumAtRisk":196}],"otherEvents":[{"term":"Redness/swelling/rash on the skin","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":196},{"groupId":"EG001","numAffected":19,"numAtRisk":196}]},{"term":"Sleeping Problems","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":196},{"groupId":"EG001","numAffected":14,"numAtRisk":196}]},{"term":"Nausea or Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":196},{"groupId":"EG001","numAffected":14,"numAtRisk":196}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Nicole Nollen","organization":"University of Kanas Medical Center","email":"nnollen@kumc.edu","phone":"913-588-3784"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2020-03-23","uploadDate":"2023-01-30T18:36","filename":"Prot_SAP_000.pdf","size":555511},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2022-02-03","uploadDate":"2023-01-30T18:37","filename":"ICF_001.pdf","size":360176}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","submissionTracking":{"firstMcpInfo":{"postDateStruct":{"date":"2023-02-28","type":"ACTUAL"}}}},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D061485","term":"Tobacco Use Cessation Devices"},{"id":"D009538","term":"Nicotine"},{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D013812","term":"Therapeutics"},{"id":"D012991","term":"Solanaceous Alkaloids"},{"id":"D000470","term":"Alkaloids"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011725","term":"Pyridines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}