{"protocolSection":{"identificationModule":{"nctId":"NCT00666978","orgStudyIdInfo":{"id":"10332"},"secondaryIdInfos":[{"id":"R01CA091912","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01CA091912"},{"id":"KUMC-HSC-10332"},{"id":"KUMC-070313"}],"organization":{"fullName":"University of Kansas Medical Center","class":"OTHER"},"briefTitle":"Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking","officialTitle":"Enhancing Tobacco Use Treatment for African American Light Smokers"},"statusModule":{"statusVerifiedDate":"2017-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2007-12"},"primaryCompletionDateStruct":{"date":"2010-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-06","type":"ACTUAL"},"studyFirstSubmitDate":"2008-04-24","studyFirstSubmitQcDate":"2008-04-24","studyFirstPostDateStruct":{"date":"2008-04-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-04-17","resultsFirstSubmitQcDate":"2017-06-23","resultsFirstPostDateStruct":{"date":"2017-07-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-10-11","lastUpdatePostDateStruct":{"date":"2017-11-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Lisa Sanderson Cox, PhD","investigatorTitle":"Research Assistant Professor","investigatorAffiliation":"University of Kansas Medical Center"},"leadSponsor":{"name":"Lisa Sanderson Cox, PhD","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"RATIONALE: A stop-smoking plan that includes health education counseling and bupropion may help African-American smokers stop smoking. It is not yet known whether health education counseling is more effective with or without bupropion in helping African Americans stop smoking.\n\nPURPOSE: This clinical trial is studying health education counseling and bupropion to see how well they work compared with a placebo and health education counseling in helping African Americans smokers stop smoking.","detailedDescription":"OBJECTIVES:\n\nPrimary\n\n* To evaluate the efficacy of bupropion hydrochloride and health education counseling vs placebo and health education counseling for smoking cessation among African Americans who are light smokers.\n\nSecondary\n\n* To characterize CYP2A6 activity in African Americans who are light smokers by evaluating phenotype (3'hydroxycotinine/cotinine ratio \\[3HC/COT\\]) and CYP2A6 genotype.\n* To evaluate the relationship between CYP2A6 activity and smoking cessation outcomes.\n* To evaluate CYP2A6 genetic polymorphisms associated with nicotine and cotinine metabolism in African Americans who are light smokers.\n* To measure baseline cotinine and metabolite levels to evaluate the nicotine metabolism phenotype of 3HC/COT.\n* To evaluate the relationship between nicotine metabolism phenotype of 3HC/COT and smoking cessation outcomes.\n* To evaluate CYP2A6 genotype as a predictor of smoking cessation outcomes.\n\nTertiary\n\n* To characterize CYP2B6 activity in African Americans who are light smokers by evaluating phenotype and CYP2B6 genotype.\n* To evaluate the relationship between CYP2B6 activity and smoking cessation outcomes.\n* To measure steady state bupropion hydrochloride and metabolite levels to identify a bupropion metabolism phenotype.\n* To evaluate the relationship between bupropion hydrochloride metabolism phenotype and smoking cessation outcomes.\n* To evaluate the relationship between CYP2B6 genetic polymorphisms (genotype) and blood levels of bupropion hydrochloride and active metabolites (phenotype).\n* To determine the effects of CYP2B6 genotype as predictors of smoking cessation outcomes.\n\nOUTLINE: Participants are randomized to one of two arms.\n\n* Arm I: Participants receive oral bupropion hydrochloride once or twice daily in weeks 0-6. Participants also undergo 6 sessions of health education counseling conducted in person during clinic visits in weeks 0, 3, and 7 and via telephone in weeks 1, 5, and 16. The health education counseling sessions include providing information about the risks of continued smoking and the benefits of quitting, developing a quit plan, outlining a concrete quit day preparation plan, discussing strategies for successful quitting, building social support, reducing stress, recognizing and managing withdrawal and craving, overcoming barriers to abstinence, and using medication for smoking cessation. Participants receive Kick It at Swope: Stop Smoking Guide, a culturally-sensitive smoking cessation guide, to review with their study counselor during the first counseling session.\n* Arm II: Participants receive an oral placebo once or twice daily in weeks 0-6. Participants also undergo health education counseling as in arm I.\n\nParticipants complete baseline questionnaires about demographics, smoking history, and psychometrics, including the following: racial identity, depressive symptoms, alcohol use, stress, smoking consequences, social support, environmental influences of smoking, adherence to study medication, nicotine withdrawal, craving, and mood.\n\nParticipants undergo serum sample collection in weeks 0 and 3. To standardize the time since the last cigarette, participants are asked to smoke one cigarette prior to serum sample collection in week 0. Samples are analyzed for nicotine metabolism phenotype and bupropion hydrochloride metabolism phenotype by liquid chromatography and mass spectrometry and CYP2A6 and CYP2B6 genotype by polymerase chain reaction and polymorphism analysis. Participants who self-report abstinence also undergo saliva sample collection in weeks 7 and 26 to measure cotinine levels to verify smoking status.\n\nAfter completion of study intervention, participants are followed at 6 months."},"conditionsModule":{"conditions":["Bladder Cancer","Cervical Cancer","Esophageal Cancer","Gastric Cancer","Head and Neck Cancer","Kidney Cancer","Leukemia","Liver Cancer","Lung Cancer","Pancreatic Cancer","Tobacco Use Disorder"],"keywords":["bladder cancer","cervical cancer","esophageal cancer","gastric cancer","renal cell carcinoma","adult primary liver cancer","non-small cell lung cancer","small cell lung cancer","pancreatic cancer","hypopharyngeal cancer","laryngeal cancer","lip and oral cavity cancer","nasopharyngeal cancer","oropharyngeal cancer","paranasal sinus and nasal cavity cancer","adult acute myeloid leukemia","tobacco use disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":540,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion Arm","type":"EXPERIMENTAL","description":"Subjects undergo smoking cessation intervention and take bupropion.","interventionNames":["Behavioral: smoking cessation intervention","Drug: bupropion hydrochloride","Genetic: gene expression analysis","Genetic: polymerase chain reaction","Other: counseling intervention","Other: educational intervention","Procedure: psychosocial assessment and care"]},{"label":"Health Education Arm","type":"PLACEBO_COMPARATOR","description":"Subjects receive counseling intervention and take placebo.","interventionNames":["Behavioral: smoking cessation intervention","Genetic: gene expression analysis","Genetic: polymerase chain reaction","Other: counseling intervention","Other: educational intervention","Procedure: psychosocial assessment and care"]}],"interventions":[{"type":"BEHAVIORAL","name":"smoking cessation intervention","armGroupLabels":["Bupropion Arm","Health Education Arm"]},{"type":"DRUG","name":"bupropion hydrochloride","armGroupLabels":["Bupropion Arm"]},{"type":"GENETIC","name":"gene expression analysis","armGroupLabels":["Bupropion Arm","Health Education Arm"]},{"type":"GENETIC","name":"polymerase chain reaction","armGroupLabels":["Bupropion Arm","Health Education Arm"]},{"type":"OTHER","name":"counseling intervention","armGroupLabels":["Bupropion Arm","Health Education Arm"]},{"type":"OTHER","name":"educational intervention","armGroupLabels":["Bupropion Arm","Health Education Arm"]},{"type":"PROCEDURE","name":"psychosocial assessment and care","armGroupLabels":["Bupropion Arm","Health Education Arm"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months","description":"Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Number of Slow and Fast Metabolizers by Metabolite Ratio","description":"Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.\n\nThe variants present in people in the slow genotype group include \\*17, \\*20, \\*23,\\*27, \\*35, \\*9, \\*2, \\*25, \\*26, and \\*4. The fast metabolizers have none of the variant alleles tested.\n\nBlood samples were collected for 3HC/COT ratio at Week 0.","timeFrame":"Weeks 0"},{"measure":"Number of Participants for Each CYP2B6 Allele","description":"We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.","timeFrame":"Week 3"},{"measure":"Number of Slow and Fast Metabolizers by Genotype","description":"Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include \\*17, \\*20, \\*23,\\*27, \\*35, \\*9, \\*2, \\*25, \\*26, and \\*4. The fast metabolizers have none of the variant alleles tested.\n\nSlow metabolizers have any reduction or loss of function variant. Fast metabolizers are \\*1/\\*1 genotype by exclusion.","timeFrame":"Week 0"}]},"eligibilityModule":{"eligibilityCriteria":"DISEASE CHARACTERISTICS:\n\n* African American who has smoked ≤ 10 cigarettes per day for ≥ 2 years AND has smoked for ≥ 25 days within the past month\n\n  * Not a heavy smoker\n  * No other forms of tobacco within the past 30 days\n* Must be interested in stopping smoking\n* No other smoker in the household enrolled in this study\n\nPATIENT CHARACTERISTICS:\n\n* Has a home address and a functioning telephone number\n* Not planning to move from the Kansas City metro area within the next 12 months\n* Not pregnant or nursing\n* Negative pregnancy test\n* No alcohol or substance abuse within the past year\n* Not currently drinking ≥ 14 alcoholic drinks per week\n* No binge drinking (5 or more drinks on one occasion) on at least two occasions within the past month\n* No history of seizures or head trauma\n* No history of bulimia or anorexia nervosa\n* No myocardial infarction within the past 30 days\n* No reported use of opiates, cocaine, or stimulants\n* No diabetes requiring oral hypoglycemics or insulin\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 30 days since prior nicotine replacement therapy, fluoxetine, clonidine, buspirone, or doxepin\n* No other concurrent medication that contains bupropion hydrochloride\n* No concurrent psychoactive medications","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lisa S. Cox, PhD","affiliation":"University of Kansas","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center","city":"Kansas City","state":"Kansas","zip":"66160-7357","country":"United States","geoPoint":{"lat":39.11417,"lon":-94.62746}},{"facility":"Swope Health Central","city":"Kansas City","state":"Missouri","zip":"64130","country":"United States","geoPoint":{"lat":39.09973,"lon":-94.57857}}]},"referencesModule":{"references":[{"pmid":"37230961","type":"DERIVED","citation":"Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6."},{"pmid":"34791718","type":"DERIVED","citation":"Chenoweth MJ, Peng AR, Zhu AZX, Cox LS, Nollen NL, Ahluwalia JS, Benowitz NL, Knight J, Swardfager W, Tyndale RF. Does sex alter the relationship between CYP2B6 variation, hydroxybupropion concentration and bupropion-aided smoking cessation in African Americans? A moderated mediation analysis. Addiction. 2022 Jun;117(6):1715-1724. doi: 10.1111/add.15742. Epub 2021 Dec 3."},{"pmid":"34611902","type":"DERIVED","citation":"Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4."},{"pmid":"33300144","type":"DERIVED","citation":"El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1."},{"pmid":"23733379","type":"DERIVED","citation":"Nollen NL, Mayo MS, Ahluwalia JS, Tyndale RF, Benowitz NL, Faseru B, Buchanan TS, Cox LS. Factors associated with discontinuation of bupropion and counseling among African American light smokers in a randomized clinical trial. Ann Behav Med. 2013 Dec;46(3):336-48. doi: 10.1007/s12160-013-9510-x."},{"pmid":"22241828","type":"DERIVED","citation":"Clausius RL, Krebill R, Mayo MS, Bronars C, Martin L, Ahluwalia JS, Cox LS. Evaluation of the brief questionnaire of smoking urges in Black light smokers. Nicotine Tob Res. 2012 Sep;14(9):1110-4. doi: 10.1093/ntr/ntr267. Epub 2012 Jan 12."},{"pmid":"21775497","type":"DERIVED","citation":"Berg CJ, Cox LS, Choi WS, Mayo MS, Krebill R, Bronars CA, Ahluwalia JS. Assessment of depression among African American light smokers. J Health Psychol. 2012 Mar;17(2):197-206. doi: 10.1177/1359105311414953. Epub 2011 Jul 20."},{"pmid":"21266057","type":"DERIVED","citation":"Cox LS, Faseru B, Mayo MS, Krebill R, Snow TS, Bronars CA, Nollen NL, Choi WS, Okuyemi KS, Salzman GA, Benowitz NL, Tyndale RF, Ahluwalia JS. Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data. Trials. 2011 Jan 25;12:22. doi: 10.1186/1745-6215-12-22."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Bupropion Arm","description":"270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling."},{"id":"FG001","title":"Placebo Arm","description":"270 African American adults received placebo for 7 weeks in addition to health education counseling."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"270"},{"groupId":"FG001","numSubjects":"270"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"192"},{"groupId":"FG001","numSubjects":"187"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"83"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion Arm","description":"270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling."},{"id":"BG001","title":"Placebo Arm","description":"270 African American adults received placebo for 7 weeks in addition to health education counseling."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"46.8","spread":"11.1"},{"groupId":"BG001","value":"46.2","spread":"11.5"},{"groupId":"BG002","value":"46.5","spread":"11.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"174"},{"groupId":"BG001","value":"183"},{"groupId":"BG002","value":"357"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"183"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"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":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]},{"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","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}]}]},{"title":"Married or living with partner","populationDescription":"One participant refused the question.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"91"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"166"}]}]}]},{"title":"Monthly family income <$1800","populationDescription":"6 participants refused the question.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"267"},{"groupId":"BG001","value":"267"},{"groupId":"BG002","value":"534"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"169"},{"groupId":"BG001","value":"158"},{"groupId":"BG002","value":"327"}]}]}]},{"title":"Education > or = high school","populationDescription":"One participant refused the question.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"225"},{"groupId":"BG001","value":"229"},{"groupId":"BG002","value":"454"}]}]}]},{"title":"Weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"lbs","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"196.1","spread":"51.8"},{"groupId":"BG001","value":"194.8","spread":"54.0"},{"groupId":"BG002","value":"195.5","spread":"52.9"}]}]}]},{"title":"BMI","populationDescription":"One participant refused to collect weight.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m 2","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"31.1","spread":"7.6"},{"groupId":"BG001","value":"31.1","spread":"8.1"},{"groupId":"BG002","value":"31.1","spread":"7.9"}]}]}]},{"title":"Depression(CESD-10) score","description":"CESD-10 assessed distress associated with depressive symptoms: possible total score ranges from 0 to 30, with a score of 10 or greater reflecting clinically significant depression.","populationDescription":"One participant refused the questions.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7.2","spread":"4.9"},{"groupId":"BG001","value":"8.2","spread":"5.5"},{"groupId":"BG002","value":"7.7","spread":"5.2"}]}]}]},{"title":"Stress (PSS-4)","description":"PSS-4 assessed self-appraised global stress: possible total score ranges from 0 to 16. Higher scores indicate more stress.","populationDescription":"One participant refused to answer.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4.9","spread":"3.1"},{"groupId":"BG001","value":"5.5","spread":"3.3"},{"groupId":"BG002","value":"5.2","spread":"3.2"}]}]}]},{"title":"Serum Cotinine","populationDescription":"4 participants had samples that were unable to be analyzed.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ng/ml","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"267"},{"groupId":"BG002","value":"536"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"268.7","spread":"160.2"},{"groupId":"BG001","value":"283.0","spread":"151.2"},{"groupId":"BG002","value":"275.8","spread":"155.8"}]}]}]},{"title":"Exhaled Carbon monoxide","populationDescription":"Exhaled carbon monoxide was added after the study began and was collected only on 411 of 540 participants.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ppm","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"202"},{"groupId":"BG001","value":"209"},{"groupId":"BG002","value":"411"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"15.8","spread":"9.4"},{"groupId":"BG001","value":"17.1","spread":"10.5"},{"groupId":"BG002","value":"16.4","spread":"10.0"}]}]}]},{"title":"Cigarettes per day","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes per day","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8.0","spread":"2.6"},{"groupId":"BG001","value":"7.9","spread":"2.4"},{"groupId":"BG002","value":"8.0","spread":"2.5"}]}]}]},{"title":"Fagerstrom Test for Nicotine Dependence- 6 item","description":"FTND assessed nicotine dependence: possible total score ranges from 0 to 10. 0 indicates minimum physical nicotine dependence and 10 indicates maximum physical nicotine dependence.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"score","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3.1","spread":"1.7"},{"groupId":"BG001","value":"3.3","spread":"1.7"},{"groupId":"BG002","value":"3.2","spread":"1.7"}]}]}]},{"title":"Time to first cigarette,< or = 30 minutes","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"191"},{"groupId":"BG001","value":"199"},{"groupId":"BG002","value":"390"}]}]}]},{"title":"Smoke Menthol Cigarettes","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"224"},{"groupId":"BG001","value":"228"},{"groupId":"BG002","value":"452"}]}]}]},{"title":"Quit Attempts","description":"Number of 24-hour quit attempts made in the past year.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Quit Attempts","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3.5","spread":"7.9"},{"groupId":"BG001","value":"3.9","spread":"7.4"},{"groupId":"BG002","value":"3.7","spread":"7.7"}]}]}]},{"title":"Pharmacotherapy use during most recent quit attempt","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"133"}]}]}]},{"title":"Age of first cigarette","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"17.5","spread":"5.8"},{"groupId":"BG001","value":"18.1","spread":"7.3"},{"groupId":"BG002","value":"17.6","spread":"5.9"}]}]}]},{"title":"Age started smoking regularly","populationDescription":"One participant declined to respond.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"269"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"539"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"21.1","spread":"6.7"},{"groupId":"BG001","value":"21.3","spread":"7.4"},{"groupId":"BG002","value":"21.1","spread":"7.1"}]}]}]},{"title":"Motivation Scale","description":"Motivation to quit smoking scale asking about how important it is to quit smoking in the next week. 1 item scale. Scale of 0 = not important and 10 = extremely important.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"9.7","spread":"0.8"},{"groupId":"BG001","value":"9.8","spread":"0.7"},{"groupId":"BG002","value":"9.7","spread":"0.8"}]}]}]},{"title":"Confidence Scale","description":"Confidence to quit smoking scale asking about how confident you are that you could quit smoking completely in the next week. 1 item scale. Scale of 0 = not confident and 10 = extremely confident.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7.9","spread":"2.1"},{"groupId":"BG001","value":"7.8","spread":"2.0"},{"groupId":"BG002","value":"7.9","spread":"2.4"}]}]}]},{"title":"Smoke-free household","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"132"}]}]}]},{"title":"California Tobacco Survey: Inhale deeply","description":"Question asks \"Which statement best describes how or whether you inhale?\" Response options include 'I inhale deeply into my chest', I inhale partly into my chest', I inhale as far back as my throat', 'I inhale back into my throat', 'I just puff, I don't really inhale'.\n\nReporting number of participants who answered 'I inhale deeply into my chest'.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"270"},{"groupId":"BG001","value":"270"},{"groupId":"BG002","value":"540"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"126"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months","description":"Salivary cotinine-verified smoking abstinence at 6 months. A cut point of 15 ng/ml was used to differentiate smokers from nonsmokers.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Bupropion Arm","description":"270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling."},{"id":"OG001","title":"Placebo Arm","description":"270 African American adults received placebo for 7 weeks in addition to health education counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"270"},{"groupId":"OG001","value":"270"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"27"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Based on our previous studies, sample size was determined a priori assuming a two-sided x2 test with a type I error rate of .05, a power of 80%, and a cotinine-verified abstinence rate of 15% in the placebo group and 25% in the bupropion SR group at week 26, with the assumption that those lost to follow-up would be imputed as smokers.","nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"The x2 test was used to determine whether there was a difference between treatment groups (bupropion SR vs placebo) in verified 7-day point prevalence abstinence at week 26, imputing the missing participants as smokers.","pValue":".23","pValueComment":"All tests of statistical significance were two-sided, and all P values less than .05 were considered statistically significant.","statisticalMethod":"t-test, 2 sided","paramType":"Odds Ratio (OR)","paramValue":"1.39","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.82","ciUpperLimit":"2.35","estimateComment":"Raw proportions were used to estimate the verified cessation rate in each group and corresponding odds ratio along with its 95% confidence interval ."}]},{"type":"SECONDARY","title":"Number of Slow and Fast Metabolizers by Metabolite Ratio","description":"Analyzed CYP2A6 by activity, called the nicotine metabolite ratio using a split between slow and fast metabolism at 0.31.\n\nThe variants present in people in the slow genotype group include \\*17, \\*20, \\*23,\\*27, \\*35, \\*9, \\*2, \\*25, \\*26, and \\*4. The fast metabolizers have none of the variant alleles tested.\n\nBlood samples were collected for 3HC/COT ratio at Week 0.","populationDescription":"This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Weeks 0","groups":[{"id":"OG000","title":"All Study Participants","description":"All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"450"}]}],"classes":[{"title":"Fast Metabolizers by Nicotine Metabolite Ratio","categories":[{"measurements":[{"groupId":"OG000","value":"236"}]}]},{"title":"Slow Metabolizers by Nicotine Metabolite Ratio","categories":[{"measurements":[{"groupId":"OG000","value":"214"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.0022","pValueComment":"This reflects Week 7.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.95","ciUpperLimit":"0.99","estimateComment":"This reflects Week 7."}]},{"type":"SECONDARY","title":"Number of Participants for Each CYP2B6 Allele","description":"We genotyped CYP2B6 in 268 from the Bupropion arm as this polymorphism is related to bupropion metabolism.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 3","groups":[{"id":"OG000","title":"Bupropion Arm","description":"270 African American adults received bupropion (150mg bid)for 7 weeks in addition to health education counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"268"}]}],"classes":[{"title":"CYP2B6*4 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]},{"title":"CYP2B6*5 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]},{"title":"CYP2B6*6 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"95"}]}]},{"title":"CYP2B6*9 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"CYP2B6*16 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"CYP2B6*18 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"17"}]}]},{"title":"CYP2B6*22 Allele Frequency","categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"<0.05","pValueComment":"Analysis relied on examining quit rates using linear regression, where the hydroxybupropion was a significant predictor of smoking cessation. CYP2B6 genotype was not a direct significant predictor of cessation in either the placebo or bupropion arm.","statisticalMethod":"Regression, Linear","paramType":"Odds Ratio (OR)","paramValue":"2.82","ciNumSides":"TWO_SIDED","estimateComment":"Bupropion adherent individuals with higher hydroxybupropion levels were more likely to be abstinent at Weeks 3, 7 and 26 compared to individuals with lower hydroxybupropion levels."}]},{"type":"SECONDARY","title":"Number of Slow and Fast Metabolizers by Genotype","description":"Analyzed CYP2A6 by genotype. The variants present in people in the slow genotype group include \\*17, \\*20, \\*23,\\*27, \\*35, \\*9, \\*2, \\*25, \\*26, and \\*4. The fast metabolizers have none of the variant alleles tested.\n\nSlow metabolizers have any reduction or loss of function variant. Fast metabolizers are \\*1/\\*1 genotype by exclusion.","populationDescription":"This variant is related to nicotine metabolism and was collected from all study participants but not analyzed by study arm as it does not relate to the study medication. Data pre-specified to be collected and reported as a single arm. Blood was unable to be analyzed for CYP2A6 genotype for 6 participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Week 0","groups":[{"id":"OG000","title":"All Study Participants","description":"All study participants were African American adults and received either bupropion (150mg bid) for 7 weeks in addition to health education counseling or placebo for 7 weeks in addition to health education counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"534"}]}],"classes":[{"title":"Slow Metabolizers by Genotype","categories":[{"measurements":[{"groupId":"OG000","value":"265"}]}]},{"title":"Fast Metabolizers by Genotype","categories":[{"measurements":[{"groupId":"OG000","value":"269"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"3","timeFrame":"16 weeks","eventGroups":[{"id":"EG000","title":"Bupropion Arm","description":"270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.","deathsNumAffected":0,"deathsNumAtRisk":270,"seriousNumAffected":8,"seriousNumAtRisk":270,"otherNumAffected":46,"otherNumAtRisk":270},{"id":"EG001","title":"Placebo Arm","description":"270 African American adults received placebo for 7 weeks in addition to health education counseling.","deathsNumAffected":0,"deathsNumAtRisk":270,"seriousNumAffected":13,"seriousNumAtRisk":270,"otherNumAffected":29,"otherNumAtRisk":270}],"seriousEvents":[{"term":"Atrioventricular block","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Chest Pain","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Infection, Skin","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Muscle Weakness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Syncope","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Upper extremity dysfunction","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]},{"term":"Acoustic nerve disorder","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Arthritis","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Coagulation","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Depression","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":270}]},{"term":"Lung infection","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":270}]},{"term":"MIddle ear infection","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Toothache","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Treatment related secondary malignancy","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":270}]},{"term":"Tumor pain","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":270},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":270}]},{"term":"Personality Change","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":270},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":270}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":270},{"groupId":"EG001","numEvents":15,"numAffected":15,"numAtRisk":270}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":26,"numAffected":26,"numAtRisk":270},{"groupId":"EG001","numEvents":9,"numAffected":9,"numAtRisk":270}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":11,"numAtRisk":270},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":270}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Over half of the participants who expressed interest in this study were ineligible according to study protocol. The lack of assessment between standardized assessment points limited the ability to characterize the process of relapse."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Lisa Sanderson Cox","organization":"University of Kansas Medical Center","email":"lcox@kumc.edu","phone":"913-588-2643"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001749","term":"Urinary Bladder Neoplasms"},{"id":"D002583","term":"Uterine Cervical Neoplasms"},{"id":"D004938","term":"Esophageal Neoplasms"},{"id":"D013274","term":"Stomach Neoplasms"},{"id":"D006258","term":"Head and Neck Neoplasms"},{"id":"D007680","term":"Kidney Neoplasms"},{"id":"D007938","term":"Leukemia"},{"id":"D008113","term":"Liver Neoplasms"},{"id":"D008175","term":"Lung Neoplasms"},{"id":"D010190","term":"Pancreatic Neoplasms"},{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D002292","term":"Carcinoma, Renal Cell"},{"id":"D006528","term":"Carcinoma, Hepatocellular"},{"id":"D002289","term":"Carcinoma, Non-Small-Cell Lung"},{"id":"D055752","term":"Small Cell Lung Carcinoma"},{"id":"D007012","term":"Hypopharyngeal Neoplasms"},{"id":"D007822","term":"Laryngeal Neoplasms"},{"id":"D009062","term":"Mouth Neoplasms"},{"id":"D009303","term":"Nasopharyngeal Neoplasms"},{"id":"D009959","term":"Oropharyngeal Neoplasms"},{"id":"D015470","term":"Leukemia, Myeloid, Acute"}],"ancestors":[{"id":"D014571","term":"Urologic Neoplasms"},{"id":"D014565","term":"Urogenital Neoplasms"},{"id":"D009371","term":"Neoplasms by Site"},{"id":"D009369","term":"Neoplasms"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D001745","term":"Urinary Bladder Diseases"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D014594","term":"Uterine Neoplasms"},{"id":"D005833","term":"Genital Neoplasms, Female"},{"id":"D002577","term":"Uterine Cervical Diseases"},{"id":"D014591","term":"Uterine Diseases"},{"id":"D005831","term":"Genital Diseases, Female"},{"id":"D000091662","term":"Genital Diseases"},{"id":"D005770","term":"Gastrointestinal Neoplasms"},{"id":"D004067","term":"Digestive System Neoplasms"},{"id":"D004066","term":"Digestive System Diseases"},{"id":"D004935","term":"Esophageal Diseases"},{"id":"D005767","term":"Gastrointestinal Diseases"},{"id":"D013272","term":"Stomach Diseases"},{"id":"D007674","term":"Kidney Diseases"},{"id":"D009370","term":"Neoplasms by Histologic Type"},{"id":"D006402","term":"Hematologic Diseases"},{"id":"D006425","term":"Hemic and Lymphatic Diseases"},{"id":"D008107","term":"Liver Diseases"},{"id":"D012142","term":"Respiratory Tract Neoplasms"},{"id":"D013899","term":"Thoracic Neoplasms"},{"id":"D008171","term":"Lung Diseases"},{"id":"D012140","term":"Respiratory Tract Diseases"},{"id":"D004701","term":"Endocrine Gland Neoplasms"},{"id":"D010182","term":"Pancreatic Diseases"},{"id":"D004700","term":"Endocrine System Diseases"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D000230","term":"Adenocarcinoma"},{"id":"D002277","term":"Carcinoma"},{"id":"D009375","term":"Neoplasms, Glandular and Epithelial"},{"id":"D002283","term":"Carcinoma, Bronchogenic"},{"id":"D001984","term":"Bronchial Neoplasms"},{"id":"D010610","term":"Pharyngeal Neoplasms"},{"id":"D010039","term":"Otorhinolaryngologic Neoplasms"},{"id":"D010608","term":"Pharyngeal Diseases"},{"id":"D009057","term":"Stomatognathic Diseases"},{"id":"D010038","term":"Otorhinolaryngologic Diseases"},{"id":"D007818","term":"Laryngeal Diseases"},{"id":"D009059","term":"Mouth Diseases"},{"id":"D009302","term":"Nasopharyngeal Diseases"},{"id":"D007951","term":"Leukemia, Myeloid"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"},{"id":"D020869","term":"Gene Expression Profiling"},{"id":"D016133","term":"Polymerase Chain Reaction"},{"id":"D003376","term":"Counseling"},{"id":"D018479","term":"Early Intervention, Educational"},{"id":"D000067250","term":"Psychiatric Rehabilitation"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D005821","term":"Genetic Techniques"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D021141","term":"Nucleic Acid Amplification Techniques"},{"id":"D008605","term":"Mental Health Services"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D003153","term":"Community Health Services"},{"id":"D006296","term":"Health Services"},{"id":"D005159","term":"Health Care Facilities Workforce and Services"},{"id":"D002662","term":"Child Health Services"},{"id":"D011314","term":"Preventive Health Services"},{"id":"D012046","term":"Rehabilitation"},{"id":"D013812","term":"Therapeutics"}]}},"hasResults":true}