{"protocolSection":{"identificationModule":{"nctId":"NCT00534001","orgStudyIdInfo":{"id":"CDR0000565103"},"secondaryIdInfos":[{"id":"I 57805","type":"OTHER","domain":"Roswell Park Cancer Institute"}],"organization":{"fullName":"Roswell Park Cancer Institute","class":"OTHER"},"briefTitle":"Bupropion in Helping Adults Stop Smoking","officialTitle":"A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation"},"statusModule":{"statusVerifiedDate":"2015-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-01"},"primaryCompletionDateStruct":{"date":"2008-05","type":"ACTUAL"},"completionDateStruct":{"date":"2015-07","type":"ACTUAL"},"studyFirstSubmitDate":"2007-09-20","studyFirstSubmitQcDate":"2007-09-20","studyFirstPostDateStruct":{"date":"2007-09-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-02-20","resultsFirstSubmitQcDate":"2017-04-24","resultsFirstPostDateStruct":{"date":"2017-05-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-04-24","lastUpdatePostDateStruct":{"date":"2017-05-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Roswell Park Cancer Institute","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine withdrawal. Giving bupropion over a longer period of time may be effective in helping people stop smoking.\n\nPURPOSE: This randomized phase II trial is studying how well bupropion works in helping adults stop smoking.","detailedDescription":"OBJECTIVES:\n\nPrimary\n\n* Determine the feasibility of conducting a full-scale clinical trial to evaluate whether extending the duration of pre-cessation bupropion hydrochloride enhances smoking cessation, as measured by 3-month prolonged abstinence rates, in adult smokers.\n\nSecondary\n\n* Assess baseline smoking and mood characteristics (nicotine dependence, smoking history, anxiety, and depression).\n* Assess measures to address the hypothesized extinction mechanism (subjective effects of smoking, collection of cigarette butts for an assessment of nicotine and tar exposure, craving for smoking, and expectations for the consequences of smoking).\n* Assess changes in affective state as measured by Withdrawal Symptoms Checklist and by Positive and Negative Affect Schedule (PANAS) questionnaire.\n* Assess side effects, pill counts, and changes in daily smoking rate.\n* Assess mental health, personality traits, interpersonal skills, demand simulation, impulsivity, motivation, and perceived stress using validated measures.\n\nOUTLINE: Participants are stratified according to gender. Participants are randomized to 1 of 2 pre-cessation intervention arms.\n\n* Arm I (1-week run-in): Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n* Arm II (4-week run-in): Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nIn both arms, participants are asked to quit smoking (target quit date) in week 5. All participants then receive oral bupropion hydrochloride once or twice daily in weeks 5-11 and undergo 90-minute behavioral group counseling sessions once in weeks 5, 7, and 9.\n\nParticipants complete questionnaires to collect information on tobacco use history, health habits, depression, anxiety scales/symptoms, and sociodemographics at baseline. Participants also complete a series of validated questionnaires about smoking patterns, smoking satisfaction, mental health, personality traits, interpersonal skills, demand simulation, impulsivity, motivation, and perceived stress at baseline and then periodically during study. Participants undergo saliva sample collection at baseline and then periodically during study. Samples are analyzed for the presence of cotinine. Buccal cells are also collected at baseline for subsequent DNA analyses. Cigarette butts from the first cigarette of the day, including the quit day, are collected during group counseling sessions in weeks 1, 2, 4, and 5 and are assessed for a marker that indicates the amount of nicotine and tar consumed.\n\nAfter finishing study treatment, participants are followed at 6 and 12 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":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":95,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Arm I (1-week run-in)","type":"EXPERIMENTAL","description":"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.","interventionNames":["Drug: bupropion hydrochloride","Other: placebo"]},{"label":"Arm II (4-week run-in)","type":"EXPERIMENTAL","description":"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.","interventionNames":["Drug: bupropion hydrochloride"]}],"interventions":[{"type":"DRUG","name":"bupropion hydrochloride","description":"Given orally","armGroupLabels":["Arm I (1-week run-in)","Arm II (4-week run-in)"]},{"type":"OTHER","name":"placebo","description":"Given orally","armGroupLabels":["Arm I (1-week run-in)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Prequit Change in Cigarettes Per Day","description":"Prequit Change in Cigarettes Per Day","timeFrame":"3-Week PreQuit Drug Manipulation Phase"}],"secondaryOutcomes":[{"measure":"Abstinence","description":"Bioverified 4-week continuous abstinence","timeFrame":"4 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"DISEASE CHARACTERISTICS:\n\n* Currently smokes ≥ 15 cigarettes per day for at least 1 year\n* Motivated to quit smoking within the next 3 months\n\nPATIENT CHARACTERISTICS:\n\n* Willing to attend clinic visits\n* Willing to refrain from nicotine replacement therapy (NRT) use during study participation\n* Able to speak and read English fluently\n* Has a home telephone and plans to reside in Western New York for the next year\n* Not pregnant or nursing\n* Negative pregnancy test\n* Not planning a pregnancy\n* Fertile patients must use effective contraception during and for 3 months after study participation\n* No history of chronic renal or hepatic disease\n* No history of head trauma or seizure\n* No history of a seizure disorder, brain tumor, or CNS tumor\n* No history of or currently diagnosed bulimia or anorexia nervosa\n* No history of psychotic disorder\n* No diabetes requiring oral hypoglycemics or insulin\n* No excessive use of alcohol or alcoholism\n* No current addiction to opiates, cocaine, or stimulants\n* No poorly controlled hypertension (i.e., systolic blood pressure \\[BP\\] \\> 170 mm Hg and/or diastolic BP \\> 110 mm Hg)\n* No allergy to bupropion hydrochloride\n* No other surgical or medical condition that may significantly alter absorption, distribution, metabolism, or excretion of bupropion hydrochloride\n* No history of noncompliance to medical regimens\n* No other clinical contraindication\n* No major depressive disorder\n\nPRIOR CONCURRENT THERAPY:\n\n* At least 14 days since prior and no concurrent monoamine oxidase inhibitor\n* No recent discontinuation of a benzodiazepine\n* No concurrent Hypericum perforatum (St. John's wort)\n* No other concurrent drugs containing bupropion hydrochloride (e.g., Wellbutrin or Zyban)\n* No concurrent antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants or anorectics, or levodopa\n* No concurrent active treatment for cancer (e.g., chemotherapy or radiotherapy)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Martin Mahoney, MD","affiliation":"Roswell Park Cancer Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","zip":"14263-0001","country":"United States","geoPoint":{"lat":42.88645,"lon":-78.87837}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"1-week Run In (Standard)"},{"id":"FG001","title":"4-week Run-in (Extended)"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"47"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"43"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Arm I (1-week run-in)","description":"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally\n\nplacebo: Given orally"},{"id":"BG001","title":"Arm II (4-week run-in)","description":"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"95"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.7","spread":"9.3"},{"groupId":"BG001","value":"45.8","spread":"10.1"},{"groupId":"BG002","value":"46","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"50"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"45"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Racial/Ethnic Minority","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}]}]},{"title":"White/Not Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"86"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"47"},{"groupId":"BG002","value":"95"}]}]}]},{"title":"Cigarettes Smoked Per Day (CPD)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"CPD","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22.0","spread":"6.0"},{"groupId":"BG001","value":"23.4","spread":"7.9"},{"groupId":"BG002","value":"23","spread":"7"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Prequit Change in Cigarettes Per Day","description":"Prequit Change in Cigarettes Per Day","populationDescription":"Excludes participants with missing data (2 in Arm 1, 3 in Arm 2)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"Cigarettes Per Day","timeFrame":"3-Week PreQuit Drug Manipulation Phase","groups":[{"id":"OG000","title":"Arm I (1-week run-in)","description":"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally\n\nplacebo: Given orally"},{"id":"OG001","title":"Arm II (4-week run-in)","description":"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"46"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.6","spread":"0.5"},{"groupId":"OG001","value":"-3.9","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Abstinence","description":"Bioverified 4-week continuous abstinence","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"4 weeks","groups":[{"id":"OG000","title":"Arm I (1-week run-in)","description":"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally\n\nplacebo: Given orally"},{"id":"OG001","title":"Arm II (4-week run-in)","description":"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"47"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"15"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"8 weeks","description":"Only participant-volunteered side effects were noted.","eventGroups":[{"id":"EG000","title":"Arm I (1-week run-in)","description":"Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally\n\nplacebo: Given orally","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"otherNumAffected":48,"otherNumAtRisk":48},{"id":"EG001","title":"Arm II (4-week run-in)","description":"Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4.\n\nbupropion hydrochloride: Given orally","deathsNumAffected":0,"deathsNumAtRisk":47,"seriousNumAffected":0,"seriousNumAtRisk":47,"otherNumAffected":47,"otherNumAtRisk":47}],"otherEvents":[{"term":"Any Non-Serious Adverse Event","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.","stats":[{"groupId":"EG000","numEvents":48,"numAffected":48,"numAtRisk":48},{"groupId":"EG001","numEvents":47,"numAffected":47,"numAtRisk":47}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Martin Mahoney","organization":"Roswell Park Cancer Institute","email":"martin.mahoney@roswellpark.org","phone":"716-845-2300"}}},"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"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}