{"protocolSection":{"identificationModule":{"nctId":"NCT00129272","orgStudyIdInfo":{"id":"NIDA-15131-1"},"organization":{"fullName":"National Institute on Drug Abuse (NIDA)","class":"NIH"},"briefTitle":"Effectiveness of Bupropion for Treating Nicotine Dependence in Young People","officialTitle":"Stress Response and Smoking Cessation in Depressed Youth"},"statusModule":{"statusVerifiedDate":"2017-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-05"},"primaryCompletionDateStruct":{"date":"2011-01","type":"ACTUAL"},"completionDateStruct":{"date":"2011-01","type":"ACTUAL"},"studyFirstSubmitDate":"2005-08-04","studyFirstSubmitQcDate":"2005-08-04","studyFirstPostDateStruct":{"date":"2005-08-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-01-16","resultsFirstSubmitQcDate":"2017-03-06","resultsFirstPostDateStruct":{"date":"2017-04-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-04-17","lastUpdatePostDateStruct":{"date":"2017-05-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Uma Rao","investigatorTitle":"Professor of Psychiatry","investigatorAffiliation":"National Institute on Drug Abuse (NIDA)"},"leadSponsor":{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.","detailedDescription":"Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.\n\nDepressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.\n\nParticipants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment."},"conditionsModule":{"conditions":["Tobacco Use Cessation","Tobacco Use Disorder"],"keywords":["adolescents, cigarettes, smoking, tobacco"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":172,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion (Wellbutrin-SR)","type":"ACTIVE_COMPARATOR","description":"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.","interventionNames":["Drug: Bupropion-SR"]},{"label":"Matching Placebo","type":"PLACEBO_COMPARATOR","description":"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.","interventionNames":["Other: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion-SR","description":"150mg tablets taken orally twice daily for 9 weeks.","armGroupLabels":["Bupropion (Wellbutrin-SR)"],"otherNames":["Wellbutrin-SR"]},{"type":"OTHER","name":"Placebo","description":"Matching placebo (to Buproion-SR) twice daily for 9 weeks.","armGroupLabels":["Matching Placebo"],"otherNames":["Placebo match for Bupropion (Wellbutrin) SR"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Smoking Behavior","description":"Number of cigarettes smoked daily in the previous week","timeFrame":"Nine weeks"}],"secondaryOutcomes":[{"measure":"Withdrawal Symptoms","description":"Hughes-Hatsukami Withdrawal Scale","timeFrame":"Nine weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Has smoked at least 10 cigarettes each day for 3 or more months\n* Weighs at least 90 lbs\n* Motivated to quit smoking and has had at least one previous failed attempt\n* Speaks, reads, and writes English\n* Either diagnosed as depressed OR no history of a psychiatric disorder\n\nExclusion Criteria:\n\n* History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry\n* Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry\n* Psychotic symptoms\n* Use of psychotropic medication(s)\n* Serious medical condition\n* Prior use of bupropion for smoking cessation\n* Currently using other smoking cessation treatments","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"25 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Uma Rao, MD","affiliation":"University of Texas Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","zip":"75390 9101","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"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."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants completed an assessment for nicotine dependence and psychiatric disorders, and a laboratory stress study to assess baseline salivary cortisol over 2 hours and cortisol responses to a psychosocial stressor (public speaking and arithmetic tasks). Those who continued to meet study criteria were then randomized to active drug or placebo.","recruitmentDetails":"Participants between ages 12 and 25 years who smoked at least 10 cigarettes per day over a period of 6 months were recruited between 2004 and 2010 through advertisements in local newspapers and flyers in local community agencies and primary care clinics.","groups":[{"id":"FG000","title":"Active Drug (Burpropion-SR)","description":"In total 172 participants were recruited, and 144 were randomized.\n\nUsing a double-blind, randomized, placebo-controlled design, participants were randomized to active drug or placebo using the modified Efron's biased coin toss method to ensure that the drug/placebo cells are balanced with respect to severe depression, presence of nicotine dependence symptoms and gender.\n\nParticipants received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nThe participants had weekly visits with the target quitting date set for Day 8. The medication checks lasted about 30-45 minutes. The focus was on elicitation of smoking status, nicotine craving and withdrawal symptoms, depressive symptoms and side effects. Body weight and vital signs were measured as well as expired air for CO and urine cotinine levels. Plasma drug levels were obtained at 5 and 9 weeks of treatment."},{"id":"FG001","title":"Matching Placebo","description":"This arm included placebo treatment twice daily for 9 weeks. Drug and placebo were compounded to look identical, masking both drug type and dosage.\n\nAll participants (both drug and placebo groups) received a modified version of the brief office intervention program for adolescent smokers, developed by the American Medical Association. Subjects met with a research counselor for 10 consecutive weekly sessions. The initial session (baseline visit) was 60 min. while the remaining sessions were 20-30 min. Each session was individualized to the needs of the adolescent, based on information gathered at the baseline assessment. The brief office intervention materials include checklists and guidelines for each session to assist the counselor in tailoring the session to the needs of the youth. It involved motivational interviewing, incorporating stages of change, peer and parental and other social influences; negative affect and other psychological factors, addiction and self-efficacy."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"71"},{"groupId":"FG001","numSubjects":"73"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"22"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"11"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Active Drug (Bupropion-SR)","description":"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nBupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."},{"id":"BG001","title":"Matching Placebo","description":"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nPlacebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"144"}]}],"measures":[{"title":"Age, Continuous","description":"Participants were between 12 and 25 years of age.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.6","spread":"3.2"},{"groupId":"BG001","value":"18.3","spread":"3.9"},{"groupId":"BG002","value":"19.0","spread":"3.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"67"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Black : non-Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]}]},{"title":"Black : Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]},{"title":"White : non-Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"103"}]}]},{"title":"White : Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]},{"title":"More than one race : non-Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]},{"title":"More than one race : Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Region of Enrollment","description":"The data were collected in Southwestern Region of the United States","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"73"},{"groupId":"BG002","value":"144"}]}]}]},{"title":"Daily smoking diary","description":"Number of cigarettes smoked per day","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes/day in previous week","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17.5","spread":"7.6"},{"groupId":"BG001","value":"16.4","spread":"6.8"},{"groupId":"BG002","value":"16.9","spread":"7.2"}]}]}]},{"title":"Withdrawal symptoms","description":"Hughes-Hatsukami Withdrawal Scale","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale;range 0-36;higher worse","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.3","spread":"3.3"},{"groupId":"BG001","value":"4.1","spread":"3.5"},{"groupId":"BG002","value":"4.2","spread":"3.5"}]}]}]},{"title":"Nicotine dependence","description":"Fagerstrom Tolerance Questionnaire","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale;range 0-9;higher worse","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.6","spread":"1.6"},{"groupId":"BG001","value":"5.4","spread":"1.3"},{"groupId":"BG002","value":"5.5","spread":"1.5"}]}]}]},{"title":"Expired carbon monoxide","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Parts per million; higher worse","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13.9","spread":"5.3"},{"groupId":"BG001","value":"14.0","spread":"8.9"},{"groupId":"BG002","value":"13.9","spread":"6.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Smoking Behavior","description":"Number of cigarettes smoked daily in the previous week","populationDescription":"Analyzed all randomized participants with last observation carried forward (LOCF).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cigarettes/day in the previous week","timeFrame":"Nine weeks","groups":[{"id":"OG000","title":"Active Drug (Bupropion-SR)","description":"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nBupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."},{"id":"OG001","title":"Matching Placebo","description":"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nPlacebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.4","spread":"4.3"},{"groupId":"OG001","value":"8.9","spread":"5.4"}]}]}]},{"type":"SECONDARY","title":"Withdrawal Symptoms","description":"Hughes-Hatsukami Withdrawal Scale","populationDescription":"Analyzed all participants with last observation carried forward (LOCF).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale;range0-36;higher worse","timeFrame":"Nine weeks","groups":[{"id":"OG000","title":"Active Drug (Bupropion-SR)","description":"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nBupropion-SR: 150mg tablets taken orally twice daily for 9 weeks."},{"id":"OG001","title":"Matching Placebo","description":"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nPlacebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"73"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5","spread":"3.3"},{"groupId":"OG001","value":"3.1","spread":"4.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Time frame for adverse events was over 9 weeks of treatment.","description":"Adverse events were recorded based on Hughes-Hatsukami Withdrawal Scale and Side Effects Form.","eventGroups":[{"id":"EG000","title":"Active Drug (Bupropion-SR)","description":"Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-Sr (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nBupropion-SR: 150mg tablets taken orally twice daily for 9 weeks.","deathsNumAffected":0,"deathsNumAtRisk":71,"seriousNumAffected":0,"seriousNumAtRisk":71,"otherNumAffected":7,"otherNumAtRisk":71},{"id":"EG001","title":"Matching Placebo","description":"Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.\n\nPlacebo: Matching placebo (to Buproion-SR) twice daily for 9 weeks.","deathsNumAffected":0,"deathsNumAtRisk":73,"seriousNumAffected":0,"seriousNumAtRisk":73,"otherNumAffected":8,"otherNumAtRisk":73}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":23,"numAffected":7,"numAtRisk":71},{"groupId":"EG001","numEvents":16,"numAffected":6,"numAtRisk":73}]},{"term":"Negative affect","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"negative mood/affect reported during the course of treatment","stats":[{"groupId":"EG000","numEvents":5,"numAffected":3,"numAtRisk":71},{"groupId":"EG001","numEvents":23,"numAffected":8,"numAtRisk":73}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Uma Rao, MD","organization":"The University of Tennessee","email":"urao@utk.edu","phone":"615-794-3351"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D020340","term":"Tobacco Use Cessation"},{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D012907","term":"Smoking"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}