{"protocolSection":{"identificationModule":{"nctId":"NCT01806779","orgStudyIdInfo":{"id":"Pro00042699"},"secondaryIdInfos":[{"id":"1P50DA027840-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1P50DA027840-01A1"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers","officialTitle":"Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers","acronym":"ConNic5"},"statusModule":{"statusVerifiedDate":"2015-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-03"},"primaryCompletionDateStruct":{"date":"2014-12","type":"ACTUAL"},"completionDateStruct":{"date":"2015-03","type":"ACTUAL"},"studyFirstSubmitDate":"2013-03-06","studyFirstSubmitQcDate":"2013-03-06","studyFirstPostDateStruct":{"date":"2013-03-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-09-03","resultsFirstSubmitQcDate":"2015-09-03","resultsFirstPostDateStruct":{"date":"2015-10-08","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-12-14","lastUpdatePostDateStruct":{"date":"2016-01-18","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"},{"name":"Philip Morris USA, Inc.","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study."},"conditionsModule":{"conditions":["Nicotine Dependence"],"keywords":["Nicotine addiction","Cigarette smoking","Smoking cessation","Zyban","Chantix","Nicotine patches","varenicline","bupropion"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","CARE_PROVIDER"]}},"enrollmentInfo":{"count":376,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Chantix","type":"EXPERIMENTAL","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.","interventionNames":["Drug: Chantix","Drug: Nicotine patches"]},{"label":"Chantix + Zyban","type":"EXPERIMENTAL","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.","interventionNames":["Drug: Chantix","Drug: Zyban","Drug: Nicotine patches"]}],"interventions":[{"type":"DRUG","name":"Chantix","armGroupLabels":["Chantix","Chantix + Zyban"],"otherNames":["Varenicline"]},{"type":"DRUG","name":"Zyban","armGroupLabels":["Chantix + Zyban"],"otherNames":["Bupropion"]},{"type":"DRUG","name":"Nicotine patches","description":"All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.","armGroupLabels":["Chantix","Chantix + Zyban"],"otherNames":["NRT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits","description":"This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \\<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.","timeFrame":"Period between 8-week and 11-week visits post target Quit Day"}],"secondaryOutcomes":[{"measure":"Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day","description":"This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.","timeFrame":"6 months post Quit Day"},{"measure":"Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit","description":"This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \\<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.","timeFrame":"Quit Day to 11-week post Quit Day study visit"}],"otherOutcomes":[{"measure":"Change in Smoking Withdrawal Symptoms","description":"Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.","timeFrame":"Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Have no known serious medical conditions;\n* Male;\n* Are 18-65 years old;\n* Smoke an average of at least 10 cigarettes per day;\n* Have smoked at least one cumulative year;\n* Have an expired air carbon monoxide (CO) reading of at least 10ppm;\n* Able to read and understand English;\n* Express a desire to quit smoking in the next thirty days.\n\nPotential subjects must agree to use acceptable contraception.\n\nPotential subjects must agree to avoid the following:\n\n* participation in any other nicotine-related modification strategy outside of this protocol;\n* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;\n* use of experimental (investigational) drugs or devices;\n* use of illegal drugs;\n* use of opiate medications.\n\nExclusion Criteria:\n\n* Hypertension;\n* Hypotension with symptoms;\n* Coronary heart disease;\n* Lifetime history of heart attack;\n* Cardiac rhythm disorder (irregular heart rhythm);\n* Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);\n* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);\n* History of skin allergy;\n* Active skin disorder (e.g., psoriasis) within the last five years;\n* Liver or kidney disorder (except kidney stones, gallstones);\n* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;\n* Active ulcers in the past 30 days;\n* Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);\n* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);\n* Migraine headaches that occur more frequently than once per week;\n* Recent, unexplained fainting spells;\n* Problems giving blood samples;\n* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);\n* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);\n* Other major medical condition;\n* Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);\n* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;\n* Current depression;\n* Bulimia or anorexia;\n* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;\n* Smoking more than one cigar a month.\n* Alcohol abuse;\n* Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.\n* Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.\n* Current participation in another research study.\n\nUse (within the past 30 days) of:\n\n* Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),\n* Experimental (investigational) drugs;\n* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);\n* Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;\n* Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.","healthyVolunteers":false,"sex":"MALE","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jed E Rose, Ph.D.","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke Center for Smoking Cessation","city":"Charlotte","state":"North Carolina","zip":"28210","country":"United States","geoPoint":{"lat":35.22709,"lon":-80.84313}},{"facility":"Duke Center for Smoking Cessation","city":"Durham","state":"North Carolina","zip":"27705","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}},{"facility":"Duke Center for Smoking Cessation","city":"Raleigh","state":"North Carolina","zip":"27609","country":"United States","geoPoint":{"lat":35.7721,"lon":-78.63861}},{"facility":"Duke Center for Smoking Cessation","city":"Winston-Salem","state":"North Carolina","zip":"27103","country":"United States","geoPoint":{"lat":36.09986,"lon":-80.24422}}]},"referencesModule":{"references":[{"pmid":"37142273","type":"DERIVED","citation":"Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8."},{"pmid":"29054128","type":"DERIVED","citation":"Rose JE, Behm FM. Combination Varenicline/Bupropion Treatment Benefits Highly Dependent Smokers in an Adaptive Smoking Cessation Paradigm. Nicotine Tob Res. 2017 Aug 1;19(8):999-1002. doi: 10.1093/ntr/ntw283."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Of the 376 subjs. enrolled, 179 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1). 197 subjs. met all study criteria, attended V1 \\& given NRT for 1 week; 176 subjs. attended V2 \\& completed SE quest.; 2 subjs. dropped out during this visit before randomization; 174 subjs. randomized.","recruitmentDetails":"Recruitment began on 3/4/2013 and ended on 9/7/2014. Of the 376 subjects (subjs.) consented during this period, 197 subjects met all study criteria.","groups":[{"id":"FG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"FG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"FG002","title":"Nicotine Patches Only","description":"These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"90"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","comment":"All 197 subjects received nicotine patches but 23 dropped before receiving other study drugs.","numSubjects":"23"}]},{"type":"Completed SE Quest. After Using Patches","achievements":[{"groupId":"FG000","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"90"},{"groupId":"FG001","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"84"},{"groupId":"FG002","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"2"}]},{"type":"Randomized at Visit 2","achievements":[{"groupId":"FG000","numSubjects":"90"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Completed SE Quest. After Randomization","achievements":[{"groupId":"FG000","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"87"},{"groupId":"FG001","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"83"},{"groupId":"FG002","comment":"SE quest. = Side Effects Questionnaire","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"40"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"23"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"23"},{"groupId":"FG002","numSubjects":"22"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"BG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"174"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"174"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.75","spread":"11.381"},{"groupId":"BG001","value":"43.12","spread":"10.562"},{"groupId":"BG002","value":"43.96","spread":"10.992"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"174"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"171"}]},{"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":"1"},{"groupId":"BG002","value":"1"}]},{"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":"20"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"46"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"123"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"90"},{"groupId":"BG001","value":"84"},{"groupId":"BG002","value":"174"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits","description":"This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) \\<10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Period between 8-week and 11-week visits post target Quit Day","groups":[{"id":"OG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"OG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"38"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day","description":"This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"6 months post Quit Day","groups":[{"id":"OG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"OG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"19"}]}]}]},{"type":"SECONDARY","title":"Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit","description":"This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) \\<10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Quit Day to 11-week post Quit Day study visit","groups":[{"id":"OG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"OG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"15"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Change in Smoking Withdrawal Symptoms","description":"Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.","populationDescription":"A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"percentage of change","timeFrame":"Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day","groups":[{"id":"OG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."},{"id":"OG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"76"}]}],"classes":[{"title":"Craving -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-18.15","spread":"2.354"},{"groupId":"OG001","value":"-15.49","spread":"3.117"}]}]},{"title":"Craving -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-27.06","spread":"3.520"},{"groupId":"OG001","value":"-28.64","spread":"4.439"}]}]},{"title":"Craving -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-30.94","spread":"3.124"},{"groupId":"OG001","value":"-28.75","spread":"5.104"}]}]},{"title":"Craving -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-26.97","spread":"4.471"},{"groupId":"OG001","value":"-30.82","spread":"5.201"}]}]},{"title":"Craving -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-42.96","spread":"6.563"},{"groupId":"OG001","value":"-33.52","spread":"9.020"}]}]},{"title":"Negative Affect -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-11.45","spread":"2.551"},{"groupId":"OG001","value":"-7.15","spread":"2.791"}]}]},{"title":"Negative Affect -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-9.74","spread":"2.494"},{"groupId":"OG001","value":"-4.72","spread":"4.230"}]}]},{"title":"Negative Affect -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-10.16","spread":"2.885"},{"groupId":"OG001","value":"-10.88","spread":"4.177"}]}]},{"title":"Negative Affect -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-15.06","spread":"3.396"},{"groupId":"OG001","value":"-8.52","spread":"4.567"}]}]},{"title":"Negative Affect -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-8.55","spread":"10.707"},{"groupId":"OG001","value":"21.96","spread":"19.660"}]}]},{"title":"Appetite -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-10.53","spread":"3.148"},{"groupId":"OG001","value":"-4.40","spread":"3.224"}]}]},{"title":"Appetite -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-11.04","spread":"5.065"},{"groupId":"OG001","value":"-4.42","spread":"5.553"}]}]},{"title":"Appetite -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-9.30","spread":"5.981"},{"groupId":"OG001","value":"-11.66","spread":"6.403"}]}]},{"title":"Appetite -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-16.20","spread":"7.153"},{"groupId":"OG001","value":"-8.64","spread":"8.199"}]}]},{"title":"Appetite -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-33.88","spread":"10.872"},{"groupId":"OG001","value":"-35.44","spread":"15.819"}]}]},{"title":"Arousal -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"8.03","spread":"5.620"},{"groupId":"OG001","value":"10.72","spread":"3.716"}]}]},{"title":"Arousal -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"5.87","spread":"5.675"},{"groupId":"OG001","value":"-4.40","spread":"3.643"}]}]},{"title":"Arousal -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"6.94","spread":"6.763"},{"groupId":"OG001","value":"-4.03","spread":"3.950"}]}]},{"title":"Arousal -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"7.33","spread":"6.117"},{"groupId":"OG001","value":"-1.56","spread":"3.928"}]}]},{"title":"Arousal -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"19.80","spread":"15.516"},{"groupId":"OG001","value":"49.01","spread":"32.352"}]}]},{"title":"Anxiety -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-8.22","spread":"3.480"},{"groupId":"OG001","value":"-12.26","spread":"2.780"}]}]},{"title":"Anxiety -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-8.66","spread":"4.001"},{"groupId":"OG001","value":"-14.40","spread":"3.517"}]}]},{"title":"Anxiety -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-11.82","spread":"3.25"},{"groupId":"OG001","value":"-12.50","spread":"5.000"}]}]},{"title":"Anxiety -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-9.34","spread":"3.526"},{"groupId":"OG001","value":"-19.83","spread":"3.768"}]}]},{"title":"Anxiety -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-66.77","spread":"3.269"},{"groupId":"OG001","value":"-57.15","spread":"6.064"}]}]},{"title":"Gastrointestinal -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-0.69","spread":"3.720"},{"groupId":"OG001","value":"-7.78","spread":"2.692"}]}]},{"title":"Gastrointestinal -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-5.14","spread":"2.994"},{"groupId":"OG001","value":"-10.07","spread":"2.791"}]}]},{"title":"Gastrointestinal -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-7.67","spread":"3.231"},{"groupId":"OG001","value":"-8.44","spread":"4.777"}]}]},{"title":"Gastrointestinal - % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-8.05","spread":"3.357"},{"groupId":"OG001","value":"-9.60","spread":"3.897"}]}]},{"title":"Gastrointestinal - % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-67.72","spread":"3.245"},{"groupId":"OG001","value":"-56.61","spread":"6.026"}]}]},{"title":"Respiratory -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"1.41","spread":"3.113"},{"groupId":"OG001","value":"-7.47","spread":"2.887"}]}]},{"title":"Respiratory -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-1.12","spread":"4.694"},{"groupId":"OG001","value":"-8.81","spread":"3.697"}]}]},{"title":"Respiratory -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"0.92","spread":"6.534"},{"groupId":"OG001","value":"-18.04","spread":"4.120"}]}]},{"title":"Respiratory -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-4.36","spread":"6.014"},{"groupId":"OG001","value":"-19.67","spread":"4.507"}]}]},{"title":"Respiratory -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-65.87","spread":"3.293"},{"groupId":"OG001","value":"-55.77","spread":"6.618"}]}]},{"title":"Habit -- % change 1 week from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-5.15","spread":"4.878"},{"groupId":"OG001","value":"1.64","spread":"5.120"}]}]},{"title":"Habit -- % change 3 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-17.67","spread":"4.959"},{"groupId":"OG001","value":"-16.07","spread":"3.735"}]}]},{"title":"Habit -- % change 7 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-14.46","spread":"6.666"},{"groupId":"OG001","value":"-20.55","spread":"4.868"}]}]},{"title":"Habit -- % change 11 weeks from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-16.61","spread":"6.601"},{"groupId":"OG001","value":"-24.78","spread":"6.085"}]}]},{"title":"Habit -- % change 6 months from Quit Day","categories":[{"measurements":[{"groupId":"OG000","value":"-56.97","spread":"4.807"},{"groupId":"OG001","value":"-53.40","spread":"5.905"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Subjects (subjs.) received (rcvd.) study drugs for 13 weeks. At each study session during this period subjs. completed a questionnaire about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome.","description":"Serious Adverse Events (AE) were evaluated for all subjs. who rcvd. nic. patches at Visit (V) 1 (197), \\& subjs. randomized to receive Chantix (90) or Chantix+Zyban (84) at V2. Other AEs were evaluated for all subjs. receiving nic. patches \\& completing V2 SE quest. (176), \\& randomized subjs. completing SE quest. at V3 (170) \\& at subsequent visits.","eventGroups":[{"id":"EG000","title":"Chantix","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.\n\nChantix\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.","seriousNumAffected":3,"seriousNumAtRisk":90,"otherNumAffected":39,"otherNumAtRisk":87},{"id":"EG001","title":"Chantix + Zyban","description":"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.\n\nChantix\n\nZyban\n\nNicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week.","seriousNumAffected":2,"seriousNumAtRisk":84,"otherNumAffected":53,"otherNumAtRisk":83},{"id":"EG002","title":"Nicotine Patch","description":"All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.","seriousNumAffected":0,"seriousNumAtRisk":197,"otherNumAffected":57,"otherNumAtRisk":176}],"seriousEvents":[{"term":"Allergic Reaction to Chantix or Zyban","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":90},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":84},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":197}]},{"term":"Non-cardiac Chest Pain & Right Ventricular Hypertrophy","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":197}]},{"term":"Jaw & upper extremity fracture due to an accident","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":197}]},{"term":"COPD and reactive airway disease","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":90},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":84},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":197}]},{"term":"Left sided weakness, headache, blurred vision","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":90},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":84},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":197}]}],"otherEvents":[{"term":"Headache","organSystem":"Nervous system 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":13,"numAffected":8,"numAtRisk":87},{"groupId":"EG001","numEvents":19,"numAffected":11,"numAtRisk":83},{"groupId":"EG002","numEvents":4,"numAffected":4,"numAtRisk":176}]},{"term":"Thirst","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":6,"numAtRisk":87},{"groupId":"EG001","numEvents":32,"numAffected":15,"numAtRisk":83},{"groupId":"EG002","numEvents":10,"numAffected":10,"numAtRisk":176}]},{"term":"Joint/Muscle/Back Pain","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":4,"numAtRisk":87},{"groupId":"EG001","numEvents":12,"numAffected":6,"numAtRisk":83},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":176}]},{"term":"Irritability","organSystem":"Nervous system 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":87},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":83},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":176}]},{"term":"Decreased Libido","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":87},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":83},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":176}]},{"term":"Itching/Burning at Patch Site","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":87},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":83},{"groupId":"EG002","numEvents":16,"numAffected":16,"numAtRisk":176}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Jed E. Rose","organization":"Duke Center for Smoking Cessation","email":"jed.rose@duke.edu","phone":"919-668-5055"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D014029","term":"Tobacco Use Disorder"},{"id":"D000073865","term":"Cigarette Smoking"},{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D000073869","term":"Tobacco Smoking"},{"id":"D012907","term":"Smoking"},{"id":"D001519","term":"Behavior"},{"id":"D064424","term":"Tobacco Use"},{"id":"D015438","term":"Health Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"},{"id":"D061485","term":"Tobacco Use Cessation Devices"}],"ancestors":[{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D013812","term":"Therapeutics"}]}},"hasResults":true}