Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT01303861
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2011-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Concurrent Bupropion / Varenicline for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'id': 'D009538', 'term': 'Nicotine'}], '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'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jed.rose@dm.duke.edu', 'phone': '919-668-5055', 'title': 'Dr. Jed E. Rose', 'organization': 'Duke University Medical Center - Duke Center for Smoking Cessation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subjects were receiving study drugs for 13 weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.', 'description': 'Twenty-two subjects discontinued study participation prior to being assigned a condition; therefore, no side effects data were collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.', 'otherNumAtRisk': 109, 'otherNumAffected': 76, 'seriousNumAtRisk': 109, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week', 'otherNumAtRisk': 50, 'otherNumAffected': 33, 'seriousNumAtRisk': 50, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date', 'otherNumAtRisk': 55, 'otherNumAffected': 38, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.', 'otherNumAtRisk': 113, 'otherNumAffected': 80, 'seriousNumAtRisk': 113, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dropped Prior to Condition Assignment', 'description': 'These subjects discontinued study participation prior to being assigned to a condition.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal / Sinus Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in Taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth / Throat Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 24, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 26, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint / Muscle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jaw / Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vivid Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 41, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 56, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nightmares', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching at Patch Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tightness in Chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 113, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Four-week Continuous Abstinence From Cigarette Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.'}, {'id': 'OG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week'}, {'id': 'OG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date'}, {'id': 'OG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.93', 'groupId': 'OG000', 'lowerLimit': '17.97', 'upperLimit': '35.25'}, {'value': '46.94', 'groupId': 'OG001', 'lowerLimit': '32.53', 'upperLimit': '61.73'}, {'value': '43.64', 'groupId': 'OG002', 'lowerLimit': '30.30', 'upperLimit': '57.68'}, {'value': '39.82', 'groupId': 'OG003', 'lowerLimit': '30.73', 'upperLimit': '49.46'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study week 8 thru week 11', 'description': 'The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Seven Day Point Abstinence From Cigarette Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.'}, {'id': 'OG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week'}, {'id': 'OG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date'}, {'id': 'OG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '27'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '19'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '29', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '39'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Six months post quit date', 'description': 'Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Continuous Cigarette Abstinence From Quit Date', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '113', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.'}, {'id': 'OG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week'}, {'id': 'OG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date'}, {'id': 'OG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '23'}, {'value': '17', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '26'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Quit date to end of treatment (week 11)', 'description': 'Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '1 subject from varenicline group excluded from analysis due to pregnancy. 1 subject from Nicotine Patches only group excluded due to meeting an exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.'}, {'id': 'FG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week'}, {'id': 'FG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date'}, {'id': 'FG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '113'}]}, {'type': 'Finished Treatment Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began on 3/07/11 and ended on 11/30/12. Of the 702 subjects consented during this period, 218 were in our Charlotte, NC office, 157 were in our Durham, NC office, 151 were in our Raleigh, NC office and 176 were in our Winston-Salem, NC office. Only 349 subjects met all study criteria, and 22 discontinued prior to being assigned.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '349', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.'}, {'id': 'BG001', 'title': 'Nicotine Patches Only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week'}, {'id': 'BG002', 'title': 'Nicotine Patches With Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.\n\nNicotine patches: Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week\n\nNicotine Inhaler: Nicotine inhaler to use as needed after quit date'}, {'id': 'BG003', 'title': 'Varenicline With Bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.\n\nVarenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.\n\nBupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.'}, {'id': 'BG004', 'title': 'Dropped Prior to Condition Assignment', 'description': 'These subjects discontinued study participation prior to being assigned to a condition.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '347', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.58', 'spread': '11.39', 'groupId': 'BG000'}, {'value': '45.20', 'spread': '10.56', 'groupId': 'BG001'}, {'value': '42.09', 'spread': '12.22', 'groupId': 'BG002'}, {'value': '44.22', 'spread': '10.47', 'groupId': 'BG003'}, {'value': '44.77', 'spread': '11.28', 'groupId': 'BG004'}, {'value': '44.42', 'spread': '11.20', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '195', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '154', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '340', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '121', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '210', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '349', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects who failed to respond to pre-cessation nicotine patch treatment were randomized to receive varenicline, or varenicline + bupropion. Subjects who showed reductions in ad lib smoking were randomly assigned to nicotine patch only or patch + nicotine inhaler. 22 Subjects discontinued study participation prior to being assigned to a condition.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 702}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2011-02-23', 'resultsFirstSubmitDate': '2014-07-05', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-05', 'studyFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Four-week Continuous Abstinence From Cigarette Smoking', 'timeFrame': 'Study week 8 thru week 11', 'description': 'The primary dependent measures will be continuous four-week abstinence from weeks 8-11 post target quit date, defined as a self-report of no smoking confirmed by expired air carbon monoxide.'}], 'secondaryOutcomes': [{'measure': 'Seven Day Point Abstinence From Cigarette Smoking', 'timeFrame': 'Six months post quit date', 'description': 'Secondary outcome will include point abstinence (no smoking in the previous 7-day) at 6 months post-quit.'}, {'measure': 'Continuous Cigarette Abstinence From Quit Date', 'timeFrame': 'From Quit date to end of treatment (week 11)', 'description': 'Secondary outcome will include continuous abstinence from quit date to end of treatment (week 11).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nicotine addiction', 'Cigarette smoking', 'Smoking cessation', 'Zyban', 'Chantix', 'Nicotine patches', 'Nicotrol Inhaler', 'varenicline', 'bupropion'], 'conditions': ['Nicotine Dependence']}, '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': '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': '24934962', 'type': 'DERIVED', 'citation': 'Rose JE, Behm FM. Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm. Am J Psychiatry. 2014 Nov 1;171(11):1199-205. doi: 10.1176/appi.ajp.2014.13050595.'}]}, 'descriptionModule': {'briefSummary': 'This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years old;\n* smoked an average of at least 10 cigarettes per day for three cumulative years;\n* have an expired air CO reading assessed at screening of at least 10ppm;\n* express a desire to quit smoking within the next 30 days.\n\nExclusion Criteria:\n\n* Hypertension (systolic \\>140 mm Hg, diastolic \\>100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.\n* Hypotension with symptoms (systolic \\<90 mm Hg, diastolic \\<60 mm Hg).\n* Coronary heart disease;\n* Lifetime history of heart attack;\n* Cardiac rhythm disorder (irregular heart rhythm);\n* Chest pains (unless history, exam, and 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, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);\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* Pregnant or nursing mothers;\n* Alcohol abuse;\n* Use of Opiate medications for pain or sleep in the past 14 days;\n* Significant adverse reaction to nicotine patches, nicotine inhalers, bupropion / Wellbutrin / Zyban or Chantix / Varenicline in the past.\n* Use (within the past 30 days) of:\n* Illegal drugs (or if the urine drug screen is positive),\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), cigars, pipes or e-cigarettes;\n* Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.'}, 'identificationModule': {'nctId': 'NCT01303861', 'acronym': 'ConNic4', 'briefTitle': 'Concurrent Bupropion / Varenicline for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Concurrent Bupropion / Varenicline for Smoking Cessation', 'orgStudyIdInfo': {'id': 'Pro00027351'}, 'secondaryIdInfos': [{'id': '1P50DA027840-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1P50DA027840-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'varenicline', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.', 'interventionNames': ['Drug: Varenicline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Patches only', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.', 'interventionNames': ['Drug: Nicotine patches']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nicotine Patches with Nicotine Inhaler', 'description': 'This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.', 'interventionNames': ['Drug: Nicotine patches', 'Drug: Nicotine Inhaler']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'varenicline with bupropion', 'description': 'This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.', 'interventionNames': ['Drug: Varenicline', 'Drug: Bupropion']}], 'interventions': [{'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline 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 weeks.', 'armGroupLabels': ['varenicline', 'varenicline with bupropion']}, {'name': 'Bupropion', 'type': 'DRUG', 'otherNames': ['Zyban'], 'description': 'For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.', 'armGroupLabels': ['varenicline with bupropion']}, {'name': 'Nicotine patches', 'type': 'DRUG', 'otherNames': ['Nicoderm'], 'description': 'Nicotine Replacement Therapy Groups:\n\n1. For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or\n2. For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.\n\nVarenicline and varenicline in combination with bupropion groups:\n\n1. For smokers with high baseline CO: 42 mg/24 h for 1 week\n2. For smokers with low baseline CO: 21 mg/24 h for 1 week', 'armGroupLabels': ['Nicotine Patches only', 'Nicotine Patches with Nicotine Inhaler']}, {'name': 'Nicotine Inhaler', 'type': 'DRUG', 'otherNames': ['Nicotrol Inhaler'], 'description': 'Nicotine inhaler to use as needed after quit date', 'armGroupLabels': ['Nicotine Patches with Nicotine Inhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Nicotine and Smoking Cessation Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Nicotine and Smoking Cessation Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Nicotine and Smoking Cessation Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center for Nicotine and Smoking Cessation Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Jed E Rose, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Philip Morris USA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}