Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT02551692
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073865', 'term': 'Cigarette Smoking'}], 'ancestors': [{'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anthony.devito@duke.edu', 'phone': '919-684-1377', 'title': 'Anthony DeVito, MD', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Bacterial blood infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood in urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Craving Score During Cue Exposure Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.'}, {'id': 'OG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.'}, {'id': 'OG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.17', 'spread': '24.93', 'groupId': 'OG000'}, {'value': '-8.84', 'spread': '28.3', 'groupId': 'OG001'}, {'value': '-14.29', 'spread': '25.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.534', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Partial sum of squares', 'ciNumSides': 'TWO_SIDED', 'paramValue': '855.65', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'Scores range from 0 (no craving) to 100 (extreme craving).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Change in Latency to Smoke During Cue Exposure Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.'}, {'id': 'OG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.'}, {'id': 'OG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.22', 'spread': '71.58', 'groupId': 'OG000'}, {'value': '48.04', 'spread': '95.79', 'groupId': 'OG001'}, {'value': '65.15', 'spread': '133.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Partial sum of squares', 'ciNumSides': 'TWO_SIDED', 'paramValue': '29602.69', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'The latency is the interval between smoking one cigarette and wanting, craving, or needing another.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study.'}, {'type': 'PRIMARY', 'title': 'Change in Smoke Intake During Cue Exposure Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.'}, {'id': 'OG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.'}, {'id': 'OG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.42', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '12.21', 'spread': '4.42', 'groupId': 'OG001'}, {'value': '12.98', 'spread': '7.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Partial sum of squares', 'ciNumSides': 'TWO_SIDED', 'paramValue': '101.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'Measured by number of puffs.', 'unitOfMeasure': 'puffs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.'}, {'id': 'FG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.'}, {'id': 'FG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '37 participants were withdrawn from the study prior to treatment assignment due to either loss of interest, lost to contact, or inability to complete baseline procedures per protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (PLAC)', 'description': 'Placebo Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt, continue to wear the 21mg patches for 6 weeks, then step down to 14mg patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.'}, {'id': 'BG001', 'title': 'Transdermal Nicotine Patch (NRT)', 'description': 'Nicotine Patch: Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.'}, {'id': 'BG002', 'title': 'Varenicline (VAR)', 'description': 'Varenicline: Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '47.4', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '11.9', 'groupId': 'BG002'}, {'value': '44.4', 'spread': '12.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-12', 'size': 734161, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-12-20T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-06', 'studyFirstSubmitDate': '2015-09-15', 'resultsFirstSubmitDate': '2020-01-06', 'studyFirstSubmitQcDate': '2015-09-15', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Craving Score During Cue Exposure Task', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'Scores range from 0 (no craving) to 100 (extreme craving).'}, {'measure': 'Change in Latency to Smoke During Cue Exposure Task', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'The latency is the interval between smoking one cigarette and wanting, craving, or needing another.'}, {'measure': 'Change in Smoke Intake During Cue Exposure Task', 'timeFrame': 'Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)', 'description': 'Measured by number of puffs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cigarette Smoking']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. generally healthy \\[(i.e. ambulatory, not currently sick)\\]\n2. between the ages of 18 and 60\n3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for \\> 1 year\n4. an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine \\>1000 ng/mL (NicAlert = 6).\n5. interest in quitting smoking within the timeframe of the experiment.\n6. ability to identify 4 personal smoking and 4 personal non-smoking places.\n\nExclusion criteria:\n\n1. immediate or no desire to quit smoking;\n2. inability to attend all required experimental sessions;\n3. use of psychoactive medications;\n4. use of smokeless tobacco including e-cigarettes in the past 30 days;\n5. current alcohol or drug abuse;\n6. use of illegal drugs as measured by urine drug screen (excluding marijuana);\n7. use of experimental (investigational) drugs;\n8. current use of nicotine replacement therapy or other smoking cessation treatment;\n9. 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. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual\'s safety;\n10. Hypotension with symptoms (systolic \\<90 mm Hg, diastolic \\<60 mm Hg);\n11. Coronary heart disease;\n12. Lifetime history of heart attack;\n13. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure, arrhythmia); Abnormal EKG results suggestive of ischemia or undiagnosed cardiovascular disease please consider adding if it seems reasonable. For example, ST-segment depression or elevation, T-wave abnormalities, and lack of R wave are obtained with a 12-lead EKG).\n14. Active skin disorder (e.g., psoriasis) within the last year, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);\n15. Medical condition that may contraindicate participation in the opinion of the investigator and study physician.(for example, EKG results)\n16. Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);\n17. Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;\n18. Current depression - The Prime-MD will be used to screen for current (within 2 weeks) depression. Potential subjects who score \\>9 (or who score \\>0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;\n19. Bulimia or anorexia;\n20. Significant adverse reaction to Chantix/Varenicline in the past;\n21. Currently pregnant, breast feeding or likely to become pregnant;\n22. History of seizure disorder.\n23. A quit attempt within the last 30 days'}, 'identificationModule': {'nctId': 'NCT02551692', 'briefTitle': 'Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Effects of Smoking Environments on Craving and Smoking', 'orgStudyIdInfo': {'id': 'Pro00063505'}, 'secondaryIdInfos': [{'id': '1R01DA038442', 'link': 'https://reporter.nih.gov/quickSearch/1R01DA038442', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'NRT', 'interventionNames': ['Drug: Nicotine Patch', 'Drug: Placebo Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'VAR', 'interventionNames': ['Drug: Varenicline', 'Drug: Placebo Nicotine Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLAC', 'interventionNames': ['Drug: Nicotine Patch', 'Drug: Placebo Nicotine Patch', 'Drug: Placebo Capsule']}], 'interventions': [{'name': 'Nicotine Patch', 'type': 'DRUG', 'otherNames': ['NicoDerm CQ'], 'description': 'Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.', 'armGroupLabels': ['NRT', 'PLAC']}, {'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Chantix'], 'description': 'Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.', 'armGroupLabels': ['VAR']}, {'name': 'Placebo Nicotine Patch', 'type': 'DRUG', 'description': 'In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the VAR group, participants will wear a placebo patch while taking varenicline.', 'armGroupLabels': ['PLAC', 'VAR']}, {'name': 'Placebo Capsule', 'type': 'DRUG', 'description': 'In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.\n\nIn the NRT group, participants will take a placebo capsule while wearing nicotine patches.', 'armGroupLabels': ['NRT', 'PLAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Francis J McClernon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}