Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT01656733
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2012-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nicotine Replacement for Smoking Cessation During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'oncken@uchc.edu', 'phone': '860-679-3425', 'title': 'Cheryl Oncken, MD, MPH', 'organization': 'University of Connecticut School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from baseline visit up to delivery of infant.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper\n\nNicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.\n\nNicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 12, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bad taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased mucus in throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Low Birth Weigh (<2500 grams)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 4}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Preterm delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spontaneous Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Perinatal Mortality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neonatal Abstinence Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 13}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Maternal Hospitalizationfor Medical Condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fetal Cardiac Anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Club Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infant Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infant Low Blood Sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infant Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper'}, {'id': 'OG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '32-34 weeks gestation (Visit 6)', 'description': 'Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Carbon Monoxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper'}, {'id': 'OG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.50', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '32-34 weeks gestation', 'description': 'As measured by parts per million (ppm) on CO breathalyzer', 'unitOfMeasure': 'parts per million', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants includes only those that attended the 32-34 gestation week visit'}, {'type': 'SECONDARY', 'title': 'Birth Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper'}, {'id': 'OG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '3036.78', 'spread': '583.8', 'groupId': 'OG000'}, {'value': '3141.12', 'spread': '561.94', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At delivery', 'description': 'Birth weight in grams', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.'}, {'type': 'SECONDARY', 'title': 'Gestational Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper'}, {'id': 'OG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.61', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '39.11', 'spread': '2.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At delivery', 'description': 'Measure of age of pregnancy at delivery', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper\n\nNicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}, {'id': 'FG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.\n\nNicotrol Inhaler: Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Placebo Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Baseline Visit (randomization)', 'achievements': [{'comment': '4 discontinued after BL visit (lost to follow up)', 'groupId': 'FG000', 'numSubjects': '67'}, {'comment': '5 discontinued after BL visit ( lost to follow up)', 'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'Visit 1 (1 Week After Quit Date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Visit 2 (2 Weeks After Quit Date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Visit 3 (3 Weeks After Quit Date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'Visit 4 (4 Weeks After Quit Date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Visit 5 (6 Weeks After Quit Date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Visit 6 ( 32-36 Weeks Gestation)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Participants With Perinatal Outcomes', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Visit 7 (1 Month Postpartum) Phone Call', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Visit 8 (6 Months Postpartum)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'No permission to collect birth outcomes', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Delivery at another hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Spontaneous abortion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited beginning August 20, 2012. Enrollment sites included Hartford Hospital (Hartford, CT) and Baystate Medical Center (Springfield, MA).', 'preAssignmentDetails': '154 participants gave written consent for study participation and 137 were randomized. Therefore, 17 participants were excluded for the following reasons: no show after screen (10), high PHQ9 (2), moved out of area (2), current drug use (1), advanced gestational age (1), and stress too high to continue (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper'}, {'id': 'BG001', 'title': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.24', 'spread': '6.30', 'groupId': 'BG000'}, {'value': '26.97', 'spread': '5.45', 'groupId': 'BG001'}, {'value': '27.59', 'spread': '5.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic, White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic, Black', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Highest level of education completed', 'classes': [{'title': 'Grade School Completed', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'High School Completed', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'College or post college completed', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Cigs/day', 'classes': [{'categories': [{'measurements': [{'value': '8.04', 'spread': '4.59', 'groupId': 'BG000'}, {'value': '8.66', 'spread': '4.71', 'groupId': 'BG001'}, {'value': '8.36', 'spread': '4.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'number of cigarettes per day reported at baseline', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of cigarettes per day last two weeks', 'classes': [{'categories': [{'measurements': [{'value': '5.03', 'spread': '4.69', 'groupId': 'BG000'}, {'value': '3.48', 'spread': '3.29', 'groupId': 'BG001'}, {'value': '4.14', 'spread': '3.99', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-18', 'size': 863169, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-15T10:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-27', 'studyFirstSubmitDate': '2012-08-01', 'resultsFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-27', 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days', 'timeFrame': '32-34 weeks gestation (Visit 6)', 'description': 'Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days'}], 'secondaryOutcomes': [{'measure': 'Exhaled Carbon Monoxide', 'timeFrame': '32-34 weeks gestation', 'description': 'As measured by parts per million (ppm) on CO breathalyzer'}, {'measure': 'Birth Weight', 'timeFrame': 'At delivery', 'description': 'Birth weight in grams'}, {'measure': 'Gestational Age', 'timeFrame': 'At delivery', 'description': 'Measure of age of pregnancy at delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking Cessation', 'Pregnancy', 'Nicotrol Inhaler', 'Placebo Inhaler', 'Nicotine Inhaler'], 'conditions': ['Nicotine Dependence', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '31380506', 'type': 'DERIVED', 'citation': 'Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).', 'detailedDescription': 'This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.\n\nSubjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.\n\nPregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoking at least 5 cigarettes per day for the preceding 7 days\n* previous attempt to quit smoking during pregnancy by self report\n* 13-26 weeks gestation\n* at least 16 years of age\n* able to speak English or Spanish\n* intent to carry pregnancy to term\n* stable residence\n\nExclusion Criteria:\n\n* current drug or alcohol abuse or dependence (other than methadone maintenance)\n* twins or other multiple gestation\n* unstable psychiatric disorder\n* unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)\n* known congenital abnormality'}, 'identificationModule': {'nctId': 'NCT01656733', 'briefTitle': 'Nicotine Replacement for Smoking Cessation During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Nicotine Replacement for Smoking Cessation During Pregnancy', 'orgStudyIdInfo': {'id': '11-057-6'}, 'secondaryIdInfos': [{'id': '1R01HD069314-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HD069314-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotrol Inhaler', 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.', 'interventionNames': ['Drug: Nicotrol Inhaler']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Inhaler', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper', 'interventionNames': ['Drug: Placebo Inhaler']}], 'interventions': [{'name': 'Nicotrol Inhaler', 'type': 'DRUG', 'otherNames': ['Nicotine Inhaler'], 'description': 'Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper', 'armGroupLabels': ['Nicotrol Inhaler']}, {'name': 'Placebo Inhaler', 'type': 'DRUG', 'description': 'Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper', 'armGroupLabels': ['Placebo Inhaler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Women's Ambulatory Health Services at Hartford Hospital", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Wesson Women's Clinic at Baystate Medical Center", 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Cheryl Oncken, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Cheryl Oncken', 'investigatorAffiliation': 'UConn Health'}}}}