Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT01286402
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2011-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Angela.L.Stotts@uth.tmc.edu', 'phone': '713-500-7590', 'title': 'Angela Stotts, PhD, PI', 'organization': 'University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bupropion SR (Sustained Release)', 'description': 'Group receiving bupropion SR medication\n\nBupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days\n\n\\- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment', 'otherNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Group receiving placebo\n\n-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Newborn readmission for respiratory failure on day of life 5', 'notes': 'MOTHER HAD UPPER RESPIRATORY SYMPTOMS SUGGESTIVE OF INFECTION. INFANT HAD DECREASED FEEDING, LETHARY, DEHYDRATION AND DEVELOPED APNOEA AND WAS INTUBATED FOR RESPIRATORY SUPPORT. EVENT THOUGHT NOT BE RELATED TO STUDY MEDICATION AND IS RESOLVED.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hyperbilirubinemia secondary to ABO incompatibility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion SR (Sustained Release)', 'description': 'Group receiving bupropion SR medication\n\nBupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days\n\n\\- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Group receiving placebo\n\n-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week post treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Enrollment, Retention and Compliance Rates', 'timeFrame': '1 year (estimated)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Continuous Abstinence From End of Treatment Through the 2 Week Followup', 'timeFrame': 'at two week followup visit', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Continuous Abstinence From Birth to 2nd Week Postpartum Followup', 'timeFrame': 'at 2nd week postpartum followup visit', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Self-reported Reduction in Number of Cigarettes Smoked Per Day', 'timeFrame': 'at 1 week post treatment and at 2 week postpartum visit', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Maternal Side Effects', 'timeFrame': 'during treatment, end of treatment and at 2 week postpartum visit', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Perinatal/Neonatal Outcomes', 'timeFrame': 'at neonatal discharge from hospital following delivery', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupropion SR (Sustained Release)', 'description': 'Group receiving bupropion SR medication\n\nBupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days\n\n\\- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Group receiving placebo\n\n-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupropion SR (Sustained Release)', 'description': 'Group receiving bupropion SR medication\n\nBupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days\n\n\\- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Group receiving placebo\n\n-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '26.7', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': '# cigs smoked in past 30 days', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '8.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age started smoking', 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '17.5', 'spread': '4.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Carbon monoxide reading', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '15.2', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '12.0', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'parts per million', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2011-01-25', 'resultsFirstSubmitDate': '2015-06-30', 'studyFirstSubmitQcDate': '2011-01-27', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-05', 'studyFirstPostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment', 'timeFrame': '1 week post treatment'}], 'secondaryOutcomes': [{'measure': 'Enrollment, Retention and Compliance Rates', 'timeFrame': '1 year (estimated)'}, {'measure': 'Continuous Abstinence From End of Treatment Through the 2 Week Followup', 'timeFrame': 'at two week followup visit'}, {'measure': 'Continuous Abstinence From Birth to 2nd Week Postpartum Followup', 'timeFrame': 'at 2nd week postpartum followup visit'}, {'measure': 'Self-reported Reduction in Number of Cigarettes Smoked Per Day', 'timeFrame': 'at 1 week post treatment and at 2 week postpartum visit'}, {'measure': 'Maternal Side Effects', 'timeFrame': 'during treatment, end of treatment and at 2 week postpartum visit'}, {'measure': 'Perinatal/Neonatal Outcomes', 'timeFrame': 'at neonatal discharge from hospital following delivery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking cessation during pregnancy', 'bupropion'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.', 'detailedDescription': 'A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women ≥ 18 years of age\n* Gestational age between 14 and 26 weeks confirmed by ultrasound\n* Currently smoking ≥ 5 cigarettes per day\n\nExclusion Criteria:\n\n* Abnormal liver function tests\n* History of or current seizure disorder or closed head injury with loss of consciousness\n* Known hypersensitivity to bupropion\n* Any psychiatric disorder requiring psychotropic medication\n* Current anorexia or bulimia\n* Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks\n* Major Depressive Disorder or current suicidal risk\n* Use of any illicit substances since receiving knowledge of pregnancy\n* Regular use of alcohol (\\>1 drink/week on average)\n* Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus\n* Twins or other multiple gestation\n* Fetal abnormality on the 14 week ultrasound\n* Plans to deliver at a hospital other than Memorial Hermann\n* Inability to communicate with research staff or make study visits due to lack of phone or transportation access\n* Participation in another clinical study which may affect study outcomes\n* Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)'}, 'identificationModule': {'nctId': 'NCT01286402', 'briefTitle': 'Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy', 'orgStudyIdInfo': {'id': 'HSC-MS-09-0681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupropion SR (sustained release)', 'description': 'Group receiving bupropion SR medication', 'interventionNames': ['Drug: Bupropion SR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Bupropion SR', 'type': 'DRUG', 'otherNames': ['Zyban, Wellbutrin'], 'description': '* 150mg, taken orally, taken daily for the 1st 3 days\n* 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment', 'armGroupLabels': ['Bupropion SR (sustained release)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston, Professional Building', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Angela L Stotts, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Gilstrap, Larry C, M.D.', 'class': 'INDIV'}, {'name': 'The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Family Medicine', 'investigatorFullName': 'Angela Stotts', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}