Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT00136760
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2005-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
Sponsor:
Organization:
Raw JSON
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'description': 'Contingent reinforcement plus bupropion', 'otherNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CM + PLA', 'description': 'Contingent reinforcement plus placebo', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'NR + BUP', 'description': 'Non-contingent reinforcement plus bupropion', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NR + PLA', 'description': 'Non-contingent reinforcement plus placebo', 'otherNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'opiate detoxification', 'notes': 'self-report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea, vomiting', 'notes': 'self-report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'blackout', 'notes': 'self-report, not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety, restlessness', 'notes': 'self-report, not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding ulcer', 'notes': 'self-report, not related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'notes': 'self-report', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Cotinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CM + BUP', 'description': 'Contingent reinforcement plus bupropion'}, {'id': 'OG001', 'title': 'CM + PLA', 'description': 'Contingent reinforcement plus placebo'}, {'id': 'OG002', 'title': 'NR + BUP', 'description': 'Non-contingent reinforcement plus bupropion'}, {'id': 'OG003', 'title': 'NR + PLA', 'description': 'Non-contingent reinforcement plus placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '755', 'spread': '533', 'groupId': 'OG000'}, {'value': '1102', 'spread': '639', 'groupId': 'OG001'}, {'value': '1534', 'spread': '489', 'groupId': 'OG002'}, {'value': '1408', 'spread': '490', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'description': 'Urinary Cotinine levels at Week 4 (average of last 3 study visits)', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CM + BUP', 'description': 'Contingent reinforcement plus bupropion'}, {'id': 'OG001', 'title': 'CM + PLA', 'description': 'Contingent reinforcement plus placebo'}, {'id': 'OG002', 'title': 'NR + BUP', 'description': 'Non-contingent reinforcement plus bupropion'}, {'id': 'OG003', 'title': 'NR + PLA', 'description': 'Non-contingent reinforcement plus placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '18.8', 'spread': '12.9', 'groupId': 'OG002'}, {'value': '21.0', 'spread': '9.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks', 'unitOfMeasure': 'cigarettes per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CM + BUP', 'description': 'Contingent reinforcement plus bupropion'}, {'id': 'FG001', 'title': 'CM + PLA', 'description': 'Contingent reinforcement plus placebo'}, {'id': 'FG002', 'title': 'NR + BUP', 'description': 'Non-contingent reinforcement plus bupropion'}, {'id': 'FG003', 'title': 'NR + PLA', 'description': 'Non-contingent reinforcement plus placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the community, using advertisements, and were recruited from an outpatient clinic at a local VA medical Center.', 'preAssignmentDetails': 'Participants underwent telephone and in-person screening for eligibility criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'CM + BUP', 'description': 'Contingent reinforcement plus bupropion'}, {'id': 'BG001', 'title': 'CM + PLA', 'description': 'Contingent reinforcement plus placebo'}, {'id': 'BG002', 'title': 'NR + BUP', 'description': 'Non-contingent reinforcement plus bupropion'}, {'id': 'BG003', 'title': 'NR + PLA', 'description': 'Non-contingent reinforcement plus placebo'}, {'id': 'BG004', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '46.3', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '7.3', 'groupId': 'BG002'}, {'value': '46.9', 'spread': '6.8', 'groupId': 'BG003'}, {'value': '45.1', 'spread': '8.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2005-08-25', 'resultsFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2005-08-25', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-19', 'studyFirstPostDateStruct': {'date': '2005-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Cotinine', 'timeFrame': '3 weeks', 'description': 'Urinary Cotinine levels at Week 4 (average of last 3 study visits)'}], 'secondaryOutcomes': [{'measure': 'Cigarettes Smoked Per Day', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tobacco'], 'conditions': ['Schizophrenia and Disorders With Psychotic Features', 'Tobacco Use Disorder']}, 'referencesModule': {'references': [{'pmid': '21475970', 'type': 'RESULT', 'citation': 'Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8.'}, {'pmid': '22197799', 'type': 'RESULT', 'citation': 'Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9.'}]}, 'descriptionModule': {'briefSummary': 'There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.', 'detailedDescription': 'There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications\n\nExclusion Criteria:\n\nPregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants'}, 'identificationModule': {'nctId': 'NCT00136760', 'briefTitle': 'Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Brown University'}, 'officialTitle': 'Incentives Plus Bupropion for Smoking in Schizophrenics', 'orgStudyIdInfo': {'id': 'NIDA-17566-1'}, 'secondaryIdInfos': [{'id': 'R01DA017566', 'link': 'https://reporter.nih.gov/quickSearch/R01DA017566', 'type': 'NIH'}, {'id': 'R01-17566-1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Contingent reinforcement plus bupropion', 'interventionNames': ['Drug: Bupropion']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Contingent reinforcement plus placebo', 'interventionNames': ['Drug: Contingent reinforcement plus placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Non-contingent reinforcement plus bupropion', 'interventionNames': ['Drug: non-contingent reinforcement plus bupropion']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Non-contingent reinforcement plus placebo', 'interventionNames': ['Drug: Non-contingent reinforcement plus placebo']}], 'interventions': [{'name': 'Bupropion', 'type': 'DRUG', 'otherNames': ['zyban, wellbutrin'], 'description': 'Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)', 'armGroupLabels': ['1']}, {'name': 'Contingent reinforcement plus placebo', 'type': 'DRUG', 'description': 'contingent reinforcement plus placebo (3 weeks)', 'armGroupLabels': ['2']}, {'name': 'non-contingent reinforcement plus bupropion', 'type': 'DRUG', 'otherNames': ['zyban, wellbutrin'], 'description': 'non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)', 'armGroupLabels': ['3']}, {'name': 'Non-contingent reinforcement plus placebo', 'type': 'DRUG', 'description': 'Non-contingent reinforcement plus placebo', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02912', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Jennifer W. Tidey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brown University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor (Research), Dept Psychiatry and Human Behavior', 'investigatorFullName': 'Jennifer Tidey', 'investigatorAffiliation': 'Brown University'}}}}