Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT01040260
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2009-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-Cost Contingency Management for Smoking Cessation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D000095488', 'term': 'Nicotine Replacement Therapy'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Timothy.Carmody@ucsf.edu', 'phone': '(415) 221-4810', 'title': 'Dr. Timothy Carmody', 'phoneExt': '26344', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Participants are asked about adverse at each follow-up assessment visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Contingency Management', 'description': 'Use of tangible rewards for verified abstinence', 'otherNumAtRisk': 53, 'otherNumAffected': 2, 'seriousNumAtRisk': 53, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Counseling Plus Nicotine Patches', 'description': 'Counseling plus nicotine patches, CO testing without contingency management', 'otherNumAtRisk': 50, 'otherNumAffected': 2, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abstinence Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Contingency Management', 'description': 'Use of tangible rewards for verified abstinence'}, {'id': 'OG001', 'title': 'Counseling Plus Nicotine Patches', 'description': 'Counseling plus nicotine patches, CO testing without contingency management'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '52 weeks', 'description': 'Number of participants who abstained from smoking during the 7 day period verified by CO testing', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Contingency Management', 'description': 'Use of tangible rewards for verified abstinence'}, {'id': 'FG001', 'title': 'Counseling Plus Nicotine Patches', 'description': 'Counseling plus nicotine patches, carbon monoxide (CO) testing without contingency management'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Contingency Management', 'description': 'Use of tangible rewards for verified abstinence'}, {'id': 'BG001', 'title': 'Counseling Plus Nicotine Patches', 'description': 'Counseling plus nicotine patches, CO testing without contingency management'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.4', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '47.3', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '46.3', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2009-12-27', 'resultsFirstSubmitDate': '2013-06-23', 'studyFirstSubmitQcDate': '2009-12-28', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-23', 'studyFirstPostDateStruct': {'date': '2009-12-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence Rate', 'timeFrame': '52 weeks', 'description': 'Number of participants who abstained from smoking during the 7 day period verified by CO testing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tobacco use disorder'], 'conditions': ['Tobacco Use Cessation']}, 'descriptionModule': {'briefSummary': 'An innovative low-cost form of contingency management has been developed in which participants receive the chance to draw vouchers from a fish bowl depending on whether or not their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can be redeemed for prizes of varying value. This form of contingency management has been shown to be effective in the treatment of a variety of substance use disorders, but has not been investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of the proposed study will be to investigate the effects of a low-cost prize-based form of contingency management in the treatment of nicotine dependence. To accomplish this objective, we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the contingency management intervention for 8 weeks, and the participants in Study Arm 2 had their smoking status assessed but did not receive the contingency management intervention. Both interventions received brief counseling and nicotine replacement therapy. The counseling was conducted in two 60-minute individual sessions scheduled one week apart with two follow-up phone calls at weeks 3, 4, and 6.\n\nThe primary outcome for this study was biochemically-validated smoking status at 3 months (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent abstinence rates were determined. Saliva cotinine levels were measured in all participants reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These estimates included an anticipated 15% loss to follow-up over the 12-month study period.', 'detailedDescription': 'Contingency management as a treatment for substance use disorders involves the use of tangible rewards for confirmed abstinence. There is preliminary evidence that contingency management shows promise as a smoking cessation intervention. An innovative low-cost form of contingency management has been developed in which participants receive the chance to draw vouchers from a fish bowl depending on whether or not their abstinence from tobacco is confirmed by expired-air carbon monoxide. The vouchers can be redeemed for prizes of varying value. This form of contingency management has been shown to be effective in the treatment of a variety of substance use disorders, but has not been investigated in a clinical trial focusing on smoking cessation. Thus, the primary purpose of the proposed study was to investigate the effects of a low-cost prize-based form of contingency management in the treatment of nicotine dependence. To accomplish this objective, we enrolled 103 current smokers into the study. The participants in Study Arm 1 received the contingency management intervention for 8 weeks, and the participants in Study Arm 2 had their smoking status assessed but did not receive the contingency management intervention. Both interventions received brief counseling and nicotine replacement therapy. The counseling was conducted in two 60-minute individual sessions scheduled one week apart with two follow-up phone calls at weeks 3, 4, and 6.\n\nThe primary outcome for this study was biochemically-validated smoking status at 3 months (end of treatment), and at 6- and 12-month follow-up. Both continuous and point-prevalent abstinence rates were determined. Saliva cotinine levels were measured in all participants reporting abstinence at each assessment. This study had 80% power to detect a 10% absolute difference in smoking cessation rates between the two treatment conditions (i.e., a 28% quit rate in Study Arm 1 versus a 18% quit rate in Study Arm 2) with alpha set at 0.05. These estimates included an anticipated 15% loss to follow-up over the 12-month study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Smoke at least 5 cigarettes per day\n* Interested in quitting\n\nExclusion Criteria:\n\n* Cognitive impairment or unstable psychotic disorder that would significantly interfere with the individual's ability to participate in the study.\n* Self-reported problem with alcohol or other drugs during the past three months\n* Current use of any smoking cessation medication\n* Presence of any contraindications for nicotine patches, lozenges, or gum\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT01040260', 'briefTitle': 'Low-Cost Contingency Management for Smoking Cessation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Low-Cost Contingency Management for Smoking Cessation', 'orgStudyIdInfo': {'id': '17RT-0081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contingency management', 'description': 'Use of tangible rewards for verified abstinence', 'interventionNames': ['Behavioral: Contingency management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Counseling plus nicotine patches', 'description': 'Counseling plus nicotine patches', 'interventionNames': ['Other: Counseling', 'Drug: Nicotine patches']}], 'interventions': [{'name': 'Counseling', 'type': 'OTHER', 'otherNames': ['Smoking cessation counseling'], 'description': 'Smoking cessation counseling', 'armGroupLabels': ['Counseling plus nicotine patches']}, {'name': 'Contingency management', 'type': 'BEHAVIORAL', 'otherNames': ['Low-cost contingency management'], 'description': 'Use of tangible rewards for abstinence from smoking', 'armGroupLabels': ['Contingency management']}, {'name': 'Nicotine patches', 'type': 'DRUG', 'otherNames': ['Nicotine replacement'], 'description': 'Nicotine patches', 'armGroupLabels': ['Counseling plus nicotine patches']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Timothy P Carmody, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}