Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT00718835
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2008-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incentive-based Smoking Cessation for Methadone Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-20', 'studyFirstSubmitDate': '2008-07-17', 'studyFirstSubmitQcDate': '2008-07-17', 'lastUpdatePostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent of subjects abstinent during the second week of the two-week monitoring period', 'timeFrame': 'continuously and at end of 2-week trial'}], 'secondaryOutcomes': [{'measure': 'mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous)', 'timeFrame': 'continuously and at end of 2-week trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smoking cessation', 'behavioral treatment', 'contingency management', 'opioid maintenance', 'methadone', 'buprenorphine'], 'conditions': ['Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence']}, 'referencesModule': {'references': [{'pmid': '26638126', 'type': 'DERIVED', 'citation': 'Sigmon SC, Miller ME, Meyer AC, Saulsgiver K, Badger GJ, Heil SH, Higgins ST. Financial incentives to promote extended smoking abstinence in opioid-maintained patients: a randomized trial. Addiction. 2016 May;111(5):903-12. doi: 10.1111/add.13264. Epub 2016 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. The overarching goal of this project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse.', 'detailedDescription': 'The prevalence of cigarette smoking among patients receiving opioid agonist treatment, such as methadone or buprenorphine maintenance, is more than three-fold that of the general population and is associated with increased morbidity and mortality. Despite these statistics, little is known about how to effectively help opioid-maintained patients to quit smoking. We believe a treatment that successfully promotes smoking cessation in these patients would offer exciting potential for dissemination. First, these treatment modalities are uniquely situated to offer an ideal setting for implementing smoking-cessation interventions. Many patients achieve significant periods of stability and drug abstinence and remain engaged in treatment for long periods of time, which can promote the frequent and prolonged clinical contact to enable success with smoking cessation. Second, opioid treatment programs often adhere to a uniform set of state and federal regulations, which could support the dissemination of an effective intervention throughout clinics across the country. Therefore, the overarching goal of this Behavior Therapy Development project is to systematically develop a voucher-based contingency-management (CM) intervention for promoting initial and longer-term abstinence from cigarette smoking in patients receiving methadone or buprenorphine treatment for their opioid abuse. Our first aim is to develop a CM treatment that will promote initial smoking abstinence in these patients using an intensive but brief 2-week intervention (Study 1). Our second aim will then be to integrate procedures for establishing initial abstinence with those designed for maintaining abstinence with the overarching goal of promoting smoking cessation that is sustained after the incentive program is discontinued (Study 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For inclusion in the proposed study, subjects must report smoking 10 or more cigarettes per day and have smoked at least that amount for the past year. Subjects must be maintained on a stable methadone or buprenorphine dose for the month before study intake, with no evidence of regular illicit-drug abuse (\\<30% positive specimens for illicit drugs in the past 30 days).\n\nExclusion Criteria:\n\n* Participants will be excluded if they are currently pregnant and/or nursing or if they report regular THC use and are unwilling to stop before beginning the study (THC use will confound CO values when we aim to monitor smoking status).'}, 'identificationModule': {'nctId': 'NCT00718835', 'briefTitle': 'Incentive-based Smoking Cessation for Methadone Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont Medical Center'}, 'officialTitle': 'Incentive-based Smoking Cessation for Methadone Patients', 'orgStudyIdInfo': {'id': 'R01DA019550', 'link': 'https://reporter.nih.gov/quickSearch/R01DA019550', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01DA019550', 'link': 'https://reporter.nih.gov/quickSearch/R01DA019550', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Contingent Voucher condition', 'description': 'Subjects in this condition will receive a brief education intervention plus voucher-based incentives contingent on demonstrating objective evidence of recent smoking abstinence.', 'interventionNames': ['Behavioral: incentive-based contingency management']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Noncontingent control condition', 'description': 'Subjects assigned to this control condition will receive the brief education and vouchers delivered independent of smoking status and yoked to the schedule of voucher earnings in the Contingent Voucher condition.', 'interventionNames': ['Behavioral: incentive-based contingency management']}], 'interventions': [{'name': 'incentive-based contingency management', 'type': 'BEHAVIORAL', 'description': 'Direct comparison of Contingent versus Noncontingent incentives in promoting abstinence from smoking among opioid-treatment patients. The biochemical measures of breath carbon monoxide levels and urinary cotinine are used to confirm smoking status. Participants receive voucher-based incentives either contingent upon demonstrating abstinence from recent smoking (Contingent condition) or independent of smoking status (Noncontingent control condition).', 'armGroupLabels': ['Contingent Voucher condition', 'Noncontingent control condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Substance Abuse Treatment Center, University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Stacey C. Sigmon, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont, Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stacey C. Sigmon', 'investigatorAffiliation': 'University of Vermont Medical Center'}}}}