Incentive-based Smoking Cessation for Methadone Patients
| Tracking Information | |||||
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| First Received Date ICMJE | July 17, 2008 | ||||
| Last Updated Date | March 7, 2013 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
percent of subjects abstinent during the second week of the two-week monitoring period [ Time Frame: continuously and at end of 2-week trial ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00718835 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous) [ Time Frame: continuously and at end of 2-week trial ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Incentive-based Smoking Cessation for Methadone Patients | ||||
| Official Title ICMJE | Incentive-based Smoking Cessation for Methadone Patients | ||||
| Brief Summary | 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. |
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| Detailed Description | 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence | ||||
| Intervention ICMJE | Behavioral: incentive-based contingency management
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). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 170 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00718835 | ||||
| Other Study ID Numbers ICMJE | R01-DA019550, R01DA019550 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stacey C. Sigmon, Fletcher Allen Health Care | ||||
| Study Sponsor ICMJE | Fletcher Allen Health Care | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Fletcher Allen Health Care | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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