- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718835
Incentive-based Smoking Cessation for Methadone Patients
February 20, 2014 updated by: Stacey C. Sigmon, University of Vermont Medical Center
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.
Study Overview
Status
Completed
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
170
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Vermont
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Burlington, Vermont, United States, 05401
- Substance Abuse Treatment Center, University of Vermont
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Contingent Voucher condition
Subjects in this condition will receive a brief education intervention plus voucher-based incentives contingent on demonstrating objective evidence of recent smoking abstinence.
|
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).
|
Placebo Comparator: Noncontingent control condition
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percent of subjects abstinent during the second week of the two-week monitoring period
Time Frame: continuously and at end of 2-week trial
|
continuously and at end of 2-week trial
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
continuously and at end of 2-week trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Stacey C. Sigmon, Ph.D., University of Vermont, Department of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 17, 2008
First Submitted That Met QC Criteria
July 17, 2008
First Posted (Estimate)
July 21, 2008
Study Record Updates
Last Update Posted (Estimate)
February 21, 2014
Last Update Submitted That Met QC Criteria
February 20, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA019550 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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