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Clinical Trials/NCT00718835
NCT00718835
Completed
Phase 2

Incentive-based Smoking Cessation for Methadone Patients

University of Vermont Medical Center1 site in 1 country170 target enrollmentJune 2007

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence
Sponsor
University of Vermont Medical Center
Enrollment
170
Locations
1
Primary Endpoint
percent of subjects abstinent during the second week of the two-week monitoring period
Status
Completed
Last Updated
12 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
June 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stacey C. Sigmon

Associate Professor

University of Vermont Medical Center

Eligibility Criteria

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).

Outcomes

Primary Outcomes

percent of subjects abstinent during the second week of the two-week monitoring period

Time Frame: continuously and at end of 2-week trial

Secondary Outcomes

  • mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous)(continuously and at end of 2-week trial)

Study Sites (1)

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