Incentive-Based Smoking Cessation for Methadone Patients
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on October 19, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence
Intervention: incentive-based contingency management (Behavioral)
Phase: Phase 2
Status: Recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s): Stacey C. Sigmon, Ph.D., Principal Investigator, Affiliation: University of Vermont, Department of Psychiatry
Overall contact: Stacey C. Sigmon, Ph.D., Phone: 802-656-9987, Email: stacey.sigmon@uvm.edu
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.
Clinical Details
Official title: Incentive-Based Smoking Cessation for Methadone Patients
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: percent of subjects abstinent during the second week of the two-week monitoring period
Secondary outcome: mean days of continuous abstinence achieved during the 2-week abstinence monitoring period and mean number days abstinent (non-continuous)
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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).
Locations and Contacts
Stacey C. Sigmon, Ph.D., Phone: 802-656-9987, Email: stacey.sigmon@uvm.edu
Substance Abuse Treatment Center, University of Vermont, Burlington, Vermont 05401, United States; Recruiting Stacey C. Sigmon, Ph.D., Phone: 802-656-9987, Email: stacey.sigmon@uvm.edu Stacey C. Sigmon, Ph.D., Principal Investigator
Additional Information
Starting date: June 2007
Ending date: May 2012
Last updated: July 17, 2008
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