Incentive-based Smoking Cessation for Methadone Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stacey C. Sigmon, Fletcher Allen Health Care
ClinicalTrials.gov Identifier:
NCT00718835
First received: July 17, 2008
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking Among Patients Currently Receiving Methadone or Buprenorphine Treatment for Opioid Dependence
Behavioral: incentive-based contingency management
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incentive-based Smoking Cessation for Methadone Patients

Resource links provided by NLM:


Further study details as provided by Fletcher Allen Health Care:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 170
Study Start Date: June 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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).
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.
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).

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718835

Locations
United States, Vermont
Substance Abuse Treatment Center, University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Fletcher Allen Health Care
Investigators
Principal Investigator: Stacey C. Sigmon, Ph.D. University of Vermont, Department of Psychiatry
  More Information

No publications provided

Responsible Party: Stacey C. Sigmon, Associate Professor, Fletcher Allen Health Care
ClinicalTrials.gov Identifier: NCT00718835     History of Changes
Other Study ID Numbers: R01-DA019550, R01DA019550
Study First Received: July 17, 2008
Last Updated: February 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Fletcher Allen Health Care:
smoking cessation
behavioral treatment
contingency management
opioid maintenance
methadone
buprenorphine

Additional relevant MeSH terms:
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014