Incentive-Based Smoking Cessation for Methadone Patients - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00718835

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 II

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:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (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).

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

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

Contacts

Contact: Stacey C. Sigmon, Ph.D.

802-656-9987

stacey.sigmon@uvm.edu

Locations

United States, Vermont
Substance Abuse Treatment Center, University of Vermont	Recruiting
Burlington, Vermont, United States, 05401
Contact: Stacey C. Sigmon, Ph.D. 802-656-9987 stacey.sigmon@uvm.edu
Principal Investigator: Stacey C. Sigmon, Ph.D.

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Stacey C. Sigmon, Ph.D.

University of Vermont, Department of Psychiatry

More Information

No publications provided

Responsible Party:	Stacey C. Sigmon, Ph.D., University of Vermont
ClinicalTrials.gov Identifier:	NCT00718835 History of Changes
Other Study ID Numbers:	R01-DA019550, R01-DA019550
Study First Received:	July 17, 2008
Last Updated:	July 17, 2008
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):

smoking cessation
behavioral treatment
contingency management

opioid maintenance
methadone
buprenorphine

Additional relevant MeSH terms:

Smoking
Opioid-Related Disorders
Habits
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012