Grant Number:	1R01CA129226-01A1 Interpret this number
Primary Investigator:	Stein, Michael
Organization:	Butler Hospital (Providence, Ri)
Project Title:	Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
Fiscal Year:	2008

DESCRIPTION (provided by applicant): Opiate dependent persons who are successfully engaged in the treatment of their primary drug of addiction often continue to use other drugs such as nicotine. With the high prevalence of smoking in this population, treatment providers are recognizing that a disproportionate number of those they help recover are now dying of smoking-related illnesses including cancer. Recent studies indicate that persons enrolled in methadone maintenance treatment programs are interested in receiving smoking cessation treatment, but success with standard behavioral and pharmacologic treatments have been disappointing for this population. New hope for dramatic improvement in cessation outcomes now exists with the recent FDA approval of varenicline tartrate, a nicotinic receptor partial agonist. The long-term aim of our proposal is to advance knowledge and produce interventions to help achieve optimal dissemination of smoking cessation strategies for persons with the dual diagnosis of opioid dependence and nicotine dependence. The design of this proposal builds on lessons learned from the successful recent completion of randomized clinical trial of a nicotine replacement smoking cessation intervention based in methadone programs. In the current proposal, we directly compare two forms of pharmacotherapy, combination nicotine- replacement-therapy versus non-nicotine-replacement therapy with varenicline, and compare these against varenicline-placebo. Using this three-group design, we will enroll 602 methadone- maintained cigarettes smokers from five methadone treatment programs in Rhode Island. The Specific Aims are: A.1. PRIMARY AIM To perform, in the setting of a methadone maintenance program, a randomized clinical trial to determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy which combines nicotine patch prescription plus ad libitum nicotine gum delivery. We hypothesize that the 6-month post- treatment 7-day point prevalence quit rates will be 20% and 10% in the two active treatment groups, versus 2.5% in a varenicline-placebo arm. A.2. SECONDARY AIMS a) To test the effects of the treatments on the key construct variables of our theoretical model including smoking urges, withdrawal symptoms, reinforcing effects of smoking. b) To test the effects of the treatments on methadone treatment outcomes including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicological analyses. PUBLIC HEALTH RELEVANCE: Methadone-maintained smokers represent an important and large population of long- term, highly dependent smokers. This application compares, in the methadone setting, two forms of pharmacotherapy, combination nicotine-replacement-therapy versus non- nicotine-replacement therapy with varenicline tartrate, a recently approved nicotinic receptor partial agonist. With close to one million methadone treatment entries per year in the United States, this research can have a meaningful public health impact addressing a high-risk population that would otherwise be difficult to reach.




Early quit days among methadone-maintained smokers in a smoking cessation trial.
Authors: de Dios M.A. , Anderson B.J. , Caviness C.M. , Stein M.D. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2014 Nov; 16(11), p. 1463-9.
PMID: 24951495
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Intimate partner violence among individuals in methadone maintenance treatment.
Authors: de Dios M.A. , Anderson B.J. , Caviness C.M. , Stein M. .
Source: Substance Abuse, 2014; 35(2), p. 190-3.
PMID: 24821357
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Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial.
Authors: Stein M.D. , Caviness C.M. , Kurth M.E. , Audet D. , Olson J. , Anderson B.J. .
Source: Drug And Alcohol Dependence, 2013-12-01 00:00:00.0; 133(2), p. 486-93.
EPub date: 2013-12-01 00:00:00.0.
PMID: 23953658
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Perceived stress and substance use in methadone-maintained smokers.
Authors: Moitra E. , Anderson B.J. , Stein M.D. .
Source: Drug And Alcohol Dependence, 2013-12-01 00:00:00.0; 133(2), p. 785-8.
EPub date: 2013-12-01 00:00:00.0.
PMID: 24011853
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Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons.
Authors: Caviness C.M. , Bird J.L. , Anderson B.J. , Abrantes A.M. , Stein M.D. .
Source: Journal Of Substance Abuse Treatment, 2013 Apr; 44(4), p. 457-62.
PMID: 23199641
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Sitting Time, But Not Level Of Physical Activity, Is Associated With Depression In Methadone-Maintained Smokers.
Authors: Stein M.D. , Caviness C.M. , Anderson B.J. , Abrantes A. .
Source: Mental Health And Physical Activity, 2013-03-01 00:00:00.0; 6(1), p. 43-48.
PMID: 23894252
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The social support and social network characteristics of smokers in methadone maintenance treatment.
Authors: de Dios M.A. , Stanton C.A. , Caviness C.M. , Niaura R. , Stein M. .
Source: The American Journal Of Drug And Alcohol Abuse, 2013 Jan; 39(1), p. 50-6.
PMID: 22571553
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Prescription medication exchange patterns among methadone maintenance patients.
Authors: Caviness C.M. , Anderson B.J. , de Dios M.A. , Kurth M. , Stein M. .
Source: Drug And Alcohol Dependence, 2013-01-01 00:00:00.0; 127(1-3), p. 232-8.
EPub date: 2013-01-01 00:00:00.0.
PMID: 22854293
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Project Impact: a pharmacotherapy pilot trial investigating the abstinence and treatment adherence of Latino light smokers.
Authors: de Dios M.A. , Anderson B.J. , Stanton C. , Audet D.A. , Stein M. .
Source: Journal Of Substance Abuse Treatment, 2012 Oct; 43(3), p. 322-30.
PMID: 22377389
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Trazodone for sleep disturbance during methadone maintenance: a double-blind, placebo-controlled trial.
Authors: Stein M.D. , Kurth M.E. , Sharkey K.M. , Anderson B.J. , Corso R.P. , Millman R.P. .
Source: Drug And Alcohol Dependence, 2012-01-01 00:00:00.0; 120(1-3), p. 65-73.
EPub date: 2012-01-01 00:00:00.0.
PMID: 21798674
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