Improving Varenicline Adherence and Outcomes in Homeless Smokers

Study Overview
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Brief Summary
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the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.

Detailed Description
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Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking. Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.

Official Title
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Improving Varenicline Adherence and Outcomes in Homeless Smokers

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Other: Varenicline plus Motivational Interviewing counseling
* Other: Varenicline without counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: currently homeless smoke 5 or more cigarettes per day smoked 100 cigarettes in lifetime aged 18 years or older Exclusion Criteria: unstable mental illness pregnancy current history of psychoactive or alcohol dependence or psychotic disorder cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive NRT and Motivational Interviewing counseling | Other: Varenicline plus Motivational Interviewing counseling<br>* Motivational Interviewing; 8 weeks of counseling<br>* Other names: Chantix;|
| Active Comparator: 2<br>Varenicline plus brief advice | Other: Varenicline without counseling<br>* Brief advice, one time during initial session<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence from smoking |  | 6 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to treatment |  | 12 weeks and 6 months after enrollment | 
| Moderating effects of psychiatric co-morbidities and other substance abuse on treatment |  | 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Underserved populations, Homelessness, Nicotine replacement therapy, Counseling, Cancer Prevention and control