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Improving Varenicline Adherence and Outcomes in Homeless Smokers

Improving Varenicline Adherence and Outcomes in Homeless Smokers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00786149
Enrollment
428
Registered
2008-11-06
Start date
2007-09-30
Completion date
2011-03-31
Last updated
2014-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Cessation

Keywords

Underserved populations, Homelessness, Nicotine replacement therapy, Counseling, Cancer Prevention and control

Brief summary

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

Detailed description

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.

Interventions

OTHERVarenicline plus Motivational Interviewing counseling

Motivational Interviewing; 8 weeks of counseling

OTHERVarenicline without counseling

Brief advice, one time during initial session

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
7-day point prevalence abstinence from smoking6 months after enrollment

Secondary

MeasureTime frame
Adherence to treatment12 weeks and 6 months after enrollment
Moderating effects of psychiatric co-morbidities and other substance abuse on treatment6 months after enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026