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Improving Varenicline Adherence and Outcomes in Homeless Smokers

Phase 3
18 Years
Not Enrolling
Tobacco Use Cessation

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Trial Information

Improving Varenicline Adherence and Outcomes in Homeless Smokers

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

7-day point prevalence abstinence from smoking

Outcome Time Frame:

6 months after enrollment

Safety Issue:


Principal Investigator

Kolawole S Okuyemi, MD,MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

March 2011

Related Keywords:

  • Tobacco Use Cessation
  • Underserved populations
  • Homelessness
  • Nicotine replacement therapy
  • Counseling
  • Cancer Prevention and control



University of MinnesotaMinneapolis, Minnesota  55455