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Completed

NCT Number: NCT00786149

Improving Varenicline Adherence and Outcomes in Homeless Smokers

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

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline plus Motivational Interviewing counseling

Other

Motivational Interviewing; 8 weeks of counseling

Other names: Chantix

Varenicline without counseling

Other

Brief advice, one time during initial session

Other names: Chantix

Primary outcomes

  1. 7-day point prevalence abstinence from smoking

    Time frame: 6 months after enrollment

Secondary outcomes

  1. Adherence to treatment

    Time frame: 12 weeks and 6 months after enrollment

  2. Moderating effects of psychiatric co-morbidities and other substance abuse on treatment

    Time frame: 6 months after enrollment

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Nov 6, 2008
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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