Improving Varenicline Adherence and Outcomes in Homeless Smokers

Tobacco Use Cessation Clinical Trial

Official title:

Improving Varenicline Adherence and Outcomes in Homeless Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786149
• Other study ID #: 0708M14444
• Secondary ID: HL081522NIH-522
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2008
• Last updated: September 2, 2014
• Start date: September 2007
• Est. completion date: March 2011

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Other:
• Varenicline plus Motivational Interviewing counseling
Motivational Interviewing; 8 weeks of counseling
• Varenicline without counseling
Brief advice, one time during initial session

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence from smoking		6 months after enrollment	No
Secondary	Adherence to treatment		12 weeks and 6 months after enrollment	No
Secondary	Moderating effects of psychiatric co-morbidities and other substance abuse on treatment		6 months after enrollment	No