Improving Varenicline Adherence and Outcomes in Homeless Smokers - Full Text View

Sponsored by:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00786149

Purpose

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

Condition	Intervention	Phase
Tobacco Use Cessation	Other: Varenicline plus Motivational Interviewing counseling Other: Varenicline without counseling	Phase III

MedlinePlus related topics: Smoking

Drug Information available for: Varenicline Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Improving Varenicline Adherence and Outcomes in Homeless Smokers

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

7-day point prevalence abstinence from smoking [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adherence to treatment [ Time Frame: 12 weeks and 6 months after enrollment ] [ Designated as safety issue: No ]
Moderating effects of psychiatric co-morbidities and other substance abuse on treatment [ Time Frame: 6 months after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	428
Study Start Date:	September 2007
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive NRT and Motivational Interviewing counseling	Other: Varenicline plus Motivational Interviewing counseling Motivational Interviewing; 8 weeks of counseling
2: Active Comparator Varenicline plus brief advice	Other: Varenicline without counseling Brief advice, one time during initial session

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786149

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator:

Kolawole S Okuyemi, MD,MPH

University of Minnesota

More Information

Responsible Party:	University of Minnesota ( Dr. Kolawole Okuyemi / Director of the Program in Health Disparities Research )
Study ID Numbers:	0708M14444, HL081522, NIH-522
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786149
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Underserved populations
Homelessness
Nicotine replacement therapy
Counseling
Cancer Prevention and control

Study placed in the following topic categories:

Nicotine polacrilex
Nicotine

ClinicalTrials.gov processed this record on January 16, 2009