Improving Varenicline Adherence and Outcomes in Homeless Smokers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 428
- 试验地点
- 2
- 主要终点
- 7-day point prevalence abstinence from smoking
研究概览
简要总结
the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •currently homeless
- •smoke 5 or more cigarettes per day
- •smoked 100 cigarettes in lifetime
- •aged 18 years or older
排除标准
- •unstable mental illness
- •pregnancy
- •current history of psychoactive or alcohol dependence or psychotic disorder
- •cognitive impairment
结局指标
主要结局
7-day point prevalence abstinence from smoking
时间窗: 6 months after enrollment
次要结局
- Moderating effects of psychiatric co-morbidities and other substance abuse on treatment(6 months after enrollment)
- Adherence to treatment(12 weeks and 6 months after enrollment)
