跳至主要内容
临床试验/NCT00786149
NCT00786149已完成3 期

Improving Varenicline Adherence and Outcomes in Homeless Smokers

University of Minnesota2 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2007年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验