Improving Varenicline Adherence and Outcome in Homeless Smokers

描述（由申请人提供）：一个服务不足的群体是美国400万无家可归者，其中吸烟率高达70%或更高;这些比率是全国平均水平的3倍。无家可归者死亡的三个主要原因中的两个-心脏病和癌症-与烟草有关。尽管这一人群的吸烟率和疾病负担非常高，但戒烟研究尚未扩展到无家可归者。最近的研究，包括我们研究小组的数据显示，无家可归的吸烟者在相当程度上愿意戒烟，尼古丁替代疗法加上咨询显示出希望。然而，无家可归者面临着许多挑战，这些挑战可能构成他们坚持戒烟治疗的障碍，即使这种治疗已被证明在一般人群中有效。为了减少吸烟相关的健康差距在这一服务不足的人口，至关重要的是，戒烟干预措施，包括战略，以提高治疗依从性，包括无家可归的吸烟者。本研究的主要目的是评估以坚持为中心的动机访谈，以帮助无家可归者戒烟的效果。这项以社区为基础的随机研究将从明尼阿波利斯/圣保罗大都会区7个县的无家可归者收容所和设施中招募428名参与者。该研究将分为干预组和比较组，两组受试者均将接受21 mg尼古丁贴片，持续8周。此外，干预组中的那些将接受五次以依从性为重点的MI会话，而比较组中的那些将接受一次性的戒烟简短建议。该研究的主要结果是6个月时经生化验证的7天点戒烟率。其他结果包括对尼古丁贴片的依从性以及物质滥用和精神共病对无家可归吸烟者中MI功效的调节作用。此外，该研究采用了一种创新的“斑贴检查”方案，通过直接观察来测量对研究药物治疗的依从性。将通过使用公共汽车通行证、借记卡、有吸引力的干预材料、与无家可归者收容所的合作以及社区咨询委员会的建议来加强招聘和保留。该研究在许多方面具有创新性，包括：通过使用循证方法药物治疗和动机访谈咨询将戒烟研究扩展到贫困和服务不足的人群，填补了吸烟研究的关键空白;它评估了一种咨询方法，允许参与者解决可能影响吸烟和治疗依从性的多种挑战;我们希望这项研究的结果能够推动无家可归人群循证戒烟干预的“最佳实践”，并为如何克服癌症预防服务的障碍提供一个模式。

DESCRIPTION (provided by applicant): 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. 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 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 to help homeless persons quit smoking. This community-based randomized study will recruit 428 participants from homeless shelters and facilities in the 7-County greater Minneapolis/St. Paul metro area. The study will have an Intervention and a Comparison arm. Participants in both arms will receive 21 mg nicotine patches for eight weeks. In addition, those in the Intervention arm will receive five adherence- focused Ml sessions while those in the Comparison arm will receive a one-time brief advice to quit smoking. The primary outcome of the study is biochemically-verified 7-day point prevalence abstinence from cigarettes at 6 months. Other outcomes include adherence to nicotine patch and the moderating effects of substance abuse and psychiatric co-morbidities on the efficacy of Ml among homeless smokers. In addition the study employs an innovative protocol for "patch checks" to measure by direct observation adherence to study pharmacotherapy. 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. The study is innovative in a number of ways including, it fills a critical gap in smoking research by extending smoking cessation research to a poor and underserved population using evidence- based approaches pharmacotherapy and motivational interviewing counseling; it evaluates a counseling approach that allows participants to address multiple challenges that could impact smoking and treatment adherence; and we expect that findings from the proposed study would serve as impetus to establish "best practices" for evidence-based smoking cessation interventions for homeless populations and to provide a model for how to overcome barriers to cancer prevention services.