Improving Varenicline Adherence and Outcome in Homeless Smokers

改善无家可归吸烟者的伐尼克兰依从性和结果

• 批准号: 7845137
• 负责人: Kolawole S Okuyemi
• 金额: $ 23.03万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7845137
• 关键词: Abstinence; Address; Adherence; Alcohol or Other Drugs use; Area; Cause of Death; Cessation Research; Cigarette; Clothing; Collaborations; Communities; Counseling; County; Data; Event; Evidence based practice; Face; Fill-It; Food; General Population; Goals; Heart Diseases; Homeless persons; Homelessness; Intervention; Life; Malignant Neoplasms; Measures; Mediating; Mediation; Methods; Modeling; Morbidity - disease rate; Outcome; Outcome Study; Participant; Pharmacotherapy; Population; Prevalence; Protocols documentation; Randomized; Readiness; Recording of previous events; Recruitment Activity; Research; Shelter facility; Side; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Substance abuse problem; Testing; Time; Tobacco; Tobacco use; Transportation; Underserved Population; Upper arm; Withholding Treatment; base; burden of illness; cancer prevention; cigarette smoking; depression; design; effective therapy; evidence base; experience; health disparity; improved; innovation; mortality; motivational enhancement therapy; nicotine patch; nicotine replacement; patient oriented; prevention service; primary outcome; residence; smoking cessation; smoking prevalence; standard care; treatment adherence; varenicline

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.

描述（由申请人提供）：一个服务不足的群体是美国的400万无家可归者吸烟率的人为70％以上；这些费率是全国平均水平的3倍。无家可归者，心脏病和癌症的三个主要死亡原因中有两个与烟草有关。尽管吸烟率很高，但在这种种群中吸烟研究中的疾病负担尚未扩展到无家可归者。最近的研究包括来自我们研究团队的数据，表明，无家可归的吸烟者的吸烟有很大程度的准备，尼古丁替代疗法加上咨询表明有希望。但是，无家可归的人面临许多挑战，即使证明这种治疗对普通人群有效，也可能构成他们坚持戒烟治疗的障碍。为了减少该服务不足的人群中与吸烟有关的健康差异，至关重要的是，戒烟干预措施包括提高治疗依从性的策略以包括无家可归的吸烟者。这项研究的主要目的是评估以依从性动机访谈的影响，以帮助无家可归者戒烟。这项基于社区的随机研究将招募428名来自无家可归者庇护所的参与者，其中7县大明尼阿波利斯/ST。保罗都会区。该研究将有干预和比较部门。双臂的参与者将获得21毫克尼古丁贴片，持续8周。此外，干预部门中的人将获得五个以依从性为中心的ML疗程，而在比较部门中的那些则将获得一次性简短建议以戒烟。这项研究的主要结果是在6个月时对香烟的生化验证的7天点戒酒。其他结果包括遵守尼古丁补丁以及药物滥用和精神病合并症对无家可归吸烟者中ML功效的调节作用。此外，该研究还采用了“斑块检查”的创新协议，通过直接观察依从性研究药物治疗。通过使用公交通行证，借记卡，有吸引力的干预材料，与无家可归者庇护所的合作以及社区顾问委员会的建议，将通过使用公交通行证，借记卡，有吸引力的干预材料，与之合作来增强招聘和保留。这项研究以多种方式具有创新性，包括使用循证方法的药物治疗和动机访谈咨询来扩展吸烟研究，从而填补了吸烟研究的关键差距；它评估了一种咨询方法，该方法使参与者能够应对可能影响吸烟和治疗依从性的多重挑战；我们预计，拟议的研究的发现将成为为无家可归者人群提供基于证据的戒烟干预措施的“最佳实践”的动力，并为如何克服预防癌症预防服务的障碍提供模型。