Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

描述(由申请人提供)：该提案旨在为Nahvi博士提供高级培训和指导研究，使其成为脆弱人群烟草控制方面的独立调查员。在密集的指导、教学计划和强大的研究环境的基础上，拟议的研究和职业发展计划将使纳维博士能够扩大她在以下方面的培训：临床试验的设计和实施；戒烟研究方法；以及为吸毒者制定和评估量身定制的行为干预措施。这项培训将促进Nahvi博士成为一名独立的临床研究人员，并指导未来的R01拨款申请，对美沙酮维持吸烟者进行量身定制的戒烟干预的随机试验。这项建议解决了烟草控制研究中的两个挑战：1)在烟草使用率高得不成比例的人群中确定有效的干预措施；2)促进遵守戒烟干预措施。美沙酮维持治疗患者中有明显的烟草使用和烟草相关疾病的流行。由于依从性差，在吸毒者中非常普遍，varenicline被证明的疗效可能不适用于美沙酮维持吸烟者。坚持戒烟药物与戒烟密切相关，是少数几个在美沙酮维持吸烟者中增加戒烟的因素之一，但促进戒烟药物坚持的策略尚未在美沙酮患者中进行评估。基于信息、动机和行为模型，我们提出了一种基于直接观察疗法(DOT)的干预方法，以达到最佳依从性所必需的行为技能为目标。由于基于美沙酮诊所的DOT干预措施已被证明可以改善艾滋病毒和结核病的用药依从性和临床结果，我们建议在一项随机试验中确定在美沙酮诊所提供的DOT varenicline在促进戒烟和提高依从性方面是否比自我给药的varenicline更有效。我们还将评估药物和酒精使用以及精神症状对DOT效应的缓解作用。 公共卫生相关性：减少烟草使用和增加成年人的戒烟尝试是2010年健康人的目标，确定增加使用经过验证的戒烟治疗的策略在NIH烟草使用状况声明中被确定为优先事项。我们希望通过开发和评估在美沙酮维持吸烟者中优化戒烟药物使用的干预措施来帮助美沙酮维持吸烟者戒烟。如果有效，这种干预措施有可能预防癌症和其他与吸烟相关的疾病，并可能拯救生命。

DESCRIPTION (provided by applicant): This proposal is for advanced training and mentored research for Dr. Nahvi to become an independent investigator in tobacco control among vulnerable populations. Building on intensive mentorship, didactic programs, and a strong research environment, the proposed research and career development plan will allow Dr. Nahvi to expand her training in the design and conduct of clinical trials; smoking cessation research methods; and the development and evaluation of tailored behavioral interventions for drug users. This training will foster Dr. Nahvi's development as an independent clinical investigator and guide a future R01 grant application to conduct a randomized trial of a tailored smoking cessation intervention for methadone maintained smokers. This proposal addresses two challenges in tobacco control research: 1) Determining effective interventions among populations with a disproportionately high tobacco use prevalence; and 2) promoting adherence to smoking cessation interventions. There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, we propose a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, we propose to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self- administered varenicline for promoting smoking cessation and enhancing adherence. We will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. PUBLIC HEALTH RELEVANCE: Reducing tobacco use and increasing smoking cessation attempts among adults are objectives of Healthy People 2010, and determining strategies to increase use of proven cessation treatments was identified as a priority in the NIH State-of-the-Science statement on tobacco use. We hope to help methadone maintained smokers quit smoking by developing and evaluating an intervention to optimize smoking cessation medication use among methadone maintained smokers. If effective, this intervention has the potential to prevent cancer and other smoking-related diseases, and may save lives.