Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

描述（由申请人提供）：本提案旨在为Nahvi博士提供高级培训和指导研究，使其成为弱势群体烟草控制方面的独立调查员。在强化指导、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Nahvi博士能够扩大她在临床试验设计和实施方面的培训；戒烟研究方法；以及为吸毒者量身定制的行为干预措施的开发和评估。该培训将促进Nahvi博士作为独立临床研究者的发展，并指导未来的R01拨款申请，为美沙酮维持吸烟者进行量身定制的戒烟干预的随机试验。该建议解决了烟草控制研究中的两个挑战：1)在烟草使用率过高的人群中确定有效的干预措施；2)促进坚持戒烟干预措施。在美沙酮维持患者中，烟草使用和烟草相关疾病明显流行。由于依从性差，伐尼克兰的疗效可能不适用于维持美沙酮的吸烟者，这在吸毒者中非常普遍。坚持戒烟药物与戒烟密切相关，并且是少数几个被证明可以增加美沙酮维持吸烟者戒烟的因素之一，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，针对最佳依从性所需的行为技能。由于基于美沙酮诊所的DOT干预已被证明可以改善HIV和TB患者的药物依从性和临床结果，我们建议通过一项随机试验来确定美沙酮诊所提供的DOT伐伦克林在促进戒烟和增强依从性方面是否比自我给药的伐伦克林更有效。我们还将评估药物和酒精使用以及精神症状对DOT效应的缓和作用。

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.