Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

美沙酮维持治疗患者的伐尼克兰戒烟治疗

• 批准号: 8311822
• 负责人: Shadi Nahvi
• 金额: $ 18.17万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-21 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8311822
• 关键词: Address; Adherence; Adjuvant; Adult; Agonist; Alcohol abuse; Alcohol consumption; Anti-Retroviral Agents; Applications Grants; Behavior; Behavior Therapy; Behavioral; Bupropion; Cessation Research; Characteristics; Clinic; Clinical; Clinical Investigator; Clinical Trials; Complement; Conduct Clinical Trials; Development; Development Plans; Directly Observed Therapy; Disease; Drug usage; Drug user; Environment; Evaluation; Fostering; Future; General Population; HIV; Health; Healthy People 2010; High Prevalence; Illicit Drugs; Intervention; Link; Malignant Neoplasms; Mentors; Mentorship; Methadone; Modeling; Morbidity - disease rate; Motivation; Opioid; Outcome; Patients; Persons; Pharmaceutical Preparations; Population; Prevalence; Regimen; Research; Research Methodology; Research Personnel; Science; Self-Administered; Services; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Specific qualifier value; Substance abuse problem; Symptoms; Testing; Time; Tobacco; Tobacco Control Research; Tobacco Use Cessation; Tobacco use; Training; Treatment outcome; Tuberculosis; United States National Institutes of Health; Vulnerable Populations; Withholding Treatment; base; burden of illness; career development; design; effective intervention; improved; medication compliance; methadone clinic/center; methadone maintenance; mortality; nicotine replacement; novel; prevent; programs; psychologic; public health relevance; randomized trial; reduce tobacco use; research and development; skills; smoking cessation; substance abuse treatment; substance abuser; tobacco control; treatment program; varenicline

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.

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。拟议的研究和职业发展计划以强化指导、教学计划和强大的研究环境为基础，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；为吸毒者制定和评估量身定制的行为干预措施。此次培训将促进 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，以对美沙酮维持吸烟者进行量身定制的戒烟干预措施进行随机试验。 该提案解决了烟草控制研究中的两个挑战：1）确定烟草使用流行率过高的人群的有效干预措施； 2) 促进坚持戒烟干预措施。美沙酮维持治疗患者中烟草使用和烟草相关疾病的患病率明显较高。由于依从性差，伐尼克兰所证实的疗效可能无法推广到美沙酮维持吸烟者，而这种情况在吸毒者中非常普遍。坚持戒烟药物与戒烟密切相关，是为数不多的可提高美沙酮维持吸烟者戒烟率的因素之一，但尚未在美沙酮患者中评估促进戒烟药物依从性的策略。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）的干预措施，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 干预措施已被证明可以改善艾滋病毒和结核病的药物依从性和临床结果，因此我们建议在一项随机试验中确定美沙酮诊所提供的 DOT 伐尼克兰在促进戒烟和提高依从性方面是否比自行给药伐尼克兰更有效。我们还将评估药物和酒精使用以及精神症状对 DOT 效应的调节作用。 公共健康相关性：减少成年人的烟草使用和增加成年人的戒烟尝试是《健康人 2010》的目标，确定增加使用经过验证的戒烟治疗的策略被 NIH 关于烟草使用的科学状况声明确定为优先事项。我们希望通过制定和评估一项干预措施来优化美沙酮维持吸烟者的戒烟药物使用，从而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有关的疾病，并可能挽救生命。