Use and Effectiveness of Tobacco Pharmacotherapy: A Phase IV Sex Difference Study

 描述（由申请人提供）：女性在戒烟方面存在显著差异，研究已经确定了治疗反应不良的关键因素，包括对戒烟药物的差异反应。尽管有这些知识，但研究结果尚未转化为戒烟的临床效果改善，目前的指南提供的关于基于性别的做法的信息很少。转化为临床实践的一个关键障碍是缺乏来自IV期人群研究的证据。迄今为止，证据仅来自III期临床试验数据;戒烟药物在现实世界中的有效性的性别差异仍然未知。我们将在美国全国代表性样本中进行一项关于戒烟有效性性别差异的IV期药物流行病学研究。[]][[]][][[]][[]][][[]][[]][]][[]][][[][]][][[]][[]][我们的研究将是第一波烟草与健康人口评估（PATH）研究（计划于2015年秋季发布）的二次分析，该研究由NIDA和FDA发起和资助。该研究的大样本量（约59，000）及其在尝试戒烟期间包含的药物/电子烟使用信息将为实现研究目标提供独特且前所未有的机会。该项目还将作为R 01应用程序的基础，用于随后分析PATH数据的纵波。[我们的主要目的是检查真实的世界中戒烟药物比较有效性的性别差异，使用回归和倾向评分方法，并遵循已发表的使用次要数据源进行药物有效性研究的指南。将分析在访谈前12个月内至少尝试戒烟一次（成功或失败）的当前和既往吸烟者的数据（n~ 8，215; 4，240名男性和3，975名女性）。本研究将检查以下药物的比较有效性：尼古丁替代疗法（贴剂、口服NRT、鼻喷雾剂）、伐尼克兰/Chantix和安非他酮/Wellbutrin/Zyban。我们将探讨药物有效性的性别差异是否受教育水平、年收入、种族/民族、尼古丁依赖水平和心理健康的调节。[[[We还将探讨在戒烟尝试期间使用电子烟与成功戒烟可能性之间的关联的性别差异。这项研究解决了国家药物滥用研究所（NIDA）呼吁的项目，“评估目前的药物滥用治疗在男性和女性的差异有效性”（PA-14-037：妇女和性别/性别差异药物和酒精/依赖）。

 DESCRIPTION (provided by applicant): Women experience significant disparities with regards to smoking cessation, and research has identified key factors underlying poor treatment response including differential response to smoking cessation medications. Despite this knowledge, findings have yet to translate into improved clinical outcomes for smoking cessation, and current guidelines provide little information on sex-based practices. One critical barrier for the translation to clinical practice is the lack of evidence from Phase-IV population-based studies. To date, evidence has exclusively emerged from Phase-III clinical trial data; sex differences in real-world effectiveness of stop smoking medications remain unknown. We will conduct a Phase-IV pharmacoepidemiologic study of sex differences in smoking cessation effectiveness in a U.S. nationally representative sample. [[[E-cigarette use during cessation attempts and associations with quitting will also be examined.]]] Our study will be a secondary analysis of the first wave of the Population Assessment of Tobacco and Health (PATH) study (scheduled to be released in the Fall of 2015), which was initiated and funded by NIDA and the FDA. The study's large sample size (~59,000) and its inclusion of information on medication/e-cigarette use during attempts to stop smoking will present a unique and unprecedented opportunity to address the study's aims. The project will also serve as the foundation for an R01 application for subsequent analyses of longitudinal waves of PATH data. [[[Our primary aim will be to examine sex differences in the real world comparative effectiveness of smoking cessation medications, using both regression and propensity score approaches, and following published guidelines for medication effectiveness studies using secondary data sources.]]] Data from current and former smokers who attempted to quit smoking (either successfully or unsuccessfully) at least once during the 12 months prior to their interview (n~8,215; 4,240 men and 3,975 women) will be analyzed. The investigation will examine the comparative effectiveness of the following medications: nicotine replacement therapy (the patch, oral NRT, nasal spray), varenicline/Chantix, and bupropion/Wellbutrin/Zyban. We will explore whether sex differences in medication effectiveness are moderated by education level, annual income, race/ethnicity, nicotine dependence level, and mental health. [[[We will also explore sex differences in associations between use of e-cigarettes during cessation attempts and likelihood of successful cessation.]]] This study addresses the National Institute on Drug Abuse's (NIDA) call for projects that "assess the differential effectiveness of current drug abuse treatments in males and females" (PA-14-037: Women & Sex/Gender Differences in Drug and Alcohol/Dependence).