Individualizing pharmacotherapy: A novel optimization strategy to increase smoking cessation in the African American community.

项目摘要/摘要 非裔美国人(AA)吸烟者在与烟草有关的发病率和死亡率中所占比例不成比例。戒烟 吸烟是吸烟者可以做出的最重要的改变，以改善他们的健康，但AA体验 与其他种族/民族相比，戒烟难度更大，尽管吸烟者较少(每支10支 一天；CPD)和做出更多的尝试。在大多数戒烟试验中，参与者继续服用 在研究结束时，他们被随机接受药物治疗。这些试验没有提供任何 在治疗过程中改变药物治疗的机会，尽管有证据表明 吸烟者在开始治疗后4周内不能实现戒烟，永远不会实现长期戒烟 禁欲。改变或加强药物治疗的优化方法已成功地应用于 其他学科，但对烟草依赖研究相对较新。鉴于烟草依赖是一种 慢性复发性障碍的特征是多次戒烟尝试失败，在 治疗反应，以及没有新的药物治疗进展，是改善的最佳机会 对AA吸烟者的烟草治疗在于使用探索如何优化治疗的新方法 通过提供密集的戒烟咨询，同时改变时间、顺序或组合 药物疗法，以最大限度地提高疗效。此应用程序的目标是1)评估短期和长期- 经过生化验证的优化(OPT)与强化日常护理(UC)治疗7天的远期疗效 非裔美国人吸烟者的戒烟情况，2)确定治疗效果的调节因素和调节因素 禁欲，3)表征需要优化的受试者的比例和已验证的禁欲比率 沿着每条优化路径，以及4)表征治疗过程因素(例如，戒断、渴求) 对优化治疗的反应时间。这些目标将通过随机开放- 392名非裔美国吸烟者的LABEL优化戒烟治疗试验。参与者 随机化的OPT(n=196)将接受戒烟咨询、尼古丁贴片和最多两次 基于2周时证实的吸烟状况的安非他酮和/或伐伦克林的药物治疗适应性 6.随机接受增强UC治疗的参与者(n=196)将接受相同的戒烟咨询 和尼古丁贴片；不会在药物治疗中进行适应性调整。在审判结束时，我们将 向研究和临床社区提供有关优化与非优化的有效性的知识 实现AA短期和长期戒断的优化方法，以及对 治疗效果的中介者和调节者。创新的研究设计评估了 治疗烟草依赖的方法，如果有效，可能对烟草依赖的治疗产生广泛的影响 美国有近600万AA成人吸烟者。

PROJECT SUMMARY/ABSTRACT African American (AA) smokers bear a disproportionate share of tobacco-related morbidity and mortality. Quitting smoking is the single most important change a smoker can make to improve their health, yet AA experience greater difficulty quitting relative to other racial/ethnic groups despite being lighter smokers (< 10 cigarettes per day; CPD) and making more attempts. In the majority of smoking cessation trials, participants stay on the pharmacotherapy to which they were randomized through the end of the study. These trials do not provide any opportunity to make changes to pharmacotherapy during the course of treatment despite evidence that the smokers who fail to achieve abstinence within 4 weeks of initiating treatment never achieve long-term abstinence. Optimized approaches that change or augment pharmacotherapy have been successfully used in other disciplines but are relatively new to tobacco dependence research. Given that tobacco dependence is a chronic, relapsing disorder characterized by multiple failed quit attempts, the high degree of heterogeneity in treatment response, and the absence of new pharmacotherapy advances, the best opportunities to improve tobacco treatment for AA smokers lie in the use of novel methodologies that explore how to optimize treatment by providing intensive smoking cessation counseling while altering the timing, sequencing, or combining of pharmacotherapies to maximize efficacy. The objectives of this application are to 1) evaluate short- and long- term efficacy of optimized (OPT) versus enhanced usual care (UC) treatment on biochemically-verified 7-day abstinence in African American smokers, 2) identify mediators and moderators of treatments effect on abstinence, 3) characterize the proportion of subjects requiring optimization and the rate of verified abstinence along each optimization pathway, and 4) characterize treatment process factors (e.g., withdrawal, craving) over time in response to optimized treatment. These objectives will be accomplished through a randomized open- label optimized treatment trial for smoking cessation in 392 African American smokers. Participants randomized to OPT (n=196) will receive smoking cessation counseling, nicotine patch, and up to two pharmacotherapy adaptations to bupropion and/or varenicline based on verified smoking status at Weeks 2 and 6. Participants randomized to enhanced UC (n=196) will receive the same smoking cessation counseling and nicotine patch; no adaptations in pharmacotherapy will be made. At the conclusion of the trial we will provide the research and clinical communities with knowledge about the efficacy of optimized versus non- optimized approaches for achieving short- and long-term abstinence for AA , as well as an understanding of the mediators and moderators of treatment effect. The innovative study design evaluates a major shift in the approach to tobacco dependence treatment and, if effective, could have broad treatment implications for the nearly 6 million AA adult smokers in the U.S.