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

个体化药物治疗：一种促进非裔美国人社区戒烟的新型优化策略。

• 批准号: 10397553
• 负责人: NICOLE L NOLLEN
• 金额: $ 64.64万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10397553
• 关键词: Abstinence; Adult; African American; African American population; Age; Biochemical; Bupropion; Chronic; Chronic Disease; Cigarette; Clinical; Communities; Counseling; Diabetes Mellitus; Discipline; Disease; Early treatment; Ethnic group; Failure; Funding; Gender; Goals; Health; Health Priorities; Heterogeneity; Hypertension; Intervention; Knowledge; Mediating; Mediator of activation protein; Menthol; Methodology; Morbidity - disease rate; Nicotine; Nicotine Dependence; Outcome; Participant; Pathway interactions; Pharmaceutical Preparations; Pharmacotherapy; Prediction of Response to Therapy; Process; Provider; Randomized; Relapse; Research; Research Design; Self Efficacy; Smoker; Smoking; Smoking Cessation Intervention; Smoking Status; Socioeconomic Status; Testing; Time; Tobacco; Tobacco Dependence; Treatment Efficacy; Treatment outcome; United States National Institutes of Health; Ursidae Family; Withdrawal; base; clinical practice; craving; efficacy evaluation; experience; improved; innovation; mortality; negative affect; nicotine exposure; nicotine patch; novel; novel strategies; open label; preemptive intervention; primary endpoint; process optimization; public health relevance; racial and ethnic; response; side effect; smoking cessation; success; treatment as usual; treatment effect; treatment optimization; treatment response; treatment trial; varenicline

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.

项目总结/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。退出 吸烟是吸烟者可以改善健康的最重要的改变，但AA经验 与其他种族/族裔群体相比，尽管吸烟量较轻，但戒烟难度更大（每支< 10支 #21453;，并进行更多的尝试。在大多数戒烟试验中，参与者保持在 在研究结束时，他们被随机分配到药物治疗组。这些试验不提供任何 有机会在治疗过程中改变药物治疗，尽管有证据表明， 在开始治疗后4周内未能实现戒烟的吸烟者永远不会实现长期戒烟。 禁欲改变或增强药物治疗的优化方法已成功用于 其他学科，但相对较新的烟草依赖研究。鉴于烟草依赖是一个 慢性复发性疾病，其特征为多次戒烟尝试失败， 治疗反应，以及缺乏新的药物治疗进展，这是改善的最佳机会 AA吸烟者的烟草治疗在于使用新的方法，探索如何优化治疗 通过提供密集的戒烟咨询，同时改变时间，顺序，或结合 药物疗法以最大限度地提高疗效。本申请的目的是1）评估短期和长期- 经生化验证的7天优化（OPT）与加强常规护理（UC）治疗的长期疗效 非裔美国人吸烟者的戒烟率，2）确定治疗效果的中介者和调节者， 禁欲，3）描述需要优化的受试者比例和经验证的禁欲率 沿着每个优化途径，以及4）表征处理工艺因素（例如，退缩，渴望）超过 优化治疗的时间。这些目标将通过一项随机开放的研究来实现- 392名非裔美国吸烟者戒烟的标签优化治疗试验。参与者 随机分配至OPT组的患者（n=196）将接受戒烟咨询、尼古丁贴片和最多两个 根据第2周时经验证的吸烟状态，对安非他酮和/或伐尼克兰进行药物治疗调整 和6.随机分配至加强UC组的受试者（n=196）将接受相同的戒烟咨询 和尼古丁贴片;不会对药物治疗进行调整。在审判结束时，我们将 为研究和临床社区提供关于优化与非优化的有效性的知识， 实现AA短期和长期禁欲的优化方法，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一个重大转变， 烟草依赖治疗的方法，如果有效，可能对治疗产生广泛的影响。 美国有近600万AA成年吸烟者。