Improving smoking abstinence outcomes in the African American community through extended treatment

项目摘要/摘要 在美国，非裔美国人背负着不成比例的烟草负担。非裔美国人吸烟者 烟草引起的疾病、癌症发病率和死亡率最高。惊人的健康 尽管非裔美国人的吸烟率与白人相似，但仍存在差异 每天减少吸烟(CPD)。为了对非裔美国吸烟者的过早死亡率产生影响， 必须确定对整个吸烟过程中的吸烟者进行有效的治疗。此外，因为吸烟 非裔美国人吸烟者的戒烟率往往较低，有必要找到提高戒烟率的方法 对药物治疗的反应，以更好地促进这一高危群体的戒烟。延长治疗时间有 已证实可增加白人吸烟者的戒烟率，但从未在非洲进行过试验 美国吸烟者，他们可能受益于延长戒烟和减少复发的药物支持。 这项研究的主要目的是评估FDA批准的领先药物varenicline的延长使用 烟草治疗药物，目的是提高非裔美国人日常吸烟者的戒烟率， 包括所有轻、中、重度吸烟者。我们的具体目标是：1)评估 在治疗结束(6个月)和治疗结束后(6个月)推广使用varenicline促进戒烟的疗效 长期随访(9个月和12个月)，2)检查治疗过程中的用药依从性和 对治疗结果的影响，3)评估治疗期间负面情绪、戒断和渴望的变化 条件及其对治疗结果的影响，4)确定预测戒烟的个人因素， 5)描述标准和推广过程中的烟草使用和戒烟模式 治疗。这些目标将通过双臂随机设计来实现，以评估 延长(6个月)的varenicline治疗与标准的(12周)varenicline治疗相比。基线 按性别分层的随机分组将分配参与者(N=500)接受延长治疗(Ext；26 Varenicline 12周(n=250)或标准治疗(ST)。所有参与者将 接受与文化相关的个性化戒烟咨询，包括药物支持 坚持，并将跟踪到12个月。这项研究是第一次检查延长的疗效 Varenicline治疗增加非裔美国吸烟者的戒烟率，包括 每日吸烟水平。这是第一次对所有吸烟者进行延长的varenicline检查，不仅是确认戒烟者， 这是第一批研究非裔美国吸烟者戒烟、戒烟和旧病复发的人之一。 这些发现将丰富我们对关键生物因素与吸烟因素之间相互关系的理解 治疗反应。成功提高长期禁酒率将对临床产生重大影响 对这一高危人群的治疗实践。治疗效果的提高将对减少 与烟草有关的差异、发病率和死亡率。

PROJECT SUMMARY / ABSTRACT African Americans are disproportionality burdened by tobacco in the United States. African American smokers experience the highest rates of tobacco-attributable disease, cancer incidence and mortality. Striking health disparities exist despite the fact that African Americans have similar smoking prevalence as Whites, yet smoke fewer cigarettes per day (cpd). To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Further, because smoking cessation rates tend to be lower for African American smokers, it is necessary to find methods of increasing response to pharmacotherapy to better promote abstinence in this high-risk group. Extended treatment has been demonstrated to increase abstinence in White smokers but has never been examined in African American smokers, who might benefit from extended medication support for quitting and for reducing relapse. The primary objective of this study is to evaluate extended use of varenicline, the leading FDA-approved medication for tobacco treatment, with the goal of enhancing abstinence in African American daily smokers, including the full spectrum of light, moderate, and heavy smokers. Our specific aims are to 1) evaluate the efficacy of extended varenicline treatment to promote smoking cessation at end of treatment (Month 6) and at long-term follow-up (Months 9 and 12), 2) examine medication adherence over the course of treatment and its impact on treatment outcomes, 3) evaluate change in negative affect, withdrawal, and craving across treatment conditions and their impact on treatment outcomes, 4) identify individual factors predicting smoking abstinence, and 5) characterize patterns of tobacco use and abstinence over the course of standard and extended treatment. These aims will be accomplished using a two-arm, randomized design to evaluate the efficacy of extended (6 months) varenicline treatment compared to standard (12 weeks) varenicline treatment. Baseline randomization stratified by gender will assign participants (N=500) to receive extended treatment (EXT; 26 weeks of varenicline, n=250) or standard treatment (ST; 12 weeks of varenicline, n=250). All participants will receive culturally-relevant, individualized smoking cessation counseling, including support for medication adherence, and will be followed through Month 12. This study is the first to examine the efficacy of extended varenicline treatment to increase abstinence among African American smokers, including the full spectrum of daily smoking level. It is the first to examine extended varenicline for all smokers, not only confirmed quitters, and among the first to examine patterns of quitting, lapse, and relapse among African American smokers. Findings will enrich our understanding of the interrelationship of key biological factors to smoking factors and treatment response. Success in increasing long-term abstinence rates would significantly impact clinical practice for treatment of this high-risk group. Increased treatment efficacy will have major impact on reducing tobacco-related disparities, morbidity, and mortality.