Advancing Tobacco Use Treatment for African American Smokers

描述（由申请人提供）：非裔美国人吸烟导致肺癌的相对风险比白人高50%，并且在美国癌症发病率和死亡率最高，因此非裔美国人承受着不成比例的更大的烟草相关疾病负担。尽管非裔美国人的吸烟率与白人相似，但他们每天的吸烟量更少（cpd），但惊人的健康差距仍然存在。事实上，超过一半的非裔美国吸烟者是轻度吸烟者（每天吸烟10支或更少）。为了对非裔美国人吸烟者的过早死亡产生影响，必须确定对吸烟连续体的吸烟者的有效治疗。Varenicline是治疗烟草使用的主要一线药物，与安慰剂相比，在每天吸烟10 - 10次的人群中，Varenicline长期戒烟的可能性是安慰剂的三倍。迄今为止，伐尼克兰在非裔美国人吸烟者或轻度吸烟者中的疗效尚未确定。这项研究的长期目标是推进对所有非裔美国吸烟者的治疗，以减少与烟草有关的疾病和死亡。我们的主要目的是在一项双盲、安慰剂对照、随机临床试验中评估varenicline对500名非裔美国吸烟者的烟草使用治疗效果，包括全范围的慢性阻塞性肺病。我们将以3:2的比例随机分配参与者，让他们接受varenicline （1 mg bid; n=300）或安慰剂（n=200）治疗12周，同时对所有参与者进行个性化的健康教育咨询。我们的具体目标是评估伐尼克兰促进非裔美国吸烟者在吸烟水平上的戒烟效果，检查轻度吸烟者和中度到重度吸烟者的疗效，描述尼古丁和致癌物暴露的特征，描述这一群体的生物心理社会特征并评估与戒烟有关的特征。这项创新的研究将首次对非裔美国吸烟者进行安慰剂对照评估，并首次对轻度吸烟者进行瓦伦尼克兰的检查。研究结果将有助于促进对非洲的有效治疗

DESCRIPTION (provided by applicant): With a 50% greater relative-risk of smoking attributed lung cancer than Whites, and the highest overall rates of cancer incidence and mortality in the U.S., African Americans experience disproportionately greater tobacco- related disease burden. Striking health disparities exist despite the fact that African Americans have similar smoking prevalence as Whites, yet smoke fewer cigarettes per day (cpd). In fact, over half of all African American smokers are light smokers (smoke 10 or fewer cpd). To have an impact on the premature mortality of African American smokers, effective treatment for smokers across the smoking continuum must be identified. Varenicline, the leading first-line medication for tobacco use treatment, triples the likelihood of long-term abstinence relative to placebo in those smoking >10 cpd. To date, efficacy of varenicline has not been established in African American smokers or light smokers. The long-term goal of this research is to advance treatment for all African American smokers in order to reduce tobacco-related disease and death. Our primary objective is to evaluate the efficacy of varenicline for tobacco use treatment among 500 African American smokers, including a full range of cpd, within a double-blind, placebo-controlled, randomized clinical trial. We will randomize participants in a 3:2 ratio to receive varenicline (1 mg bid; n=300) or placebo (n=200) for 12 weeks, along with individualized health education counseling for all participants. Our specific aims are to evaluate the efficacy of varenicline to promote abstinence in African American smokers across the continuum of smoking level, to examine efficacy in light smokers and also in moderate to heavy smokers, to characterize nicotine and carcinogen exposure, and to describe biopsychosocial characteristics of this group and evaluate in relation to abstinence. This innovative study will provide the first placebo-controlled evaluatin of varenicline in the full spectrum of African American smokers, and the first to examine varenicline in light smokers. Findings will contribute to advancing effective treatment for African American smokers and for light smokers, and enhancing individualized treatment. Increased treatment efficacy will have major impact on reducing tobacco- related morbidity and mortality in this high-risk population.