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%，癌症发病率和死亡率是美国最高的，非洲裔美国人承受着不成比例的更大的烟草相关疾病负担。尽管非洲裔美国人的吸烟率与白人相似，但每天吸烟(CPD)较少，但仍存在显著的健康差距。事实上，超过一半的非裔美国人吸烟者是轻度吸烟者(吸烟量不超过CPD 10支)。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。Varenicline是烟草使用治疗的领先一线药物，在吸烟者中，长期戒烟的可能性是安慰剂的三倍。到目前为止，varenicline在非裔美国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，以减少与烟草相关的疾病和死亡。我们的主要目标是在一项双盲、安慰剂对照、随机临床试验中，评估在500名非裔美国吸烟者中使用varenicline治疗烟草的疗效，其中包括各种CPD。我们将以3：2的比例随机将参与者分为两组，分别接受varenicline(1 mg，2次；n=300)或安慰剂(n=200)治疗12周，同时为所有参与者提供个性化的健康教育咨询。我们的具体目标是评估varenicline在整个吸烟水平的非裔美国吸烟者中促进戒烟的有效性，检查在轻度吸烟者和中到重度吸烟者中的有效性，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，并评估与戒烟的关系。这项创新的研究将首次在非裔美国吸烟者中提供对varenicline的安慰剂对照评估，并首次在轻度吸烟者中检测varenicline。研究结果将有助于推进非洲人的有效治疗 美国吸烟者和轻度吸烟者，并加强个体化治疗。提高治疗效果将对减少这一高危人群中与烟草有关的发病率和死亡率产生重大影响。

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.