Advancing Tobacco Use Treatment for African American Smokers

描述（由申请人提供）：吸烟导致的肺癌相对风险比白人高50%，并且在美国癌症发病率和死亡率最高，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，但每天吸烟量较少（cpd），但存在显著的健康差异。事实上，超过一半的非裔美国人吸烟者是轻度吸烟者（吸烟10或更少cpd）。为了对非裔美国人吸烟者的过早死亡率产生影响，必须确定对整个吸烟连续体的吸烟者的有效治疗。伐尼克兰是治疗烟草使用的主要一线药物，与安慰剂相比，吸烟>10 cpd.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促进所有非洲裔美国人吸烟者的治疗，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伐尼克兰在500名非裔美国吸烟者中治疗烟草使用的疗效，包括全范围的CPD。我们将以3：2的比例随机分配受试者接受伐尼克兰（1 mg bid; n=300）或安慰剂（n=200）治疗12周，沿着所有受试者的个体化健康教育咨询。我们的具体目标是评价伐尼克兰促进非裔美国人吸烟者戒烟的有效性，检查轻度吸烟者和中度至重度吸烟者的有效性，描述尼古丁和致癌物暴露的特征，描述该组的生物心理社会特征，并评价与戒烟的关系。这项创新性研究将首次对伐尼克兰在全谱非裔美国人吸烟者中的作用进行安慰剂对照评估，也是首次对轻度吸烟者进行伐尼克兰研究。研究结果将有助于促进非洲人的有效治疗。 美国吸烟者和轻度吸烟者，并加强个性化治疗。提高治疗效果将对降低这一高危人群中与烟草相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.