Advancing Tobacco Use Treatment for African American Smokers

推进非裔美国吸烟者的烟草使用治疗

基本信息

批准号：
8694609
负责人：
LISA SANDERSON COX
金额：
$ 66.67万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-01 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8694609
关键词：
Abstinence Adherence Adverse effects African American Biochemical Bupropion Carcinogen exposure Cessation of life Characteristics Cigarette Cotinine Counseling Disease Double-Blind Method Employee Strikes Ethnic Origin Evaluation Exposure to FDA approved Funding Goals Health education Incidence Intake Knowledge Light Malignant Neoplasms Malignant neoplasm of lung Menthol Metabolism Modeling Morbidity - disease rate Nicotine Nicotine Dependence Participant Pharmaceutical Preparations Pharmacotherapy Placebo Control Placebos Population Premature Mortality Prevalence Race Randomized Randomized Clinical Trials Relative (related person)Relative Risks Research Safety Smoke Smoker Smoking Smoking Behavior Tobacco Tobacco use Treatment Efficacy Treatment Factor Treatment outcome United States National Institutes of Health Withdrawal biobehavior biopsychosocial burden of illness clinical care craving effective therapy experience health disparity high risk improved innovation mortality nicotine replacement primary outcome psychologic public health priorities public health relevance smoking prevalence trait varenicline

项目摘要

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.

描述（由申请人提供）：非裔美国人因吸烟而患肺癌的相对风险比白人高 50%，并且癌症发病率和死亡率在美国最高，因此非裔美国人承受的烟草相关疾病负担要高得多。尽管非洲裔美国人的吸烟率与白人相似，但每天吸的香烟数量较少，但仍存在显着的健康差异。事实上，超过一半的非裔美国吸烟者是轻度吸烟者（每日吸烟 10 克或更少）。为了对非裔美国吸烟者的过早死亡率产生影响，必须确定针对整个吸烟过程的吸烟者的有效治疗方法。伐尼克兰是治疗烟草使用的主要一线药物，对于吸烟量 > 10 cpd 的患者来说，相对于安慰剂，长期戒烟的可能性增加了三倍。迄今为止，伐尼克兰对非裔美国吸烟者或轻度吸烟者的疗效尚未确定。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，评估伐尼克兰对 500 名非裔美国吸烟者（包括各种慢性持续性烟民）的烟草使用治疗的疗效。我们将以 3:2 的比例随机分配参与者接受伐尼克兰（1 mg bid；n=300）或安慰剂（n=200）治疗 12 周，并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伐尼克兰在整个吸烟水平范围内促进非裔美国吸烟者戒烟的功效，检查轻度吸烟者以及中度至重度吸烟者的功效，描述尼古丁和致癌物暴露的特征，并描述生物心理社会特征该组并评估与禁欲的关系。这项创新研究将首次对所有非裔美国吸烟者进行伐尼克兰的安慰剂对照评估，并首次对轻度吸烟者进行伐尼克兰检查。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，加强个体化治疗。治疗效果的提高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。