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

通过延长治疗改善非裔美国人社区的戒烟结果

基本信息

批准号：
10612435
负责人：
LISA SANDERSON COX
金额：
$ 63.25万
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：
2022
资助国家：
美国
起止时间：
2022-05-01 至 2027-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10612435
关键词：
Abstinence Adherence African American African American population Age Biological Factors Blood Cessation of life Cigarette Clinical Trials Communities Cotinine Counseling Country Disease Disparity Evaluation FDA approved Gender Goals Health Incidence Individual Light Longterm Follow-up Malignant Neoplasms Malignant neoplasm of lung Measurement Mediation Mediator Menthol Metabolism Methods Morbidity - disease rate Nicotine Outcome Participant Pattern Pharmaceutical Preparations Pharmacotherapy Predictive Factor Premature Mortality Prevalence Psychological reinforcement Randomized Recovery Relapse Relative Risks Safety Smoke Smoker Smoking Smoking Behavior Socioeconomic Status Time Tobacco Tobacco smoking behavior Tobacco use Treatment Efficacy Treatment outcome United States Variant Visit Withdrawal Work arm biobehavior clinical practice clinically relevant craving design effective therapy efficacy evaluation experience health disparity high risk population improved long term abstinence medication compliance mortality multidisciplinary negative affect nicotine exposure novel strategies pill public health priorities relapse prevention response smoking abstinence smoking cessation smoking prevalence standard care success tobacco abstinence treatment adherence treatment comparison treatment effect treatment group treatment response varenicline

项目摘要

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.

项目概要/摘要在美国，非裔美国人承受着不成比例的烟草负担。非裔美国吸烟者烟草引起的疾病、癌症发病率和死亡率最高。健康显着尽管非洲裔美国人的吸烟率与白人相似，但吸烟率仍然存在差异每天吸更少的香烟（cpd）。为了对非裔美国吸烟者的过早死亡产生影响，必须确定针对整个吸烟过程的吸烟者的有效治疗方法。此外，由于吸烟非裔美国吸烟者的戒烟率往往较低，因此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人群的戒酒。延长治疗有已被证明可以提高白人吸烟者的戒烟率，但从未在非洲进行过检验美国吸烟者可能会受益于长期的戒烟药物支持和减少复吸。本研究的主要目的是评估伐尼克兰的扩展使用，伐尼克兰是 FDA 批准的领先药物用于烟草治疗的药物，目的是增强非裔美国日常吸烟者的戒烟，包括全范围的轻度、中度和重度吸烟者。我们的具体目标是 1) 评估伐尼克兰延长治疗在治疗结束时（第 6 个月）和治疗后促进戒烟的功效长期随访（第 9 个月和第 12 个月），2) 检查治疗过程中的药物依从性及其效果对治疗结果的影响，3) 评估治疗过程中负面情绪、戒断和渴望的变化条件及其对治疗结果的影响，4) 确定预测戒烟的个体因素， 5) 描述标准和扩展过程中烟草使用和戒烟模式的特征治疗。这些目标将使用双臂随机设计来评估以下药物的功效来实现：与标准（12 周）伐尼克兰治疗相比，延长（6 个月）伐尼克兰治疗。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 伐尼克兰周，n=250）或标准治疗（ST；伐尼克兰 12 周，n=250）。所有参与者将接受文化相关的个性化戒烟咨询，包括药物支持依从性，并将跟踪至第 12 个月。这项研究是第一个检验延长治疗效果的研究伐尼克兰治疗可提高非裔美国吸烟者的戒烟率，包括全方位每日吸烟水平。它是第一个针对所有吸烟者（不仅是已确认戒烟者）进行延长伐尼克兰检查的项目，也是最早研究非裔美国吸烟者戒烟、戒烟和复吸模式的人之一。研究结果将丰富我们对关键生物因素与吸烟因素和吸烟因素之间相互关系的理解。治疗反应。成功提高长期戒断率将显着影响临床治疗这一高危人群的实践。治疗效果的提高将对减少与烟草相关的差异、发病率和死亡率。