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

• 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
• 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

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.

项目总结/摘要 在美国，非裔美国人是烟草的负担。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。惊人的健康 尽管非裔美国人的吸烟率与白人相似，但仍存在差异， 每日吸烟量（CPD）为了降低非裔美国人吸烟者的过早死亡率， 必须为吸烟者确定有效的治疗方法。此外，由于吸烟 戒烟率往往是较低的非洲裔美国人吸烟者，有必要找到增加的方法， 对药物治疗的反应，以更好地促进这一高危人群的禁欲。延长治疗 已被证明可以增加白色吸烟者的戒烟率，但从未在非洲人中进行过研究。 美国吸烟者，他们可能受益于延长戒烟和减少复发的药物支持。 本研究的主要目的是评估伐尼克兰的长期使用，伐尼克兰是FDA批准的主要药物。 治疗烟草的药物，目的是提高非裔美国人日常吸烟者的戒烟率， 包括轻度、中度和重度吸烟者的全部范围。我们的具体目标是：1）评估 在治疗结束时（第6个月）和治疗结束时， 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 对治疗结果的影响，3）评估治疗期间负面影响、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， 和5）在标准和扩展的过程中描述烟草使用和戒烟的模式 治疗这些目标将采用两组、随机设计来实现，以评价 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 按性别分层的随机化将分配参与者（N=500）接受扩展治疗（EXT; 26 伐尼克兰12周，n=250）或标准治疗（ST;伐尼克兰12周，n=250）。所有参与者将 接受与文化相关的个性化戒烟咨询，包括药物支持 坚持，并将随访至第12个月。这项研究是第一次检查的有效性， 伐尼克兰治疗，以增加非裔美国人吸烟者的戒烟，包括全方位的 每日吸烟量这是第一次对所有吸烟者进行延长的伐伦克林检查，不仅是确认戒烟者， 也是第一个研究非裔美国人吸烟者戒烟、戒烟失败和复发模式的人。 研究结果将丰富我们对关键生物因素与吸烟因素之间相互关系的理解， 治疗反应。成功提高长期戒烟率将显著影响临床 为治疗这一高风险群体提供实践。治疗效果的提高将对减少 与烟草有关的差异、发病率和死亡率。