Understanding Disparities in Quitting in African American and White Smokers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 449
- 试验地点
- 2
- 主要终点
- Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
研究概览
简要总结
The purpose of this study is to describe the differences in quitting smoking between African Americans (AA) and White smokers treated with varenicline.
详细描述
While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.
Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Hispanic African American or non-Hispanic White
- •≥ 18 years of age
- •Smoked 3-20 cigarettes per day
- •Smoked on >25 days of the past 30 days
- •Functioning telephone
- •Interested in quitting smoking
- •Interested in taking 3 months of varenicline
- •Willing to complete all study visits
排除标准
- •Renal impairment
- •Evidence or history of clinically significant allergic reactions to varenicline
- •A cardiovascular event in the past month Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:
- •Myocardial infarction
- •Peripheral vascular disease
- •New onset of chest pain or arrhythmia in the past 2 months
- •History of alcohol or drug dependency in the past year
- •Major depressive disorder in the last year requiring treatment
- •History of panic disorder, psychosis, bipolar disorder, or eating disorders
- •Use of tobacco products other than cigarettes in past 30 days
- •Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
- •Pregnant, contemplating getting pregnant, or breastfeeding
- •Plans to move from Kansas City during the treatment and follow-up phase
- •Another household member enrolled in the study
研究组 & 干预措施
African American (AA) Smokers
AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
干预措施: Varenicline (Drug)
White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
干预措施: Varenicline (Drug)
结局指标
主要结局
Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
时间窗: Change from Baseline to Week 26
Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
次要结局
未报告次要终点
研究者
Nikki Nollen, PhD, MA
Associate Professor
University of Kansas Medical Center