Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percent Compliance With Chantix
研究概览
简要总结
Little is known about the support needed to improve compliance with Chantix for smoking cessation. This is a two arm pilot study of African American smokers to provide varying levels of side effect management and compliance support during a 12 week treatment period. The primary aim of the study is to estimate the effect of induction support compared to standard care in increasing compliance with Chantix at month 3
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American
- •18-75 years of age
- •Smoke more than 10 cigarettes per day
- •Have a functioning telephone number
- •Be interested in quitting smoking
- •Be willing to take 3 months of Chantix
- •Be willing to complete all study visits
排除标准
- •Renal impairment
- •Evidence or history of clinically significant allergic reactions to Chantix
- •Cardiovascular event in the past month
- •History of alcohol or drug abuse/dependency in the past year
- •Major depressive disorder in the last year requiring treatment
- •History of panic disorder
- •Psychosis, bipolar or eating disorder
- •Use of antidepressants, antipsychotics, mood stabilizers/anticonvulsants or naltrexone
- •Use of tobacco products other than cigarettes
- •Use of nicotine replacement therapy, bupropion, clonidine or nortriptyline in the month prior to enrollment
- •Prior use of Chantix
- •Women who are pregnant, contemplating getting pregnant or breastfeeding
- •Plans to move from Kansas City during the 3 month treatment phase
- •Another household member enrolled in the study
研究组 & 干预措施
1
Chantix for 3 months and Standard Counseling
干预措施: Chantix (Drug)
1
Chantix for 3 months and Standard Counseling
干预措施: Standard Counseling (Behavioral)
2
Chantix for 3 months and Adherence Counseling
干预措施: Chantix (Drug)
2
Chantix for 3 months and Adherence Counseling
干预措施: Adherence Counseling (Behavioral)
2
Chantix for 3 months and Adherence Counseling
干预措施: Standard Counseling (Behavioral)
结局指标
主要结局
Percent Compliance With Chantix
时间窗: Months 1, 2, 3
Compliance with Chantix calculated as the total doses taken over the total number of doses prescribed. Adherence was measured by pill counts. Measurements taken during monthly medication refill visits. There was no specific predetermined cutoff number on the scale which determined non-compliance. All results from compliance calculations are included in the table.
次要结局
- Cotinine Verified 7 Day Point Prevalence Smoking Abstinence(Month 3)
- Carbon Monoxide-verified Abstinence(Month 2)
研究者
Nikki Nollen, PhD, MA
Assistant Professor
University of Kansas Medical Center