Individualizing Pharmacotherapy: A Novel Optimization Strategy to Increase Smoking Cessation in the African American Community
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
研究概览
简要总结
Improving cessation outcomes for African American smokers through the use of novel, empirically-based strategies is a national health priority. In the vast majority of smoking cessation studies and in clinical practice, when smokers are provided a medication to help them quit, they are expected to continue that medication regardless of how well it is working. This study will assess whether African Americans smokers respond better if they continue with a single treatment or if their treatment is changed when that treatment is not working.
详细描述
The objective of this study is to examine the efficacy of optimized (OPT) versus enhanced usual care (UC) treatment for smoking cessation. African American smokers randomized to OPT (n=196) will receive high intensity smoking cessation counseling, nicotine patch (NP), and up to two pharmacotherapy optimizations [varenicline (VAR), bupropion (BUP) plus NP, ] based on verified smoking status at Weeks 2 and 6. African American smokers randomized to enhanced UC (n=196) will receive the same high intensity counseling and NP with no optimizations in pharmacotherapy. Pharmacotherapy and counseling in both groups will last for 18 weeks with long-term follow-up through Week 26. The primary outcome is biochemically-verified smoking status at Week 12.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Hispanic African American
- •≥ 18 years of age
- •Smoke 5-30 cigarettes per day (CPD)
- •Daily cigarette smoker
- •Smoked at current rate for > 6 months
- •Verified smoker (CO > 5 ppm)
- •Functioning telephone
- •Interested in quitting smoking
- •Willing to take NP, VAR , and/or BUP+NP for 18 weeks and complete all study visits
排除标准
- •Use of non-cigarette tobacco products in past 30 days
- •Medical contraindications to NP, BUP, or VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; medications contraindicated ; history of clinically significant allergic reactions; history of epilepsy, seizure, head trauma, psychosis, bipolar disorder, eating disorder; unstable panic disorder or depression; active suicidal ideation; treatment for alcohol or drug dependence in the past year
- •Use of pharmacotherapy in the month prior to enrollment
- •Pregnant, contemplating getting pregnant, or breastfeeding
- •Unstable housing (e.g., street, shelter)
- •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
Usual Care (UC)
196 African American smokers will receive 12 weeks of smoking cessation counseling and 18 weeks of nicotine patch.
干预措施: Nicotine patch (Drug)
Optimized Care (OPT)
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
干预措施: Nicotine patch (Drug)
Optimized Care (OPT)
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
干预措施: Varenicline Tartrate (Drug)
Optimized Care (OPT)
196 African American smokers will receive 12 weeks of smoking cessation counseling. They will receive the nicotine patch and up to two pharmacotherapy adaptations (VAR, BUP+NP) based on verified smoking status at Weeks 2 and 6 for a total of 18 weeks of pharmacotherapy.
干预措施: Bupropion (Drug)
结局指标
主要结局
Number of Participants With Biochemically Verified Smoking Abstinence at Week 12
时间窗: Week 12
Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit. This will evaluate the short-term efficacy of optimized pharmacotherapy for smoking cessation in African American smokers.
次要结局
- Number of Participants With Biochemically Verified Smoking Abstinence at Week 18(Week 18)
- Number of Participants With Biochemically Verified Smoking Abstinence at Week 26(Week 26)
研究者
Nikki Nollen, PhD, MA
Associate Professor
University of Kansas Medical Center