Genetically Informed Smoking Cessation Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 822
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Quit Rate
研究概览
简要总结
The investigators' goal is to identify the most appropriate smoking cessation treatments for smokers based on genetic information. Smokers try to quit smoking but relapses are common.
详细描述
The investigators' goal is to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. Smoking is a leading cause of preventable death and disability, and smoking cessation reverses the risk of mortality. However, cessation failure is common despite available cessation medications, which are associated with different efficacy, side effects, adherence, use constraints, and costs. This challenge can be addressed by improving current treatments via personalized medicine based on individual genetic markers to maximize efficacy and minimize side effects.
The investigators propose a prospective, genotype-based stratified randomization trial to compare two smoking cessation medications (combination NRT [patch and lozenge], varenicline vs. placebo) for 3 months in 720 smokers with known genotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (≥21 years of age), seeking treatment for smoking cessation.
- •Able to speak English,
- •Active smoking (Cigarettes Per Day (CPD) ≥5), and exhaled Carbon Monoxide (CO) ≥8 ppm
- •Agree to participate in this randomized smoking cessation trial with follow up assessments up to 12 months.
排除标准
- •Pregnancy or breast feeding,
- •Active use or recent use (< or equal to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month,
- •Allergy to nicotine patch, lozenge, or varenicline,
- •Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only),
- •Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months,
- •Current heavy alcohol consumption (≥6 drinks/day, 6 days/week),
- •Active psychosis or poorly controlled depression within the past 6 months,
- •Any prior suicide attempt or suicidal ideation within the past 6 months,
- •End stage renal disease with hemodialysis.
研究组 & 干预措施
Combination NRT and Counseling
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
干预措施: Combination NRT (Nicotine patch, Nicotine lozenge) (Drug)
Combination NRT and Counseling
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
干预措施: Intensive smoking counseling (Behavioral)
Varenicline (Chantix) and Counseling
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
干预措施: Varenicline (Drug)
Varenicline (Chantix) and Counseling
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
干预措施: Intensive smoking counseling (Behavioral)
Placebo Medicine and Counseling
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
干预措施: Placebo (Drug)
Placebo Medicine and Counseling
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
干预措施: Intensive smoking counseling (Behavioral)
结局指标
主要结局
7-day Point Prevalence Quit Rate
时间窗: Week 12
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
次要结局
- Continuous Abstinence(12 weeks (with first 1 week initial grace period))
- 7-day Point Prevalence Quit Rate(Week 24)
- Number of Days to Lapse(Assessed from the target quit day through 52 weeks)
- Number of Days to Relapse(Assessed from the target quit day through 52 weeks)
- Initial Cessation(Assessed for the first seven days after the target quit date)
- Longitudinal Models of Abstinence Outcomes Across Multiple Time Points(0-52 Weeks)
- Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.(0-52 Weeks)
- Medication Adherence(Pre-quit week to Week 12)
- Side Effects(Pre-quit week to Week 12)
- Withdrawal(Pre-quit, quit, week 1, week 2, and week 4)