The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Number of participants who switch from cigarettes to electronic cigarettes at Week 12
研究概览
简要总结
This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.
详细描述
Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes 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
- Prevention
- 盲法
- None
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
- •≥ 21 years of age
- •Smoke ≥ 5 cigarettes per day (CPD)
- •Smoke menthol cigarettes for ≥ 6 months
- •Verified smoker (CO >5ppm)
- •Functioning telephone
- •Interested in switching to E-cigarettes
排除标准
- •Interested in quitting smoking
- •Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes)
- •E-cigarette use on ≥ 4 of the past 30 days
- •Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic)
- •Use of smoking cessation pharmacotherapy in the month prior to enrollment
- •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
Menthol Flavor Electronic Cigarette
400 adult cigarette smokers will receive 12 weeks of menthol-flavored electronic cigarettes.
干预措施: Menthol-flavored electronic cigarette (Other)
Tobacco Flavor Electronic Cigarette
400 adult cigarette smokers will receive 12 weeks of tobacco-flavored electronic cigarettes.
干预措施: Tobacco-flavored electronic cigarette (Other)
结局指标
主要结局
Number of participants who switch from cigarettes to electronic cigarettes at Week 12
时间窗: Week 12
Complete switching is defined as exclusive use of e-cigarettes, confirmed with CO\< 6ppm and predominant switching; defined as use of the e-cigarette with \>50% reduction in CPD. This will compare the effectiveness of menthol versus tobacco e-cigarettes at facilitating switching at Week 12.
次要结局
- Amount of e-liquid consumed(Week 12)
- Assessment of respiratory symptoms using spirometry(Week 12)
研究者
Nikki Nollen, PhD, MA
Professor
University of Kansas Medical Center