The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Change in Cigarette Consumption
研究概览
简要总结
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.
详细描述
The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •age 18 years or older, and smoking cigarettes for at least 3 years
- •smoking, on average, 4-27 days per month
- •smoking at current rate for at least the previous 3 months
- •willingness to try novel cigarettes
排除标准
- •active plans to quit or actively seeking smoking cessation treatment in the next 3 months
- •severe psychiatric disorders that may interfere with study procedures
- •current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
- •exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
- •[for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report
- •current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
- •occurrence of heart attack, stroke, or angina in the past 3 months
研究组 & 干预措施
Very low nicotine content cigarettes
干预措施: Very low nicotine content cigarettes (Drug)
Normal nicotine content cigarettes
干预措施: Normal nicotine content cigarettes (Drug)
结局指标
主要结局
Change in Cigarette Consumption
时间窗: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period
Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data
次要结局
- Exposure Measure - Solanesol(Post-randomization time points at study weeks 4, 8, 12)
- Exposure Measure - Smoking Topography(Post-randomization study visits at study weeks 4, 8, 12)
- Exposure Measure - Cotinine (Logged)(Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study))
- Exposure Measure - Cigarette Butt Weight(Entire length of study, through completion, up to 12 weeks)
研究者
Saul Shiffman
Research Professor
University of Pittsburgh