Telehealth Study Assessing the Removal of Filter Ventilation on Smoking Behavior and Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Change in Cigarettes Per Day (CPD)
研究概览
简要总结
The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette.
The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.
详细描述
This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples.
Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes.
Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed.
Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.
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
- Single (Participant)
盲法说明
Single blind
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
- •At least 21 years of age
- •Biochemically confirmed regular cigarette smoker
- •Daily smoker, 5-30 cigarettes per day.
- •Usual brand cigarettes 16-36% ventilation
排除标准
- •Unstable health
- •Unstable medications
- •Pregnant or nursing
研究组 & 干预措施
Ventilated Cigarette Filter
Filters with approximately 24-32% filter ventilation
干预措施: Ventilated Cigarette Filter (Other)
Unventilated Cigarette Filter
Filters with approximately 0-5.0% filter ventilation
干预措施: Unventilated Cigarette Filter (Other)
结局指标
主要结局
Change in Cigarettes Per Day (CPD)
时间窗: 7 days prior to week 0 visit and 7 days prior to week 6 visit
Change in cigarettes per day, daily diary reviewed data.
Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine]
时间窗: 6 weeks randomized intervention
Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
次要结局
未报告次要终点