Changes in Biomarkers Associated With Use of Electronic Cigarettes Among African American Menthol and Nonmenthol Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- Change in Biomarker Concentrations: Nicotine Equivalents
研究概览
简要总结
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
详细描述
This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.
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
- Single (Participant)
盲法说明
All participants are blinded to intervention group
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
- •self-identify as African American or Black;
- •age 18 years or older;
- •smoke at least five cigarettes daily for the past year;
- •not interested in quitting smoking in the next 6 months;
- •Willing to use e-cigarettes;
- •Good physical health (no unstable medical or mental health condition);
- •no contraindications for e-cigarette use.
排除标准
- •Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria;
- •use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes;
- •participation in a smoking cessation program in the past 30 days;
- •pregnant or nursing.
结局指标
主要结局
Change in Biomarker Concentrations: Nicotine Equivalents
时间窗: Baseline, Week 6
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Change in Biomarker Concentrations: NNAL
时间窗: Baseline, Week 6
Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.
次要结局
未报告次要终点