Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Total Cigarettes Per Day
研究概览
简要总结
Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.
详细描述
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
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
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Ages 18-44 years
- •Gestational age ≤ 25 weeks
排除标准
- •Under 18 years old
- •Over 44 years old
- •Gestational age > 25 weeks
研究组 & 干预措施
Very low nicotine content cigarettes
干预措施: Very low nicotine content cigarettes (Other)
Usual Brand
结局指标
主要结局
Total Cigarettes Per Day
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Sarah Heil
Professor
University of Vermont