NCT01896518已完成不适用
Novel Methods to Reduce Children's Secondhand Smoke Exposure II
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Child Salivary Cotinine
研究概览
简要总结
The overall aim of the current study is to determine if the use of nicotine containing products by caregivers who smoke and who are not interested in quitting, is effective in reducing children's secondhand smoke exposure.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be included in the study, participants must:
- •be the primary caregiver(defined as a person who spends the most time with the child and spends a minimum of 4 hours per day in the presence of the child) of a child between the ages of 3-11 (if caregiver has more > 1 child between 3-11 years, we will include the youngest),
- •smoke at least 10 cigarettes per day for the past year,
- •indicate that they smoke around their child or in the car or home at least one time per week],
- •have no intention of quitting smoking in the next 12-weeks,
- •aged 18-65 years,
- •be fluent in English,
- •have no recent history of cardiovascular distress that may contraindicate medicinal nicotine lozenge use (heart attack in the past year, arrhythmia, uncontrolled hypertension),
- •not currently pregnant, planning to become pregnant, or breastfeeding,
- •do not use non-cigarette tobacco (cigars, chewing tobacco)
- •have no prior use of any potential reduced exposure product,
- •have no major psychiatric impairment, including psychosis, suicidality, and/or any current alcohol/drug abuse or dependence
排除标准
- •Does not meet all of the requirements of inclusion criteria
研究组 & 干预措施
Nicotine lozenge
Experimental
Participants will receive nicotine lozenge to use as needed for 12 weeks.
干预措施: Nicotine polacrilex (Drug)
Tobacco lozenge
Experimental
Participants will receive tobacco lozenge to use as needed for 12 weeks.
干预措施: Tobacco lozenge (Drug)
结局指标
主要结局
Change in Child Salivary Cotinine
时间窗: 3, 6, and 12 weeks
Child salivary cotinine will be measured to assess the level of secondhand smoke exposure. We will measure the change throughout the study.
次要结局
- Change in Parent and Child Lung Function(3, 6, 12 weeks)
研究者
研究点 (1)
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