NCT00888979已完成不适用
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
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
- 10
- 试验地点
- 1
- 主要终点
- Number of Days of Inhaler Use
研究概览
简要总结
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
详细描述
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •13-26 weeks pregnant
- •Smoking at least 5 cigarettes per day the preceding 7 days
- •Motivated to quit smoking (at least 7 on a 10 pt. scale)
- •Able to speak English
- •Intend to carry pregnancy to term
- •Stable residence
排除标准
- •Current drug or alcohol abuse or dependence (other than methadone maintenance
- •Twins or multiple gestation
- •Unstable psychiatric disorder
- •Unstable medical problems
- •Known congenital abnormality
- •High risk pregnancy
研究组 & 干预措施
Nicotrol with Behavioral Counseling
Experimental
Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
干预措施: Nicotrol Inhaler (Drug)
结局指标
主要结局
Number of Days of Inhaler Use
时间窗: Baseline to 4 weeks
次要结局
- Cartridge Use(Baseline to 4 weeks)
- Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.(Baseline to 4 weeks)
研究者
研究点 (1)
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