Nicotine Replacement for Smoking Cessation During Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
研究概览
简要总结
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).
详细描述
This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.
Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.
Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •smoking at least 5 cigarettes per day for the preceding 7 days
- •previous attempt to quit smoking during pregnancy by self report
- •13-26 weeks gestation
- •at least 16 years of age
- •able to speak English or Spanish
- •intent to carry pregnancy to term
- •stable residence
排除标准
- •current drug or alcohol abuse or dependence (other than methadone maintenance)
- •twins or other multiple gestation
- •unstable psychiatric disorder
- •unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- •known congenital abnormality
研究组 & 干预措施
Placebo Inhaler
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
干预措施: Placebo Inhaler (Drug)
Nicotrol Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper.
干预措施: Nicotrol Inhaler (Drug)
结局指标
主要结局
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
时间窗: 32-34 weeks gestation (Visit 6)
Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days
次要结局
- Exhaled Carbon Monoxide(32-34 weeks gestation)
- Birth Weight(At delivery)
- Gestational Age(At delivery)
研究者
Cheryl Oncken
Professor of Medicine
UConn Health