Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- biologically verified smoking cessation or reduction
研究概览
简要总结
The purpose of this study is to determine whether bupropion SR increases cessation and/or smoking reduction among pregnant smokers.
详细描述
Primary Objective:
To evaluate the efficacy of a pharmacologic agent (bupropion SR) to achieve higher rates of smoking cessation and greater reduction in smoking during pregnancy
Secondary Objective:
To evaluate the safety of using a pharmacologic agent (bupropion SR) for smoking cessation in pregnancy.
Hypotheses to be tested:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Smoked at least one puff in the past 7 days
- •Confirmed viable gestation
排除标准
- •All patients found to have a non-viable fetus or major congenital anomaly
- •History of seizure disorder
- •Family history of seizure disorder
- •History of severe head trauma
- •History of anorexia nervosa or bulimia
- •Current use of nicotine-replacement therapy
- •Unstable medical or psychiatric condition
- •Current use of an monoamine oxidase inhibitor or bupropion hydrochloride products
研究组 & 干预措施
Bupropion SR
Study medication (150 mg bupropion SR) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day (150 mg bid). Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
干预措施: Bupropion SR (Drug)
Bupropion SR
Study medication (150 mg bupropion SR) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day (150 mg bid). Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
干预措施: smoking cessation counseling (Behavioral)
Placebo
Study medication (placebo) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day. Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
干预措施: placebo (Drug)
Placebo
Study medication (placebo) daily for 14 days. Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day. Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
干预措施: smoking cessation counseling (Behavioral)
结局指标
主要结局
biologically verified smoking cessation or reduction
时间窗: 8 weeks and delivery
change in smoking from study enrollment to end of treatment (8 weeks) and at delivery
次要结局
- adverse events reported during pregnancy(8 weeks and delivery)
- self reported smoking cessation or reduction(8 weeks and delivery)
研究者
Hugh Miller
Medical Director
Watching Over Mothers & Babies Foundation