Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
研究概览
简要总结
This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.
详细描述
A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women ≥ 18 years of age
- •Gestational age between 14 and 26 weeks confirmed by ultrasound
- •Currently smoking ≥ 5 cigarettes per day
排除标准
- •Abnormal liver function tests
- •History of or current seizure disorder or closed head injury with loss of consciousness
- •Known hypersensitivity to bupropion
- •Any psychiatric disorder requiring psychotropic medication
- •Current anorexia or bulimia
- •Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks
- •Major Depressive Disorder or current suicidal risk
- •Use of any illicit substances since receiving knowledge of pregnancy
- •Regular use of alcohol (>1 drink/week on average)
- •Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus
- •Twins or other multiple gestation
- •Fetal abnormality on the 14 week ultrasound
- •Plans to deliver at a hospital other than Memorial Hermann
- •Inability to communicate with research staff or make study visits due to lack of phone or transportation access
- •Participation in another clinical study which may affect study outcomes
- •Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)
研究组 & 干预措施
Bupropion SR (sustained release)
Group receiving bupropion SR medication
干预措施: Bupropion SR (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
时间窗: 1 week post treatment
次要结局
- Enrollment, Retention and Compliance Rates(1 year (estimated))
- Continuous Abstinence From Birth to 2nd Week Postpartum Followup(at 2nd week postpartum followup visit)
- Self-reported Reduction in Number of Cigarettes Smoked Per Day(at 1 week post treatment and at 2 week postpartum visit)
- Maternal Side Effects(during treatment, end of treatment and at 2 week postpartum visit)
- Perinatal/Neonatal Outcomes(at neonatal discharge from hospital following delivery)
- Continuous Abstinence From End of Treatment Through the 2 Week Followup(at two week followup visit)
研究者
Angela Stotts
Associate Professor - Family Medicine
The University of Texas Health Science Center, Houston