Bupropion for the Prevention of Postpartum Smoking Relapse
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Point prevalence smoking abstinence
研究概览
简要总结
This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Ability to provide informed consent
- •Age 18 to 45 years old
- •Stable health
- •7-day point prevalence abstinence demonstrated at randomization
- •Lifetime history of at least 100 cigarettes smoked
- •Quit smoking during the current pregnancy
- •Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale
- •Uncomplicated delivery
- •Denies plans to become pregnant again during the trial.
- •Full-term delivery ≥ 37 weeks gestation
- •Home within 10 days of delivery
排除标准
- •Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.)
- •Current use of cessation aids (e.g., varenicline, NRT)
- •Current use of illicit drugs or alcohol dependence
- •Current use of antidepressant medication
- •Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview
- •Medications & conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6)
- •Family history of seizures or seizure disorder
- •Maternal use of medications that lower seizure threshold
- •Newborn with an elevated risk of seizure
研究组 & 干预措施
Placebo
Participants randomized to placebo. Once-daily
干预措施: Placebo oral tablet (Drug)
Bupropion
Participants randomized to extended-release bupropion. Once-daily
干预措施: Bupropion Extended Release Oral Tablet (Drug)
结局指标
主要结局
Point prevalence smoking abstinence
时间窗: 24 weeks post randomization
7-day point prevalence abstinence
次要结局
未报告次要终点