NCT01621022
已完成
4 期
Efficacy of Bupropion Alone and in Combination With Nicotine Gum
概览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- 7-day point prevalence abstinence measured at 6 months
概览
简要总结
Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smoke 10 or more cigarettes per day
- •Motivated to quit
- •No physical or mental health issues that would prevent participation
- •Not pregnant or willing to prevent pregnancy during treatment
排除标准
- •Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
- •Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
- •Heavy alcohol use
- •History of eating disorder
- •Suicidality
研究组 & 干预措施
Active bupropion-Active gum
Active Comparator
150 mg bupropion twice daily + 4 mg nicotine gum as needed (up to 12 pcs/day)
干预措施: bupropion + nicotine gum (Drug)
Active bupropion-Placebo gum
Active Comparator
150mg bupropion twice daily + placebo gum as needed (up to 12 pcs/day)
干预措施: Active bupropion-Placebo gum (Drug)
Placebo medication-Placebo gum
Active Comparator
Placebo bupropion, twice daily, plus placebo gum as needed (up to 12 pcs/day)
干预措施: Placebo bupropion-Placebo gum (Drug)
结局指标
主要结局
7-day point prevalence abstinence measured at 6 months
时间窗: 6 months
No smoking, not evan a puff, during the 7 days prior to the 6 month follow-up
次要结局
未报告次要终点
研究者
研究点 (1)
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