A Randomized Controlled Clinical Trial of Bupropion SR and Individual Smoking Cessation Counseling
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 1
- 主要终点
- 7-day Point Prevalence Abstinence From Smoking at 6 Months
研究概览
简要总结
The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.
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
- •Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
- •Motivated to quit smoking (score of 3 on 4-point self-report scale)
- •Willing to fulfill study requirements
排除标准
- •Carbon monoxide breath test score below 9 ppm
- •Serious psychopathology (bipolar disorder, psychosis)
- •Center for Epidemiologic Studies Depression Scale CES-D)score over 16
- •Contraindications for use of bupropion
- •History of seizure disorder
- •History of eating disorder
- •Current heavy drinking
- •Risk of pregnancy
- •Current breastfeeding
研究组 & 干预措施
Active bupropion + counseling
Active bupropion SR plus eight 10-minute individual counseling sessions.
干预措施: Active bupropion + counseling (Drug)
Active bupropion , No counseling
Active bupropion, No counseling, only medication checks
干预措施: Active bupropion, No counseling (Drug)
Placebo medication + counseling
Placebo bupropion plus eight 10-minute individual counseling sessions
干预措施: Placebo medication + counseling (Drug)
Placebo medication, No counseling
Placebo bupropion, No counseling, just medication checks
干预措施: Placebo medication, No counseling (Drug)
结局指标
主要结局
7-day Point Prevalence Abstinence From Smoking at 6 Months
时间窗: 6 months
No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.
次要结局
未报告次要终点