NCT00060814已完成2 期
Pilot Study Examining the Effects of Combined Pharmacotherapy (Zyban/NRT)/Behavioral Treatment on Smoking Cessation Among MMT Patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Behavioral
研究概览
简要总结
The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.
详细描述
This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in long-term methadone maintenance treatment
- •Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months
排除标准
- •Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
- •Patients with cardiovascular disease, asthma, COPD
- •Patients who are pregnant or breastfeeding
- •Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)
结局指标
主要结局
Behavioral
时间窗: 6 months
次要结局
- Number of cigarettes smoked per day(six months)
研究者
研究点 (2)
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