Phase 2 Study of Smoke Free Tobacco and Group Support for Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Continuous Smoking cessation quit rate after 6 and 12 months
研究概览
简要总结
The purpose of this trial is to examine if smokeless tobacco combined with group support might increase smoking cessation rate compared with groups support in smokers.
详细描述
The purpose of this trial is to examine if smokeless tobacco (Oliwer Twist) combined with group support (15-20 per group) might increase smoking cessation rate compared with groups support cold turkey in smokers.The test product should be used for 7 weeks. Seven group meetings are planned during the first 3 months followed bu follow-up sessions after 6 and 12 months. The design is open, randomized. Assessment of ECG, blood pressure, body-weight, carbon monoxide,lung function, stress, quality of life,withdrawal symptoms,adverse events and plasma nicotine, cotinine and thiocyante at entry and after 4 weeks etc.
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
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoking > 13 cigarettes/day
- •healthy (allowed: hypertension, diabetes type 2, mild asthma/COPD, hypercholesterolemia)
- •motivated for cessation
- •motivated to use tobacco pastils
- •motivated for group support
排除标准
- •severe diseases
- •psychiatric diseases
- •using antipsychotic drugs
- •used NRT/bupropion in the last 3 months
- •consuming > 6 drinks/day
- •pregnant/lactating
- •stopped smoking more than 2 days during last 3 months
结局指标
主要结局
Continuous Smoking cessation quit rate after 6 and 12 months
次要结局
- Side effects from tested tobacco product
- Intake of nicotine and thiocyanate