Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Abstinence from smoking after ½ year (point and continuous abstinence)
研究概览
简要总结
To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.
Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.
详细描述
This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.
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
- •smokers (>7 cig/day)
- •Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
- •mild asthma and COPD,
- •Motivated to quit smoking
- •Motivated to follow the protocol
- •Motivated to use medication in this trial
排除标准
- •Severe diseases
- •Psychiatric diseases
- •Used NRT or Zyban the last 2 weeks
- •Stopped smoking >2 days during last 3 months
- •More than 6 alcoholic drinks per day
- •Smokes other products than cigarettes
- •Pregnant of lactating
研究组 & 干预措施
Smokeless Tobacco
Smokeless Tobacco and individual visits
干预措施: Smokeless tobacco (Oliver Twist pellets) (Drug)
Smokeless Tobacco
Smokeless Tobacco and individual visits
干预措施: smoking cessation counseling (Behavioral)
Nicotine tablets
Nicotine tablets
干预措施: smoking cessation counseling (Behavioral)
3
7-mg nicotine patch acts as placebo
干预措施: smoking cessation counseling (Behavioral)
结局指标
主要结局
Abstinence from smoking after ½ year (point and continuous abstinence)
时间窗: 6 months from entry
次要结局
- Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)(3 and 6 months from entry)
- Adherence to study(6,12,24 months from entry)
- Effect of retreatment (abstinence after 1, 1½ and 2 years)(12,18 and 24 months from entry)
- Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status(6,12,24 months from entry)
- Adverse events between 3 arms(Up to 6 months from entry)