A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
研究概览
简要总结
The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
详细描述
In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake.
All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
- •Daily smoking more than 1 year
- •Motivated to quit smoking using a smokefree tobacco product
- •Good general health
排除标准
- •Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
- •Unable to refrain from nicotine replacement therapy during the study
- •Current oral condition that could be made worse by study interventions
- •History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
- •History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
- •History of alcohol or substance abuse other than cigarette smoking within the past year
研究组 & 干预措施
1
Tobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants
干预措施: Low-nitrosamine smokefree tobacco product for oral use (Drug)
2
Non-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants
干预措施: Non-tobacco, non-nicotine placebo product (Other)
结局指标
主要结局
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
时间窗: Week 6-28
次要结局
- Minnesota Nicotine Withdrawal Scale(Baseline, week 6, 10, 16 and 28)
- Fagerström Test for Nicotine Dependence(Baseline, week 16 and 28)
- Biomarkers(Baseline, week 6, 16, and 28)
- Point Prevalence Smoking Cessation(6, 16, 28 weeks)
- Continuous Smoking Cessation(6-16 weeks)