NCT00601042已完成4 期
Randomized, Placebo-controlled, Double-blind, Phase IV Trial to Assess the Efficacy of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Reduce or Replace Cigarette Smoking Among Adult Smokers in Serbia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 4
- 主要终点
- Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line
研究概览
简要总结
The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus) can help adult smokers to reduce and eventually completely 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
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female smokers in good general health aged 20-65 years regularly smoking >10 cigarettes per day for more than 1 year who are motivated to reduce or quit smoking
排除标准
- •Subjects with uncontrolled hypertension, history of coronary heart disease or other significant heart condition
- •History of other significant medical condition that might interfere with study procedures
- •Pregnant or nursing mother
- •Current drug abuse.
结局指标
主要结局
Smoking reduction defined as a reduction in self-reported number of smoked cigarettes per day >50% compared to base-line, verified by a reduction in CO in exhaled air of >1 ppm compared to base-line
时间窗: 6 months
次要结局
- Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm(3, 6, 9 and 12 months)
- Clinical tests and biomarkers relevant for exposure to tobacco(3, 6, 9, and 12 months)
- Smoking reduction(12, 24, 36 and 48 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement TherapyTobacco DependenceNCT02355665McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.1,198
已完成
3 期
Nicotine Lozenges for Treatment of Smokeless Tobacco AddictionSmokeless Tobacco UseNCT00392379Mayo Clinic270
已完成
4 期
Statin Therapy in Heart Failure: Potential Mechanisms of BenefitHeart Failure, CongestiveNCT00233480University of California, Los Angeles27
已完成
1 期
Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa TherapyParkinson's DiseaseNCT00957918Neuraltus Pharmaceuticals, Inc.65
Unknown
不适用
Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 InfectionCOVID-19 InfectionNCT05175768Vedic Lifesciences Pvt. Ltd.375