Serbian Smoking Reduction/Cessation Trial (2SRT)
Phase 4
Completed
- Conditions
- Cigarette Smoking
- Registration Number
- NCT00601042
- Lead Sponsor
- Swedish Match AB
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 319
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 6 months
- Secondary Outcome Measures
Name Time Method Smoking reduction 12, 24, 36 and 48 months Smoking reduction compared to baseline according to self-report
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie snus-induced nicotine absorption and its impact on nicotinic acetylcholine receptors in smoking cessation?
How does the efficacy of Swedish snus compare to FDA-approved smoking cessation therapies like varenicline and nicotine replacement therapy in clinical trials?
Are there specific biomarkers in saliva or blood that correlate with successful snus use for smoking reduction in Serbian populations?
What are the long-term adverse events associated with snus use in cigarette smokers, and how do they compare to combustible tobacco risks?
How do low-nitrosamine snus products compare to other smokeless tobacco variants in terms of carcinogen exposure and nicotine delivery profiles?
Trial Locations
- Locations (2)
Institute of Nuclear Sciences "Vinca"
🇷🇸Belgrade, Serbia
Ambulanta Medicine Rada, Nis-Jugopetrol
🇷🇸Novi Beograd, Serbia
Institute of Nuclear Sciences "Vinca"🇷🇸Belgrade, Serbia