Cigarette Smoking Clinical Trial
— 2SRTOfficial title:
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
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.
Status | Completed |
Enrollment | 319 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Serbia | Institute of Nuclear Sciences "Vinca" | Belgrade | |
Serbia | Ambulanta Medicine Rada, Nis-Jugopetrol | Novi Beograd |
Lead Sponsor | Collaborator |
---|---|
Swedish Match AB |
Serbia,
Joksic G, Spasojevic-Tišma V, Antic R, Nilsson R, Rutqvist LE. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation. Harm Reduct J. 2011 Sep 13;8:25. doi: 10.1186/1477-7517-8-25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm | 3, 6, 9 and 12 months | No | |
Secondary | Clinical tests and biomarkers relevant for exposure to tobacco | 3, 6, 9, and 12 months | Yes | |
Secondary | Smoking reduction | Smoking reduction according to self-report | 12, 24, 36 and 48 months | No |
Secondary | Smoking reduction | Smoking reduction compared to baseline according to self-report | 12, 24, 36 and 48 months | No |
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