Serbian Smoking Reduction/Cessation Trial (2SRT)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Other: Swedish snus (smokeless tobacco)
* Other: Onico


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Swedish snus ad libitum as a substitute for cigarettes | Other: Swedish snus (smokeless tobacco)<br>* Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.<br>|
| Placebo Comparator: 2<br>Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes | Other: Onico<br>* Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum.<br>* Other names: Onico (brand name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Smoking reduction according to self-report | 12, 24, 36 and 48 months | 
| Smoking reduction | Smoking reduction compared to baseline according to self-report | 12, 24, 36 and 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking reduction, smoking cessation, randomized trial, Swedish snus, smokeless tobacco