Serbian Smoking Reduction/Cessation Trial (2SRT)

Phase 4

Completed

• Conditions: Cigarette Smoking
• Interventions: Other: Swedish snus (smokeless tobacco); Other: Onico

• 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

Study Timeline

• Study First Submitted: 2007-12-27
• Study Start: 2008-01
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

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

Arm && Interventions

Group	Intervention	Description
1	Swedish snus (smokeless tobacco)	Swedish snus ad libitum as a substitute for cigarettes
2	Onico	Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes

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

Trial Locations

Locations (2)

Ambulanta Medicine Rada, Nis-Jugopetrol; 🇷🇸 Novi Beograd, Serbia

Institute of Nuclear Sciences "Vinca"; 🇷🇸 Belgrade, Serbia