Serbian Smoking Reduction/Cessation Trial (2SRT)

Sponsor

Swedish Match AB (Industry)

Overall Status

Completed

CT.gov ID

NCT00601042

Collaborator

(none)

319

Enrollment

Locations

Arms

Duration (Months)

159.5

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking	Other: Swedish snus (smokeless tobacco) Other: Onico	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

319 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Swedish snus ad libitum as a substitute for cigarettes	Other: Swedish snus (smokeless tobacco) Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
Placebo Comparator: 2 Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes	Other: Onico 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. Other Names: Onico (brand name)

Arm

Intervention/Treatment

Experimental: 1

Swedish snus ad libitum as a substitute for cigarettes

Other: Swedish snus (smokeless tobacco)

Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.

Placebo Comparator: 2

Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes

Other: Onico

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.

Other Names:

Onico (brand name)

Outcome Measures

Primary Outcome Measures

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

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]
Smoking reduction according to self-report
Smoking reduction [12, 24, 36 and 48 months]
Smoking reduction compared to baseline according to self-report

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Nuclear Sciences "Vinca"	Belgrade		Serbia	11001
2	Ambulanta Medicine Rada, Nis-Jugopetrol	Novi Beograd		Serbia	110 70

Sponsors and Collaborators

Swedish Match AB

Investigators

Principal Investigator: Gordana Joksic, Ph D, Institute for Nuclear Research "Vinca", Belgrade, Serbia
Study Chair: Robert Nilsson, Ph D, Prof, Stockholm University, Stockholm, Sweden