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Serbian Smoking Reduction/Cessation Trial (2SRT) (2SRT)

This study has been completed.
Information provided by (Responsible Party):
Swedish Match AB Identifier:
First received: December 27, 2007
Last updated: December 10, 2013
Last verified: December 2013
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 Intervention Phase
Cigarette Smoking
Other: Swedish snus (smokeless tobacco)
Other: Onico
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Swedish Match AB:

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 [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm [ Time Frame: 3, 6, 9 and 12 months ]
  • Clinical tests and biomarkers relevant for exposure to tobacco [ Time Frame: 3, 6, 9, and 12 months ]
  • Smoking reduction [ Time Frame: 12, 24, 36 and 48 months ]
    Smoking reduction according to self-report

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

Enrollment: 319
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Onico (brand name)


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
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
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Please refer to this study by its identifier: NCT00601042

Institute of Nuclear Sciences "Vinca"
Belgrade, Serbia, 11001
Ambulanta Medicine Rada, Nis-Jugopetrol
Novi Beograd, Serbia, 110 70
Sponsors and Collaborators
Swedish Match AB
Principal Investigator: Gordana Joksic, Ph D Institute for Nuclear Research "Vinca", Belgrade, Serbia
Study Chair: Robert Nilsson, Ph D, Prof Stockholm University, Stockholm, Sweden
  More Information

Responsible Party: Swedish Match AB Identifier: NCT00601042     History of Changes
Other Study ID Numbers: SM 07-01
Study First Received: December 27, 2007
Last Updated: December 10, 2013

Keywords provided by Swedish Match AB:
smoking reduction
smoking cessation
randomized trial
Swedish snus
smokeless tobacco

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents processed this record on April 28, 2017