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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00601042
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : December 11, 2013
Information provided by (Responsible Party):
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.

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

Study Type : Interventional  (Clinical Trial)
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 : January 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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 Name: Onico (brand name)

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Clinical tests and biomarkers relevant for exposure to tobacco [ Time Frame: 3, 6, 9, and 12 months ]
  3. Smoking reduction [ Time Frame: 12, 24, 36 and 48 months ]
    Smoking reduction according to self-report

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Swedish Match AB Identifier: NCT00601042     History of Changes
Other Study ID Numbers: SM 07-01
SM 07-01
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 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