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Serbian Smoking Reduction/Cessation Trial (2SRT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Match AB
ClinicalTrials.gov Identifier:
NCT00601042
First received: December 27, 2007
Last updated: June 20, 2012
Last verified: June 2012
History of Changes

December 27, 2007
June 20, 2012
January 2008
June 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601042 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Clinical tests and biomarkers relevant for exposure to tobacco [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Smoking reduction [ Time Frame: 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]
    Smoking reduction according to self-report
  • Smoking reduction [ Time Frame: 12, 24, 36 and 48 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
  • Clinical tests and biomarkers relevant for exposure to tobacco [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Smoking reduction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Serbian Smoking Reduction/Cessation Trial (2SRT)
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cigarette Smoking
  • Other: Swedish snus (smokeless tobacco)
    Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
  • 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)
  • Experimental: 1
    Swedish snus ad libitum as a substitute for cigarettes
    Intervention: Other: Swedish snus (smokeless tobacco)
  • Placebo Comparator: 2
    Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes
    Intervention: Other: Onico
Joksić G, Spasojević-Tišma V, Antić R, Nilsson R, Rutqvist LE. Randomized, placebo-controlled, double-blind trial of Swedish snus for smoking reduction and cessation. Harm Reduct J. 2011 Sep 13;8(1):25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
319
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Serbia
 
NCT00601042
SM 07-01, SM 07-01
Yes
Swedish Match AB
Swedish Match AB
Not Provided
Principal Investigator: Gordana Joksic, Ph D Institute for Nuclear Research "Vinca", Belgrade, Serbia
Study Chair: Robert Nilsson, Ph D, Prof Stockholm University, Stockholm, Sweden
Swedish Match AB
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP