Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
319 participants
INTERVENTIONAL
2008-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Swedish snus ad libitum as a substitute for cigarettes
Swedish snus (smokeless tobacco)
Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
2
Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes
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.
Interventions
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Swedish snus (smokeless tobacco)
Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of other significant medical condition that might interfere with study procedures
* Pregnant or nursing mother
* Current drug abuse.
20 Years
65 Years
ALL
Yes
Sponsors
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Swedish Match AB
INDUSTRY
Responsible Party
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Principal Investigators
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Gordana Joksic, Ph D
Role: PRINCIPAL_INVESTIGATOR
Institute for Nuclear Research "Vinca", Belgrade, Serbia
Robert Nilsson, Ph D, Prof
Role: STUDY_CHAIR
Stockholm University, Stockholm, Sweden
Locations
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Institute of Nuclear Sciences "Vinca"
Belgrade, , Serbia
Ambulanta Medicine Rada, Nis-Jugopetrol
New Belgrade, , Serbia
Countries
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References
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Joksic G, Spasojevic-Tisma V, Antic 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;8:25. doi: 10.1186/1477-7517-8-25.
Other Identifiers
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SM 07-01
Identifier Type: -
Identifier Source: secondary_id
SM 07-01
Identifier Type: -
Identifier Source: org_study_id