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Completed

NCT Number: NCT00601042

Serbian Smoking Reduction/Cessation Trial (2SRT)

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.

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Key information

Conditions

Cigarette Smoking Behavior Health Behavior Smoking Smoking Cessation Smoking Reduction Tobacco Smoking Tobacco Use

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Nuclear Sciences "Vinca", Belgrade, Serbia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Swedish snus (smokeless tobacco)

Other

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

Onico

Other

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swedish Match AB

Industry

Registry information

Official study 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

Acronym: 2SRT

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2008
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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