Serbian Smoking Reduction/Cessation Trial (2SRT)

Cigarette Smoking Clinical Trial

— 2SRT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601042
• Other study ID #: SM 07-01
• Secondary ID: SM 07-01
• Status: Completed
• Phase: Phase 4
• First received: December 27, 2007
• Last updated: December 10, 2013
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: Swedish Match AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia:Eticki komitet, Institut Nuklearne nauke "Vinca"
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Serbia	Institute of Nuclear Sciences "Vinca"	Belgrade
Serbia	Ambulanta Medicine Rada, Nis-Jugopetrol	Novi Beograd

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Match AB

Country where clinical trial is conducted

Serbia, 

References & Publications (1)

Joksic G, Spasojevic-Tišma 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	No
Secondary	Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm		3, 6, 9 and 12 months	No
Secondary	Clinical tests and biomarkers relevant for exposure to tobacco		3, 6, 9, and 12 months	Yes
Secondary	Smoking reduction	Smoking reduction according to self-report	12, 24, 36 and 48 months	No
Secondary	Smoking reduction	Smoking reduction compared to baseline according to self-report	12, 24, 36 and 48 months	No