Serbian Smoking Reduction/Cessation Trial (2SRT)

NCT00601042 | Completed Phase 4 DMC

• 1 other identifier: SM 07-01
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 2

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.

Conditions

Cigarette Smoking

Keywords

smoking reduction; smoking cessation; randomized trial; Swedish snus; smokeless tobacco

Outcome Measures

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

  6 months

Secondary Outcomes (4)

• Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm

  3, 6, 9 and 12 months

• Clinical tests and biomarkers relevant for exposure to tobacco

  3, 6, 9, and 12 months

• Smoking reduction

  12, 24, 36 and 48 months

• Smoking reduction

  12, 24, 36 and 48 months

Study Arms (2)

1

EXPERIMENTAL

Swedish snus ad libitum as a substitute for cigarettes

Other: Swedish snus (smokeless tobacco)

2

PLACEBO COMPARATOR

Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes

Other: Onico

Interventions

Swedish snus (smokeless tobacco) OTHER

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

1

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.

Also known as: Onico (brand name)

2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Swedish Match AB: lead

Study Sites (2)

Institute of Nuclear Sciences "Vinca"

Belgrade, 11001, Serbia

Location

Ambulanta Medicine Rada, Nis-Jugopetrol

New Belgrade, 110 70, Serbia

Location

Related Publications (1)

• 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.

  PMID: 21914165 RESULT

MeSH Terms

Conditions

Cigarette Smoking; Smoking Reduction; Smoking Cessation; Tobacco Use

Interventions

Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Tobacco Products; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Gordana Joksic, Ph D

  Institute for Nuclear Research "Vinca", Belgrade, Serbia

  PRINCIPAL INVESTIGATOR

• Robert Nilsson, Ph D, Prof

  Stockholm University, Stockholm, Sweden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 25, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

SE (2)