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: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking
Other: Swedish snus (smokeless tobacco)
Other: Onico
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Swedish Match AB:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 319
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Swedish snus ad libitum as a substitute for cigarettes
Other: Swedish snus (smokeless tobacco)
Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
Placebo Comparator: 2
Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes
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)

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601042

Locations
Serbia
Institute of Nuclear Sciences "Vinca"
Belgrade, Serbia, 11001
Ambulanta Medicine Rada, Nis-Jugopetrol
Novi Beograd, Serbia, 110 70
Sponsors and Collaborators
Swedish Match AB
Investigators
Principal Investigator: Gordana Joksic, Ph D Institute for Nuclear Research "Vinca", Belgrade, Serbia
Study Chair: Robert Nilsson, Ph D, Prof Stockholm University, Stockholm, Sweden
  More Information

Publications:
Responsible Party: Swedish Match AB
ClinicalTrials.gov Identifier: NCT00601042     History of Changes
Other Study ID Numbers: SM 07-01, SM 07-01
Study First Received: December 27, 2007
Last Updated: December 10, 2013
Health Authority: Serbia:Eticki komitet, Institut Nuklearne nauke "Vinca"

Keywords provided by Swedish Match AB:
smoking reduction
smoking cessation
randomized trial
Swedish snus
smokeless tobacco

Additional relevant MeSH terms:
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014