Serbian Smoking Reduction/Cessation Trial (2SRT) (2SRT)

December 10, 2013 updated by: Swedish Match AB

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

319

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11001
        • Institute of Nuclear Sciences "Vinca"
      • Novi Beograd, Serbia, 110 70
        • Ambulanta Medicine Rada, Nis-Jugopetrol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Onico (brand name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6, 9 and 12 months
Clinical tests and biomarkers relevant for exposure to tobacco
Time Frame: 3, 6, 9, and 12 months
3, 6, 9, and 12 months
Smoking reduction
Time Frame: 12, 24, 36 and 48 months
Smoking reduction according to self-report
12, 24, 36 and 48 months
Smoking reduction
Time Frame: 12, 24, 36 and 48 months
Smoking reduction compared to baseline according to self-report
12, 24, 36 and 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM 07-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cigarette Smoking

Clinical Trials on Swedish snus (smokeless tobacco)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe