Serbian Smoking Reduction/Cessation Trial (2SRT)

NCT ID: NCT00601042

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cigarette Smoking

Keywords

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smoking reduction smoking cessation randomized trial Swedish snus smokeless tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Swedish snus ad libitum as a substitute for cigarettes

Group Type EXPERIMENTAL

Swedish snus (smokeless tobacco)

Intervention Type OTHER

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

2

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

Group Type PLACEBO_COMPARATOR

Onico

Intervention Type 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.

Interventions

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Swedish snus (smokeless tobacco)

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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Onico (brand name)

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Match AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordana Joksic, Ph D

Role: PRINCIPAL_INVESTIGATOR

Institute for Nuclear Research "Vinca", Belgrade, Serbia

Robert Nilsson, Ph D, Prof

Role: STUDY_CHAIR

Stockholm University, Stockholm, Sweden

Locations

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Institute of Nuclear Sciences "Vinca"

Belgrade, , Serbia

Site Status

Ambulanta Medicine Rada, Nis-Jugopetrol

New Belgrade, , Serbia

Site Status

Countries

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Serbia and Montenegro Serbia

References

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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.

Reference Type RESULT
PMID: 21914165 (View on PubMed)

Other Identifiers

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SM 07-01

Identifier Type: -

Identifier Source: secondary_id

SM 07-01

Identifier Type: -

Identifier Source: org_study_id