Cigarette SmokingPhase 42SRTNCT00601042
Serbian Smoking Reduction/Cessation Trial (2SRT)
A Phase 4 study testing Swedish snus (smokeless tobacco) and Onico in people with Cigarette Smoking, run by Swedish Match AB at 2 sites in Serbia.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Swedish snus (smokeless tobacco) and Onico
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 319 participants
- Where
- 2 sitesSerbia
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites
Institute of Nuclear Sciences "Vinca"
Belgrade, 11001
Ambulanta Medicine Rada, Nis-Jugopetrol
New Belgrade, 110 70
About this study
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
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
- Being tested
- Swedish snus (smokeless tobacco), Onico
- Keywords
- smoking reduction, smoking cessation, randomized trial, Swedish snus, smokeless tobacco
- Medical subject headings
- Cigarette Smoking, Smoking Reduction, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swedish snus (smokeless tobacco)Other
Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.
OnicoOther
Also called Onico (brand name)
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Swedish snus ad libitum as a substitute for cigarettes Receives: Other: Swedish snus (smokeless tobacco) |
| 2 | Placebo comparator | Tobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes Receives: Other: Onico |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Smoking cessation defined as self-reported total abstention from cigarettes verified by CO in exhaled air <10 ppm
Measured: 3, 6, 9 and 12 months
Clinical tests and biomarkers relevant for exposure to tobacco
Measured: 3, 6, 9, and 12 months
Smoking reduction
Smoking reduction according to self-report
Measured: 12, 24, 36 and 48 months
Smoking reduction
Smoking reduction compared to baseline according to self-report
Measured: 12, 24, 36 and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Match AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordana Joksic, Ph D, Principal investigator, Institute for Nuclear Research "Vinca", Belgrade, SerbiaRobert Nilsson, Ph D, Prof, Study chair, Stockholm University, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601042
- Sponsor's protocol ID
- SM 07-01
- Other IDs
- SM 07-01
- Acronym
- 2SRT
- Status last verified
- Dec 2013
- First submitted
- 27 Dec 2007
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21914165
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00601042
- Acronym / sponsor ID
- 2SRT / SM 07-01
- Conditions
- Cigarette Smoking
- Keywords
- smoking reduction, smoking cessation, randomized trial, Swedish snus, smokeless tobacco
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Swedish Match ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Swedish snus (smokeless tobacco)Swedish snus ad libitum as a substitute for cigarettes |
| 2 | Placebo comparator | Other: OnicoTobacco-free, nicotine-free placebo snus ad libitum as a substitute for cigarettes |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swedish snus (smokeless tobacco)Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum. | Other | 1 |
| OnicoAlso: Onico (brand name)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 | 2 |
Primary outcome
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
4 secondary outcomes
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
Clinical tests and biomarkers relevant for exposure to tobacco
Time frame: 3, 6, 9, and 12 months
Smoking reduction
Time frame: 12, 24, 36 and 48 months
Smoking reduction
Time frame: 12, 24, 36 and 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Results publication: PubMed 21914165Joksic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordana Joksic, Ph D principal investigator
Institute for Nuclear Research "Vinca", Belgrade, Serbia
Robert Nilsson, Ph D, Prof study chair
Stockholm University, Stockholm, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Swedish snus (smokeless tobacco) and Onico in people with Cigarette Smoking, run by Swedish Match AB at 2 sites in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.