Cigarette SmokingPhase 4NCT00843622
Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers
A Phase 4 study testing Low-nitrosamine smokefree tobacco product for oral use in people with Cigarette Smoking, run by Swedish Match AB at 4 sites in United States.
Trial summary
The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Low-nitrosamine smokefree tobacco product for oral use
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
- Daily smoking more than 1 year
- Motivated to quit smoking using a smokefree tobacco product
- Good general health
Who cannot join
- Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
- Unable to refrain from nicotine replacement therapy during the study
- Current oral condition that could be made worse by study interventions
- History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
- History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
- History of alcohol or substance abuse other than cigarette smoking within the past year
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Covance Clinical Research Unit
Austin, Texas, 78752
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
Covance Clinical Research Unit
Evansville, Indiana, 47710
Covance Clinical Research Unit
Portland, Oregon, 97239
About this study
Official title: A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking
The study aims to assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
Read the detailed description
In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake.
All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.
- Conditions
- Cigarette Smoking
- Being tested
- Low-nitrosamine smokefree tobacco product for oral use, Non-tobacco, non-nicotine placebo product
- Keywords
- Smoking, Smoking cessation, Smokeless tobacco, Snus
- Medical subject headings
- Cigarette Smoking, Smoking, Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-nitrosamine smokefree tobacco product for oral useDrug
Also called Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"), Placebo "snus" ("Onico"-type product)
Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
Non-tobacco, non-nicotine placebo productOther
Placebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants Receives: Drug: Low-nitrosamine smokefree tobacco product for oral use |
| 2 | Placebo comparator | Non-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants Receives: Other: Non-tobacco, non-nicotine placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
Measured: Week 6-28
Secondary outcomes (5)
Minnesota Nicotine Withdrawal Scale
Measured: Baseline, week 6, 10, 16 and 28
Fagerström Test for Nicotine Dependence
Measured: Baseline, week 16 and 28
Biomarkers
Measured: Baseline, week 6, 16, and 28
Point Prevalence Smoking Cessation
7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less
Measured: 6, 16, 28 weeks
Continuous Smoking Cessation
Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits
Measured: 6-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Match AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Fagerström, Ph. D., Study chair, Smoker's Information Center, Hälsingborg, SwedenRandall R Stoltz, MD, Principal investigator, Covance Clinical Research Unit, Evansville, InFrank H Farmer, Jr, MD, Ph D, CPI, Principal investigator, Covance Clinical Research Unit, Daytona Beach, FLDavid C Carter, MD, Principal investigator, Covance Clinical Research Unit, Austin, TXKeith Klatt, MD, Principal investigator, Covance Clinical Research Unit, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843622
- Sponsor's protocol ID
- SM 08-01
- Status last verified
- May 2014
- First submitted
- 12 Feb 2009
- Last updated
- 17 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fagerstrom K, Rutqvist LE, Hughes JR. Snus as a smoking cessation aid: a randomized placebo-controlled trial. Nicotine Tob Res. 2012 Mar;14(3):306-12. doi: 10.1093/ntr/ntr214. Epub 2011 Oct 12.
PubMed 21994343
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of the Ability of a Traditional Swedish Smokeless Tobacco Product ("Snus") to Increase the Quit Rate Among Cigarette Smokers Who Wish to Stop Smoking
- ClinicalTrials.gov ID
- NCT00843622
- Acronym / sponsor ID
- SM 08-01
- Conditions
- Cigarette Smoking
- Keywords
- Smoking, Smoking cessation, Smokeless tobacco, Snus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Swedish Match ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Feb 2009 (estimated)
- Results
- Posted 17 Jun 2014
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 assess if use of a low-nitrosamine, Swedish, smokefree tobacco product for oral use ("snus") can increase the quit rate among cigarette smokers who wish to stop smoking
Detailed description
In a multicenter, double-blind, placebo-controlled setting, participants are randomly allocated to either a smokefree, oral tobacco product or a non-tobacco, non-nicotine placebo product with identical flavoring and physical appearance. The study consists of three phases: Study Product Test Period (4 weeks), Intervention Phase (12 weeks), and a Follow-Up Phase (12 weeks). The participants are all cigarette smokers who are motivated to quit. They are encouraged to gradually substitute as many cigarettes as possible with study products during the Study Product Test Period and to refrain from all cigarettes at the latest by the first day of Week 5. Use of study products will continue during the 12 week Intervention Phase. The participants are encouraged to cut down on use of study products during the last 3 weeks to avoid a too abrupt ending of nicotine intake.
All subjects are encouraged to continue in the study for clinical follow-up independent of smoking status although use of study products is discontinued during the Follow-Up Phase. If a subject has managed to quit smoking during the Intervention Phase but there is an imminent danger of smoking relapse during the Follow-Up Phase, that subject is informed that use of nicotine replacement therapy or a smokefree tobacco product is a better option in terms of health risks than a smoking relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Low-nitrosamine smokefree tobacco product for oral useTobacco-based, smokefree product in pouch format for oral use, pouch size 1.0 or 0.5 g to be used ad libitum by participants |
| 2 | Placebo comparator | Other: Non-tobacco, non-nicotine placebo productNon-tobacco, non-nicotine placebo product in pouch format for oral use, pouch size 1.0 g or 0.5 g, to be used ad libitum by the participants |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cigarette smoker who smoke more than 9 cigarettes per day (average during past month)
- Daily smoking more than 1 year
- Motivated to quit smoking using a smokefree tobacco product
- Good general health
Key exclusion criteria (6 listed)
- Use of smokefree/smokeless tobacco during past 6 months or any type of pharmaceutical product for smoking cessation during past 3 months
- Unable to refrain from nicotine replacement therapy during the study
- Current oral condition that could be made worse by study interventions
- History of clinically significant renal, hepatic, neurological, or chronic pulmonary disease that in the judgement of the investigator might preclude participation
- History of significant cardiovascular disease, including myocardial infarction, within the last 3 months, significant cardiac arrythmias, or poorly controlled hypertension that in the judgement of the investigator might preclude participation
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 |
|---|---|---|
| Low-nitrosamine smokefree tobacco product for oral useAlso: Swedish tobacco-based smokefree product for oral use ("General"-type Swedish "snus"), Placebo "snus" ("Onico"-type product)Smokeless tobacco in paper sachets containing 1.0 or 0.5 g of the product. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets. | Drug | 1 |
| Non-tobacco, non-nicotine placebo productPlacebo product in paper sachets containing 1.0 or 0.5 g. Product made of cocoa bean fibers and oat fibers. Usage ad libitum. Recommended dosages: 10-24 sachets per day (1.0 g sachets). Among participants who typically smoke >15-20 cigarettes per day and/or has a Fagerström score of 7 or higher, the recommended maximum number of sachets per day is 30. For participants who use small sachets (0.5 g) the recommended daily use is double compared that of 1.0 g sachets. | Other | 2 |
Primary outcome
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm
Time frame: Week 6-28
5 secondary outcomes
Minnesota Nicotine Withdrawal Scale
Time frame: Baseline, week 6, 10, 16 and 28
Fagerström Test for Nicotine Dependence
Time frame: Baseline, week 16 and 28
Biomarkers
Time frame: Baseline, week 6, 16, and 28
Point Prevalence Smoking Cessation
Time frame: 6, 16, 28 weeks
Continuous Smoking Cessation
Time frame: 6-16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21994343Fagerstrom K, Rutqvist LE, Hughes JR. Snus as a smoking cessation aid: a randomized placebo-controlled trial. Nicotine Tob Res. 2012 Mar;14(3):306-12. doi: 10.1093/ntr/ntr214. Epub 2011 Oct 12.
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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.
Karl Fagerström, Ph. D. study chair
Smoker's Information Center, Hälsingborg, Sweden
Randall R Stoltz, MD principal investigator
Covance Clinical Research Unit, Evansville, In
Frank H Farmer, Jr, MD, Ph D, CPI principal investigator
Covance Clinical Research Unit, Daytona Beach, FL
4 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 Low-nitrosamine smokefree tobacco product for oral use in people with Cigarette Smoking, run by Swedish Match AB at 4 sites in United States.
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 4 inclusion and 6 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 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm (time frame: Week 6-28). 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 NCT00843622, 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 17 Jun 2014.