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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-nitrosamine smokefree tobacco product for oral use | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | Week 6-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | Baseline, week 6, 10, 16 and 28 | |
| Fagerström Test for Nicotine Dependence | Baseline, week 16 and 28 | |
| Biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Fagerström, Ph. D. | Smoker's Information Center, Hälsingborg, Sweden | Study Chair |
| Randall R Stoltz, MD | Covance Clinical Research Unit, Evansville, In | Principal Investigator |
| Frank H Farmer, Jr, MD, Ph D, CPI | Covance Clinical Research Unit, Daytona Beach, FL | Principal Investigator |
| David C Carter, MD | Covance Clinical Research Unit, Austin, TX | Principal Investigator |
| Keith Klatt, MD | Covance Clinical Research Unit, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Covance Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21994343 | Result | 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. |
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Participants were checked for eligibility prior to group assignment
Participants recruited from database of clinical trial volunteers, and media ads
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Snus | Tobacco-based, smokefree product |
| FG001 | Placebo Snus | Non-tobacco, non-nicotine placebo product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Non-tobacco, non-nicotine placebo product | Other | 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. |
|
| 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 | 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 | 6-16 weeks |
| Evansville |
| Indiana |
| 47710 |
| United States |
| Covance Clinical Research Unit | Portland | Oregon | 97239 | United States |
| Covance Clinical Research Unit | Austin | Texas | 78752 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Snus | Tobacco-based, smokefree product |
| BG001 | Placebo Snus | Non-tobacco, non-nicotine placebo product |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Continuous Rate of Smoking Cessation by Self-report and Confirmed by Expired Air Carbon Monoxide Less or Equal Than 8 Ppm | Posted | Number | participants | Week 6-28 |
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| Secondary | Minnesota Nicotine Withdrawal Scale | Not Posted | Baseline, week 6, 10, 16 and 28 | ||||||||||||||||||||||||||||||||||||
| Secondary | Fagerström Test for Nicotine Dependence | Not Posted | Baseline, week 16 and 28 | ||||||||||||||||||||||||||||||||||||
| Secondary | Biomarkers | Not Posted | Baseline, week 6, 16, and 28 | ||||||||||||||||||||||||||||||||||||
| Secondary | Point Prevalence Smoking Cessation | 7-day point prevalence smoking cessation verified by CO in exhaled air of 8 ppm or less | Not Posted | 6, 16, 28 weeks | |||||||||||||||||||||||||||||||||||
| Secondary | Continuous Smoking Cessation | Continuous cessation according to self-report and CO in exhaled air of 8 ppm or less att all clinical visits | Not Posted | 6-16 weeks |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Snus | Tobacco-based, smokefree product | 2 | 125 | 53 | 125 | ||
| EG001 | Placebo Snus | Non-tobacco, non-nicotine placebo product | 2 | 125 | 37 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal bleeding | Reproductive system and breast disorders | Standard terminology | Non-systematic Assessment |
| |
| Severe visual disturbance | Nervous system disorders | Standard terminology | Non-systematic Assessment | Severe visual disturbance secondary to cerebrovascular incident |
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| severe multiple fractures in right ankle due to car accident | Musculoskeletal and connective tissue disorders | Standard terminology | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival pain, nausea, dyspepsia etc | Gastrointestinal disorders | Standard terminology | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Karl Fagerström | Fagerström Consulting AB | karl.fagerstrom@swipnet.se |
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D015438 | Health Behavior |
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| >=65 years |
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| Male |
|