Controlled Study of the Ability of a Smokefree Tobacco Product to Increase the Quit Rate Among Cigarette Smokers

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Cigarette Smoking

Intervention / Treatment
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* Drug: Low-nitrosamine smokefree tobacco product for oral use
* Other: Non-tobacco, non-nicotine placebo product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: Low-nitrosamine smokefree tobacco product for oral use<br>* 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.<br>* Other names: Placebo snus (Onico-type product);|
| Placebo Comparator: 2<br>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 | Other: Non-tobacco, non-nicotine placebo product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Smoking cessation, Smokeless tobacco, Snus