Methods Project 4: Clinical Trial

Study Overview
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Brief Summary
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Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to one of the three experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.

Detailed Description
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Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured including a record of their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR). Experimental Period: After the baseline assessment, subjects will be randomized to one of five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution (i.e., no smoking) and use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. Snus, but not cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.

Official Title
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PROJECT 4: CLINICAL TRIAL METHODS FOR ASSESSING A TOBACCO PRODUCT Part of MODELS FOR TOBACCO PRODUCT EVALUATION

Conditions
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Smoker

Intervention / Treatment
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* Other: Cigarettes
* Other: Snus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who are at least 18 years of age; Daily smoker; Generally good health; Subject has provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves continued use of tobacco products and new tobacco products); Exclusion Criteria: Unstable health Pregnant or breastfeeding (due to toxic effects from tobacco products). Unable to read for comprehension or completion of study documents.

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Brand Cigarette<br>Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice); | Other: Cigarettes<br>* Smoke their usual brand of cigarettes and follow their normal patterns of use.<br>|
| Experimental: Complete Substitution<br>Use snus in place of cigarettes | Other: Snus<br>* Winterchill or Robust flavors<br>* Other names: Camel Snus;|
| Experimental: Partial Substitution (Snus and Cigarettes)<br>Use snus and cigarettes how ever you like | Other: Cigarettes<br>* Smoke their usual brand of cigarettes and follow their normal patterns of use.<br>Other: Snus<br>* Winterchill or Robust flavors<br>* Other names: Camel Snus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoke-free Days | Number of days subjects smoked no cigarettes during the intervention was compared between groups. | 8 weeks (56 (+/-5) days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CEMA (2-cyanoethylmercapturic Acid) | 2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure. | 8 weeks | 
| Total Nicotine Exposure | Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose | 8 weeks | 
| Urinary Total NNAL | Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarette, snus, smoking, tobacco