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To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.
US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (control) continue smoking their usual brand of CC | Active Comparator |
| |
| tobacco flavor and unflavored options of ZYN | Active Comparator |
| |
| unrestricted flavor options of ZYN | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cigarette smoking | Other | continue smoking usual brand of cigarette |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in urine | Concentrations of total NNAL measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat). | Measured from baseline to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian E Erkkila, PhD | Swedish Match | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Raleigh | North Carolina | 27617 | United States |
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| tobacco flavored and unflavored pouch | Other | provide tobacco flavored and unflavored options of nicotine pouch |
|
| unrestricted flavor options pouch | Other | provide unrestricted flavor options of nicotine pouch |
|
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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