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| Name | Class |
|---|---|
| Swedish Match AB | INDUSTRY |
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In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.
Comparisons:
A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.
C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.
D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.
Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General 1 g pouch | Active Comparator | Oral pouch 0.3-1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
|
| Catch Licoice 1 g pouch | Active Comparator | Oral pouch 1g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
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| Catch Licorice Mini 0.5 g pouch | Active Comparator | Oral pouch 0.5g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
|
| Catch Licorice dry mini 0.3 g pouch | Active Comparator | Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes. Buccal Administration of nicotine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buccal Administration of nicotine | Procedure | Oral pouch 1g, single dose. One pouch administered over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-vivo extraction of cadmium | Extracted amount = mean of 10 unused sachets - residual amount | 30 minutes' use |
| Measure | Description | Time Frame |
|---|---|---|
| in-vivo extraction of tobacco specific nitrosamines (TSNAs) | Extracted amount = mean of 10 unused sachets - residual amount in used sachet | 30 minutes' use |
| In-vivo extraction of lead | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Lunell, MD, PhD | Croel AB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CROel AB | Helsingborg | SE25284 | Sweden |
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| Buccal Administration of nicotine | Procedure | Oral pouch 1g, single dose. One pouch administered over 30 minutes. |
|
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| Buccal Administration of nicotine | Procedure | Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes. |
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| Buccal Administration of nicotine | Procedure | Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes. |
|
|
| 30 minutes' use |
| In-vivo extraction of nicotine | Extracted amount = mean of 10 unused sachets - residual amount in one used sachet | 30 minutes' use |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D040261 | Harm Reduction |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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