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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA141531 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure
This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low nicotine | Active Comparator | Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight |
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| Medium nicotine | Active Comparator | Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight. |
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| High nicotine | Active Comparator | Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low nicotine | Other | Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| 1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States | ||
| Oregon Research Institute |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Medium nicotine | Other | Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels. |
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| High nicotine | Other | Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels. |
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| Eugene |
| Oregon |
| 97403 |
| United States |