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| ID | Type | Description | Link |
|---|---|---|---|
| 0911M74614 | Other Identifier | IRB, University of Minnesota |
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Funding expired prior to implementing subject recruitment.
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With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.
Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Lozenge | Active Comparator | 4 mg nicotine lozenge (LOZ |
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| Camel Snus Frost | Active Comparator |
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| Stonewall Spearment Tablet | Active Comparator |
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| Skoal Wintergreen | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Lozenge | Other | 4 mg for 12 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Withdrawal Severity | Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL). | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition Impairments | Comparing differences between the smokeless tobacco products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL). | Week 10 |
| Startle Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Mooney, Ph.D. | Dept. Psychiatry, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Research Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Stonewall Dissolvable Tobacco Pieces | Other | 5.6 mg nicotine pieces for 12 days |
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| Camel Snus Frost | Other | pouches, 6.2 mg nicotine, for 12 days |
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| Skoal Wintergreen | Other | Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period. |
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Negative emotional responses to nicotine-relevant stimulant (based on physiologoical and electrophysiological measures, and self-reports of affective valence, arousal and control/dominance) differences between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
| Week 10 |
| Reinforcement | The break point (response workload at which subjects do not respond sufficiently to obtain a dosage of product in a defined time period) is expected to differ significantly between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL). | Week 10 |