Smokeless Tobacco Clinical Trial
Official title:
Human Laboratory Study of Smokeless Tobacco Products
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT. - Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant. - Subjects will have used SLT for at least 1 year.. - Subjects will be English speaking and reading. - Provide written informed consent. Exclusion Criteria: - Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months. - Subjects who take medications that might affect the outcome of laboratory measures. - Subjects with a history of major mood, thought, anxiety or attentional disorders. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Tobacco Research Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Startle Response | 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 | No |
Secondary | 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 | No |
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