Human Laboratory Study of Smokeless Tobacco Products

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Human Laboratory Study of Smokeless Tobacco Products

Conditions
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Smokeless Tobacco

Intervention / Treatment
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* Other: Nicotine Lozenge
* Other: Stonewall Dissolvable Tobacco Pieces
* Other: Camel Snus Frost
* Other: Skoal Wintergreen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Lozenge<br>4 mg nicotine lozenge (LOZ | Other: Nicotine Lozenge<br>* 4 mg for 12 days<br>* Other names: Commit Nicotine Lozenge;|
| Active Comparator: Camel Snus Frost<br> | Other: Camel Snus Frost<br>* pouches, 6.2 mg nicotine, for 12 days<br>* Other names: Camel Snus Frost Pouches;|
| Active Comparator: Stonewall Spearment Tablet<br> | Other: Stonewall Dissolvable Tobacco Pieces<br>* 5.6 mg nicotine pieces for 12 days<br>* Other names: Stonewall Spearmint Tablet;|
| Active Comparator: Skoal Wintergreen<br> | Other: Skoal Wintergreen<br>* Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.<br>* Other names: Skoal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smokeless tobacco, nicotine, snus, snuff, chewing tobacco, oral tobacco