Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use

Conditions
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Tobacco Use Disorder, Nicotine Dependence

Intervention / Treatment
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* Other: Low nicotine
* Other: Medium nicotine
* Other: High nicotine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year; In good physical health (no unstable medical condition); Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria). Exclusion Criteria: Subjects must not be currently using other tobacco or nicotine products. Female subjects cannot be pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low nicotine<br>Conventional smokeless tobacco product with 1) NNN plus NNK of <2 μg/gram and nicotine levels of >5 mg/g wet weight | Other: Low nicotine<br>* Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.<br>|
| Active Comparator: Medium nicotine<br>Conventional smokeless tobacco product with ) NNN plus NNK of <2 μg/gram and nicotine levels of 3-5 mg/g wet weight. | Other: Medium nicotine<br>* Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.<br>|
| Active Comparator: High nicotine<br>Conventional smokeless tobacco product with NNN plus NNK of <2 μg/gram and nicotine levels of <3 mg/g wet weight | Other: High nicotine<br>* Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biomarkers of tobacco exposure, Smokeless Tobacco