Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Study Overview
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Brief Summary
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The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.

Detailed Description
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This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined. Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.

Official Title
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Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors

Conditions
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Tobacco Addiction, Dual Tobacco Use

Intervention / Treatment
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* Other: VLNC cigarettes
* Other: Combusted Products
* Other: Non-combusted products
* Other: CN cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications. Subject has provided written informed consent to participate in the study Exclusion Criteria: Regular use of tobacco products (including e-cigarettes) other than cigarettes Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting. Pregnant or breastfeeding (due to toxic effects from tobacco products). Planned quit date within the next two months. Does not have a way that the research team can communicate with them by phone or e-mail. Not able to read and write English well enough to complete study activities without translation.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CN + combusted & non-combusted products<br>Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. | Other: Combusted Products<br>* Options for combusted tobacco products include cigars, cigarillos, and little cigars, .<br>Other: Non-combusted products<br>* Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.<br>Other: CN cigarettes<br>* Experimental cigarettes with conventional nicotine content.<br>|
| Experimental: VLNC + combusted & non-combusted products<br>Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. | Other: VLNC cigarettes<br>* Modified risk tobacco product<br>* Other names: Very Low Nicotine Content Cigarettes;Other: Combusted Products<br>* Options for combusted tobacco products include cigars, cigarillos, and little cigars, .<br>Other: Non-combusted products<br>* Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.<br>|
| Experimental: VLNC with non-combusted products<br>Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. | Other: VLNC cigarettes<br>* Modified risk tobacco product<br>* Other names: Very Low Nicotine Content Cigarettes;Other: Non-combusted products<br>* Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Days Using Alternative Products | The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions. | 8 week intervetnion period | 
| Number of Combusted Products Smoked | Number of combusted products smoked per day during the last two weeks of the intervention period. | At weeks 6-8 (last two weeks of intervention period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of 24 Hour Quit Attempts | Rate of 24 hour quit attempts during the intervention period | 8 week intervention period | 
| Carcinogen Exposure Biomarker: Total NNAL | Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention. | Week 8 (end of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cigarette Smoking, Very Low Nicotine Content cigarettes (VLNC), Dual Tobacco Use