Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

Study Overview
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Brief Summary
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In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive credits that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.

Official Title
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Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

Conditions
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Tobacco Use Disorder

Intervention / Treatment
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* Other: Menthol ban on cigarettes
* Other: Menthol ban on cigarettes and e-cigarettes
* Other: No menthol ban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between the ages of 18 and 64 Purchase exclusively menthol cigarettes Not currently motivated to quit smoking Smoking a minimum number of cigarettes per day Exclusion Criteria: Report a serious, unstable medical or psychiatric condition Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking) Have used any smoking cessation therapy during the past month Regularly use any form of tobacco other than cigarettes Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menthol ban only for cigarettes<br>Participants will have available to them non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge | Other: Menthol ban on cigarettes<br>* Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes<br>|
| Experimental: Menthol ban for cigarettes and e-cigarettes<br>Participants will have available to them non-menthol cigarettes, tobacco flavored version of a cigarette-like e-cigarette, tobacco flavored version of a tank like e-cigarette and nicotine gum and lozenge | Other: Menthol ban on cigarettes and e-cigarettes<br>* Participants will have neither menthol flavored cigarettes or e-cigarettes available<br>|
| Other: No Menthol Ban<br>Participants will have available to them menthol and non-menthol cigarettes, menthol and tobacco flavored versions of a cigarette-like e-cigarette, menthol and tobacco flavored versions of a tank like e-cigarette and nicotine gum and lozenge | Other: No menthol ban<br>* Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Tobacco Product Used | Total number of cigarettes smoked and puffs of e-cigarettes used | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How Much of Each Product is Obtained From the Experimental Marketplace | Number of packs of cigarettes obtained and amount of e-liquid obtained from the experimental marketplace | 6 weeks | 
| Motivation to Quit Smoking Cigarettes | Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time | 6 weeks |