Effects of E-Cigarettes in Menthol Smokers

Study Overview
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Brief Summary
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The current laboratory study examines e-cigarette preferences and smoking behaviors in menthol cigarette smokers.

Official Title
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Effects of E-Cigarettes in Menthol Smokers

Conditions
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E-cigarette Use, Smoking Behaviors

Intervention / Treatment
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* Device: JUUL E-Cigarette Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily cigarette smoking for at least the past 2 years Interest in trying e-cigarettes Report smoking mentholated cigarettes Exclusion Criteria: -- Pregnancy and/or breastfeeding

Ages Eligible for Study
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Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-Cigarette Flavor 1 Condition<br>Participants will self-administer a flavored e-cigarette. | Device: JUUL E-Cigarette Device<br>* We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.<br>|
| Experimental: E-Cigarette Flavor 2 Condition<br>Participants will self-administer a flavored e-cigarette. | Device: JUUL E-Cigarette Device<br>* We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.<br>|
| Experimental: E-Cigarette Flavor 3 Condition<br>Participants will self-administer a flavored e-cigarette. | Device: JUUL E-Cigarette Device<br>* We will use the commercially available and popular JUUL e-cigarette device and e-cigarette solutions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference Ratings | Self-report measures of product preference will be completed following the e-cigarette self-administration. Scores can range from 0 to 100 for the preference rating, with lower scores representing less preference and higher scores representing higher preference. | 1 hour | 
| Mood - Positive Affect Negative Affect Schedule | This measure is obtained through the completion of the Positive Affect Negative Affect Schedule. A total score will be calculated for both Positive and Negative Affect. Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. | 4 hours | 
| Mood - Profile of Mood States | This measure is obtained through the completion of the Profile of Mood States. A total score will be calculated. Scores can range from 10 to 260, with the lower scores representing lower levels of mood disturbance and higher scores representing higher levels of mood disturbance. | 4 hours | 
| Cigarette Craving | This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges. A total score will be calculated. Scores can range from 10 to 70, with the lower scores representing a lower level of cigarette craving and higher scores representing greater levels of cigarette craving. | 4 hours | 
| Nicotine Withdrawal - Minnesota Nicotine Withdrawal Scale | This measure is obtained through the completion of the Minnesota Nicotine Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 32, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal. | 4 hours | 
| Nicotine Withdrawal - Wisconsin Smoking Withdrawal Scale | This measure is obtained through the completion of the Wisconsin Smoking Withdrawal Scale. A total score will be calculated. Scores can range from 0 to 112, with the lower scores representing a lower level of nicotine withdrawal and higher scores representing greater levels of nicotine withdrawal. | 4 hours | 
| Smoking Motivation | This measure is obtained through the completion of a computerized behavioral task. | 2 hours after experimental session outset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol, cigarette, smoking