Effects of e-Cigarettes on Perceptions and Behavior

Study Overview
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Brief Summary
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This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.

Official Title
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Effects of e-Cigarettes on Perceptions and Behavior

Conditions
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Electronic Cigarettes

Intervention / Treatment
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* Other: e-Cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vapers E-cigarette use >3 day/week for >2 months Report regularly using e-cigarette products with nicotine Positive cotinine test via NicAlert test strip Smokers Daily cigarette smoking for ≥ 2 years Currently smoke > 4 cig/day Interest in trying an e-cigarette or current use of e-cigarettes Exclusion Criteria: Vapers Pregnancy/breastfeeding Desire to immediately reduce e-cigarette use Smokers Breath CO < 9ppm at intake Pregnancy / breastfeeding Current daily use of other combustible tobacco products (e.g., cigars)

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sweet-Flavor 4.5% Nicotine (Salt)<br>Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Placebo Comparator: Sweet-Flavor 0 mg/mL Nicotine (Free-Base)<br>Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: Sweet-Flavor 6 mg/mL Nicotine (Free-Base)<br>Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Active Comparator: Usual e-Cigarette<br>Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration. | Other: e-Cigarette<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Appeal | Self-report measures of product appeal will be completed following the e-cigarette administration. | 1 hour | 
| Positive Affect Negative Affect Schedule | The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect. | 4 hours | 
| Questionnaire of Vaping Urges | 10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes. | 4 hours |