Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

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 in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) 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, nicotine formulation).

Official Title
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Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

Conditions
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Electronic Cigarette Use, Cigarette Use, Electronic, Vaping, Cigarette Smoking

Intervention / Treatment
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* Drug: E-cigarette e-liquid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vapers/E-cigarette Users E-cigarette/vaping device use at least three days per week for at least 2 months Regular use of e-cigarettes/vaping devices containing nicotine Cigarette Smokers Daily cigarette smoking for at least two years Currently smoke at least four cigarettes per day Interested in trying an e-cigarette or current use of an e-cigarette Exclusion Criteria: Vapers/E-cigarette Users Pregnant or breastfeeding Desire to cut down on use of e-cigarette/vaping device Cigarette Smokers Pregnant or breastfeeding Current daily use of other combustible tobacco products (such as 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E-cigarette e-liquid 1<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 2<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 3<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 4<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 5<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 6<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 7<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 8<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 9<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 10<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 11<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 12<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 13<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 14<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 15<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 16<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 17<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 18<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 19<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<br>* Participants will self-administer an experimenter-provided e-cigarette.<br>|
| Experimental: E-cigarette e-liquid 20<br>Participants will self-administer an e-cigarette e-liquid. | Drug: E-cigarette e-liquid<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 e-cigarette self-administration. | 1 hour | 
| Sensory Appeal | Self-report measures of product appeal will be completed following e-cigarette self-administration. | 1 hour |