Effects of e-Cigarettes on Perceptions and Behavior

Not Applicable

Completed

• Conditions: Electronic Cigarettes
• Interventions: Other: e-Cigarette

• Registration Number: NCT03742817
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2019-02-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Vapers

1. E-cigarette use >3 day/week for >2 months
2. Report regularly using e-cigarette products with nicotine
3. Positive cotinine test via NicAlert test strip

Smokers

1. Daily cigarette smoking for ≥ 2 years
2. Currently smoke > 4 cig/day
3. Interest in trying an e-cigarette or current use of e-cigarettes

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Exclusion Criteria

Vapers

1. Pregnancy/breastfeeding
2. Desire to immediately reduce e-cigarette use

Smokers

1. Breath CO < 9ppm at intake
2. Pregnancy / breastfeeding
3. Current daily use of other combustible tobacco products (e.g., cigars)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sweet-Flavor 0 mg/mL Nicotine (Free-Base)	e-Cigarette	Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine.
Sweet-Flavor 4.5% Nicotine (Salt)	e-Cigarette	Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume.
Sweet-Flavor 6 mg/mL Nicotine (Free-Base)	e-Cigarette	Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine.
Usual e-Cigarette	e-Cigarette	Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States