Effects of e-Cigarettes on Perceptions and Behavior

Electronic Cigarettes Clinical Trial

Official title:

Effects of e-Cigarettes on Perceptions and Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742817
• Other study ID #: HS-18-00839 - Pilot Study
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Electronic Cigarettes

Intervention

Other:
• e-Cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Appeal	Self-report measures of product appeal will be completed following the e-cigarette administration.	1 hour
Primary	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
Primary	Questionnaire of Vaping Urges	10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.	4 hours