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

Cigarette Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399031
• Other study ID #: HS-18-00839 Substudy 1
• Status: Completed
• Phase: N/A
• Start date: December 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• 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/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)

Related Conditions & MeSH terms

• Cigarette Smoking
• Cigarette Use, Electronic
• Electronic Cigarette Use
• Vaping

Intervention

Drug:
• E-cigarette e-liquid
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 e-cigarette self-administration.	1 hour
Primary	Sensory Appeal	Self-report measures of product appeal will be completed following e-cigarette self-administration.	1 hour