Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2

Cigarette Smoking Clinical Trial

Official title:

Effects of e-Cigarettes on Perceptions and Behavior - Substudy 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05958966
• Other study ID #: HS-18-00839 Substudy 2
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 1, 2023

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, adult smokers (N=200) will attend two laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation) and smoke their own cigarettes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Regular use of cigarettes containing nicotine.

Exclusion Criteria:

• Pregnant or planning to become pregnant.

Related Conditions & MeSH terms

• Cigarette Smoking
• Cigarette Use, Electronic
• E-Cig Use
• Electronic Cigarette Use

Intervention

Other:
• E-cigarette e-liquid self-administration
Participant 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 Rating Questionnaire	This self-report measure of product appeal will be completed following e-cigarette self-administration. Scores can range from 0 to 100 for the appeal rating, with lower scores representing lower levels of appeal and higher scores representing higher levels of appeal.	1 hour
Primary	Sensory Attributes Rating Questionnaire	This self-report measure of product sensory attributes will be completed following e-cigarette self-administration. Scores can range from 0 to 100 for the sensory attribute rating, with lower scores representing lower levels of liking the sensory attribute and higher scores representing greater liking of the sensory attribute.	1 hour
Primary	Smoking Delay Task	Minutes delayed before purchasing time to smoke own cigarettes. Scores can range from 0mins to 50mins for the smoking delay task, with lower scores representing fewer minutes delayed from smoking and higher scores representing longer minutes delayed from smoking.	1 hour