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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT05958966

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Electronic Cigarette Use E-Cig Use Cigarette Smoking Cigarette Use, Electronic	Other: E-cigarette e-liquid self-administration	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

73 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

May 1, 2023

Actual Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: E-cigarette e-liquid 1 Participants will self-administer an e-cigarette e-liquid.	Other: E-cigarette e-liquid self-administration Participant will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 2 Participants will self-administer an e-cigarette e-liquid.	Other: E-cigarette e-liquid self-administration Participant will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 3 Participants will self-administer an e-cigarette e-liquid.	Other: E-cigarette e-liquid self-administration Participant will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 4 Participants will self-administer an e-cigarette e-liquid.	Other: E-cigarette e-liquid self-administration Participant will self-administer an experimenter-provided e-cigarette.
No Intervention: No e-liquid Participants do not receive an e-cigarette e-liquid to self-administer.

Outcome Measures

Primary Outcome Measures

Subjective Appeal Rating Questionnaire [1 hour]
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.
Sensory Attributes Rating Questionnaire [1 hour]
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.
Smoking Delay Task [1 hour]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Regular use of cigarettes containing nicotine.

Exclusion Criteria:

Pregnant or planning to become pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California	Los Angeles	California	United States	90033

Sponsors and Collaborators

University of Southern California

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adam Leventhal, Professor, Department of Preventive Medicine, University of Southern California

ClinicalTrials.gov Identifier:

NCT05958966

Other Study ID Numbers:

HS-18-00839 Substudy 2

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 25, 2023