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

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT05958992

Collaborator

(none)

461

Enrollment

Location

Arms

20.2

Actual Duration (Months)

22.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study assess the ways in which e-cigarette product characteristics, such as flavors and nicotine salts, impact user experience to inform potential regulations.

Condition or Disease	Intervention/Treatment	Phase
Electronic Cigarette Use Cigarette Smoking Cigarette Use, Electronic Vaping	Other: E-cigarette	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

461 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to use an e-liquidParticipants will be randomly assigned to use an e-liquid

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 25, 2020

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Subjective Appeal [1 hour]
This self-report measures of subjective 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 [1 hour]
This self-report measures 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.
Vaping Delay [1 hour]
Minutes delayed before purchasing time to vape an e-liquid.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Vapers/E-cigarette Users - Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

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 of Preventive Medicine, University of Southern California

ClinicalTrials.gov Identifier:

NCT05958992

Other Study ID Numbers:

Substudy #2: UP-20-00744

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:

Keywords provided by Adam Leventhal, Professor of Preventive Medicine, University of Southern California

Study Results

No Results Posted as of Jul 25, 2023