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

NCT05958966 | Completed DMC

• 1 other identifier: HS-18-00839 Substudy 2
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (5)

E-cigarette e-liquid 1

EXPERIMENTAL

Participants will self-administer an e-cigarette e-liquid.

Other: E-cigarette e-liquid self-administration

E-cigarette e-liquid 2

EXPERIMENTAL

Participants will self-administer an e-cigarette e-liquid.

Other: E-cigarette e-liquid self-administration

E-cigarette e-liquid 3

EXPERIMENTAL

Participants will self-administer an e-cigarette e-liquid.

Other: E-cigarette e-liquid self-administration

E-cigarette e-liquid 4

EXPERIMENTAL

Participants will self-administer an e-cigarette e-liquid.

Other: E-cigarette e-liquid self-administration

No e-liquid

NO INTERVENTION

Participants do not receive an e-cigarette e-liquid to self-administer.

Interventions

E-cigarette e-liquid self-administration OTHER

Participant will self-administer an experimenter-provided e-cigarette.

E-cigarette e-liquid 1; E-cigarette e-liquid 2; E-cigarette e-liquid 3; E-cigarette e-liquid 4

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regular use of cigarettes containing nicotine.

You may not qualify if:

• Pregnant or planning to become pregnant.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Vaping; Cigarette Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking; Tobacco Use

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Preventive Medicine

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 25, 2023
• Study Start: April 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)