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

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarette Use; Cigarette Smoking; Cigarette Use, Electronic; E-Cig Use
• Intervention / Treatment: Other: E-cigarette e-liquid self-administration

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Regular use of cigarettes containing nicotine.

Exclusion Criteria:

• Pregnant or planning to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HS-18-00839 Substudy 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No