Effects of e-Cigarettes on Perceptions and Behavior

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 across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarettes
• Intervention / Treatment: Other: e-Cigarette

• Study Type: Interventional
• Enrollment (Actual): 45
• 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: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Vapers

1. E-cigarette use >3 day/week for >2 months
2. Report regularly using e-cigarette products with nicotine
3. Positive cotinine test via NicAlert test strip

Smokers

1. Daily cigarette smoking for ≥ 2 years
2. Currently smoke > 4 cig/day
3. Interest in trying an e-cigarette or current use of e-cigarettes

Exclusion Criteria:

Vapers

1. Pregnancy/breastfeeding
2. Desire to immediately reduce e-cigarette use

Smokers

1. Breath CO < 9ppm at intake
2. Pregnancy / breastfeeding
3. Current daily use of other combustible tobacco products (e.g., cigars)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sweet-Flavor 4.5% Nicotine (Salt); Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume.	Other: e-Cigarette; Participants will self-administer an experimenter-provided e-cigarette.
Placebo Comparator: Sweet-Flavor 0 mg/mL Nicotine (Free-Base); Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine.	Other: e-Cigarette; Participants will self-administer an experimenter-provided e-cigarette.
Experimental: Sweet-Flavor 6 mg/mL Nicotine (Free-Base); Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine.	Other: e-Cigarette; Participants will self-administer an experimenter-provided e-cigarette.
Active Comparator: Usual e-Cigarette; Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration.	Other: e-Cigarette; Participants will self-administer an experimenter-provided e-cigarette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Affect Negative Affect Schedule	The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.	4 hours
Subjective Appeal	Self-report measures of product appeal will be completed following the e-cigarette administration.	1 hour
Questionnaire of Vaping Urges	10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.	4 hours

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Adam M Leventhal, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HS-18-00839 - Pilot Study

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