Effects of e-Cigarettes on Perceptions and Behavior

NCT03742817 | Completed DMC

• 1 other identifier: HS-18-00839 - Pilot Study
• Study Type: interventional
• Target: 45
• 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 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.

Conditions

Electronic Cigarettes

Outcome Measures

Primary Outcomes (3)

• Subjective Appeal

  Self-report measures of product appeal will be completed following the e-cigarette administration.

  1 hour

• 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

• Questionnaire of Vaping Urges

  10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.

  4 hours

Study Arms (4)

Sweet-Flavor 4.5% Nicotine (Salt)

EXPERIMENTAL

Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume.

Other: e-Cigarette

Sweet-Flavor 0 mg/mL Nicotine (Free-Base)

PLACEBO COMPARATOR

Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine.

Other: e-Cigarette

Sweet-Flavor 6 mg/mL Nicotine (Free-Base)

EXPERIMENTAL

Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine.

Other: e-Cigarette

Usual e-Cigarette

ACTIVE COMPARATOR

Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration.

Other: e-Cigarette

Interventions

e-Cigarette OTHER

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

Sweet-Flavor 0 mg/mL Nicotine (Free-Base); Sweet-Flavor 4.5% Nicotine (Salt); Sweet-Flavor 6 mg/mL Nicotine (Free-Base); Usual e-Cigarette

Eligibility Criteria

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

You may qualify if:

• Vapers
• E-cigarette use \>3 day/week for \>2 months
• Report regularly using e-cigarette products with nicotine
• Positive cotinine test via NicAlert test strip
• Smokers
• Daily cigarette smoking for ≥ 2 years
• Currently smoke \> 4 cig/day
• Interest in trying an e-cigarette or current use of e-cigarettes

You may not qualify if:

• Vapers
• Pregnancy/breastfeeding
• Desire to immediately reduce e-cigarette use
• Smokers
• Breath CO \< 9ppm at intake
• Pregnancy / breastfeeding
• Current daily use of other combustible tobacco products (e.g., cigars)

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Han DH, Wong M, Peraza N, Vogel EA, Cahn R, Mason TB, Kirkpatrick M, Tackett AP, Leventhal AM. Dose-response effects of two nicotine salt formulations on electronic cigarette appeal and sensory attributes. Tob Control. 2023 Jan 2:tobaccocontrol-2022-057553. doi: 10.1136/tc-2022-057553. Online ahead of print.

  PMID: 36593119 DERIVED

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Adam M Leventhal, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Preventive Medicine

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 15, 2018
• Study Start: February 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)