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OpenTrials
Completed

NCT Number: NCT03742817

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

E-Cigarette

Other

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

Primary outcomes

  1. Subjective Appeal

    Time frame: 1 hour

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

  2. Positive Affect Negative Affect Schedule

    Time frame: 4 hours

    The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.

  3. Questionnaire of Vaping Urges

    Time frame: 4 hours

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2018
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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