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OpenTrials
Completed

NCT Number: NCT04399031

Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

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, young adult vapers (N=100) and adult smokers (N=100) 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, nicotine formulation).

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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 Users

  • E-cigarette/vaping device use at least three days per week for at least 2 months
  • Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

  • Daily cigarette smoking for at least two years
  • Currently smoke at least four cigarettes per day
  • Interested in trying an e-cigarette or current use of an e-cigarette

Exclusion criteria

Vapers/E-cigarette Users

  • Pregnant or breastfeeding
  • Desire to cut down on use of e-cigarette/vaping device

Cigarette Smokers

  • Pregnant or breastfeeding
  • Current daily use of other combustible tobacco products (such as cigars)

Treatment and study plan

E-cigarette e-liquid

Drug

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 e-cigarette self-administration.

  2. Sensory Appeal

    Time frame: 1 hour

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

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
May 22, 2020
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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