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OpenTrials
Completed

NCT Number: NCT05958966

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.

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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

  • Regular use of cigarettes containing nicotine.

Exclusion criteria

  • Pregnant or planning to become pregnant.

Treatment and study plan

E-cigarette e-liquid self-administration

Other

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

Primary outcomes

  1. Subjective Appeal Rating Questionnaire

    Time frame: 1 hour

    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.

  2. Sensory Attributes Rating Questionnaire

    Time frame: 1 hour

    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.

  3. Smoking Delay Task

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 25, 2023
Registry last updated
Jul 25, 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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