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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04399031
Other study ID # HS-18-00839 Substudy 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date March 1, 2020

Study information

Verified date July 2023
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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).


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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)

Study Design


Intervention

Drug:
E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective Appeal Self-report measures of product appeal will be completed following e-cigarette self-administration. 1 hour
Primary Sensory Appeal Self-report measures of product appeal will be completed following e-cigarette self-administration. 1 hour
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