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

July 7, 2023 updated by: Adam Leventhal, University of Southern California
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E-cigarette e-liquid 1
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 2
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 3
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 4
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 5
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 6
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 7
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 8
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 9
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 10
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 11
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 12
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 13
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 14
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 15
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 16
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 17
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 18
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 19
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.
Experimental: E-cigarette e-liquid 20
Participants will self-administer an e-cigarette e-liquid.
Drug: E-cigarette e-liquid
Participants will self-administer an experimenter-provided e-cigarette.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Appeal
Time Frame: 1 hour
Self-report measures of product appeal will be completed following e-cigarette self-administration.
1 hour
Sensory Appeal
Time Frame: 1 hour
Self-report measures of product appeal will be completed following e-cigarette self-administration.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Adam M Leventhal, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HS-18-00839 Substudy 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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