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

July 14, 2023 updated by: Adam Leventhal, University of Southern California

This study assess the ways in which e-cigarette product characteristics, such as marketing strategies, impact user experience to inform potential regulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

601

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

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Vapers/E-cigarette Users

Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

- Regular use of cigarettes containing nicotine

Exclusion Criteria:

Pregnant or planning to become pregnant

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: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Appeal Rating Measure Time Frame: 1 hour	This self-report measures of subjective product appeal will be completed following e-cigarette self-administration and review of marketing strategies. 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.	1 hour
Sensory Attributes Time Frame: 1 hour	Self-report measures of product sensory attributes will be completed following e-cigarette self-administration and review of marketing strategies. 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.	1 hour

Collaborators and Investigators

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

Sponsor

University of Southern California

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)

August 25, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Substudy #1: UP-20-00744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Electronic Cigarette Use

Clinical Trials on Control Marketing Strategies

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