NCT05958992

Brief Summary

This study assess the ways in which e-cigarette product characteristics, such as flavors and nicotine salts, impact user experience to inform potential regulations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

July 7, 2023

Last Update Submit

July 14, 2023

Conditions

Keywords

vapinge-cigarettevapenicotinetobacco

Outcome Measures

Primary Outcomes (3)

  • Subjective Appeal

    This self-report measures of subjective 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.

    1 hour

  • Sensory Attributes

    This self-report measures 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.

    1 hour

  • Vaping Delay

    Minutes delayed before purchasing time to vape an e-liquid.

    1 hour

Study Arms (5)

E-Liquid 1

EXPERIMENTAL

Participants will self-administer an assigned e-liquid.

Other: E-cigarette

E-Liquid 2

EXPERIMENTAL

Participants will self-administer an assigned e-liquid.

Other: E-cigarette

E-liquid 3

EXPERIMENTAL

Participants will self-administer an assigned e-liquid.

Other: E-cigarette

E-liquid 4

EXPERIMENTAL

Participants will self-administer an assigned e-liquid.

Other: E-cigarette

No e-liquid

NO INTERVENTION

Participants will not receive an e-liquid to self-administer.

Interventions

Participants will self-administer experimenter-provided e-cigarettes

E-Liquid 1E-Liquid 2E-liquid 3E-liquid 4

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vapers/E-cigarette Users - Regular use of e-cigarettes/vaping devices containing nicotine
  • Cigarette Smokers
  • \- Regular use of cigarettes containing nicotine

You may not qualify if:

  • Pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

VapingCigarette Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco SmokingTobacco Use

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to use an e-liquid
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Preventive Medicine

Study Record Dates

First Submitted

July 7, 2023

First Posted

July 25, 2023

Study Start

August 25, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations