Impact of E-cigarette Device Warnings

NCT05714982 | Completed Results DMC

• 2 other identifiers: 21-0469R01DA048390
• Study Type: interventional
• Target: 1,369
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized clinical trial is to determine whether e-cigarette warnings increase intentions to quit vaping without the unintended consequence of pushing users toward smoking. This trial addresses these issues by evaluating the impact of e-cigarette warnings by randomly assigning vapers to have their devices and refills labeled with control messages, text warnings, or pictorial warnings. Participants will be US adult (ages 21+) vapers. The trial expects \~1,200 participants to complete Visits 1, 3, and 5.

Conditions

Vaping Behaviors

Keywords

Vaping; Tobacco use; E-cigarette use

Outcome Measures

Primary Outcomes (1)

• Mean Vaping Quit Intentions Score

  The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions.

  Up to 4 weeks

Secondary Outcomes (16)

• Mean Knowledge Score

  Up to 4 weeks

• Mean Cognitive Elaboration Score

  Up to 4 weeks

• Mean Perceived Likelihood of Illness Score

  Up to 4 weeks

• Mean Negative Affect Score

  Up to 4 weeks

• Mean Attention Score

  Up to 4 weeks

Study Arms (3)

Label with text health warning

EXPERIMENTAL

Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills.

Other: Label with text health warning

Label with pictorial health warning

EXPERIMENTAL

Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills.

Other: Label with pictorial health warning

Label with neutral statements about vaping

OTHER

Labels with neutral statements about vaping will be applied to participants' vaping devices and refills.

Other: Label with neutral statements about vaping

Interventions

Label with text health warning OTHER

Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

Label with text health warning

Label with pictorial health warning OTHER

Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

Label with pictorial health warning

Label with neutral statements about vaping OTHER

Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 statements based on their assigned trial arm; at Visit 3, they will get 2 additional statements based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.

Label with neutral statements about vaping

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 21 years or older
• Currently vape every day or some days
• Use an e-cigarette that contains nicotine
• Be able to attend 2 in-person appointments
• Be able to bring in e-cigarette device and 2 weeks' worth or refills to 2 in-person appointments
• Be willing to let us apply a sticker to the device and refill materials
• Be willing to use only the labeled e-cigarette during the study
• Be able to complete 3 surveys online at home
• Be able to read and speak English
• Be able to complete a survey on a computer without help

You may not qualify if:

• Pregnant people
• If e-cigarette device cannot be labeled
• Vapers concurrently enrolled in any research studies about vaping or using other tobacco products
• Vapers who live in the same household as someone who has enrolled in the study

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Ewald & Wasserman Research Consultants, LLC

San Francisco, California, 94104, United States

Location

MeSH Terms

Conditions

Vaping; Tobacco Use

Interventions

Drug Labeling

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Packaging; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Results Point of Contact

• Title: Principal Investigator
• Organization: UNC

ntb@unc.edu

(919) 966-3282

Study Officials

• Noel Brewer, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 6, 2023
• Study Start: February 23, 2023
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: September 12, 2025
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: The data will be available beginning 12 to 36 months following the primary publication.
• Access Criteria: To obtain a copy of the dataset and codebook, a research scientist will have to submit a request in writing, identifying themselves and their affiliated institution, indicating what they plan to do with the data, and including assurances that they will not share the data with others without the written permission of the PI. Requestors must already have institutional review board, independent ethics committee, or research ethics board approval as applicable. Requestors must obtain a data use agreement through UNC's Office of Industry Contracting (OIC@unc.edu) to receive the dataset and codebook and agree to acknowledge NIH and the study investigators in any publications resulting from the data.

Locations

US (1)