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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05892445
Other study ID # 1422045
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2025
Est. completion date September 30, 2025

Study information

Verified date May 2023
Source University of California, San Diego
Contact Raphael E Cuomo, PhD
Phone 858-822-3552
Email racuomo@ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project aims to evaluate the effectiveness of aversive visual health warnings on e-cigarette cessation among young adults through a randomized controlled trial, as e-cigarette use among this population has been steadily increasing, posing significant public health concerns. While traditional tobacco products have long featured health warnings, e-cigarettes lack similarly aversive visual warnings, and this study seeks to inform the development of targeted e-cigarette cessation strategies and contribute to a deeper understanding of how visual health warnings can be utilized to reduce e-cigarette use and ultimately improve public health. The project has three main aims, which include a rigorous assessment of the academic literature on e-cigarette risks and adverse effects to develop evidence-based mock visual health warnings for e-cigarettes; assessing the effectiveness of aversive visual health warnings in increasing intent to cessate e-cigarettes, with a particular focus on individuals who have experienced adverse events; and examining the long-term impacts of visual health warnings on e-cigarette cessation. This study will also investigate the underlying mechanisms that may explain the relationship of the intervention on cessation. To generate visual warnings, the research team will conduct a thorough review of the scientific literature on e-cigarette risks and adverse effects and collaborate with a graphic designer. Experimental warnings will be annotated and categorized in order to understand the influence of different imagery on variations in participant response. The study will be conducted as a randomized controlled trial, recruiting participants through market research firms that will distribute an online survey to their panels of e-cigarette users. Participants will be eligible for inclusion if they are 18-29 years old and currently use e-cigarettes at least once per week. A quota will be included to ensure sufficient responses from individuals who have experienced at least one adverse event related to e-cigarette use in the past 12 months. The intervention group will be exposed to a series of aversive visual health warnings about the potential health risks of e-cigarette use, delivered through the online survey platform, while the control group will not receive any intervention and will complete the same survey as the intervention group. Data will be analyzed using appropriate statistical techniques, including logistic regression and mediation/moderation analysis, to assess the effectiveness of the aversive visual health warnings in reducing e-cigarette use and the moderating effects of prior adverse event experience. Participants will be contacted for follow-up assessments at 3-months post-intervention to investigate the impact of aversive visual health warnings on e-cigarette cessation among young adults, including the moderating effects of prior adverse event experience, and assess the underlying mechanisms that may explain the relationship between the intervention and e-cigarette cessation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date September 30, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 29 Years
Eligibility - Age 18-29 years - Basic understanding of English - Not institutionalized - Currently use e-cigarettes at least once per week

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Graphic Warning Labels
Based on a thorough review of the literature on e-cigarette risks and adverse effects, a graphic designer will be contracted to create ten experimental aversive health warnings related to e-cigarettes. These warnings will be exported as high-quality images and shown to participants in the intervention group prior to questions that obtain data on the primary endpoint.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Outcome

Type Measure Description Time frame Safety issue
Primary Intent to Cessate Use of E-Cigarettes Every participant will take a survey with a question that asks about willingness to cease e-cigarettes using the seven-point Motivation To Stop Scale, adapted for e-cigarettes, in order to assess the influence of the intervention. Immediately after exposure to intervention
Secondary E-Cigarette Cessation Attempt Participants completing the first survey will be recontacted six months after their completion date to complete a second survey. This survey will ask whether the participant has made an attempt to quit using e-cigarettes, as well as the approximate date of the quit attempt. Six months after exposure to intervention
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