Clinical trial NCT05714982: Impact of E-cigarette Device Warnings
Official title: Randomized Clinical Trial Evaluating the Impact of E-cigarette Device Warnings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping Behaviors
Keywords: Vaping
Tobacco use
E-cigarette use
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-02-06
Enrollment: 1369
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This trial will assess the impact of e-cigarette warnings on vapers' devices and refills in a randomized clinical trial.

Recruitment: Vapers will first undergo screening online or call the study center to complete the screening survey over the phone. Trial staff will schedule eligible vapers for 2 in-person visits. For each of the 2 visits, vapers will be asked to bring the vapes and refill materials they plan to use over the next 2 weeks.

Informed Consent: Prior to consenting vapers, trial staff will visually inspect photo identification of vapers to confirm that they are 21 years or older. At the beginning of the first appointment, trial staff will explain the consent form and ask the vaper to read the form. Once the participant has finished reading the form, the trial staff member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form.

Randomization: At the first visit, trial staff will randomly assign participants to one of the three trial arms by using Qualtrics software. Vapers have an equal chance of being randomized to have labels with control, text, or pictorial warnings.

Assessment: Participants will attend 2 in-person appointments at the study office (at Visit 1 and Visit 3 that are spaced 2 weeks apart). The visits will last about 45-60 minutes. At Visit 1 participants will take a survey, have their vape device and refills labeled based on their trial arm, and take another survey. At Visit 3, participants take a survey and have their vape device and refills labeled based on their trial arm. Participants will also be e-mailed 3 more surveys to complete online at home (taken at Visit 2, 4, and 5). Thus participants will take 5 weekly surveys overall.

Detailed description of the intervention: At each in-person appointment, participants will bring in the vapes and refills they plan to use over the next 2 weeks for labeling. While participants are taking the survey, trial staff will label the devices and refills based on their trial arm.

Participants randomized to the text warning arm will have labels with information about the health harms of vaping applied to their vapes and refills. Participants randomized to the pictorial arm will have labels with pictorial images and text about the health harms of vaping. Participants assigned to the control arm will have labels with neutral statements about vaping. Each trial arm will have four labels (two labels for Visit 1 and two additional labels for Visit 3). Trial staff will return labeled vapes and refills in a clear plastic bag with the e-cigarette warning labels applied to a card. Trial investigators developed the text, images, and design of these labels.

The trial staff will instruct participants in all trial arms to vape or not vape as they normally would. At the end of the trial, participants will receive a link to more information about the risks of vaping and tobacco use.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean vaping quit intentions score
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Mean knowledge score
timeFrame: Up to 4 weeks
measure: Mean cognitive elaboration score
timeFrame: Up to 4 weeks
measure: Mean perceived likelihood of illness score
timeFrame: Up to 4 weeks
measure: Mean negative affect score
timeFrame: Up to 4 weeks
measure: Mean attention score
timeFrame: Up to 4 weeks
measure: Mean information seeking score
timeFrame: Up to 4 weeks
measure: Mean number of conversations in past week
timeFrame: Up to 4 weeks
measure: Mean vaping reinforcement attitudes score
timeFrame: Up to 4 weeks
measure: Mean uncontrolled vaping score
timeFrame: Up to 4 weeks
measure: Mean number of times forgoing a vape in past week
timeFrame: Up to 4 weeks
measure: Percent of participants who made a vaping quit attempt in past 4 weeks
timeFrame: Up to 4 weeks
measure: Percent of participants who successfully quit vaping
timeFrame: At 4 weeks
measure: Mean inaccurate risk perception score
timeFrame: Up to 4 weeks
measure: Mean stigma score
timeFrame: Up to 4 weeks
measure: Mean smoking quit intentions score
timeFrame: Up to 4 weeks
measure: Percent of participants who made a smoking quit attempt in past 4 weeks
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ewald & Wasserman Research Consultants, LLC
state: California
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Noel Brewer, PhD
role: PRINCIPAL_INVESTIGATOR
References: