Responses to E-Cigarette Advertising

E-Cig Use Clinical Trial

Official title:

Young Adults Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249219
• Other study ID #: H00022646
• Secondary ID: K99DA046563
• Status: Completed
• Phase: Early Phase 1
• Start date: August 4, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: September 2023
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• 18-26 years old,

• Fluent in English,

• Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide <6 parts per million) at time of visit

• Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days

• Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire

Exclusion Criteria:

• Younger than 18 years or older than 26 years

• Not fluent in English

• Not confirmed abstinent of combusted tobacco or marijuana

• Use of an e-cigarette

• Not susceptible to e-cigarette use

Related Conditions & MeSH terms

• E-Cig Use

Intervention

Other:
• Viewing e-cigarette ads
All participants will see the same e-cigarette ads presented in a random order.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention to Specific ad Feature	Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.	Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
Primary	Arousal	Skin conductance or galvanic skin response was measured using three sensors applied to participants' fingers. Skin conductance measured if there was an emotional response and the intensity of the emotional response. A "peak" is a biological indicator that something happened, and the participant had an emotional response to it. The amplitude of each peak for each participant was measured and averaged per ad.	The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.
Primary	Attention to Specific ad Feature	Visual attention was assessed using an eye-tracker connected to the base of the computer screen. For each message, four areas of interest (AOI) were identified: 1) brand, 2) descriptor, 3) modeling, and 4) warning. All four AOIs were summed for a total number of milliseconds that a participant viewed the AOIs.	Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand
Secondary	Motivations to Avoid E-cigarettes	Self-report Please rate on a scale from 0 (not at all) to 10 (very much). "How important is it to avoid e-cigarettes in the future?" "How confident are in avoiding e-cigarettes in the future?" "How ready are you to avoid e-cigarettes in the future?" "How committed are you to avoid e-cigarettes in the future?"; Scores were averaged for each ad for each participant. Then, an overall average was taken among all participants for each ad. Higher values indicate greater motivation to avoid e-cigarettes.	Immediately after viewing each ad