Clinical trial NCT05207033: Responses to Regulated E-Cigarette Advertisements
Official title: Young Adults' Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-01-26
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.

Detailed description: 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 proposed study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs, and determine if the restriction of these ad features influences EC attitudes, experimentation, and sustained use. The investigators will experimentally estimate the causal effect of restricting high impact EC ad features on tobacco use behavior. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest. We will also examine how sensation seeking, impulsivity, and sleep health impact EC use. 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, and if restrictions reduce the use of ECs among young adults.

Eligibility criteria: Inclusion Criteria:

* 18 to 26 years old,
* fluent in English (earn a score of at least 4 on the Rapid Estimate of Adult Literacy in Medicine)
* biochemically confirmed abstinence of alcohol (BrAC=.00) and combusted tobacco or marijuana exhaled carbon monoxide (eCO\<6 parts per million) at time of visit,
* reporting never trying an e-cigarette, not even a puff OR reporting tried and e-cigarette in the past but not in the past 30 days. Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire, with only those identifying anything besides "no curiosity/interest" to all three susceptibility questions as susceptible users.

Exclusion Criteria:

* Out of age range 18-26 years
* Use of an e-cigarette in past 30 days
* Pregnant women

Primary outcomes:
measure: Tobacco Use at 1 Month
timeFrame: 1 month
measure: Tobacco Use at 3 Months
timeFrame: 3 months
measure: Tobacco Use at 6 Months
timeFrame: 6 months
measure: Perceived Severity of Using E-Cigarettes at 1 Month
timeFrame: 1 month
measure: Perceived Severity of Using E-Cigarettes at 3 Months
timeFrame: 3 months
measure: Perceived Severity of Using E-Cigarettes at 6 Months
timeFrame: 6 months
measure: Motivation to Avoid E-Cigarettes at 1 Month
timeFrame: 1 Month
measure: Motivation to Avoid E-Cigarettes at 3 Months
timeFrame: 3 Months
measure: Motivation to Avoid E-Cigarettes at 6 Months
timeFrame: 6 Months
measure: Behavioral Intentions at 1 Month
timeFrame: 1 month
measure: Behavioral Intentions at 3 Months
timeFrame: 3 months
measure: Behavioral Intentions at 6 Months
timeFrame: 6 months
measure: Number of Participants With Biochemical Verification of Tobacco Use at 1 Month
timeFrame: 1 month
measure: Number of Participants With Biochemical Verification of Tobacco Use at 3 Months
timeFrame: 3 months
measure: Number of Participants With Biochemical Verification of Tobacco Use at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School Stevens Lab
state: Massachusetts
Study officials:
References: