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Responses to Regulated E-Cigarette Advertisements

U

University of Massachusetts, Worcester

Status

Completed

Conditions

Tobacco Use

Treatments

Other: Regulated ad condition
Other: Unregulated ad condition

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05207033
4R00DA046563-04 (U.S. NIH Grant/Contract)
H00022520

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

All

Ages

18 to 26 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

195 participants in 2 patient groups

Unregulated ad condition
Active Comparator group
Description:
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Treatment:
Other: Unregulated ad condition
Regulated ad condition
Experimental group
Description:
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Treatment:
Other: Regulated ad condition

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Elise M Stevens, PhD; Elayn Byron

Data sourced from clinicaltrials.gov

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