Responses to Regulated E-Cigarette Advertisements

Young Adults' Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use - Phase 2

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use
• Intervention / Treatment: Other: Unregulated ad condition; Other: Regulated ad condition

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.

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elise M Stevens, PhD; Phone Number: 56684 (774) 455-6684; Email: elise.stevens@umassmed.edu
• Study Contact Backup: Name: Elayn Byron; Email: elayn.byron@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • UMass Chan Medical School Stevens Lab
      • Contact: Elise M Stevens, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Unregulated ad condition; This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.	Other: Unregulated ad condition; This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
Experimental: Regulated ad condition; This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.	Other: Regulated ad condition; This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Use	Use of any tobacco products	1 month
Tobacco Use	Use of any tobacco products	3 months
Tobacco Use	Use of any tobacco products	6 months
Perceived severity of using E-Cigarettes	Perceived severity of using ECs will be assessed by participants' perceived significance, severity, and seriousness of health threats from EC use. The measure is as follows: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.	1 month
Perceived severity of using E-Cigarettes	Perceived severity of using ECs will be assessed by participants' perceived significance, severity, and seriousness of health threats from EC use. The measure is as follows: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.	3 months
Perceived severity of using E-Cigarettes	Perceived severity of using ECs will be assessed by participants' perceived significance, severity, and seriousness of health threats from EC use. The measure is as follows: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.	6 months
Motivation to Avoid E-Cigarettes	Motivation to avoid ECs including importance, confidence, and readiness to avoid ECs will be collected to assess for changes in motivations. The measure is as follows: How important is it to avoid e-cigarettes in the future? 0=Not important at all 10=Very important How confident are in avoiding e-cigarettes in the future? 0=Not confident at all 10=Very confident How ready are you to avoid e-cigarettes in the future? 0=Not ready at all 10=Very ready How committed are you to avoid e-cigarettes in the future? 0=Not committed at all 10=Very committed	1 Month
Motivation to Avoid E-Cigarettes	Motivation to avoid ECs including importance, confidence, and readiness to avoid ECs will be collected to assess for changes in motivations. The measure is as follows: How important is it to avoid e-cigarettes in the future? 0=Not important at all 10=Very important How confident are in avoiding e-cigarettes in the future? 0=Not confident at all 10=Very confident How ready are you to avoid e-cigarettes in the future? 0=Not ready at all 10=Very ready How committed are you to avoid e-cigarettes in the future? 0=Not committed at all 10=Very committed	3 Months
Motivation to Avoid E-Cigarettes	Motivation to avoid ECs including importance, confidence, and readiness to avoid ECs will be collected to assess for changes in motivations. The measure is as follows: How important is it to avoid e-cigarettes in the future? 0=Not important at all 10=Very important How confident are in avoiding e-cigarettes in the future? 0=Not confident at all 10=Very confident How ready are you to avoid e-cigarettes in the future? 0=Not ready at all 10=Very ready How committed are you to avoid e-cigarettes in the future? 0=Not committed at all 10=Very committed	6 Months
Behavioral Intentions Behavioral Intentions	Behavioral intentions will be evaluated using questions "How interested are you in trying ECs?," "How willing are you to try ECs?," 'How willing would you be to purchase an EC?," and "How willing would you be to try an EC if a friend offered you one?".	1 month
Behavioral Intentions Behavioral Intentions	Behavioral intentions will be evaluated using questions "How interested are you in trying ECs?," "How willing are you to try ECs?," 'How willing would you be to purchase an EC?," and "How willing would you be to try an EC if a friend offered you one?".	3 months
Behavioral Intentions Behavioral Intentions	Behavioral intentions will be evaluated using questions "How interested are you in trying ECs?," "How willing are you to try ECs?," 'How willing would you be to purchase an EC?," and "How willing would you be to try an EC if a friend offered you one?".	6 months
Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	1 month
Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	3 months
Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	6 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: H00022520; 4R00DA046563-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No