Responses to Regulated E-Cigarette Advertisements

Tobacco Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207033
• Other study ID #: H00022520
• Secondary ID: 4R00DA046563-04
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: University of Massachusetts, Worcester
• Contact: Elise M Stevens, PhD
• Phone: (774) 455-6684
• Email: elise.stevens[@]umassmed.edu
• 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Regulated ad condition
This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
• Unregulated ad condition
This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.

Locations

Country	Name	City	State
United States	UMass Chan Medical School Stevens Lab	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	Tobacco Use	Use of any tobacco products	1 month
Primary	Tobacco Use	Use of any tobacco products	3 months
Primary	Tobacco Use	Use of any tobacco products	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	1 month
Primary	Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	3 months
Primary	Salivary Cotinine	Bioochemical confirmation of tobacco non-use will be conducted with salivary cotinine (~3 day nicotine biomarker).	6 months