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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05207033
Other study ID # H00022520
Secondary ID 4R00DA046563-04
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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