- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704295
High Impact E-cigarette Advertisement Features
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Control ad with dark gray product with tobacco flavor name
- Behavioral: Dark gray product with strawberry flavor name
- Behavioral: Colorful (strawberry color) product with strawberry flavor name
- Behavioral: Colorful (strawberry color) product with strawberry flavor name and image
- Behavioral: Colorful (strawberry color) product with strawberry flavor features
- Behavioral: Colorful (strawberry color) product with strawberry flavor features and choice claim
Detailed Description
The FDA considers the marketing plans of new e-cigarette products for premarket tobacco product application approval. Flavor-related advertisement features may entice young adults who do not use tobacco products to use the products but may also generate complete product switching interests among young adults who smoke cigarettes. This study tested the effects of several high-impact e-cigarette advertisement features related to flavors to inform the FDA's policymaking and public health preventive messages.
Setting: The trial will be an experiment delivered through an online self-administered questionnaire consisting of one session over 20 minutes.
Recruitment: Participants will be recruited from the research company Qualtrics from its research panels.
Informed Consent: Participants will provide online consent prior to taking the survey.
Randomization: After providing informed consent and answering pre-exposure questions, the investigator will use Qualtrics programming to randomize participants into one of the six trial conditions. The randomization will use least fill for the allocation of conditions where if the counts for the conditions were equal, the survey would assign the condition sequentially.
Assessment: Participants will take part in one session (estimated at about 20 mins): participants will answer questions assessing tobacco use status, cigarette smoking quit intentions and attempts (only asked young adults who smoke cigarettes), e-cigarette use, and other tobacco product use. They will then view one e-cigarette advertisement for at least 12 seconds and report immediate outcomes, including perceptions and behavioral intentions related to the e-cigarette product they see in the advertisement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Rutgers University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Three groups of young adult subjects will be included in the study. The first group is those who are exclusive cigarette smokers (n=1000), defined as those who have smoked at least 100 cigarettes in their lifetime and have smoked at least one cigarette in the past 30 days but have not used e-cigarettes in the past 30 days. The second group is those who are dual users of cigarettes and e-cigarettes (n=1000). Those in this group have smoked more than 100 cigarettes in their lifetime and have smoked a cigarette and also used an e-cigarette in the past 30 days. The third group is those who are non-tobacco users (n=1000), defined as those who have never used any tobacco product before or have never "regularly" used tobacco products before and are currently not using any tobacco products (in the past 30 days).
Exclusion Criteria:
- Any subjects not meeting the inclusion criteria will be excluded from the study. Individuals will be further excluded if they do not provide consent to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control ad: Dark gray product with tobacco flavor name
|
The e-cigarette ad with a dark gray product with a tobacco flavor name
|
|
Experimental: Dark gray product with strawberry flavor name
|
The e-cigarette ad with a dark gray product with a strawberry flavor name
|
|
Experimental: Colorful (strawberry color) product with strawberry flavor name
|
The e-cigarette ad with a colorful (strawberry color) product with strawberry flavor name
|
|
Experimental: Colorful (strawberry color) product with strawberry flavor name and strawberry image
|
The e-cigarette ad with colorful (strawberry color) product with strawberry flavor name and strawberry image
|
|
Experimental: Colorful (strawberry color) product with strawberry flavor features
Colorful (strawberry color) product with strawberry flavor name + strawberry image + strawberry flavor sensation descriptor
|
The e-cigarette advertisement with colorful (strawberry color) product with strawberry flavor name, strawberry image, and strawberry flavor sensation descriptor
|
|
Experimental: Colorful (strawberry color) product with strawberry flavor features and choice claim
Colorful (strawberry color) product with strawberry flavor name + strawberry image + strawberry flavor sensation descriptor + flavor choice claim
|
The e-cigarette ad with colorful (strawberry color) product with strawberry flavor name, strawberry image, strawberry flavor sensation descriptor, and flavor choice claim
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions of Using the E-cigarette
Time Frame: Immediately after exposure
|
A single item measuring the intentions of using the e-cigarette shown in the ad, assessed immediately after exposure (exposure took approximately 12 seconds).
Response options are from 0 (Extremely unlikely ) to 10 (Extremely likely).
|
Immediately after exposure
|
|
Intentions of Switching Completely to the E-cigarette
Time Frame: Immediately after exposure
|
A single item measuring participants' intentions of switching completely to the e-cigarette shown in the ad, assessed immediately after exposure (exposure took approximately 12 seconds).
Response options are from 0 (Extremely unlikely ) to 10 (Extremely likely).
This question is only asked among those who smoke cigarettes.
|
Immediately after exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intentions of Using the E-cigarette Compared to Cigarettes
Time Frame: Immediately after exposure
|
A single item measuring the intentions of using the e-cigarette shown in the ad compared to smoking cigarettes, assessed immediately after exposure (exposure took approximately 12 seconds).
Response options are from 0 (Much less likely ) to 10 (Much more likely).
|
Immediately after exposure
|
|
Intentions of Using the E-cigarette Compared to Other E-cigarettes
Time Frame: Immediately after exposure
|
A single item measuring the intentions of using the e-cigarette shown in the ad compared to using other e-cigarette products, assessed immediately after exposure (exposure took approximately 12 seconds).
Response options are from 0 (Much less likely ) to 10 (Much more likely).
|
Immediately after exposure
|
|
Ad Appeal
Time Frame: Immediately after exposure
|
A 3-item scale for those who do not use tobacco, measuring to what extent participants perceive the ad they saw to be appealing, assessed immediately after exposure (exposure took 12 seconds), including liking the ad, curious about the product shown in the ad, and interest in using the product shown in the ad.
Response options are from 0 (Dislike very much ) to 10 (Like very much) for ad liking and 0 (Strongly disagree) to 10 (Strongly agree) for the other two items.
Average scores of the three items were calculated (0-10).
A 4-item scale for those who smoke cigarettes, including the same 3-item scale and an additional single item measuring the agreement on whether the ad makes them want to completely switch to the e-cigarette shown in the ad.
Response options are from 0 (Strongly disagree) to 10 (Strongly agree).
Average scores of the four items were calculated (0-10).
|
Immediately after exposure
|
|
Perceived Absolute Harm of Using the E-cigarette
Time Frame: Immediately after exposure
|
A single item measuring the participants' perception of having health problems from using the e-cigarette shown in the ad, assessed immediately after exposure (exposure took 12 seconds).
Response options are from 0 (Extremely unlikely ) to 10 (Extremely likely).
|
Immediately after exposure
|
|
Perceived Absolute Addictiveness of Using the E-cigarette
Time Frame: Immediately after exposure
|
A single item measuring the participants' perception of becoming addicted to using the e-cigarette shown in the ad, assessed immediately after exposure (exposure took 12 seconds).
Response options are from 0 (Extremely unlikely ) to 10 (Extremely likely).
|
Immediately after exposure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory Appeal of the E-cigarette
Time Frame: Immediately after exposure
|
Exploratory outcome: Four items measuring the agreement with the sensory appeal of the e-cigarette shown in the ad, assessed immediately after exposure (exposure took 12 seconds): the taste of the e-cigarette would: 1) be harsh, 2) be sweet, 3) be fruity, and 4) have a tobacco taste.
Response options are from 0 (Strongly disagree) to 10 (Strongly agree).
Average scores of the four items were calculated (0-10).
The higher values indicating stronger sensory appeal of e-cigarettes.
|
Immediately after exposure
|
|
Positive Expectancy of Using the E-cigarette
Time Frame: Immediately after exposure
|
Exploratory outcome: A single item measuring the agreement with the positive expectancy (I think I might enjoy, experience pleasure, or feel good using this e-cigarette/vape product) of using the e-cigarette shown in the ad, assessed immediately after exposure (exposure took 12 seconds).
Response options are from 0 (Strongly disagree) to 10 (Strongly agree).
|
Immediately after exposure
|
|
Negative Expectancy of Using the E-cigarette
Time Frame: Immediately after exposure
|
Exploratory outcome: A single item measuring the agreement with the negative expectancy (I think I might feel bad, sick or embarrassed using this e-cigarette/vape product) of using the e-cigarette shown in the ad, assessed immediately after exposure (exposure took 12 seconds).
Response options are from 0 (Strongly disagree) to 10 (Strongly agree).
|
Immediately after exposure
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2024002290
- R00CA242589 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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