E-Cig UseEarly Phase 1NCT04249219
Responses to E-Cigarette Advertising
A Early Phase 1 study testing Viewing e-cigarette ads in people with E-Cig Use, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- E-Cig Use
- What is being tested?
- Viewing e-cigarette ads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 15 Aug 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-26 years old,
- Fluent in English,
- Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide <6 parts per million) at time of visit
- Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days
- Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire
Who cannot join
- Younger than 18 years or older than 26 years
- Not fluent in English
- Not confirmed abstinent of combusted tobacco or marijuana
- Use of an e-cigarette
- Not susceptible to e-cigarette use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Young Adults Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use
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 study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. 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.
- Conditions
- E-Cig Use
- Being tested
- Viewing e-cigarette ads
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viewing e-cigarette adsOther
All participants will see the same e-cigarette ads presented in a random order.
| Study group | Role | What they receive |
|---|---|---|
| E-Cigarette Ads | Experimental | All individuals in the study will see the same e-cigarette advertisements presented in a random order. Receives: Other: Viewing e-cigarette ads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention to Specific ad Feature
Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.
Measured: Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
Arousal
Skin conductance or galvanic skin response was measured using three sensors applied to participants' fingers. Skin conductance measured if there was an emotional response and the intensity of the emotional response. A "peak" is a biological indicator that something happened, and the participant had an emotional response to it. The amplitude of each peak for each participant was measured and averaged per ad.
Measured: The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.
Attention to Specific ad Feature
Visual attention was assessed using an eye-tracker connected to the base of the computer screen. For each message, four areas of interest (AOI) were identified: 1) brand, 2) descriptor, 3) modeling, and 4) warning. All four AOIs were summed for a total number of milliseconds that a participant viewed the AOIs.
Measured: Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand
Secondary outcomes (1)
Motivations to Avoid E-cigarettes
Self-report Please rate on a scale from 0 (not at all) to 10 (very much). "How important is it to avoid e-cigarettes in the future?" "How confident are in avoiding e-cigarettes in the future?" "How ready are you to avoid e-cigarettes in the future?" "How committed are you to avoid e-cigarettes in the future?"
Scores were averaged for each ad for each participant. Then, an overall average was taken among all participants for each ad. Higher values indicate greater motivation to avoid e-cigarettes.
Measured: Immediately after viewing each ad
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start4 Aug 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for E-Cig UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Elise Stevens, University of Massachusetts, Worcester
- Investigators
- Elise M Stevens, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249219
- Sponsor's protocol ID
- H00022646
- Other IDs
- K99DA046563
- Status last verified
- Sep 2023
- First submitted
- 24 Jan 2020
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adults Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use
- ClinicalTrials.gov ID
- NCT04249219
- Acronym / sponsor ID
- H00022646
- Conditions
- E-Cig Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Posted 8 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-Cigarette Ads | Experimental | Other: Viewing e-cigarette adsAll individuals in the study will see the same e-cigarette advertisements presented in a random order. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-26 years old,
- Fluent in English,
- Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide <6 parts per million) at time of visit
- Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days
- Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire
Key exclusion criteria (5 listed)
- Younger than 18 years or older than 26 years
- Not fluent in English
- Not confirmed abstinent of combusted tobacco or marijuana
- Use of an e-cigarette
- Not susceptible to e-cigarette use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viewing e-cigarette adsAll participants will see the same e-cigarette ads presented in a random order. | Other | E-Cigarette Ads |
Primary outcome
Attention to Specific ad Feature
Time frame: Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.
Arousal
Time frame: The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.
Skin conductance or galvanic skin response was measured using three sensors applied to participants' fingers. Skin conductance measured if there was an emotional response and the intensity of the emotional response. A "peak" is a biological indicator that something happened, and the participant had an emotional response to it. The amplitude of each peak for each participant was measured and averaged per ad.
Attention to Specific ad Feature
Time frame: Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand
Visual attention was assessed using an eye-tracker connected to the base of the computer screen. For each message, four areas of interest (AOI) were identified: 1) brand, 2) descriptor, 3) modeling, and 4) warning. All four AOIs were summed for a total number of milliseconds that a participant viewed the AOIs.
1 secondary outcome
Motivations to Avoid E-cigarettes
Time frame: Immediately after viewing each ad
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise M Stevens, PhD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Viewing e-cigarette ads in people with E-Cig Use, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention to Specific ad Feature (time frame: Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.