SmokingYLANCT04906148
Young Adults' Reactions to Low Nicotine Cigarette Advertising
A study testing Advertisement content (explicit vs. implicit) and Advertisement content (true vs. misleading) in people with Smoking, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Reducing the nicotine content in combustible cigarettes to non-addictive levels has demonstrated promise as a safe and effective public health strategy for decreasing tobacco-caused morbidity and mortality. Read more about this study
- Who is it for?
- Ages 21 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Advertisement content (explicit vs. implicit) and Advertisement content (true vs. misleading)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 21-29
- Able to use a computer or related technology (such as a smartphone or tablet) with reliable internet access and willing to use the device to participate in the research study.
- Have a valid email address and willing to use email to participate in the research study. Participants without an existing email account who are willing to create one for study purposes are eligible to participate.
- Additional inclusion criteria vary by smoking status.
Who cannot join
- Currently enrolled in a cessation program
- Report consuming ≥ 25 alcohol-containing drinks per week
- Report a history or current psychiatric diagnosis or severe medical condition
- Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
- Self-report being pregnant and/or lactating
- Are diagnosed with or test positive for COVID-19. Participants who report having traveled to a high-risk area in the past 2 weeks or who have been in close contact with someone confirmed or being evaluated for COVID-19 will be placed on a waitlist. Waitlisted participants will be asked to self-isolate for 14 days after exposure (even without symptoms) and will be re-screened for eligibility post self-isolation.
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- Additional, general reasons for exclusion include:
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator (PI) at any point throughout the study.
- Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data as determined by the PI.
- Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance as determined by the PI. Subjects may be deemed ineligible for any of the aforementioned reasons at any point throughout the study, as well as during the initial telephone screen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Reducing the nicotine content in combustible cigarettes to non-addictive levels has demonstrated promise as a safe and effective public health strategy for decreasing tobacco-caused morbidity and mortality. Little data are available, however, assessing how the marketing of low nicotine content (LNC) cigarettes could dampen their potential population health benefit. This study will examine LNC cigarette advertising content effects on message recall, viewing patterns, product perceptions, and use behaviors. Young adults (N = 340; 170 smokers, 170 non-smokers) will complete a single-session laboratory study using a 2 x 2 between-subject design to manipulate advertisement messaging accuracy (true vs. false/misleading) and content (implicit vs. explicit). Findings may be used to guide public health policy decisions related to regulating cigarette nicotine content and marketing.
- Conditions
- Smoking
- Being tested
- Advertisement content (explicit vs. implicit), Advertisement content (true vs. misleading)
- Keywords
- low nicotine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advertisement content (explicit vs. implicit)Other
Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content
Advertisement content (true vs. misleading)Other
Participants will be randomly assigned to view an advertisement with either true or misleading messaging content
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Experimental | Smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content. Receives: Other: Advertisement content (explicit vs. implicit); Other: Advertisement content (true vs. misleading) |
| Non-smokers | Experimental | Non-smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content. Receives: Other: Advertisement content (explicit vs. implicit); Other: Advertisement content (true vs. misleading) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention
Attention to areas of interest defined within the advertisement (e.g., cigarettes, Surgeon General's warning) will be captured with eye tracking software. Attention measures will be assessed in milliseconds using measures of latency (time to first view of specific regions) and dwell time (amount of time spent on regions of interest) obtained from eye-tracking equipment.
Measured: Day 0
Risk beliefs
Risk beliefs will be assessed using individual items and a summary score from a previously validated 8-item scale. Items are rated on a 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") and will ask participants to compare the advertised cigarettes to "regular" cigarettes on the following statements: a) "are lower in nicotine", b) "are lower in tar", c) "are less addictive", d) "are less likely to cause cancer", e) "have fewer chemicals", f) "are healthier", g) "make smoking safer", h) "help people quit smoking."
Measured: Day 0
Recall
Recall will be captured using forced and open items. Multiple-choice format forced items will assess recognition of specific content (e.g., "How much less nicotine is in the advertised cigarettes?") vs. bogus content, scored dichotomously (i.e., correct vs. incorrect). Participants will type answers to open item questions assessing general content (e.g. "What was the overall message of the ad you saw?").
Measured: Day 0
Perceived health risks
Participants will complete a 13-item measure2 asking them to indicate on a 7-point Likert scale (1 = "very low risk", 7 = "very high risk") their risk of developing 11 health conditions (i.e., lung cancer, heart disease, stroke, high blood pressure, diabetes, asthma, liver disease, emphysema, respiratory infections, other cancers, and addiction) after using regular or the advertised cigarettes, as well as two additional items asking them to evaluate overall risks of the cigarettes for themselves and for others.
Measured: Day 0
Secondary outcomes (2)
Purchasing behavior
Behavioral economic indices of demand will be measured using a hypothetical purchase task. Participants will be asked how many of the advertised cigarettes they would purchase and consume in the next 30 days across a range of prices, from free up to high amounts at which purchase/consumption is expected to drop off.
Measured: Day 0
Attitudes
Attitudes toward the advertised cigarettes will be assessed using the mean of an eight-item, seven-point semantic differential scale that asks, "If the advertised cigarettes became commercially available in the next 30 days, which of the words below would best describe your use of this product?" Items were a) bad/good, b) unenjoyable/enjoyable, c) unpleasant/pleasant, d) foolish/wise, e) difficult/easy, f) more/less harmful, g) not under/under my control, and h) less/more healthy. Higher and lower scores respectively indicate more and less favorable attitudes.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start27 May 2021
- Primary completion23 Jun 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Andrew Strasser, Abramson Cancer Center at Penn Medicine
- Investigators
- Andrew Strasser, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906148
- Sponsor's protocol ID
- UPCC 03021
- Other IDs
- K07CA218366, 844887
- Acronym
- YLA
- Status last verified
- Oct 2024
- First submitted
- 17 May 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- 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 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Adults' Reactions to Low Nicotine Cigarette Advertising
- ClinicalTrials.gov ID
- NCT04906148
- Acronym / sponsor ID
- YLA / UPCC 03021
- Conditions
- Smoking
- Keywords
- low nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reducing the nicotine content in combustible cigarettes to non-addictive levels has demonstrated promise as a safe and effective public health strategy for decreasing tobacco-caused morbidity and mortality. Little data are available, however, assessing how the marketing of low nicotine content (LNC) cigarettes could dampen their potential population health benefit. This study will examine LNC cigarette advertising content effects on message recall, viewing patterns, product perceptions, and use behaviors. Young adults (N = 340; 170 smokers, 170 non-smokers) will complete a single-session laboratory study using a 2 x 2 between-subject design to manipulate advertisement messaging accuracy (true vs. false/misleading) and content (implicit vs. explicit). Findings may be used to guide public health policy decisions related to regulating cigarette nicotine content and marketing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Experimental | Other: Advertisement content (explicit vs. implicit), Other: Advertisement content (true vs. misleading)Smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content. |
| Non-smokers | Experimental | Other: Advertisement content (explicit vs. implicit), Other: Advertisement content (true vs. misleading)Non-smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content. |
Who may qualify
- Ages
- 21 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 21-29
- Able to use a computer or related technology (such as a smartphone or tablet) with reliable internet access and willing to use the device to participate in the research study.
- Have a valid email address and willing to use email to participate in the research study. Participants without an existing email account who are willing to create one for study purposes are eligible to participate.
- Additional inclusion criteria vary by smoking status.
Key exclusion criteria (10 listed)
- Currently enrolled in a cessation program
- Report consuming ≥ 25 alcohol-containing drinks per week
- Report a history or current psychiatric diagnosis or severe medical condition
- Are color-blind or have another visual impairment (e.g., partial blindness, uncorrected cataract)
- Self-report being pregnant and/or lactating
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 |
|---|---|---|
| Advertisement content (explicit vs. implicit)Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content | Other | Non-smokers, Smokers |
| Advertisement content (true vs. misleading)Participants will be randomly assigned to view an advertisement with either true or misleading messaging content | Other | Non-smokers, Smokers |
Primary outcome
Attention
Time frame: Day 0
Attention to areas of interest defined within the advertisement (e.g., cigarettes, Surgeon General's warning) will be captured with eye tracking software. Attention measures will be assessed in milliseconds using measures of latency (time to first view of specific regions) and dwell time (amount of time spent on regions of interest) obtained from eye-tracking equipment.
Risk beliefs
Time frame: Day 0
Risk beliefs will be assessed using individual items and a summary score from a previously validated 8-item scale. Items are rated on a 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") and will ask participants to compare the advertised cigarettes to "regular" cigarettes on the following statements: a) "are lower in nicotine", b) "are lower in tar", c) "are less addictive", d) "are less likely to cause cancer", e) "have fewer chemicals", f) "are healthier", g) "make smoking safer", h) "help people quit smoking."
Recall
Time frame: Day 0
Recall will be captured using forced and open items. Multiple-choice format forced items will assess recognition of specific content (e.g., "How much less nicotine is in the advertised cigarettes?") vs. bogus content, scored dichotomously (i.e., correct vs. incorrect). Participants will type answers to open item questions assessing general content (e.g. "What was the overall message of the ad you saw?").
Perceived health risks
Time frame: Day 0
Participants will complete a 13-item measure2 asking them to indicate on a 7-point Likert scale (1 = "very low risk", 7 = "very high risk") their risk of developing 11 health conditions (i.e., lung cancer, heart disease, stroke, high blood pressure, diabetes, asthma, liver disease, emphysema, respiratory infections, other cancers, and addiction) after using regular or the advertised cigarettes, as well as two additional items asking them to evaluate overall risks of the cigarettes for themselves and for others.
2 secondary outcomes
Purchasing behavior
Time frame: Day 0
Attitudes
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- 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.
Andrew Strasser, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advertisement content (explicit vs. implicit) and Advertisement content (true vs. misleading) in people with Smoking, run by Abramson Cancer Center at Penn Medicine 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 4 inclusion and 10 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 3 Oct 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Day 0). The study lists 4 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 3 Oct 2024.