- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04906148
Young Adults' Reactions to Low Nicotine Cigarette Advertising (YLA)
October 2, 2024 updated by: Andrew Strasser, Abramson Cancer Center at Penn Medicine
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smokers
Smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content.
|
Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content
Participants will be randomly assigned to view an advertisement with either true or misleading messaging content
|
|
Experimental: Non-smokers
Non-smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content.
|
Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content
Participants will be randomly assigned to view an advertisement with either true or misleading messaging content
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 0
|
|
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."
|
Day 0
|
|
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?").
|
Day 0
|
|
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.
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Purchasing behavior
Time Frame: Day 0
|
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.
|
Day 0
|
|
Attitudes
Time Frame: Day 0
|
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.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew Strasser, PhD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 27, 2021
Primary Completion (Actual)
June 23, 2023
Study Completion (Actual)
August 11, 2023
Study Registration Dates
First Submitted
May 17, 2021
First Submitted That Met QC Criteria
May 25, 2021
First Posted (Actual)
May 28, 2021
Study Record Updates
Last Update Posted (Actual)
October 3, 2024
Last Update Submitted That Met QC Criteria
October 2, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UPCC 03021
- 844887 (Other Identifier: University of Pennsylvania IRB number)
- K07CA218366 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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