NCT04906148

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

May 17, 2021

Last Update Submit

October 2, 2024

Conditions

Keywords

low nicotine

Outcome Measures

Primary Outcomes (4)

  • 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.

    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."

    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?").

    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.

    Day 0

Secondary Outcomes (2)

  • Purchasing behavior

    Day 0

  • Attitudes

    Day 0

Study Arms (2)

Smokers

EXPERIMENTAL

Smokers will be randomized to view an advertisement with either true or misleading and implicit or explicit harm messaging content.

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.

Other: Advertisement content (explicit vs. implicit)Other: Advertisement content (true vs. misleading)

Interventions

Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content

Non-smokersSmokers

Participants will be randomly assigned to view an advertisement with either true or misleading messaging content

Non-smokersSmokers

Eligibility Criteria

Age21 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrew Strasser, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 28, 2021

Study Start

May 27, 2021

Primary Completion

June 23, 2023

Study Completion

August 11, 2023

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations