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OpenTrials
Completed

NCT Number: NCT04974489

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

Tobacco use is the leading preventable cause of cancer and cancer deaths in the US. While most (69%) smokers want to quit, only 6% succeed in doing so each year. For many smokers, the addictiveness of nicotine makes quitting very difficult. To reduce cigarette smoking and resulting harms, FDA has announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. Greatly reduced nicotine levels would facilitate smoking cessation. However, the maximal success of the policy may require public understanding that, although these new cigarettes are less addictive, their high toxicity and carcinogenicity are unchanged. Yet, nearly half of adult smokers incorrectly think smoking VLNC cigarettes is less harmful than smoking current cigarettes (the VLNC misperception). Additionally, 24% of smokers said they would be less likely to quit if a VLNC regulation is enacted. Thus, the VLNC misperception may partially undermine a nicotine reduction policy. Although communication research suggests it is challenging to change people's incorrect understanding, new communication techniques may help reduce the VLNC misperception. In this randomized trial we will examine whether messages about the harm of VLNC cigarettes can reduce the VLNC misperception and increase intention to quit in a nicotine reduction scenario.

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Key information

Conditions

Tobacco Use, Cigarette Use Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

About this study

In this study we will assess whether messages about the harm of VLNC cigarettes reduce the misperception that they are less harmful than regular cigarettes.

Recruitment:

We will enroll participants from an existing nationally representative panel.

Informed Consent:

Potential participants are part of an existing nationally representative panel and have already consented to participate in the panel. Before enrolling, participants will also be asked to consent to participate in this study via a consent form included in the study survey.

Randomization:

Survey software will randomly allocate participants to one of the four arms of the study (3 intervention arms or a control arm). Each study arm will have approximately the same number of participants.

Assessment:

Participants will complete a 15-minute survey. The survey will begin with an introduction to the concept of VLNC cigarettes. Then participants will be shown intervention or control messages, and their beliefs will be assessed.

Detailed Description of the Intervention:

Participants will be shown a set of 3 messages about the harms of VLNC cigarettes (intervention arms) or about littering (control arm). Each of the 3 intervention arms use a different theme to attempt to correct the VLNC misperception.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current Cigarette Smoker
  • Age 18 or older
  • Enrolled in existing nationally representative panel where recruitment is based

Exclusion criteria

  • None

Treatment and study plan

Emotion-based messages about the harm of VLNC

Behavioral

Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.

Continued-harm-framed messages about the harm of VLNC

Behavioral

Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.

Myth-refuting messages about the harm of VLNC

Behavioral

Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.

Control messages about littering

Behavioral

Participants in this arm will receive 3 control messages about littering during the survey data collection.

Primary outcomes

  1. Very Low Nicotine Content (VLNC) Misperception

    Time frame: During one day survey

    Measured by a 3 item scale. Very low nicotine content (VLNC) Misperception measured with 3 questions, the final VLNC misperception score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes.

  2. Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)

    Time frame: During one day survey

    Very low nicotine content (VLNC) Misperception of Harm was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more harmful than other cigarettes, and 5 indicates a perception that VLNC are much less harmful than other cigarettes, and 3 is a perception that VLNC are as harmful as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

  3. Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)

    Time frame: During one day survey

    Very low nicotine content (VLNC) Misperception of Risk of Cancer was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more likely to cause cancer than other cigarettes, and 5 indicates a perception that VLNC are much less likely to cause cancer than other cigarettes, and 3 is a perception that VLNC are as likely to cause cancer as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

  4. Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Death (Dichotomized)

    Time frame: During one day survey

    Very low nicotine content (VLNC) Misperception of Risk of Death was measured with 1 question, on a scale of 1 to 5, where 1 indicates a perception that VLNC are much more likely to cause death than other cigarettes, and 5 indicates a perception that VLNC are much less likely to cause death than other cigarettes, and 3 is a perception that VLNC are as likely to cause death as other cigarettes. The results were dichotomized to indicate the percentage of people who hold the misperception. Specifically, responses of "much less likely" (5) or "less likely" (4) were recoded as 1 (having the misperception), and responses of "Much more likely" (1), "More likely" (2), or "As likely" (3) were recoded as 0 (not having the misperception).

Secondary outcomes

  1. Quit Intentions

    Time frame: During one day survey

    Measured by a 3 item scale. Quit intention measured with 3 questions, the final quit intention score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low intention to quit smoking, and 5 indicates a high intention to quit.

Other outcomes

  1. Perceived Message Effectiveness

    Time frame: During one day survey

    Measured by a 3 item scale after each message, 9 items total. Perceived message effectiveness measured with 3 questions per message. The final perceived message effectiveness score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low perceived message effectiveness, and 5 indicates high perceived message effectiveness.

  2. Perceived Understandability

    Time frame: During one day survey

    Perceived Understandability is measured with 1 question on a scale of 1 to 5: "How easy was it to understand the three black and white messages we showed you earlier?", where 1 = "Not at all", 5 = "Very", and 3 = "Somewhat"

  3. Attention

    Time frame: During one day survey

    Attention is measured with 1 question on a scale of 1 to 5: "How much did the messages grab your attention?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

  4. Negative Affect

    Time frame: During one day survey

    Negative affect is measured with 1 question on a scale of 1 to 5: "How much did the messages make you feel scared?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

  5. Cognitive Reactions

    Time frame: During one day survey

    Cognitive Reactions are measured with 1 question on a scale of 1 to 5: "How much did the messages make you think about the risk of smoking cigarettes that have 95% less nicotine?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

  6. Social Interactions

    Time frame: During one day survey

    Social Interactions are measured with 1 question on a scale of 1 to 5: "How much would you talk with other people about the messages?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

  7. Reactance

    Time frame: During one day survey

    Reactance is measured with 1 question on a scale of 1 to 5: "How much do you feel that the messages are trying to manipulate you?", where 1 = "Not at all", 5 = "Very much", and 3 = "Somewhat"

  8. Interest in Other Nicotine Products

    Time frame: During one day survey

    Measured by a 3 item scale. Interest in other nicotine products with 3 questions, the final score is a mean of the response to the 3 questions, on a scale of 1 to 5, where 1 indicates low interest in other nicotine products, and 5 indicates a high interest in other nicotine products.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 23, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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