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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use, Cigarette Use
• Intervention / Treatment: Behavioral: Emotion-based messages about the harm of VLNC; Behavioral: Continued-harm-framed messages about the harm of VLNC; Behavioral: Myth-refuting messages about the harm of VLNC; Behavioral: Control messages about littering

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina, Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emotion-based messages about the harm of VLNC	Behavioral: Emotion-based messages about the harm of VLNC; Participants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection.
Experimental: Continued-harm-framed messages about the harm of VLNC	Behavioral: Continued-harm-framed messages about the harm of VLNC; Participants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection.
Experimental: Myth-refuting messages about the harm of VLNC	Behavioral: Myth-refuting messages about the harm of VLNC; Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
Active Comparator: Control messages about littering	Behavioral: Control messages about littering; Participants in this arm will receive 3 control messages about littering during the survey data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Very Low Nicotine Content (VLNC) Misperception	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.	During one day survey
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)	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).	During one day survey
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)	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).	During one day survey
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Death (Dichotomized)	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).	During one day survey

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quit Intentions	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.	During one day survey

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Message Effectiveness	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.	During one day survey
Perceived Understandability	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"	During one day survey
Attention	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"	During one day survey
Negative Affect	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"	During one day survey
Cognitive Reactions	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"	During one day survey
Social Interactions	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"	During one day survey
Reactance	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"	During one day survey
Interest in Other Nicotine Products	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.	During one day survey

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: M. Justin Byron, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-1284; R21CA234968 (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