NCT04974489

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

Completed NA Results posted Last updated 8 November 2022

What this trial tests

NA trial testing Emotion-based messages about the harm of VLNC in Tobacco Use, Cigarette Use in 1,153 participants. Completed in 3 August 2021.

Timeline

1 July 2021

Primary endpoint
3 August 2021

3 August 2021

Quick facts

Lead sponsor	UNC Lineberger Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,153
Start date	1 July 2021
Primary completion	3 August 2021
Estimated completion	3 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Emotion-based messages about the harm of VLNC
• Continued-harm-framed messages about the harm of VLNC
• Myth-refuting messages about the harm of VLNC
• Control messages about littering

Conditions studied

• Tobacco Use, Cigarette Use — all drugs for Tobacco Use, Cigarette Use →

Sponsor

UNC Lineberger Comprehensive Cancer Center — full company profile →

Who can join

18 and older, any sex, with Tobacco Use, Cigarette Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Very Low Nicotine Content (VLNC) Misperception Primary · 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.

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	3.12	± 0.56
Continued-harm-framed Messages About the Harm of VLNC	3.04	± 0.61
Myth-refuting Messages About the Harm of VLNC	3.04	± 0.54
Control Messages About Littering	3.36	± 0.80

Quit Intentions Secondary · 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.

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.88	± 1.22
Continued-harm-framed Messages About the Harm of VLNC	2.80	± 1.13
Myth-refuting Messages About the Harm of VLNC	2.87	± 1.27
Control Messages About Littering	2.85	± 1.26

Perceived Message Effectiveness Secondary · 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.

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	3.07	± 0.87
Continued-harm-framed Messages About the Harm of VLNC	3.26	± 0.86
Myth-refuting Messages About the Harm of VLNC	3.17	± 0.90
Control Messages About Littering	2.45	± 0.96

Perceived Understandability Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	4.48	± 0.82
Continued-harm-framed Messages About the Harm of VLNC	4.5	± 0.83
Myth-refuting Messages About the Harm of VLNC	4.37	± 0.86
Control Messages About Littering	4.35	± 0.94

Attention Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	3.26	± 1.22
Continued-harm-framed Messages About the Harm of VLNC	2.14	± 1.10
Myth-refuting Messages About the Harm of VLNC	3.13	± 1.16
Control Messages About Littering	2.73	± 1.12

Negative Affect Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.18	± 1.31
Continued-harm-framed Messages About the Harm of VLNC	1.97	± 1.15
Myth-refuting Messages About the Harm of VLNC	1.93	± 1.13
Control Messages About Littering	1.42	± 0.78

Cognitive Reactions Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.68	± 1.29
Continued-harm-framed Messages About the Harm of VLNC	2.68	± 1.28
Myth-refuting Messages About the Harm of VLNC	2.66	± 1.23
Control Messages About Littering	1.97	± 1.11

Social Interactions Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.28	± 1.28
Continued-harm-framed Messages About the Harm of VLNC	2.16	± 1.16
Myth-refuting Messages About the Harm of VLNC	2.24	± 1.17
Control Messages About Littering	2.09	± 1.17

Reactance Secondary · 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"

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.81	± 1.41
Continued-harm-framed Messages About the Harm of VLNC	2.61	± 1.40
Myth-refuting Messages About the Harm of VLNC	2.62	± 1.36
Control Messages About Littering	2.44	± 1.33

Interest in Other Nicotine Products Secondary · 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.

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	2.75	± 0.86
Continued-harm-framed Messages About the Harm of VLNC	2.80	± 0.78
Myth-refuting Messages About the Harm of VLNC	2.77	± 0.85
Control Messages About Littering	2.66	± 0.84

Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized) Primary · 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), "M

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	18.3	13.6 – 23.0
Continued-harm-framed Messages About the Harm of VLNC	12.6	8.6 – 16.7
Myth-refuting Messages About the Harm of VLNC	11.4	7.5 – 15.3
Control Messages About Littering	38.2	32.3 – 44.1

Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized) Primary · 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 misp

Group	Value	95% CI
Emotion-based Messages About the Harm of VLNC	16.8	12.2 – 21.4
Continued-harm-framed Messages About the Harm of VLNC	11.1	7.3 – 14.9
Myth-refuting Messages About the Harm of VLNC	9.5	5.9 – 13.1
Control Messages About Littering	31.8	26.2 – 37.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.