Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04974489

Enrollment

1153

Registered

2021-07-23

Start date

2021-07-01

Completion date

2021-08-03

Last updated

2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use, Cigarette Use

Brief summary

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.

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.

Interventions

BEHAVIORALEmotion-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.

BEHAVIORALContinued-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.

BEHAVIORALMyth-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.

BEHAVIORALControl messages about littering

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Very Low Nicotine Content (VLNC) Misperception	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.
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)	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).
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)	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).
Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Death (Dichotomized)	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

Measure	Time frame	Description
Quit Intentions	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

Measure	Time frame	Description
Social Interactions	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
Perceived Message Effectiveness	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.
Interest in Other Nicotine Products	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.
Reactance	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
Perceived Understandability	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
Attention	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
Negative Affect	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
Cognitive Reactions	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

Countries

United States

Participant flow

Recruitment details

Participants were recruited from a panel, screened for study eligibility, and invited to enroll after they were determined to be eligible.

Pre-assignment details

1,253 participants completed the study questionnaire, and the panel provider determined that of those 1,145 qualified participants completed the questionnaire. The panel provider removed 13 cases from the study who skipped half or more of the survey questions. The study team received data for 1,132 participants. For analysis purposes, we excluded anyone who did not complete the questions for the primary outcome (n=79), yielding a final analysis sample size of 1,053.

Participants by arm

Arm	Count
Emotion-based Messages About the Harm of VLNC 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.	262
Continued-harm-framed Messages About the Harm of VLNC 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.	261
Myth-refuting Messages About the Harm of VLNC 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.	263
Control Messages About Littering Control messages about littering: Participants in this arm will receive 3 control messages about littering during the survey data collection.	267
Total	1,053

Baseline characteristics

Characteristic	Continued-harm-framed Messages About the Harm of VLNC	Myth-refuting Messages About the Harm of VLNC	Emotion-based Messages About the Harm of VLNC	Control Messages About Littering	Total
Age, Continuous	54.6 years STANDARD_DEVIATION 13.6	54.4 years STANDARD_DEVIATION 13.2	54.1 years STANDARD_DEVIATION 13.7	54.9 years STANDARD_DEVIATION 13.1	54.5 years STANDARD_DEVIATION 13.4
Race/Ethnicity, Customized Black, Non-Hispanic	27 Participants	39 Participants	22 Participants	35 Participants	123 Participants
Race/Ethnicity, Customized Hispanic or Latino	19 Participants	23 Participants	22 Participants	19 Participants	83 Participants
Race/Ethnicity, Customized Other, Non-Hispanic	4 Participants	4 Participants	9 Participants	6 Participants	23 Participants
Race/Ethnicity, Customized Two Races or More, Non-Hispanic	8 Participants	5 Participants	8 Participants	10 Participants	31 Participants
Race/Ethnicity, Customized White, Non-Hispanic	203 Participants	192 Participants	201 Participants	197 Participants	793 Participants
Region of Enrollment United States	261 participants	263 participants	262 participants	267 participants	1053 participants
Sex/Gender, Customized Female	129 Participants	134 Participants	122 Participants	127 Participants	512 Participants
Sex/Gender, Customized Male	131 Participants	129 Participants	138 Participants	136 Participants	534 Participants
Sex/Gender, Customized Missing	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Sex/Gender, Customized Non-binary and Prefer to Self Describe	0 Participants	0 Participants	1 Participants	4 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

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).