Tobacco Use, Cigarette UseNCT04974489
Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes
A study testing Emotion-based messages about the harm of VLNC, Continued-harm-framed messages about the harm of VLNC and Myth-refuting messages about the harm of VLNC in people with Tobacco Use, Cigarette Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use, Cigarette Use
- What is being tested?
- Emotion-based messages about the harm of VLNC, Continued-harm-framed messages about the harm of VLNC and Myth-refuting messages about the harm of VLNC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 3 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current Cigarette Smoker
- Age 18 or older
- Enrolled in existing nationally representative panel where recruitment is based
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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.
- Conditions
- Tobacco Use, Cigarette Use
- Being 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
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion-based messages about the harm of VLNCBehavioural
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 VLNCBehavioural
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 VLNCBehavioural
Participants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection.
Control messages about litteringBehavioural
Participants in this arm will receive 3 control messages about littering during the survey data collection.
| Study group | Role | What they receive |
|---|---|---|
| Emotion-based messages about the harm of VLNC | Experimental | Not described Receives: Behavioral: Emotion-based messages about the harm of VLNC |
| Continued-harm-framed messages about the harm of VLNC | Experimental | Not described Receives: Behavioral: Continued-harm-framed messages about the harm of VLNC |
| Myth-refuting messages about the harm of VLNC | Experimental | Not described Receives: Behavioral: Myth-refuting messages about the harm of VLNC |
| Control messages about littering | Active comparator | Not described Receives: Behavioral: Control messages about littering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: During one day survey
Secondary outcomes (1)
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.
Measured: During one day survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jul 2021
- Primary completion3 Aug 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use, Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- M. Justin Byron, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974489
- Sponsor's protocol ID
- 19-1284
- Other IDs
- R21CA234968
- Status last verified
- Oct 2022
- First submitted
- 14 Jul 2021
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes
- ClinicalTrials.gov ID
- NCT04974489
- Acronym / sponsor ID
- 19-1284
- Conditions
- Tobacco Use, Cigarette Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,153 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Emotion-based messages about the harm of VLNC | Experimental | Behavioral: Emotion-based messages about the harm of VLNC |
| Continued-harm-framed messages about the harm of VLNC | Experimental | Behavioral: Continued-harm-framed messages about the harm of VLNC |
| Myth-refuting messages about the harm of VLNC | Experimental | Behavioral: Myth-refuting messages about the harm of VLNC |
| Control messages about littering | Active comparator | Behavioral: Control messages about littering |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current Cigarette Smoker
- Age 18 or older
- Enrolled in existing nationally representative panel where recruitment is based
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion-based messages about the harm of VLNCParticipants in this arm will receive 3 emotion-based messages about the harm of VLNC during the survey data collection. | Behavioural | Emotion-based messages about the harm of VLNC |
| Continued-harm-framed messages about the harm of VLNCParticipants in this arm will receive 3 continued-harm-framed messages about the harm of VLNC during the survey data collection. | Behavioural | Continued-harm-framed messages about the harm of VLNC |
| Myth-refuting messages about the harm of VLNCParticipants in this arm will receive 3 myth-refuting messages messages about the harm of VLNC during the survey data collection. | Behavioural | Myth-refuting messages about the harm of VLNC |
| Control messages about litteringParticipants in this arm will receive 3 control messages about littering during the survey data collection. | Behavioural | Control messages about littering |
Primary outcome
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.
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).
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).
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).
1 secondary outcome
Quit Intentions
Time frame: During one day survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Justin Byron, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion-based messages about the harm of VLNC, Continued-harm-framed messages about the harm of VLNC and Myth-refuting messages about the harm of VLNC in people with Tobacco Use, Cigarette Use, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Very Low Nicotine Content (VLNC) Misperception (time frame: During one day survey). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.