Clinical trial NCT04974489: Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes
Official title: Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use, Cigarette Use
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-23
Enrollment: 1153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Very Low Nicotine Content (VLNC) Misperception
timeFrame: During one day survey
measure: Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Harm (Dichotomized)
timeFrame: During one day survey
measure: Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Cancer (Dichotomized)
timeFrame: During one day survey
measure: Percentage of Participants With Very Low Nicotine Content (VLNC) Misperception About Death (Dichotomized)
timeFrame: During one day survey
Secondary outcomes:
measure: Quit Intentions
timeFrame: During one day survey
Other outcomes:
measure: Perceived Message Effectiveness
timeFrame: During one day survey
measure: Perceived Understandability
timeFrame: During one day survey
measure: Attention
timeFrame: During one day survey
measure: Negative Affect
timeFrame: During one day survey
measure: Cognitive Reactions
timeFrame: During one day survey
measure: Social Interactions
timeFrame: During one day survey
measure: Reactance
timeFrame: During one day survey
measure: Interest in Other Nicotine Products
timeFrame: During one day survey
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: M. Justin Byron, PhD
role: PRINCIPAL_INVESTIGATOR
References: