Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes
Phase: NA
Conditions: Tobacco Use, Cigarette Use
Sponsor: UNC Lineberger Comprehensive Cancer Center

Study Protocol and Statistical Analysis Plan 
Official Title: Correcting Public Misperceptions about Very Low Nicotine Content Cigarettes 
NCT Number: NCT04974489 
Document date: 7-28-22 
 
Study Protocol 
 
Objective 
The objective was to test whether communication messages can reduce the misperception that 
very low nicotine content (VLNC) cigarettes are less harmful than other cigarettes. 
 
Design 
In this between-subjects experiment, participants were recruited from a panel, screened, and 
then eligible participants were randomized to one of four study arms, each with different 
communication messages: 1) Emotion-based messages about VLNC, 2) Continued-harm-
framed messages about VLNC, 3) Myth-refuting messages about VLNC, or 4) Control 
messages about littering. In each arm, participants were exposed to three messages, and then 
outcomes were assessed. The primary outcome was the VLNC misperception, and secondary 
outcomes included quit intentions, perceived message effectiveness, perceived 
understandability, attention, negative affect, cognitive reactions, social interactions, and 
reactance. 
 
Methods 
Participants were recruited and screened by the panel provider, and then eligible participants 
were directed to an online survey that included the experiment. Participants were compensated 
for their time by the panel provider. The study was reviewed and approved by the institutional 
review board of the University of North Carolina at Chapel Hill. 
 
Scientific Background 
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 recently 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, 
smokers only benefit from a VLNC policy if they quit. The success of the policy may require 
public understanding that, although these new cigarettes are less addictive, their high toxicity 
and carcinogenicity are unchanged. Although communication research suggests it is 
challenging to change people's incorrect understanding, new communication techniques may 
help reduce the VLNC misperception.  
 
Statistical Analysis Plan 
 
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. For the analyses presented in on clinicaltrials.gov, we computed the outcome values for 
each study arm, including simple mean values for scale items. Responses from participants who 
did not complete all items within a scale were not included in the analyses for that scale. No 

adjustments were made for testing multiple variables. Future analysis to examine statistically-
significant difference between study arms for each outcome will be conducted under the 
supervision of a trained statistician and following best practices in statistical methods. Since the 
purpose of the experiment was to reduce the misperception that low nicotine cigarettes are less 
harmful, we may also dichotomize the outcome to determine the percentage of participants who 
hold the misperception in each study arm after the communication intervention.