Messages About Reduced Nicotine in Combusted Tobacco Products: An Online Randomized Controlled Trial
Phase: NA
Conditions: Health Communication, Smoking, Smoking, Tobacco, Smoking Behaviors, Risk Behavior
Sponsor: Georgia State University

Study Protocol and Statistical Analysis Plan  
Official Title: Messages About Reduced Nicotine in Combusted Tobacco Products 
NCT Number: NCT05506046 
Document Date: 02/07/2024 
 

Official Title: Messages About Reduced Nicotine in Combusted Tobacco Products 
Brief Title: Effects of messages about very low nicotine cigarettes 
 
Sponsor: National Cancer Institute of the National Institutes of Health and the Food and Drug 
Administration Center for Tobacco Products 
 
Information provided by (Responsible Party): Georgia State University 
 
Collaborator: University of South Carolina 
 
ClinicalTrials.gov Identifier: NCT05506046 
 
Other Study ID Numbers: IRB: H22639 
 
Grant number: R01CA239308 
 
Brief Summary 
This randomized controlled trial aims to examine the effects of messages about very low 
nicotine cigarettes (VLNCs) alone and in combination with messages about e-cigarettes. 
Previous research on communications about VLNCs has primarily focused on the 
examination of various textual statements and message attributes rather than fully developed 
advertisements that are used in real-world communication campaigns. In addition, no research 
so far has examined the effects of VLNC messages in combination with messages about e-
cigarettes, which are the two parallel components of the nicotine-focused regulatory approach. 
The present study accesses the effects of messages about VLNCs, e-cigarettes, and their 
combined messaging on perceptions, behavioral intentions, and behavioral outcomes among a 
nationally representative sample of different smoking status populations. 
 
The study is a four-group RCT with parallel assignment that will be delivered through an online 
self-administered questionnaire, consisting of two sessions over a two-week period. Participants 
will be randomly assigned to one of one of four trial arms: 1) VLNC messages, 2) e-cigarette 
messages, 3) combination of VLNC and e-cigarette messages, and 4) control messages. They 
will be exposed to 2 messages corresponding to the assigned condition, and answer survey 
questions immediately after message exposure and two weeks after 
 
Detailed description 
The FDA proposed a nicotine-focused regulatory approach to reduce nicotine in cigarettes to 
non-addictive levels, coupled with advising those who are not ready to quit to obtain nicotine 
from alternative nicotine delivery products (e-cigarettes). The widespread misperception that 
very low nicotine cigarettes (VLNCs) are less harmful than regular cigarettes presents 
challenges in communicating about this policy to the public, especially in a landscape that 
involves e-cigarettes. This study tested messages about VLNCs alone and combined with e-
cigarettes messages that may prepare key population segments for this groundbreaking 
regulation. 
 

Setting: The trial will be an experiment delivered through an online self-administered 
questionnaire, consisting of two sessions over a two-week period. 
Recruitment: Participants will be recruited through the research company Ipsos from its 
national research panel (KnowledgePanel). 
 
Informed Consent: Participants will provide online consent prior to taking the survey. 
 
Randomization: After providing informed consent and answer pre-exposure questions, Ipsos 
will randomize participants into one of the four trial conditions. The randomization will use least 
fill for the allocation of conditions. In least fill, the survey assigned the condition that had the 
lowest count. If the counts for the conditions were equal, the survey would assign the condition 
sequentially. 
Assessment: Participants will take part in two sessions: in session 1 (estimated at about 15 
min) participants will answer questions assessing smoking status, quit intentions and attempts 
(only asked adults who smoke exclusively and adults who dual use), e-cigarette use, other 
tobacco product use, and health literacy. They will then view the messages, and report 
immediate outcomes including perceptions and behavioral intentions. In session 2, which will 
take place 2 weeks after session 1, participants will complete a brief 5-minute survey 
measuring their recall of the messages and behaviors since message exposure. 
 
Study Type: Interventional 
 
Study Phase: N/A 
Study Design 
Allocation: Randomized 
Endpoint Classification: Participant reported outcomes  
Intervention Model: Parallel Assignment  
Masking: None (open label)  
Primary Purpose: Treatment 
 
Condition: Smoking  
 
Intervention 
1. Behavioral: exposure to messages about very low nicotine cigarettes (VLNCs) 
Two VLNC messages will be drawn at random from a pool of five messages. The 
messages communicate that VLNCs contain other harmful chemicals and cause 
diseases just as regular cigarettes, but VLNCs would be easier to quit. Messages will 
be shown in a random order to participants in the corresponding trial arm in session 1.  

2. Behavioral: messages about e-cigarettes 
Two e-cigarette messages will be drawn at random from a pool of five messages. The 
message describes that people who smoke and are not ready to quit could benefit from 
switching to e-cigarettes to reduce their health risks. They will be shown in a random 
order to participants in the corresponding trial arm in session 1. 
 
3. Behavioral: combined messaging about VLNCs and e-cigarettes 
One message from the pool of VLNC messages and one from the pool of e-cigarette 
messages will be randomly drawn and shown to the participants during session 1. 
 
4. Other: bottled water ads 
Two bottled water ads that have no smoking-related content will be randomly selected 
from a pool of five messages, and will be shown in a random order. 
Study Arm(s) 
1. Experimental: VLNC messages 
2. Experimental: e-cigarette messages 
3. Experimental: combined VLNC and e-cigarette messages 
4. Other: control messages (bottled water ads) 
Publications: N/A 
Recruitment Information  
Recruitment Status: Not active 
Actual Enrollment: 1901 
Actual Completion Date: February 28, 2023 
Actual Primary Completion Date: February 28, 2023 
Eligibility Criteria 
 
Inclusion Criteria: 
1. Being 18 years old or older; 
2. Belonging to one of three groups of participants: current exclusive smokers (adults 
who had smoked at least 100 cigarettes in their lifetime, currently smoked cigarettes 
every day or some days, and did not use e-cigarettes), dual users (adults who dual use 
had smoked at least 100 cigarettes in their lifetime, currently smoked cigarettes every 

day or some days, and had used e-cigarettes at least once in the past 30 days), and 
young adult non-smokers (adults aged 18-29 years who had not smoked 100 cigarettes 
in their lifetime) 
3. Enrolled in existing nationally representative panel where recruitment is based 
Exclusion Criteria: None 
Gender: All 
 
Contacts: Lucy Popova, PhD.  lpopova1@gsu.edu 
Listed Location Countries: United States 
 
Primary Outcome Measures: 
 
Title 
Definition 
Time Frame 
Perceived health 
risk of VLNCs 
(absolute) 
Measured with a single item, assesses participant's perception of 
own risk of overall harm to health under conditions of smoking 
VLNCs every day. Response options range from 1 (Not at all 
likely) to 5 (Extremely likely) and include "Don't know" 
Immediately 
after exposure 
Secondary Outcome Measures: 
Title 
Definition 
Time Frame 
Perceived comparative 
harm of VLNCs 
 
A single item measuring perceptions of comparative risk of 
smoking reduced nicotine cigarettes vs regular cigarettes. Response 
options are from 1 (Much less harmful) to 5 (Much more harmful) 
and include "Don't know.' 
Immediately 
after exposure 
Perceived absolute 
addictiveness of 
VLNCs 
A single item measuring participants' perception of likelihood 
developing addiction to reduced nicotine cigarettes under conditions 
of smoking them every day. Response options are from 1 (Not at all 
likely) to 5 (Extremely likely) and include "Don't know.' 
Immediately 
after exposure 
Interest in 
trying VLNC 
A single item measuring participants' interests in trying 
VLNC. Response options are from 1 (Not at all) to 7 
(Extremely) and include "Don't know”. 
Immediately after 
exposure 
Intention to 
switch 
completely to 
e-cigarettes 
A single item measuring participants' intention to switch 
completely to e-cigarettes in the next 6 months.  Response 
options are from 1 (Not at all) to 7 (Extremely) and include 
"Don't know”. 
Immediately after 
exposure 
VLNC Policy 
Support 
A single item measuring support for the policy to reduce 
nicotine by 95% in all cigarettes. Response options are from 
1 (Strongly Oppose) to 5 (Strongly Support) and include 
"Don't know." 
Immediately after 
exposure 

Analytic Plan 
1. Continuous outcomes include the primary outcome (perceived absolute harm of 
VLNCs), as well as other VLNC-related perceptions and behavioral intentions. 
Univariate analyses of covariance (ANCOVA) will be used to examine message 
effects on continuous outcomes. 
2. Binary outcomes include smoking and communication behaviors measured at the 
two-week follow-up survey, as well as quit attempt, cessation, and perceived 
relative harm of VLNCs. Logistic regression models will be fitted to test binary 
outcomes. 
3. Interaction effects of message conditions and smoking status will be tested by 
adding interaction terms to the covariate-adjusted models.  
Sample size and power 
The study intends to recruit a total of 1,800 participants, including 450 participants 
in each trial condition. It is anticipated that approximately 80% of the participants 
in session 1 will be retained for the two-week follow-up survey. Give a power set at 
80% and a significance level (alpha) of 0.05, the trial has adequate power to detect 
close to small sized effects, with effect sizes between 0.13-0.28 for continuous 
outcomes and effect sizes between 1.4-3.5 for binary outcomes.  
 
Perceived 
Message 
Effectiveness 
3-item scale measuring to what extent participants think the 
messages they saw discourage them from wanting to smoke, 
make smoking seem unpleasant, and make them concerned 
about health risks of smoking. Response options are from 1 
(Strongly disagree) to 7 (Strongly agree) and include "Don't 
know.' 
Immediately after 
exposure 
Smoking behavior 
Single item measuring the average number of cigarettes smoked per 
day in the past two weeks. 
2 weeks after 
exposure 
Perceived absolute 
health risks of VLNCs 
at post-test 
 
A single item measuring participants' perception of likelihood 
developing addiction to regular cigarettes under conditions of 
smoking them every day. Response options are from 1 (Not at all 
likely) to 5 (Extremely likely) and include "Don't know.' Measured 
with a single item, assesses participant's perception of own risk of 
overall harm to health under conditions of smoking reduced 
nicotine cigarettes every day. Response options range from 1 (Not 
at all likely) to 5 (Extremely likely) and include "Don't know" 
2 weeks after 
exposure