Cigarette Smoking Decision Study
Phase: NA
Conditions: Tobacco Smoking
Sponsor: Johns Hopkins University

Cigarette Smoking Decision Study
NCT04595279
2/18/2023

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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JHM IRB - eForm A – Protocol 
 
 
 
• 
Use the section headings to write the JHM IRB eForm A, inserting the appropriate 
material in each. If a section is not applicable, leave heading in and insert N/A. 
• 
When submitting JHM IRB eForm A (new or revised), enter the date submitted to 
the field at the top of JHM IRB eForm A. 
 
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1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the 
research hypothesis, and the importance of the research. 
 
The Family Smoking Prevention and Tobacco Control Act granted the FDA the authority 
to regulate and restrict tobacco advertising tactics that inaccurately convey reduced product 
risk, yet there is a dearth of up-to-date regulatory science to inform such regulations. Although 
the FDA has restricted use of descriptors such as “natural” and “additive-free,” research shows 
that the tobacco industry quickly pivoted to increase use of alternative, unregulated tactics. 
Greenwashing is one increasingly common tobacco marketing strategy in which products are 
portrayed as eco-friendly and/or natural. Our preliminary research indicates that greenwashing 
tactics may inaccurately convey modified product risk to consumers. The overarching objective 
of this project is to test the effect of greenwashing methods used by cigarette companies to 
market their products on actual smoking behavior in a controlled laboratory study. Our proposed 
research focuses on young adults (age 18-35), because this is a key age for smoking initiation 
and escalation, and research has found that young adults may be more susceptible than older 
adults to greenwashing in cigarette ads. This study will test the effect of greenwashing on 
behavioral economic demand and smoking topography in a laboratory-controlled cigarette self-
administration study. These data will clearly connect tobacco advertising features to product risk 
perceptions and actual smoking behavior. This work will provide FDA with an integrated set of 
evidence that identifies misleading greenwashing tactics that inaccurately convey modified 
product risk which can be used to inform regulatory action regarding restrictions of this type of 
advertising. 
 
2. 
Objectives (include all primary and secondary objectives) 
 
The proposed double-blind laboratory study in 35 non-treatment seeking dependent 
smokers will determine the test the effect of greenwashing on behavioral economic self-
administration and smoking topography. A within-subjects design will compare self-
administration choice and smoking topography between two “brands” that in reality will be 
identical cigarettes with ads/labels that include vs. lack greenwashed tactics. Behavioral 
economic sessions will determine self-administration under concurrent availability of the two 
brands at various behavioral prices. Topography sessions will test ad-lib self-administration for 
each brand. Together, these sessions encompass the two primary ways advertising could affect 
smoking behavior (the amount smoked, and how one smokes). We hypothesize that 
greenwashed cigarettes will (a) show greater self-administration than non-greenwashed 
cigarettes when available at equivalent prices, (b) show reduced sensitivity to price compared to 
non-greenwashed cigarettes, and (c) will be self-administered more than non-greenwashed 
cigarettes even when their price is higher. We also hypothesize that in topography sessions 
greenwashed cigarettes will show: greater (a) total puff volume, (b) mean puff volume, (c) mean 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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puff duration, (d) mean maximum flow rate, (e) number of puffs; and lesser (f) mean inter-puff 
interval. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
 
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) granted FDA the 
authority to regulate the tobacco product marketing and stop false or misleading advertising. 
Under the FSPTCA, tobacco companies are prevented from implicitly/explicitly conveying that a 
product is of modified risk, unless granted a permissive FDA order. In 2015, FDA issued 
warning letters to several tobacco companies regarding their use of the descriptors “natural” and 
“additive-free.” Underlying this action was research documenting that consumers inaccurately 
perceive cigarettes advertised with these descriptors to be lower risk than other cigarettes on 
the market (Gratale et al, 2019; Leas et al., 2016; Pearson et al., 2017). In early 2017, Santa Fe 
Natural Tobacco Company Inc. – manufacturer of Natural American Spirit (hereafter “American 
Spirit”) cigarettes and the largest such company – entered into a settlement agreement with the 
FDA that prohibited use of these terms (with the exception of the term “natural” in the product’s 
brand name). 
However, the tobacco industry has a documented history of quickly pivoting to new 
tactics in the face of advertising restrictions. For example, when descriptors “light,” “low,” and 
“mild” were banned, the industry started using colors, and terms such as “smooth” and 
“fine”(Connolly & Alpert, 2014; King & Borland, 2005). More recently, evidence suggests that 
American Spirit advertisements have already adopted new tactics after the settlement 
agreement with FDA. Specifically, between 2016 (pre-settlement) and 2018 (post-settlement), 
prevalence of the phrase “tobacco and water‟ increased by 59% while prevalence of claims 
about the company’s ecofriendly behaviors increased 36%. This underscores the large arsenal 
of tactics companies use to mislead consumers to perceive a product as modified risk, as well 
as their ability to rapidly shift from one tactic to another. Identification of such strategies and 
evidence of their effect on risk perceptions and smoking behavior are needed to inform FDA‟s 
regulatory action.  
Greenwashing is an increasingly common strategy deployed by the tobacco industry to 
portray products as less harmful. Greenwashing involves portraying a product or brand as eco-
friendly and/or natural (Laufer, 2003). Ours and others’ work has found this is accomplished 
through a variety of lexical and graphical tactics (Epperson et al., 2017; 2018). Lexical tactics 
include (a) Textual descriptors (e.g., additive-free, natural, organic, pure) and (b) textual 
references (e.g., claims about sustainable farming, lack of pesticides, limited ingredients (e.g., 
“Tobacco & Water”), supplemental environmental activities (e.g., planting trees). Graphical 
tactics include the use of (a) specific icons (e.g., leaves, flowers, seeds, recycling symbols) and 
(b) broader settings and background imagery (e.g., farms, forests, wood or natural background). 
Studies across multiple domains of consumer products, including tobacco, demonstrate that 
greenwashed products are seen as healthier than products that are not marketed using 
greenwashed tactics (Byron et al., 2015; Lazzarini et al., 2016; O’Connor et al., 2017).  
Behavioral economics, which bridges analysis from microeconomics with the methods 
and subject matter of behavioral science, examines how behavior is maintained by reinforcers 
under systems of constraint (Hursh, 1980, 1984). Demand analysis has been widely applied to 
human and animal drug reinforcement (Hursh et al., 2015; Johnson et al., 2004). Demand refers 
to the amount of reinforcer (e.g., cigarettes) consumed. Demand at various prices can be used 
to construct a demand curve, which can be quantified with specific metrics. Demand intensity is 
the person’s preferred level of consumption of that reinforcer when it is virtually free (at a trivial 
price). Demand elasticity refers to the sensitivity of reinforcer consumption in response to 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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changes in price (monetary price or behavioral price, i.e., how much effort is required to obtain 
the reinforcer). 
A difference in any behavioral economic demand metric would be meaningful for the 
cigarette market, and traditional reinforcement measures do not examine all reinforcement 
aspects. For example, greater demand intensity for greenwashed compared to non-
greenwashed cigarettes would indicate that greenwashing would increase cigarette 
consumption at the lower end of price ranges. Greater demand elasticity for greenwashed 
cigarettes compared to non-greenwashed cigarettes would indicate that greenwashing would 
increase cigarette consumption at higher prices in the commercial market, even if greenwashing 
had little or no effect at lower prices. Using progressive ratio breakpoint (a traditional 
reinforcement measure that corresponds to demand elasticity) would allow the study to miss 
meaningful differences in demand intensity. Using discrete choice (a traditional measure which 
typically uses a low price for both alternatives and is therefore analogous to demand intensity) 
would allow the study to miss difference in demand elasticity. Moreover, by examining reinforcer 
interactions (cross-price elasticity), demand analyses can inform the degree to which smokers 
would pay more for greenwashed cigarettes even if non-greenwashed cigarettes were available 
at a lower price. Therefore, the primary aims of the proposed study are to test the effect of 
greenwashing on behavioral economic self-administration measures. Additional topography 
measures will be conducted to determine smoking topography during ad-lib self-administration. 
Together, these sessions encompass the two primary ways advertising could affect smoking 
behavior (the amount smoked, and how one smokes). 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Interested individuals will call the study contact number, and study personnel will conduct a brief 
screening for eligibility over the phone. To facilitate timely screening of participants for eligibility, 
website ads and flyers will contain a link to a brief online interest and eligibility survey using 
JHM Qualtrics. All individuals will be phone screened and, if qualified, scheduled for an in-
person screening visit (approximately 2 hrs.) at the Behavioral Pharmacology Research Unit 
(BPRU) at the Johns Hopkins Bayview Medical Campus. Individuals will not sign consent before 
telephone screening. For those who meet phone screen eligibility, the laboratory screening will 
include physical and mental health history, drug history, physical examination, and standard 
laboratory tests of blood chemistry and hematology. 
 
General Procedures: We will recruit and consent up to 100 individuals to accrue 35 non-
treatment seeking male and female dependent cigarette smokers to complete the study by 
advertising and word-of-mouth. These volunteers will be medically healthy smokers without 
immediate intention to quit and will be fully informed community non-treatment seeking 
volunteers, who do not constitute a special vulnerable population. They will participate in a 9-
session laboratory study at the Behavioral Pharmacology Research Unit at the Johns Hopkins 
Bayview Campus. 
 
All lab visits will last approximately 4 hours total. Participants will be instructed to abstain from 
smoking for 6 hours before the beginning of each daily session in order to achieve a carbon 
monoxide (CO, a byproduct of smoking; measured by the Smokerlyzer, CoVita, Haddonfield, 
NJ, USA) measure ≤ 50% of the CO value obtained at the initial screening. If a participant fails 
to meet this criterion, the session will be rescheduled (or participation discontinued after multiple 
such instances). Sessions will be conducted at various times throughout the day, but each 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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individual participant will always begin his or her sessions at the same time of day throughout 
the experiment. 
 
Greenwashing Manipulations (Sessions 1-9): During behavioral sessions participants will 
have the opportunity to smoke at least 1 of 2 types of cigarettes (topography sessions will 
involve the opportunity to smoke 1 type per session, whereas both types will be available during 
behavioral economic sessions and participants can choose to smoke either or both). 
Participants will be exposed to advertising for two different novel cigarette brands. One brand 
will be advertised using greenwashing tactics, while the other brand will have control advertising 
lacking the greenwashing tactics. To avoid a brand x greenwashing confound, the brand that is 
advertised with greenwashing materials will randomly vary across participants (e.g., Participant 
1 may see Brand A advertised with greenwashing; Participant 2 may see Brand A advertised 
with the control ads). Participants will be exposed to the materials in two ways designed to 
replicate real world exposure to cigarette marketing for 30 minutes before sessions. First, 
posters will be placed on the walls to mimic advertising in retail settings. Participants will also be 
given printed information about each brand, designed to mimic direct mail advertisements, and 
may view this information as long as they like during the 30 minutes. These advertising 
materials and cigarette packs will remain in the room during topography and behavioral 
economic sessions. Unknown to the participants, both brands of cigarettes (Brand A and Brand 
B) will be the same commercial brand of cigarette. The study team will purchase cigarettes from 
a local store that sells commercially-available cigarettes. The study team will repackage these 
cigarettes into new packages that have either greenwashing elements or a control package that 
is similar, but without greenwashing elements. Although the two brand names and 
advertisements will be the same across participants, the actual commercial brand of cigarette 
used will be individualized for each participant to roughly the nicotine and menthol content for 
the participants typical brand of cigarettes. We will also ensure that it is a brand that lacks 
distinctive markings on the cigarettes that would allow for identification. Because this is within-
subjects research that tests the effects of greenwashing, the brand used is arbitrary aside from 
the above considerations. 
 
Topography sessions (Sessions 1-2): After assuring ≥6 hours of smoking abstinence via 
breath CO requirements, participants will take part in a 3-hour smoking topography session. In 
one session participants will have the ability smoke cigarettes associated with the greenwashing 
techniques, and in the other session participants will have the ability to smoke control cigarettes 
without the greenwashing technique used in labelling. Order of the two sessions will be 
randomized and counterbalanced across participants. Participants will be free to smoke 
cigarettes ad lib and in any manner they choose (e.g., depth and timing of inhalations) so long 
as they smoke the cigarettes through the small cigarette holder connected to our existing 
topography equipment (currently in use for IRB00107178). From this 3-hour session, 
topography measures to be determined include: total puff volume, mean puff volume, mean puff 
duration, mean inter-puff interval, mean maximum flow rate, and number of puffs. 
 
At the conclusion of the second topography session, participants will practice the targeted puff 
volume smoking required of the following behavioral economic sessions. In contrast to the 
topography sessions, the behavioral economic sessions will require participants to achieve a 
target puff volume (70 ml) when they choose to self-administer cigarette puffs. This is because it 
is necessary to standardize puffs to ensure a constant reinforcer size across conditions. Product 
appeal will be assessed for both packages during these sessions. 
 
Behavioral economics sessions (Sessions 3-9): In general, methods are modeled closely 
after those currently in place for research being conducted investigating reduced-nicotine 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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cigarettes in our laboratory (IRB00107178). In 4 sessions, a demand curve will be generated for 
greenwashed cigarettes while control cigarettes will be available at a fixed price throughout. 
Specifically, in one session, both types of cigarettes will be concurrently available for the same 
fixed, low behavioral price (10 plunger pulls for a bout of 3 cigarette puffs). In the other 3 
sessions, the control cigarettes will be available for 10 pulls, while the greenwashed cigarettes 
will be concurrently available for 100, 1000, or 10000 pulls (varying across the 3 sessions). This 
models the realistic situations in which greenwashed cigarettes are available at higher prices 
than other cigarettes. Then in another 3 sessions which provide an important comparison 
condition, we will assess the opposite situation, in which price for control cigarettes is 100, 
1000, or 10000 pulls across sessions (the session in which both are available for 10 pulls will 
have already been conducted), and greenwashed cigarettes are available at a fixed price of 10 
pulls throughout. The order of the 7 behavioral sessions (with different price combinations) will 
be randomized for each participant. 
 
During sessions, after confirming the CO breath requirement, the participant will take 1 puff of 
each type of cigarette. A 3 hour self-administration session will start 30 minutes after the initial 
puffs. Initial puffs will standardize the time since last smoking across all participants and 
sessions. Participants will complete each session in 1 of 4 existing identical ventilated smoking 
rooms, each equipped with a computer connected to a response console used to collect data. 
The console will have two Lindsley-type response plungers (custom modeled after Gerbrands 
No. G6310, Ralph Gerbrands Co., Arlington, MA, USA) horizontally spaced equidistantly along 
the front of the console. A force of 20 N will be required to operate the plunger and register a 
response. Depending on the response requirement of the session, a certain number of plunger 
pulls will result in controlled self-administration of cigarette puffs (described in more detail in 
puffing procedure subsection below). Either the left or right side plunger will be randomly 
associated across participants with either the greenwashed or control cigarettes. We will supply 
all cigarettes. 
 
Puffing procedure for behavioral economic methods: At the start of each session, the 
participant will be instructed on puffing procedures, and will be given direct verbal feedback by a 
research assistant. Participants will also be given an instruction sheet specifying the ratio 
requirement (number of plunger pulls) required to receive access to puffs. Whenever a 
response requirement is met, the participant will smoke three puffs from earned cigarette type 
according to a standard smoking procedure. Specifically, after completion of the required ratio, 
the 180 second consumption period will begin. The computer will immediately show the 
message “Puff Now” and the computer will emit two tones. The participant will then take a new 
cigarette, light it without inhaling, put it in the holder, then inhale. This cigarette holder will cover 
the last 8 mm of the cigarette, and will be connected via two plastic tubes to a volumetric low 
pressure transducer designed to measure puff volume and duration through the computer. This 
system provides real-time feedback to participants on puff volume (ml units). When 60 ml is 
reached, the computer will then emit a tone. The participant will have been instructed during the 
training session (at end of 2nd topography session) to aim for 70 ml, and the tone at 60 ml will 
give enough time for the participant to react and cease inhaling at roughly 70 ml. During any 
one session, mean puff volume will be between 65 and 75 ml or the session will be repeated. 
The participant will hold the smoke for 5 seconds, when the computer will emit two tones, 
signaling exhale time. A 25 second inter-puff interval will then begin. After 25 seconds, “Puff 
Now” once again will appear and the cycle will begin again. After the tones signaling the 
participant to exhale are emitted for the third puff, an inter-trial interval will be maintained until 
180 seconds have elapsed since ratio completion. Upon termination of this interval, the 
computer monitor will present, “You May Respond Now.”  
 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Collection and storage of electronic information: All questionnaire material will be collected 
using JHM Qualtrics, and downloaded to a JH OneDrive folder. Study-related documents, 
including PHI, will only be stored and processed within a JH OneDrive folder or using computers 
owned by Hopkins. All such computers use full-disk encryption, OS- or app-level firewalls, anti-
malware software, and are deployed in full compliance with JH standards. 
 
Description of procedures to minimize risk during the COVID-19 pandemic: Although it is 
not possible to conduct sessions remotely due to the need to collect biological measures (e.g., 
blood samples) during screening and use of specialized equipment for experimental sessions 
(e.g., smoking and response apparatus), specific safety procedure will be put into place to 
minimize person-to-person contact in the context of the COVID-19 pandemic. First, all 
participants will be required to wear a properly fitting face surgical grade mask while in in the 
laboratory. The exception to this policy will be times in which the participant is alone in the test 
smoking rooms with the door closed. These rooms each contain independent, strong external 
exhaust systems. This exception is necessary because participants will be smoking study 
cigarettes while in the test rooms, which is not feasible or possible while wearing a face mask. 
Any participant that does not have a face mask will be provided one by the study team at no 
cost. Second, participants will be asked about potential COVID-19 symptoms upon arrival to the 
laboratory. Any subjects reporting symptoms indicative of COVID-19 per the JHU Clinical 
screening algorithm will be required to return home and participation will be paused for at least 2 
weeks after which a health care professional must clear a return to participation (e.g., with a 
negative COVID-19 test). Third, appointment times will be staggered such that multiple 
participants will not be in the main laboratory room at the same time. Fourth, all equipment and 
surfaces will be wiped down following each session as well as at the beginning of each day with 
disinfectant (e.g., alcohol-based wipes or spray containing at least 70% alcohol to disinfect). 
Finally, all study staff will be required to wear properly fitting face masks while in the laboratory. 
Additionally, study staff will be required to wear a face shield for all times they are interacting 
within 6 feet of research participants. These procedures are successfully in place for an ongoing 
study in our laboratory using similar experimental procedures (IRB00107178). 
 
b. Study duration and number of study visits required of research participants. 
 
The total study duration will be approximately 2-3 weeks, depending on scheduling constraints, 
which is similar to ongoing studies in our laboratory. The total number of visits required will be 
10 in person sessions. The screening session will last approximately 2 hours, and experimental 
session will last approximately 4 hours. If an unforeseen issue arises during session (e.g., fire 
alarm, technical difficulties), or a participant does not follow study protocol (e.g., does not 
abstain from smoking prior to session) participants may be asked to repeat a session. 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Volunteers will be blind to the fact that the same brand is used for both greenwashing and non-
greenwashing conditions. Blinding is routine in human psychopharmacology studies, as it 
serves to minimize the confounding of data by expectations. It is not possible to blind volunteers 
and research staff from the greenwashing condition given the visual presentation of posters and 
flyers in the laboratory.  
 
d. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
 
N/A. This study does not involve therapy. 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
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Version 3 Dated:   06/2007 
 
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e. Justification for inclusion of a placebo or non-treatment group. 
 
N/A. This study does not involve placebo.  
 
 
f. Definition of treatment failure or participant removal criteria. 
 
Participants will be removed from this study if they fail to comply with protocol instructions that 
are outlined in the consent form or if they are not medically or psychologically suitable to 
continue. 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
The study procedures are not designed to provide therapy for cigarette smoking related 
problems. Participants will be individuals who do not have immediate plans to quit smoking.  
 
5. 
Inclusion/Exclusion Criteria 
Study Inclusion Criteria 
• 
Participants must be between 18 and 35 years of age. 
• 
Smoke at least five cigarettes per day 
• 
Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of 
more than 100 ng per milliliter 
 
Study Exclusion Criteria  
Individuals will be excluded if they meet any of the following criteria as determined by 
screening:  
• 
The intention to quit smoking in the next 30 days 
• 
Use of “roll your own” cigarettes as an exclusive form of smoking 
• 
A serious medical or psychiatric disorder or unstable condition 
• 
Any positive toxicological screening for illicit drugs other than cannabis will be excluded 
• 
Women who are pregnant, plan to become pregnant or are breast-feeding 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
Both brands of cigarettes (Brand A and Brand B) presented in this study will be the same 
commercial brand of cigarette. The study team will purchase cigarettes from a local store that 
sells commercially-available cigarettes. The study team will repackage these cigarettes into new 
packages that have either greenwashing elements or a control package that is similar, but 
without greenwashing elements. Although the two brand names and advertisements will be the 
same across participants, the actual brand of commercial cigarette used will be individualized 
for each participant to approximate the nicotine and menthol content for the participants typical 
brand of cigarettes. We will also ensure that it is a brand that lacks distinctive markings on the 
cigarettes that would allow for identification. 
 
b. Justification and safety information if FDA approved drugs will be administered for 
non-FDA approved indications or if doses or routes of administration or participant 
populations are changed. 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
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N/A 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
N/A 
 
7. 
Study Statistics 
a. Primary outcome variables.  
 
Demand Metrics: Reinforcement will be assessed by the 2 essential demand metrics: demand 
intensity and demand elasticity; which are calculated with nonlinear regression using the 
exponential demand equation (Hursh & Silberberg, 2008). Auxiliary metrics (Pmax, Omax, 
breakpoint) will also be examined, although these are derivative of the essential metrics. 
Demand elasticity and demand intensity will be calculated for each cigarette type (greenwashed 
or control) as it escalates in price and the alternative cigarette price remains fixed. Cross-price 
elasticity will be calculated to quantify the effect of increasing greenwashed cigarette work 
requirements on control cigarette consumption, and vice-versa. These measures will indicate 
how greenwashing perceptions may increase smoking. Greater demand intensity for 
greenwashed cigarettes compared to nongreenwashed cigarettes would indicate that 
greenwashing would increase cigarette consumption even at the lower end of commercial price 
ranges. Greater demand elasticity for greenwashed cigarettes compared to nongreenwashed 
cigarettes would indicate that greenwashing would increase cigarette consumption at higher 
prices in the commercial market, even if greenwashing had little or no effect at lower prices. By 
examining reinforcer interactions (cross-price elasticity), demand analyses can inform the 
degree to which smokers would pay more for greenwashed cigarettes even if non-greenwashed 
cigarettes were available at a lower price. 
 
b. Secondary outcome variables. 
 
Smoking Topography: We will collect six measures of smoking topography: total puff volume, 
mean puff volume, mean puff duration, mean inter-puff interval, mean maximum flow rate, and 
number of puffs. These data will be collected by ad lib smoking using our existing custom 
smoking topography system currently in use in our laboratory (IRB00107178). Our current 
research uses this topography system to help participants achieve a target volume per puff, but 
is already fully functional in its ability to measure topography of ad lib smoking. These measures 
will indicate the effect of greenwashing on how people smoke cigarettes in more damaging 
ways, for example, by smoking more deeply (greater puff volume), faster (greater maximum flow 
rate, lower inter-puff interval), or with increased time in lungs (greater puff duration). 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Analysis of Demand Curves: A paired-samples t-test will examine each demand metric, with 
data transformations of each demand metric if non-normally distributed (square root transform 
of Q0 and natural-log transform of α). We expect different demand profiles (greater demand 
intensity, and lower elasticity of demand) when cigarettes are greenwashed compared to control 
cigarettes. 
 
Analysis of Cross-Price Elasticity: To calculate cross price elasticity of cigarettes, any 
instances of zero self administrations within a block will be coded as 0.5 because the logarithm 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
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Version 3 Dated:   06/2007 
 
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of zero is undefined. Then, a linear regression will be performed on the log10 of consumption 
means vs. the log10 of unit prices. The resulting slope of this regression line will be the cross-
price elasticity. 
 
Analysis of Smoking Topography: Paired-samples t-tests will be used to compare measures 
of smoking topography between the greenwashed and control cigarettes. 
 
Statistical power:  
Using data from an ongoing operant demand study in our lab evaluating the substitutability of 
reduced-nicotine content cigarettes for full-nicotine cigarettes (grant R01DA042527), elasticity 
(α) of reduced-nicotine cigarettes was significantly greater than that of full-nicotine cigarettes 
(Cohen’s d = 1.33). Although these analyses were limited to single-item demand (i.e. cigarettes 
not concurrently available), the same underlying principles are applicable to the current 
analysis. Assuming an effect size half as large (d=.67), a sample size of N = 20 would  provide 
power ≥ 80% (two-tailed; α=.05) to detect a main effect of greenwashing tactics on demand 
metrics. Our proposed sample size of N = 35 would provide between 97-98% power in the 
current analyses comparing demand metrics between the cigarette packaging types, assuming 
an effect size of d=0.67 or 0.70, respectively. A previous study comparing smoking topography 
of water pipe tobacco with and without graphic warning labels demonstrated significantly 
reduced total puff volume in the water pipe with the graphic warning label relative to the 
unlabeled pipe (d=0.49) (Maziak et al., 2019). Using the effect size from Maziak et al. (2019), 
which is comparable to the current approach, a sample size of N = 35 would provide ≥80% 
power (two-tailed; α=.05). Because the published topography data represent the smallest 
encountered effect size among the outcomes, we are powering the study to address this effect, 
which will provide a sample size that is beyond sufficiently-powered to address the 
aforementioned demand outcomes.  
 
Demand metrics (demand intensity, demand elasticity, cross-price elasticity) and topography 
measures (total puff volume, mean puff volume, mean puff duration, mean inter-puff interval, 
mean maximum flow rate, and total puff number) will be compared between control and 
greenwashed cigarettes using paired-samples t-tests. Power analyses were performed for all 
primary behavioral economic and topography variables. Because topography measures showed 
the smallest anticipated effect based on published data (d = 0.49), we have conservatively 
based our sample size on topography. Despite this conservative estimation, if non-significant 
trends are observed suggesting potential effects, the proposed research will provide excellent 
data for informing power for future studies. 
 
d. Early stopping rules. 
 
No interim analyses are planned. The investigators will monitor safety data and relevant 
literature and report information to the IRB that might increase the risk assessment of the study. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency. 
 
Because the study will use participants who currently smoke, the risks associated with 
cigarettes are slight. Cigarettes to be administered in this study are expected to produce 
discernible effects with minimal safety risk. Participants are unlikely to experience side effects 
during the research, although as with any study, some risks exist. The main risk is that 
participants may experience side effects through exposure to the cigarettes or from withdrawal 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 10 of 13 
 
symptoms prior to smoking which may be unpleasant. These include dizziness, nausea, 
headache, cough, sore throat, increased heart rate, and increased blood pressure. Side-effects 
of the cigarettes would be temporary. Participants may also become tired or bored during the 
sessions. 
 
For blood samples taken intravenously, there is a minor risk of problems associated with 
insertion of the needle, including local irritation, inflammation, bleeding, and chance of infection 
at the insertion sites. Breach of confidentiality about self-reported drug use and biological tests 
indicating recent drug use is also a risk.  
 
b. Steps taken to minimize the risks. 
 
Participants are not a vulnerable population as defined by human participants protection 
guidelines; that is, they are not minors, pregnant women, under legal coercion or restriction, or 
mentally impaired. They are competent adults who provide their voluntary informed consent. 
Participants will be recruited via advertisements that clearly state the nature and intent of the 
study. The consent process will inform the participant in detail of the procedures, time 
involvement, compensation, risk, and treatment options other than participation in our study. 
Particular emphasis will be given to providing information regarding the potential risks. 
Volunteers will also be instructed that they may discontinue participation at any time without 
penalty. Research assistants at BPRU are rigorously trained in conducting and monitoring 
behavioral pharmacology experiments, and are experienced with observing and rating effects of 
drugs. Expired air samples will be collected to test for the presence of alcohol (indicating current 
impairment), and sessions will not be conducted unless alcohol concentration in the breath test 
is 0.00%. If a participant appears to be under the influence of a drug upon arrival at the BPRU, 
the session will not be run. 
 
Cigarettes provided in the present study are commercially available, and will be delivered to 
individuals who already smoke with no intention to quit, and therefore risk is minimal. Staff are 
alert and careful in the protection of participants from risks. In the unlikely event of a medical 
issue, a physician in our research unit, including our co-investigator Dr. Annie Umbricht, M.D., is 
always available via a dedicated emergency contact line. The medical and nursing staff at 
BPRU is trained in CPR. The PI and physician co-investigator will be immediately notified of any 
serious events that arise. These include accidents, or hospitalization episodes that occur while 
individuals are participating in the study. In any case in which a participant ceases study 
participation due to unlikely side effects the PI will make a detailed report to the IRB. Urine will 
be tested for evidence of recent drug use at screening and experimental sessions and any 
positive toxicological screening for illicit drugs other than cannabis will be exclusionary. 
  
Additionally, following standard hospital practices will minimize risks associated with blood 
draws. To protect participant information, participants’ names will be recorded only during the 
screening, informed consent, and on necessary medical forms. Anonymous participant 
identification numbers will be used on all other forms and labeling of biological fluids and test 
results. All information gathered will be kept in locked research staff offices or file cabinets. All 
medical information obtained will be handled in accordance with HIPAA regulations. Only 
research staff will have access to participant records. The limits of confidentiality (e.g., 
suspected child abuse or neglect, or harm to self or others) will be discussed in detail with the 
participants during the informed consent process. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 11 of 13 
 
The principle investigator will be responsible for notifying the IRB if an unanticipated problem or 
study deviation occurs.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
N/A 
 
e. Financial risks to the participants. 
 
Not applicable. There are no financial risks to study volunteers. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
There is no benefit for participants in this study other than financial compensation. This study 
will develop and provide clinically meaningful data on the impact of greenwashing 
advertisements, and will directly inform FDA policy.  
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
 
For this study, participants will be provided $75 for screening and $50 for each experimental 
session thereafter with an additional $50 bonus earned for each experimental session for those 
who complete the study (up to 9 in-person laboratory experimental sessions including initial 
exposure sessions for a total $450 in bonus payments). This payment system provides an 
approximately equivalent compensation rate per visit as provided in a previous long-term 
laboratory studies (IRB00107178). Due to the substantial time given by each participant over 
the course of roughly 2-3 weeks, participants will be able to earn up to $975 for completing the 
study. Additionally, if a participant refers someone to the study who then completes the study, 
the referring participant will receive a one-time bonus payment of $200. This referral bonus will 
be retroactively applied to any referring participant who has previously completed the study. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them. 
 
There will be no cost to study volunteers for participating in the study. 
 
 
 

Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
Page 12 of 13 
 
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Date: February 18, 2023  
Principal Investigator: Matthew Johnson, Ph.D. 
Application Number: IRB00264306 
NCT04595279 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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