Clinical trial NCT04999644
Conditions: Tobacco Use Disorder
Sponsor: Johns Hopkins University
Start date: 2022-02-23; Completion date: 2023-03-29
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this project is to experimentally evaluate how expectations about reduced-nicotine cigarettes as well as actual nicotine content interact to determine behavioral and subjective response for these novel products.

Detailed description:

Arms: arm 1: Receive reduced nicotine cigarette expecting full arm 2: Receive full nicotine cigarette expecting full arm 3: Receive full nicotine cigarette expecting reduced arm 4: Receive reduced nicotine cigarette expecting reduced
Interventions: intervention 1: Full Nicotine Cigarettes intervention 2: Reduced Nicotine Cigarettes intervention 3: Average Nicotine Expectancy intervention 4: Very Low Nicotine Expectancy
Intervention descriptions: intervention 1: A full nicotine tobacco cigarette that will be smoked by participants intervention 2: A reduced nicotine tobacco cigarette that will be smoked by participants intervention 3: Participant instructed the cigarette is "the same level of nicotine as your usual brand." intervention 4: Participant instructed the cigarette is "a very low level of nicotine compared to your usual brand."

Protocol documents:
Prot_SAP_000.pdf: 
JHMIRB eFormA 01 
Version 3 Dated: 06/2007 
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Reduced Nicotine Cigarette Purchasing 
Decisions
 NCT04999644 
Last Updated 10/19/2022 


JHMIRB eFormA 01 
Version 3 Dated: 06/2007 
 
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Johns Hopkins Medicine - eForm A 
• 
Use the section headings to write the eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
• 
When submitting eForm A (new or revised), enter the date submitted to the field at 
the top of eForm A. 
****************************************************************************** 
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 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to 
reduce public health harms of tobacco products. A key proposal is mandating nicotine reduction 
in cigarettes. It is hypothesized that reducing nicotine content will mitigate the overwhelming 
morbidity associated with smoking by decreasing smoking initiation and increasing cessation 
rates 
among 
established 
smokers. 
Clinical 
trials 
have 
provided 
promising 
support 
by 
demonstrating reductions in toxicant exposure and nicotine dependence for individuals 
randomized to reduced-nicotine cigarette conditions. Experimental work on reduced-nicotine 
cigarette pharmacodynamics has almost exclusively used blinded conditions, precluding 
systematic evaluation of how expectations about reduced-nicotine cigarettes may impact 
behavioral and subjective response. Given that real-world settings will involve unblinded products, 
information about expectancies is essential to inform how reduced-nicotine products will be 
perceived in future real-world markets. This human laboratory study will systematically determine 
the independent and interactive effects of expectancy and nicotine dose on reinforcing (behavioral 
economic demand), subjective, and topography outcomes. Participants (up to N=25) will complete 
4 experimental sessions in which expectancy (labeling of “average” nicotine versus “very low” 
nicotine) and nicotine dose (15.8 mg/g versus 0.4 mg/g) are manipulated as within-subject 
variables (i.e., 4 sessions: 15.8 told average; 15.8 told low; 0.4 told average; 0.4 told low). 
Participants will sample a study cigarette of these combinations at the start of each session and 
complete craving, mood, withdrawal, and subjective drug effect measures before and after 
smoking. Smoking topography will also be collected during cigarette administration to determine 
if expectancy and dose impact how one smokes – one way that cognitive or pharmacological 
effects can impact smoking behavior. Demand will be evaluated with an incentivized demand task 
using experienced outcomes to improve experimental rigor. Behavioral economic demand 
analyses will differentiate between effects attributable to consumption of a good at no or little cost 
(“demand intensity”) and consumption following increases in cost (“demand elasticity”). We 
hypothesize lower demand, subjective effects, and puff volume for “very low” labels and low 
nicotine dose cigarettes, with the lowest demand when in combination. This study will provide 
critical information on the reinforcing effects of smoking due to not only nicotine content, but 
nicotine expectancy – a factor that has received virtually no attention in nicotine reduction 
research. Identifying the specific behavioral mechanisms impacted by these factors is relevant as 
each have very different public health implications. These data will provide clear behavioral 
targets for subsequent research designed to optimize public health campaigns addressing 
nicotine-reduction policy. 
 
2. Objectives (include all primary and secondary objectives) 
 
Primary objective: Determine the interaction of expectancy effects and nicotine dose on 
behavioral economic demand for reduced-nicotine cigarettes. Demand will be evaluated using an 
incentivized demand task with experienced outcomes to provide experimental rigor. We 
hypothesize lower demand (via intensity and elasticity) for “very low” labels and low nicotine 
content cigarettes, with the lowest demand when in combination. 


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Secondary objective: Determine the interaction of expectancy effects and nicotine dose on 
subjective effects and smoking topography for reduced-nicotine cigarettes. Participants will 
sample the study cigarette at the start of each session and complete craving, mood, withdrawal, 
and subjective drug effect measures before and after smoking. Smoking topography will also be 
collected during cigarette administration to determine if expectancy and dose impact how one 
smokes (another primary way cognitive or pharmacological effects can impact smoking). Based 
on prior research, we hypothesize lower positive subjective effects and lower puff volume for “very 
low” labels and reduced-nicotine cigarettes with the lowest values for their combination. 
 
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 2009 Family Smoking Prevention and Tobacco Control Act grants the FDA authority to 
reduce public health harms of tobacco products. A key proposal is mandating nicotine reduction 
in cigarettes. The theory behind this policy was outlined by Benowitz and Henningfield (1994) who 
argued that regulating nicotine content below a “threshold for addiction” would help prevent 
development of nicotine dependence among initiating smokers and (possibly) reduce use in 
established smokers. Research on nicotine reduction remained limited until the 2009 Tobacco 
Control Act granted the FDA authority to mandate reduction, but not elimination, of nicotine should 
evidence support a benefit to public health. Several large-scale clinical trials then developed 
building on promising evidence from early Phase I/IIa studies (e.g., Benowitz et al., 2007, 2012; 
Hatsukami et al., 2010). One double-blind, 6-week exposure trial found that reduced-nicotine 
cigarettes (≤ 2.4 mg/g) decreased the number of daily cigarettes smoked compared to full-nicotine 
experimental or usual brand cigarettes (Donny et al., 2015). Another double-blind, 20-week trial 
found that immediate reduction to 0.4 mg/g cigarettes reduced toxicant exposure (i.e., breath 
carbon monoxide, acrolein metabolites [HPMA], and hydrocarbons [PheT]) compared to gradual 
or no reduction in daily smokers (Hatsukami et al., 2018). 
These findings are promising for the possible public health benefits of reduced-nicotine 
cigarettes, which in part led to recent FDA authorization of a reduced-nicotine cigarette for public 
sale (Moonlight brand). However, should a reduced-nicotine content policy be enacted, whether 
soft (encouraging market competition) or hard (fully mandating reduced nicotine), a critical 
component is optimizing public health campaigns for rollout. Behavioral laboratory studies are 
well equipped to address such issues by determining factors contributing to expected consumer 
response under varying conditions. For example, behavioral research has been essential in 
evaluating attention and memory mechanisms contributing to point-of-sale marketing and 
informing FDA regulation of such tactics (Robinson et al., 2016). This study will evaluate one key 
and understudied cognitive-behavioral factor – expectancy effects – and how behavioral 
economic demand is well equipped to address the public health relevance of expectancy for 
nicotine-reduction policy. 
Rigorous experimental work has demonstrated that expectancies can impact behavioral and 
subjective drug response independent of pharmacological action. This work is best exemplified 
by the balanced-placebo design widely used in alcohol research (Rohsenow & Marlatt, 1981). 
First described by Ross and colleagues (1962), this procedure involves manipulation of both drug 
(receive active/placebo) and expectation (told active/placebo) in a 2x2 design. An important and 
consistent finding of these studies is the belief that alcohol is administered irrespective of actual 
content results in subjective changes like increased craving as well as interactions with dose that 
impact reaction time and cognitive-behavioral task performance (Marlatt & Rohsenow, 1980; 
Testa et al., 2006). Similar independent or interactive effects involving expectancy have been 
observed across a variety of drugs and drug classes, including cannabinoids, stimulants, and 
opioids (e.g., Atlas et al., 2012; Lotshaw et al., 1996; Metrik et al., 2009, 2012; Ross et al., 1962). 


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Studies comparing full nicotine cigarettes to “denicotinized” cigarettes have generally found that 
cigarettes expected to have no nicotine have lower reinforcing effects and fewer positive 
subjective effects irrespective of dose (e.g., Darredeau et al., 2013; Kelemen & Kaighobadi, 2007; 
Perkins et al., 2004, 2008). Important to note is that in these studies, denicotinized cigarettes 
were Quest 3 brand, which contains trace nicotine (≤ 0.05 mg yield). Expectancy manipulations 
in nearly all studies, however, specified “no nicotine”. The single study to use a “low nicotine” 
expectancy (Perkins et al., 2004), explicitly framed those cigarettes as un-liked (i.e., “you will be 
smoking a low nicotine cigarette that is not well-liked”). Thus, existing data prohibit direct and 
unbiased evaluation of expected consumer responses to reduced-nicotine products as they are 
likely to appear in the marketplace upon an FDA mandate. 
Human laboratory work on reduced-nicotine cigarette pharmacodynamics has almost 
exclusively used blinded conditions, preventing systematic evaluation of expectancy and 
estimation of real-world response when these products would be unblinded in the marketplace. A 
small body of literature suggests that expectancy of low nicotine content can play a salient role. 
One crossover study found that participants in nicotine withdrawal that smoked blinded usual 
brand cigarettes labeled as “low” or “very low” nicotine reported less craving reduction compared 
to when labeled as “usual” (Mercincavage et al., 2016). Deeper puffs (i.e., mean puff volume) 
were also observed for the “usual” cigarette compared to the “low” cigarette in that study. Another 
study using blinded reduced-nicotine cigarettes found that participants reported lower positive 
subjective effects when labeled as “very low” nicotine relative to when labeled as “average” 
(Denlinger-Apte et al., 2017). To our knowledge, no laboratory studies on reduced-nicotine 
cigarettes have directly evaluated the interaction of expectancy (without an affective label) and 
pharmacological effects to determine the relative role of these behavioral mechanisms. Existing 
studies have also used an ad lib smoking exposure (e.g., “smoke as much as you want” in 
Denlinger-Apte et al., 2017) rather than a standardized exposure, which means that differences 
in the reported effects may be attributable to differential exposure across conditions. 
This human laboratory study will systematically determine the independent and interactive 
effects of expectancy and nicotine dose on reinforcing (behavioral economic demand), subjective, 
and topography outcomes. Participants (N=20) will complete 4 experimental sessions in which 
expectancy (labeling of “average” nicotine versus “very low” nicotine) and nicotine dose (15.8 
mg/g versus 0.4 mg/g) are manipulated as within-subject variables. Participants will sample a 
study cigarette of these combinations at the start of each session and complete craving, mood, 
withdrawal, and subjective drug effect measures before and after smoking. Smoking topography 
will also be collected during cigarette administration to determine if expectancy and dose impact 
how one smokes – one way that cognitive or pharmacological effects can impact smoking 
behavior. Demand will be evaluated with an incentivized demand task using experienced 
outcomes to improve experimental rigor. Behavioral economic demand analyses will differentiate 
between effects attributable to consumption of a good at no or little cost (“demand intensity”) and 
consumption following increases in cost (“demand elasticity”). 
 
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). 
 
General Overview 
Participants reporting current tobacco cigarette use will complete this double-blind, within-
subject laboratory study. Participation will require in-person screening and 5 laboratory sessions 
that will take over approximately 2 weeks. We plan to recruit up to 25 participants to fully complete 
the study and will enroll up to 32 participants to account for possible attrition. Potential volunteers 
will participate in a brief telephone screening after responding to posted advertisements (e.g., 
community postings, radio). Those meeting initial inclusion/exclusion criteria in telephone 


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screening will be scheduled for in-person screening at our research unit. Laboratory screening 
will include health history, drug history, and physical examination. Those passing full screening 
will participate in 1 practice session with procedures identical to experimental sessions but using 
the participant’s own-brand cigarette. This practice session will serve to acclimate the participant 
to the study procedures, account for practice effects, and provide data for exploratory 
comparisons with own-brand cigarette data. Following practice sessions, each participant will 
complete 4 experimental sessions in which nicotine content (15.8 mg/g versus 0.4 mg/g) and 
expectancy (participant instructed “average” versus “very low” nicotine; see details below) are 
manipulated as within-subject variables. The full combination of sessions will be 15.8 told 
average; 15.8 told low; 0.4 told average; 0.4 told low completed in a randomized order. 
 
Practice and Experimental Session Timeline 
Participants will complete 4 experimental sessions lasting about 4 hours. Upon arrival to the 
laboratory, carbon monoxide will be collected to verify 8-hour abstinence as indicated by a CO 
<50% of the value obtained a screening (e.g., Mercincavage et al., 2016). A battery of subjective 
effect measures will be collected prior to cigarette administration including the Minnesota Nicotine 
Withdrawal Scale (MNWS; Toll et al., 2007), the Questionnaire on Smoking Urges (QSU; Cox et 
al., 2001), and the Positive and Negative Affect Scale (PANAS; Watson et al., 1988) measuring 
nicotine withdrawal, cigarette craving, and mood, respectively. 
Participants will then smoke one of that session’s cigarette (15.8 mg/g or 0.4 mg/g). 
Participants will be instructed that this cigarette is either “the same level of nicotine as your usual 
brand” or “a very low level of nicotine compared to your usual brand” to harmonize with prior work 
on expectancy (Mercincavage et al., 2016). This manipulation will be necessary for the 
expectancy variable and success of the study protocol. A thorough debriefing about the study will 
occur at study completion or if a participant discontinues participation early. Dose will be double-
blind such that neither research staff nor participants know the dose. Expectancy will be single-
blind such that research staff who collect outcome assessments will not know the exposure 
participants receive (i.e., a separate member of research staff will deliver the manipulation). 
Participants will have 10 minutes to smoke the whole experimental cigarette. Topography will be 
collected including measures of total puff volume, mean puff volume, mean puff duration, mean 
inter-puff interval, mean maximum flow rate, and number of puffs using existing topography 
equipment. Subjective effect measures (MNWS, QSU, and PANAS) will be collected again 
following the 10-minute smoking period. Subjective effect measures about the experimental 
cigarettes will also be collected (i.e., 100-point visual analog scale drug effect measures such as 
“Strength” and “Satisfaction”). Physiological measures (e.g., CO) will be collected prior to and 
following cigarette administration. 
Participants 
will 
complete 
demand 
procedures 
following 
the 
standardized 
cigarette 
administration (see details below).. A three hour smoking period will follow demand task 
completion in which cigarette units purchased at a randomly selected price from the demand task 
are available to smoke. Topography will be collected during this time, but will not be directly 
compared across sessions due to differences in the number of cigarette units obtained across 
participants and sessions depending on demand task selections. Sessions will conclude after the 
3-hour period. Following completion of all experimental sessions (or earlier if participation is 
discontinued), participants will be debriefed about the study and experimental manipulations. Prior 
to debriefing, the validity of the expectancy blind and delivery will be assessed by asking 
participants what they believed the study purpose was. Participants will also be asked about the 
estimated nicotine content of cigarettes at the end of each session to evaluate validity of the 
manipulation.  
 
Description of Behavioral Economic Demand 


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An incentivized purchase task will be used to evaluate demand involving within-session 
incentivized consequences. The purchase task procedure is a well-validated experimental 
procedure with meta-analyses supporting concurrent validity (González-Roz et al., 2019) and 
sensitivity to experimental manipulations (Acuff et al., 2020). The current study will use a 
procedure with experienced consequences to improve rigor. Participants will receive a study 
income ($50 of the $100 session payment) to allocate for purchasing. Instructions will stipulate 
that one price will be randomly selected to be real–meaning that the cigarette units purchased at 
the selected price will be available to consume during a 3-hour period and money deducted from 
the total session payment. Instructions will stipulate that these will be the only cigarettes available 
during that time and that cigarettes cannot be stockpiled (i.e., will only be available for 
consumption in the laboratory). 
 
Study Cigarettes 
SPECTRUM research cigarettes (22nd Century Group, RTI, Clarence, NY) at doses of 15.8 
mg/g and 0.4 mg/g will be obtained from the NIDA drug supply program. The same cigarette 
paper, tipping paper, and dual plug (paper: acetone acetate) filters with a target pressure drop of 
81 mmH20 will be used. Doses were selected to approximate market nicotine levels (15.8 mg/g) 
and reduced-nicotine cigarettes recently authorized by the FDA for commercial sale (0.4 mg/g; 
Moonlight brand at 0.2-0.7 mg/g). 
 
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., urine specimens) 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 while COVID-19 pandemic restrictions are in place. 
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 have their temperature checked using a non-invasive procedure (e.g., 
forehead temperature reading) and asked about potential COVID-19 symptoms upon arrival to 
the laboratory. Any subjects who arrive with a temperate indicative of fever or 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. 
 
 
 
 
b. Study duration and number of study visits required of research participants. 
 
The total study duration will be approximately 2 weeks and requires 6 study visits (one screening 
visits, one practice session, and four experimental sessions). 
 


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c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
Participants will be instructed that this cigarette is either “the same level of nicotine as your 
usual brand” or “a very low level of nicotine compared to your usual brand” but blinded to actual 
nicotine content. This manipulation will be necessary for the expectancy variable and success of 
the study protocol. A thorough debriefing about the study will occur at study completion or if a 
participant discontinues participation early. Dose will be double-blind such that neither research 
staff nor participants know the dose. Expectancy will be double-blind such that research staff 
who collect outcome assessments will not know the exposure participants receive (i.e., a 
separate member of research staff will deliver the manipulation). 
 
d. Justification of why participants will not receive routine care or will have current 
therapy stopped. 
 
N/A. This study does not involve therapy. 
 
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.  
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 
• 
21 years or older (i.e., individuals under 21 may not legally purchase tobacco products). 
• 
Smoke five or more cigarettes per day for the past six months (e.g., Mercincavage et al., 
2016). 
• 
Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level of 
more than 8 ppm and a urinary cotinine level of more than 100 ng per milliliter at screening. 
 
General medical exclusion criteria: 
• 
Intention to quit smoking in the next 30 days (unethical to recruit treatment seeking 
participants). 
• 
Daily use of nicotine-containing products other than machine-manufactured combustible 
cigarettes. 
• 
Serious medical or psychiatric disorder precluding participation by study physician 
guidance. 
• 
Positive urine screening for illicit drugs other than cannabis or current substance use 
disorder (other than nicotine). Non-daily cannabis use will be allowed given increasing 
prevalence of cannabis use in the U.S. (Hasin, 2018). Exclusion of any cannabis use by 


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participants is considered a threat to external validity and inclusion of persons who use 
cannabis non-daily should not alter the risk profile of the study. 
• 
Women who are pregnant, plan to become pregnant, or are breast-feeding. 
• 
Medical contraindications to receiving tobacco products (e.g., cardiovascular disease) as 
assessed through a physical and self-report history. 
 
5. Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
The Family Smoking Prevention and Tobacco Control Act 2009 gave FDA authority to limit 
cigarette nicotine levels to reduce levels of nicotine dependence and therefore increase smoking 
cessation rates and decrease the overwhelming morbidity and mortality associated with smoking 
(Benowitz and Henningfield, 1994). Studies have suggested reduced nicotine cigarettes result in 
decreased nicotine intake (Benowitz et al. 2007; Donny et al., 2015) and decreased nicotine 
dependence (Donny et al., 2015). Doses were selected to approximate market nicotine levels 
(15.8 mg/g) and reduced-nicotine cigarettes recently authorized by the FDA for commercial sale 
(0.4 mg/g; Moonlight brand at 0.2-0.7 mg/g). Menthol or non-menthol cigarettes will be used 
based on participant typical brand. 
 
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. 
 
N/A 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
N/A 
 
6. Study Statistics 
a. Primary outcome variable. 
 
Behavioral economic demand curve metrics during each experimental session 
a. Q0 (demand intensity) 
b. α (demand elasticity) 
 
Demand tasks will be analyzed for derived and curve-observed measures. Derived measures 
include demand intensity (Q0; consumption at unconstrained price) and demand elasticity (a 
measure of sensitivity of consumption to changes in price) and will be computed using the 
exponential demand equation LogQ = Log Q0+k(e^(-α Q0C)-1) (Hursh & Silberberg, 2008). The 
independent variable C is cost (price/cigarette), the dependent variable Q is consumption 
(cigarettes purchased at a particular price), the scaling parameter k indicates the range of LogQ 
in the observed data. Free parameters are Q0 (demand intensity) and α (demand elasticity). 
Should zero-dense data be observed, a modified exponentiated form of the demand equation will 
be considered (Koffarnus et al., 2015; Strickland et al., 2016). Observed measures include Pmax 
(price at maximum consumption), Omax (maximum consumption), and breakpoint (Breakpoint-1; 
the price of last non-zero demand).  
 
b. Secondary outcome variables. Descriptions of Outcome Measures 
 


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Subjective Effect Measures 
Subjective effect measures will include a measure of nicotine withdrawal (MNWS), smoking 
craving (QSU), mood (PANAS), and cigarette subjective experience (Drug Effect Questionnaire). 
These measures will be collected upon arrival to the laboratory (i.e., immediately prior to cigarette 
administration) and following the 10-minute standardized smoking period. All measures will be 
scored using standard procedures. 
 
Smoking Topography 
Six measures of smoking topography will be collected including: total puff volume, mean puff 
volume, mean puff duration, mean inter-puff interval, mean maximum flow rate, and number of 
puffs (Higgins et al., 2018). These measures will be collected during the 10-minute standardized 
cigarette smoking period using a custom smoking topography system currently in use in our 
laboratory. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Primary Analysis: Low nicotine expectancy and low nicotine dose will result in lower demand 
with lowest demand in combination:  Demand variables will be computed and transformed if non-
normal (e.g., log-transform). Analyses will use a 2x2 repeated measures ANOVA with the within-
subject factors of expectancy (“average” and “very low”) and dose (15.8 mg/g and 0.4 mg/g). 
Hypothesis 1 will be supported by significant main effects indicating significantly lower demand 
under “very low” expectancy and 0.4 mg/g conditions. A significant interaction would also indicate 
different-than-additive effects of expectancy and dose. Such an interaction is plotted in Figure 3 
with hypothetical data of a greater reduction in demand intensity by nicotine content under the 
“very low” expectancy condition. 
 
Secondary Analysis: Low nicotine expectancy and low nicotine dose will result in lower positive 
subjective effects (H2) and lower puff volume (H3) with lowest values in combination. A 2x2 
ANOVA will also be used for puff topography and subjective effect measures with similar 
predictions as Hypothesis 1. Measures with pre- and post-cigarette administration measures will 
use a 2x2x2 ANOVA including a within-subject factor of time. We expect less reduction in 
withdrawal and craving with low nicotine expectancy and low nicotine dose indicated by significant 
interactions with time. 
 
Sample Size Justification: With respect to power, simulation of a 2x2 repeated measure ANOVA 
based on estimates from preliminary demand data (e.g., nicotine dose effect, SD) identified 82% 
power to detect a main effect under additive effects. More generally, the sample provides 80% 
power to detect a medium-large bivariate within-subject effects (dz = 0.66). This project is 
considered a pilot project and therefore we have focused on a feasible sample size to generate 
signals of the behavioral relevance for expectancy in reduced-nicotine policy to inform scientific 
rationale for future projects. These findings will also provide evidence for the feasibility of within-
session 
procedures 
with 
incentivized 
consequences 
for 
rapidly 
evaluating 
demand 
of 
experimental commodities, thereby serving as preliminary “proof-of-concept” data for a variety of 
proposals evaluating the reinforcing effects of novel experimental commodities. We will enroll up 
to 25 participants that complete the study to ensure that at least 20 provide fully systematic data 
on primary demand outcomes. 
 
d. Early stopping rules. 
 
Volunteers in this study may choose to stop study participation at any time. Participants who do 
not comply with study procedures, are not medically or psychiatrically suitable to continue, or 


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experience adverse effects from the study procedures may be discharged early from the study. 
Women who become pregnant will be discharged from the study. 
 
7. Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected 
frequency. 
 
The procedures employed in these studies are relatively benign. There are no specific risks 
related to the subject-rated effect assessments and other assessments. The primary risks to 
participants are those related to the well-established long-term health hazards of smoking 
cigarettes, as participants will be smoking cigarettes in the study. A main risk is that participants 
may experience side effects through minor withdrawal symptoms when asked to refrain from 
smoking prior to laboratory sessions. These side effects might include craving for cigarettes, 
nausea, headache, cough, or sore throat. These side effects would be temporary. 
 
Breach of confidentiality about self-reported drug use and biological tests indicating recent drug 
use is also a risk. 
 
Finally, full description about the intention of the study is a risk (i.e., participants will not be 
informed about the use of an expectancy manipulation). This is necessary for the valid and 
significantly rigorous study of expectation manipulations. It is possible that this may result in 
anger, confusion, or mistrust about the study, which will be mitigated through a complete 
debriefing upon completion of the study or end of participation (if participation is ended prior to 
completion). 
 
 
b. 
Steps taken to minimize the risks. 
 
Recruiting and Informed Consent. 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 media advertisements and posters 
that clearly state the study and procedures involved. The consent process will inform the 
participant in detail of the procedures, time involvement, compensation, risk, and benefits 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. Information will not be provided about the expectancy manipulation during the initial 
consent, but will be provided during a study debriefing. 
 
Debriefing: Following completion of the study or end of participation (if participation is ended prior 
to completion) participants will receive a full debriefing about the study and use of the expectancy 
manipulation. The primary goal of this debriefing process will be to inform the participants about 
the true goal of the study and remove any effects of false information. The overarching goal of 
this process is to make sure that participants feel they were an important part of the research 
process and that their participation was valued. Participants will be given a simple, clear and 
informative explanation of the rationale for the design of the study and the methods used, and 
participants will also have the opportunity to ask questions. The study PI will conduct all debriefing 
sessions to ensure that participants are comprehensively informed and all questions answered. 
 


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Source of Cigarettes. SPECTRUM research cigarettes at doses of 15.8 mg/g and 0.4 mg/g will 
be obtained from the NIDA drug supply program. The same cigarette paper, tipping paper, and 
dual plug (paper: acetone acetate) filters with a target pressure drop of 81 mmH20 will be used. 
 
Cigarettes Administration Side Effects. It is unlikely that any adverse event should arise that 
requires medical or psychiatric treatment. In the case that any adverse effects do occur, 
participants will be put in contact with medical/nursing staff. Because participants will have an 
established history of cigarette smoking, the well-known long-term harmful effects of smoking will 
not constitute a new risk for participants. The medical and nursing staff at BPRU is trained in CPR 
and mobile emergency crash carts on the same floor of our research unit in which sessions will 
occur. In any case in which a participant ceases study participation due to experimental cigarette 
side effects the PI will make a detailed report to the IRB. Research assistants at BPRU are 
rigorously trained in conducting and monitoring behavioral pharmacology experiments. Expired 
air samples will be collected to test for the presence of alcohol (indicating current impairment), 
and sessions will not be conducted unless blood alcohol concentration is 0.00%. 
 
Confidentiality. 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. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
The investigators will report adverse events to the IRB according to the Johns Hopkins and 
federal guidelines. 
 
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. 
 
8. Benefits 
a. Description of the probable benefits for the participant and for society. 
 
There is no direct benefit for participants in this study other than financial compensation. Evidence 
suggests that reduced-nicotine cigarettes may reduce the immense mortality associated with 
tobacco cigarette use. The goal of this project is to experimentally evaluate how expectations 
about reduced-nicotine cigarettes as well as actual nicotine content interact to determine 
behavioral and subjective response for these novel products. The proposed project can directly 
inform tobacco regulatory efforts by providing information about how consumers may respond to 
reduced-nicotine cigarettes and identify targets to optimize public health campaigns and policies 
concerning these product’s use. This study will therefore develop and provide clinically meaningful 
data on the effects of cigarette expectancy and dose on smoking behavior. Ultimately, completion 
of this project will increase our understanding of demand for reduced nicotine cigarettes and will 
directly inform FDA policy. 
 


JHMIRB eFormA 01 
Version 3 Dated: 06/2007 
 
Page 12 of 14 
9. 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. 
 
Participants will be monetarily compensated for participation in this study. Participants will receive 
$30 for completing the screening session. Participants will receive up to $100 for each study 
session ($50 session payment + $50 experimental income for the demand task). Participants can 
therefore make up to $530 for completion of the full study. 
 
10. 
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 trial. 
 
 


JHMIRB eFormA 01 
Version 3 Dated: 06/2007 
 
Page 13 of 14 
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manipulations of behavioral economic demand for addictive commodities: a meta-analysis. 
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2012. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking 
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al'Absi, M., Carmella, S.G., Cinciripini, P.M., Dermody, S.S., Drobes, D.J., Hecht, S.S., 
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González-Roz, A., Jackson, J., Murphy, C., Rohsenow, D.J., MacKillop, J., 2019. Behavioral 
economic tobacco demand in relation to cigarette consumption and nicotine dependence: a 
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Hasin, D.S., 2018. US epidemiology of cannabis use and associated problems. 
Neuropsychopharmacology 43(1), 195-212. PMCID: PMC5719106 
Hatsukami, D.K., Kotlyar, M., Hertsgaard, L.A., Zhang, Y., Carmella, S.G., Jensen, J.A., Allen, 
S.S., Shields, P.G., Murphy, S.E., Stepanov, I., Hecht, S.S., 2010. Reduced nicotine 
content cigarettes: effects on toxicant exposure, dependence and cessation. Addiction 
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Hatsukami, D.K., Luo, X., Jensen, J.A., al'Absi, M., Allen, S.S., Carmella, S.G., Chen, M., 
Cinciripini, P.M., Denlinger-Apte, R., Drobes, D.J., Koopmeiners, J.S., Lane, T., Le, C.T., 
Leischow, S., Luo, K., McClernon, F.J., Murphy, S.E., Paiano, V., Robinson, J.D., 
Severson, H., Sipe, C., Strasser, A.A., Strayer, L.G., Tang, M.K., Vandrey, R., Hecht, S.S., 
Benowitz, N.L., Donny, E.C., 2018. Effect of immediate vs gradual reduction in nicotine 
content of cigarettes on biomarkers of smoke exposure: a randomized clinical trial. JAMA 
320(9), 880-891. PMCID: PMC6372240. 
Hursh, S.R., Silberberg, A., 2008. Economic demand and essential value. Psychological Review 
115(1), 186-198. 


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Kelemen, W.L., Kaighobadi, F., 2007. Expectancy and pharmacology influence the subjective 
effects of nicotine in a balanced-placebo design. Experimental and Clinical 
Psychopharmacology 15(1), 93-101. PMCID: PMC2239264. 
Koffarnus, M.N., Franck, C.T., Stein, J.S., Bickel, W.K., 2015. A modified exponential behavioral 
economic demand model to better describe consumption data. Experimental and Clinical 
Psychopharmacology 23(6), 504-512. PMCID: PMC4854291. 
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expectancy effects utilizing a balanced placebo design. Journal of Drug Education 26(1), 
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content expectancies affect initial responses to smoking. Tobacco Regulatory Science 2(4), 
309-316. PMCID: PMC5129840. 
Metrik, J., Kahler, C.W., Reynolds, B., McGeary, J.E., Monti, P.M., Haney, M., de Wit, H., 
Rohsenow, D.J., 2012. Balanced placebo design with marijuana: pharmacological and 
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499. PMCID: PMC3829473. 
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C.W., 2009. Effectiveness of a marijuana expectancy manipulation: piloting the balanced-
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Perkins, K.A., Ciccocioppo, M., Conklin, C.A., Milanak, M.E., Grottenthaler, A., Sayette, M.A., 
2008. Mood influences on acute smoking responses are independent of nicotine intake and 
dose expectancy. Journal of Abnormal Psychology 117(1), 79-93. 
Perkins, K.A., Jacobs, L., Ciccocioppo, M., Conklin, C., Sayette, M., Caggiula, A., 2004. The 
influence of instructions and nicotine dose on the subjective and reinforcing effects of 
smoking. Experimental and Clinical Psychopharmacology 12(2), 91-101. 
Robinson, J.D., Drobes, D.J., Brandon, T.H., Wetter, D.W., Cinciripini, P.M., 2016. Evaluating 
point of sale tobacco marketing using behavioral laboratory methods. Tobacco Regulatory 
Science 2(4), 414-425. PMCID: PMC6019317. 
Rohsenow, D.J., Marlatt, G.A., 1981. The balanced placebo design: methodological 
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Strickland, J.C., Lile, J.A., Rush, C.R., Stoops, W.W., 2016. Comparing exponential and 
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Saenz, C., Buck, P.O., Zawacki, T., Parkhill, M.R., Jacques, A.J., Hayman, L.W., Jr., 2006. 
Understanding alcohol expectancy effects: revisiting the placebo condition. Alcoholism: 
Clinical and Experimental Research 30(2), 339-348. PMCID: PMC1403295. 
Toll, B.A., O'Malley, S.S., McKee, S.A., Salovey, P., Krishnan-Sarin, S., 2007. Confirmatory 
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ICF_001.pdf: 
 
Reduced Nicotine Cigarette Purchasing 
Decisions 
NCT04999644
Last Updated 11/22/2021
Page 1 of 12
Combined Parental Permission/Informed Consent/Authorization December 2018 Version 16


COMBINED RESEARCH PARTICIPANT INFORMED CONSENT
AND PRIVACY AUTHORIZATION FORM
Protocol Title:
Application No.:
Funded By:
Principal Investigator:
Reduced Nicotine Cigarette Purchasing Decisions
IRB00288837
National Institutes of Health (NIH)
Justin C. Strickland, PhD
5510 Nathan Shock Drive
Baltimore, MD 21224
Phone 410-550-1975
Fax: 410-550-0030
You are being asked to join a research study. Participation in this study is voluntary. Even if you decide
to join now, you can change your mind later
1.
Research Summary (Key Information):
The information in this section is intended to be an introduction to the study only. Complete details of
the study are listed in the sections below. If you are considering participation in the study, the entire
document should be discussed with you before you make your final decision. You can ask questions
about the study now and at any time in the future.
This research is being done to understand how people like cigarettes with differing nicotine amounts,
compared to cigarettes with standard amounts, and how people make decisions about smoking. In this
study, there is 1 screening session and 5 laboratory sessions. During the screening session, you will be
asked questions about your health and medication use, provide a urine sample, and undergo a breath test
and physical exam. If you are eligible to continue in the study after the screening visit, you will be asked
not to smoke for at least 6 hours before laboratory sessions which each last about 4 hours. During the
laboratory sessions, you will be asked to provide a urine sample, undergo a breath test, sample cigarettes
that differ in nicotine content, and complete tasks on the computer. We hope that the results of this study
may help us to understand factors that contribute to cigarette smoking.
Taken together, study participation is expected to last about 2 weeks. There are risks to this study that
are described in detail later in this document. The primary risks are related to potential side effects and
adverse effects after smoking cigarettes and experiencing tobacco withdrawal symptoms. There is no
benefit or cost to you for taking part in this study. You may earn up to $530 for completing the study.
2.
Why is this research being done?
This research is being done to understand how people like different types of cigarettes that vary in the
amount of nicotine and how people make decisions about smoking different cigarettes. We hope that the
results of this study may help us to understand factors that contribute to cigarette smoking.
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Are there any investigational drugs/devices/procedures?
The cigarettes being evaluated in this study are investigational tobacco products. The word
“investigational” means these investigational tobacco products cigarettes have not been authorized for
marketing by the Food and Drug Administration (FDA). The FDA Center for Tobacco Products is
allowing the use of these investigational tobacco products in this study.
Who can join this study?
People who smoke tobacco cigarettes and are older than 21 may join.
3.
What will happen if you join this study?
If you agree to be in this study, we will ask you to do the following things:
The study is organized so that you will complete it in the following order:
1.) 1 screening session
2.) 1 practice session
3.) 4 experimental sessions
First, you will complete Screening to see if you are able to continue to take part in this study. For
screening, you will be asked to:
o Complete questionnaires and interviews about your mental health history, your health
history, and drug use history
o Provide a breath sample
o Provide a urine sample
o You may undergo a pregnancy test if you are a woman capable of becoming pregnant
o Have a physical examination
The screening should take about 3 hours
If after screening, you are eligible and agree to continue to take part, you will be scheduled to come to
the laboratory at the Behavioral Pharmacology Research Unit (BPRU) for 1 practice session and 4
“experimental” sessions lasting about 4 hours each.
During these practice and experimental sessions, you will be instructed on how to complete the various
study measures and use the cigarettes. You will be asked to not smoke for 6 hours or more before the
beginning of each brand sampling and experimental sessions. We will collect a breath sample to
measure carbon monoxide, which is an indicator of how much you have smoked recently.
During the practice sessions, you will be asked to smoke cigarettes from your preferred brand that we
(the study team) purchase. You will be free to smoke the cigarettes in any manner you choose during
these sessions so long as you smoke the cigarettes through the small cigarette holder connected to our
existing computer equipment. You will also be introduced to how to complete the measures we will
collect in the study.
During the experimental sessions, you will be asked to smoke cigarettes that we (the study team) are
interested in. These cigarettes will vary in the amount of nicotine they have and we will tell you about
what the nicotine content is relative to the “average” nicotine in each session. However, you and the
study team will not know the specific amount of nicotine in the cigarette. In the case of an emergency,
the study doctor can quickly find out the amount of nicotine. You will also be free to smoke these
cigarettes in any manner you choose during these sessions so long as you smoke the cigarettes through
the small cigarette holder connected to our existing computer equipment. You will complete measures
on the computer during these sessions.
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During all sessions, you will first sample that day’s cigarette that is available. Then you will be provided
with money ($50) that you may use to purchase cigarettes of that type to smoke later in your session.
You may choose to use any, some, or none of this money. Whatever money you do not use will be
added to your session payment.
During all sessions, you will be allowed to read magazines, but you will not be allowed to use your cell
phone or read or work on other materials including work or schoolwork. For this reason, if you have a
cell phone on you it will be stored in a secure and locked location during the sessions.
If an unforeseen issue arises during session (such as a fire alarm or technical difficulties), you may be
asked to repeat a session.
You will also be asked to complete questionnaires and computer tasks, and answer questions about how
you like the cigarettes, cravings and withdrawal symptoms.
Listed below are details about the study tests and procedures that will be done.
o
You will be asked to provide a urine sample and breath samples at the beginning of each visit.
You must not be under the influence of alcohol or any drugs on the days of your study visits.
Otherwise your session will be rescheduled and you will not be paid for the session. Repeated
instances may result in ending your study participation and loss of bonus payment. Breath
samples will test for alcohol and for carbon monoxide, an indicator of recent smoking.
§ You will need to not smoke for 6 hours or more before the beginning of each practice
and experimental session. Whether you have not smoked for long enough will be
determined by a breath sample that measures carbon monoxide, which is an indicator
of how much you have smoked recently. Your carbon monoxide level will need to
equal or be lower than a specific level which will be determined for you based on
individual factors. Some people may take longer than 6 hours to reach this level, for
example 8 or 10 hours. The requirement is that you meet your target carbon
monoxide level, regardless of the time it takes to abstain from smoking to meet this
target. If you do exceed your target level when reporting for a session, we will
reschedule your session for another day and you will not be paid for that session. If
this happens repeatedly we may take you out of the study.
o
Pregnancy Testing: Pregnancy testing will be repeated before the start of smoking
administration sessions (all laboratory sessions in which cigarettes are available).
o
Questionnaires: Some questions will ask you about smoking behaviors, how you like the
cigarettes, and craving, and withdrawal. For example, you will be asked “Do you like the
cigarette?”, “Does the cigarette have any good effects?” Other questions will ask how many
cigarettes you have smoked recently.
o
Please maintain your normal schedule during the study, for example, be sure to get the amount of
sleep you are used to.
o
If you regularly drink caffeine-containing beverages like coffee, tea, or soda in the morning,
please continue to do so throughout the study.
o
You will be asked to wear a properly fitting surgical grade face mask to reduce COVID-19
transmission risk while in the laboratory area and while interacting with study staff. If you do not
have a mask, we will provide one to you at no cost.
Will research test results be shared with you?
This study involves research tests that we do not expect will be useful for your clinical care. We will not
share these results with you.
How long will you be in the study?
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You will be in the study for one screening session (about 3 hours), 1 practice session (about 4 hours
each), and 4 experimental sessions (about 4 hours each). Depending on your availability the expected
duration of this study will be about 2 weeks, but may be less or more considering scheduling.
4.
What happens to data and biospecimens that are collected in the study?
If you join this study, your data and biospecimens will be used to answer the research question and your
data will be used to publish the findings of this study. Biospecimens may include any of the following:
blood, tissue, saliva, urine, bone marrow, cells, etc. Most biospecimens contain DNA, which is the
genetic code for each person.
You will not own the data and/or biospecimens collected from you as part of this research study. If
researchers use them to create a new product or idea, including those that may have commercial value,
you will not benefit financially from those efforts.
Johns Hopkins researchers and their collaborators may use the data/biospecimens collected in this study
for future research purposes and may share some of the data/biospecimens with others.
Because science constantly advances, we do not yet know what future use of research data or
biospecimens may include. This future research may be unrelated to the current study and may include
outside collaborators.
Sharing data and/or biospecimens is part of research and may increase what we can learn from this
study. Often, data/biospecimen sharing is required as a condition of funding or for publishing study
results. It also is needed to allow other researchers to validate study findings and to come up with new
ideas. Your data and/or biospecimens may be shared with researchers at Johns Hopkins and other
institutions, for-profit companies, sponsors, government agencies, and other research partners. Your data
and/or biospecimens may also be put in government or other databases/repositories.
We (Johns Hopkins) will do our best to protect and maintain your data/biospecimens in a safe way. One
of the ways we protect data/biospecimens is by limiting the uses of the information and the type of
information that is shared, especially your personal information. This may occur through data/specimen
sharing agreements and review by oversight groups within Johns Hopkins.
If data/biospecimens are used or shared with types of information that may be likely to identify, you
such as your name, address or medical record number, further institutional review and approval would
be required. In these cases, Johns Hopkins will review whether additional consent from you is required.
Generally, if your data/biospecimens are used/shared without any personal identifiers or with
information that is less likely to identify you (such as the date of a procedure), further review and
approval is not needed.
Data/biospecimen sharing could change over time, and may continue after the study ends.
The use and sharing of your data and biospecimens is required for participation in this research study. If
you are not comfortable with the use and sharing of your data/biospecimens in future research without
further consent, you should not participate in this study.
5.
What are the risks or discomforts of the study?
Cigarettes
It is unlikely, but there may be some potential side effects and adverse effects after smoking any
cigarette. After puffing a cigarette, you may experience side effects from exposure to the cigarettes.
Before or during sessions, you may experience tobacco withdrawal symptoms which may be unpleasant.
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Taking cigarette exposure and/or withdrawal into account, these side effects could include dizziness,
nausea, headache, cough, sore throat, increased heart rate, and increased blood pressure. Side-effects of
the cigarettes would be temporary.
Interviews and questionnaires
You may get tired or bored when we are asking you questions or you are completing questionnaires.
You do not have to answer any question you do not want to answer. Questions about sensitive issues
(such as alcohol use, illegal drug use, and your mood) could make you feel uncomfortable and lead to
feelings such as anxiety, distress, sadness, or embarrassment.
Identifiable private information
There is the risk that information about you may become known to people outside this study. This study
involves the collection of sensitive data (including drug testing and diagnosis of disease). Steps are taken
to protect your confidentiality as outlined below, but a breach of confidentiality could be embarrassing,
or even affect employment.
There is a very small risk that someone could get access to the data we have stored about you. If those
data suggest something serious about your health, it could be misused. For example, it could be used to
make it harder for you to get or keep a job or insurance. There are laws against this type of misuse, but
they may not give full protection. There may be risks related to the storage of information that we do not
yet know. There is a very small chance that there could be a computer security breach when data is kept
electronically. But computers used in this study are password protected with limited access.
COVID-19
There is a possibility that participation in this research may increase your risk of COVID-19
transmission. Several procedures have been put into place to minimize this risk including the
requirement that you wear a mask at all times while interacting with study staff or in the shared
laboratory space, limiting the amount of person-to-person interactions you may have, and monitoring
COVID-19 symptoms among all study participants.
6.
Are there risks related to pregnancy?
If you are pregnant or become pregnant, you will not be able to take part in this study. If you think you
might be pregnant, you will not be able to be in the study. Cigarette smoking during pregnancy has been
found to increase the risk of premature birth and stillbirth, and reduced growth of the fetal brain, lungs
and kidneys. Cigarette smoking during pregnancy is also associated with lower birth weights and can
negatively impact fetal circulation. By signing this consent form you are also agreeing to practice an
effective means of birth control if you are having sex over the course of the study.
7.
Are there benefits to being in the study?
There is no direct benefit to you from being in this study. If you take part in this study, you may help
others in the future through the knowledge gained from this study.
8.
What are your options if you do not want to be in the study?
You do not have to join this study. If you do not join, your care at Johns Hopkins will not be affected.
9.
Will it cost you anything to be in this study?
No.
10.
Will you be paid if you join this study?
You will be paid $30 for completing the in-person screening, which takes about 3 hours.
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If you are found to be eligible, you will be asked to return to the laboratory for 1 practice session (lasting
about 4 hours each) for which you will be paid $50. Then, you will be asked to come to the laboratory
for 4 experimental sessions (lasting about 4 hours each) for which you will be paid $50 each. You will
receive an additional $50 experimental income during each session that you may use any, some, or none
of. Any money that you do not use will be added to your session payment.
We ask that you follow directions during experimental sessions. If we end your participation for no fault
of yours, before study completion, you will receive payment for the sessions completed.
Total compensation for completing the study is up to $530.
You may be required to provide your social security number to be paid for taking part in this study.
Federal tax law requires that you report your research payments when you file your taxes. If your total
payments from Johns Hopkins exceed $600 per year, Johns Hopkins will report these payments to the
Internal Revenue Service and you will receive a 1099-MISC form from us.
11.
Can you leave the study early?
·
You can agree to be in the study now and change your mind later.
·
If you wish to stop, please tell us right away.
·
Leaving this study early will not stop you from getting regular medical care.
If you leave the study early, Johns Hopkins may use or share your health information that it has already
collected if the information is needed for this study or any follow-up activities.
12.
Why might we take you out of the study early?
You may be taken out of the study if:
·
Staying in the study would be harmful.
·
You need treatment not allowed in the study.
·
You fail to follow instructions.
·     You become pregnant.
·     The study is cancelled.
·
There may be other reasons to take you out of the study that we do not know at this time.
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it
has already collected if the information is needed for this study or any follow-up activities.
13.
 How will your privacy be maintained and how will the confidentiality of your data
be protected?
HIPAA Authorization for Disclosure of Protected Health Information
What information is being collected, used, or shared?
To do this research, we will need to collect, use, and share your private health information. By signing
this document, you agree that your health care providers (including both Johns Hopkins Medicine and
others) may release your private health information to us, and that we may use any and all of your
information that the study team believes it needs to conduct the study. Your private information may
include things learned from the procedures described in this consent form, as well as information from
your medical record (which may include information such as HIV status, drug, alcohol or STD
treatment, genetic test results, or mental health treatment).
Who will see, use or share the information?
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The people who may request, receive, or use your private health information include the researchers and
their staff who may be a part of Johns Hopkins Health System, Johns Hopkins University or the Johns
Hopkins Applied Physics Laboratory. Additionally, we may share your information with other people at
Johns Hopkins, for example if needed for your clinical care or study oversight. To improve coordination
of your research and clinical care, some information about the study you join will be included in your
electronic medical record.
By signing this form, you give permission to the research team to share your information with others
outside of Johns Hopkins. This may include the sponsor of the study and its agents or contractors,
outside providers, study safety monitors, government agencies, other sites in the study, data managers
and other agents and contractors used by the study team.
We try to make sure that everyone who sees your information keeps it confidential, but we cannot
guarantee that your information will not be shared with others. If your information is disclosed by your
health care providers or the research team to others, federal and state confidentiality laws may no longer
protect it.
Do you have to sign this Authorization?
You do not have to sign this Authorization, but if you do not, you may not join the study.
How long will your information be used or shared?
Your Authorization for the collection, use, and sharing of your information does not expire.
Additionally, you agree that your information may be used for similar or related future research studies.
What if you change your mind?
You may change your mind and cancel this Authorization at any time. If you cancel, you must contact
the Principal Investigator in writing to let them know by using the contact information provided in this
consent form. Your cancellation will not affect information already collected in the study, or information
that has already been shared with others before you cancelled your authorization.
How will your information be protected?
Any paper copies of your study information, including this Informed Consent Form and study lab
reports, will be stored securely. Paper copies will be kept and destroyed according to FDA requirements.
We might talk about this research study at meetings. We might also publish the results of this research
study in relevant journals. You will not be identified in any publication or in the sharing of your data
about this study. We will always keep the names of the research participants, like you, private. After the
study is completed, the data may be placed in a central storage location and stored indefinitely. These
data will not include your name or other information that can identify you. The purpose is to make study
data available to other researchers.
14.
 Will the study require any of your other health care providers to share your health
information with the researchers of this study?
As a part of this study, the researchers may ask to see your health care records from your other health
care providers.
15.
What is a Certificate of Confidentiality?
Your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in
some cases, to refuse to give out your information even if requested using legal means.
It does not protect information that we have to report by law, such as child abuse or some infectious
diseases. The Certificate does not prevent us from disclosing your information if we learn of possible
harm to yourself or others, or if you need medical help.
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Disclosures that you consent to in this document are not protected. This includes putting research data in
the medical record or sharing research data for this study or future research. Disclosures that you make
yourself are also not protected.
16.
What treatment costs will be paid if you are injured in this study?
Johns Hopkins and the federal government do not have programs to pay you if you are hurt or have
other bad results from being in the study. However, medical care at Johns Hopkins is open to you as it
is to all sick or injured people.
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not
covered by a health insurer will be billed to you.
By signing this form you will not give up any rights you have to seek compensation for injury.
17.
What other things should you know about this research study?
During the study, we will tell you if we learn any new information that might affect whether you wish to
continue to participate.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
Law. This Web site will not include information that can identify you. At most, the Web site will
include a summary of the results. You can search this Web site at any time. If you would like to review
the information for this study, or a summary of the results, ask the study team doctor for the
ClinicalTrials.gov study registration number.
During this study, you will not have access to certain medical information and test results collected for
study purposes. If an emergency occurs while you are in the study, medical information needed for your
treatment can be made available to your study doctor and other physicians who treat you. When the
study is completed, all the information in your medical record will be available to you.
What is the Institutional Review Board (IRB) and how does it protect you?
This study has been reviewed by an Institutional Review Board (IRB), a group of people that reviews
human research studies. The IRB can help you if you have questions about your rights as a research
participant or if you have other questions, concerns or complaints about this research study. You may
contact the IRB at 410-502-2092 or jhmeirb@jhmi.edu.
What should you do if you have questions about the study, or are injured or ill as a result of being
in this study?
Call the principal investigator, Justin Strickland at 410-550-1975. If you wish, you may contact the
principal investigator by letter. The address is on page one of this consent form. If you cannot reach the
principal investigator or wish to talk to someone else, call the IRB office at 410-502-2092.
If you have an urgent medical problem or think you are injured or ill because of this study, call 911 or
go to your local emergency department. You should also call the BPRU nursing desk at (410) 550-0052
during regular office hours and at (443) 857-5738 after hours and on weekends.
18.
Optional Study Components:
This part of the consent form is about optional component(s) of the study that you can choose to take
part in or not. You can still take part in the main study even if you say “no” to this/these optional
component(s).
Future Contact
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We would like your permission for our research team to contact you in the future. Please note that your
decision below does not prevent other researchers at Johns Hopkins from contacting you about other
research.
Please sign and date your choice below:
YES   ________________________
Signature of Participant
______________
Date
NO   ________________________
Signature of Participant
______________
Date
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19.
What does your signature on this consent form mean?
Your signature on this form means that you have reviewed the information in this form, you have had a
chance to ask questions, and you agree to join the study. You will not give up any legal rights by signing
this consent form.
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM
____________________________________________________________________________________________________________
Signature of Participant
(Print Name)
Date/Time
____________________________________________________________________________________________________________
Signature of Person Obtaining Consent
(Print Name)
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY
MUST BE GIVEN TO THE PARTICIPANT. IF APPROPRIATE FOR THIS STUDY, A SCANNED COPY OF THE SIGNED CONSENT
FORM SHOULD BE UPLOADED TO THE PARTICIPANT’S EPIC/EMR RECORD (UNLESS NO MEDICAL RECORD EXISTS OR
WILL BE CREATED).
DOCUMENTATION OF PHYSICIAN/MID-LEVEL PROVIDER CONSENT PROCESS
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My signature below indicates that I have discussed the risks, benefits, and alternatives, answered any
questions, and believe the participant is able to make an informed choice to join the study.
__________________________________________________________________________________________
Signature of Physician/Mid-Level Provider
(Print Name)
Date/Time
__________________________________________________________________________________________
Signature of Participant
(Print Name)
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR AND A COPY
MUST BE GIVEN TO THE PARTICIPANT. IF APPROPRIATE FOR THIS STUDY, A SCANNED COPY OF THE SIGNED CONSENT
FORM SHOULD BE UPLOADED TO THE PARTICIPANT’S EPIC/EMR RECORD (UNLESS NO MEDICAL RECORD EXISTS OR
WILL BE CREATED).
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