Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value
Phase: NA
Conditions: Alcohol Use Disorder, Alcohol Drinking
Sponsor: McMaster University

HiREB Project #7458 
 
Protocol Version 1.6 
PI: Michael Amlung, PhD 
LPI: James MacKillop, PhD 
 
 
 
 
 
             Date 22 FEB 2023 
 
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Study Protocol 
 
Study Title: 
 
 
Brain Responses to Environmental Influences on Drinking Decisions 
 
HiREB Project #: 
 
7458 
 
ClinicalTrials.gov: 
NCT04067765 
 
Principal Investigator:  
Dr. Michael Amlung 
Department of Applied Behavioral Science and Cofrin Logan Center for 
Addiction Research and Treatment, University of Kansas, Lawrence, KS 
66045 
Email: mamlung@ku.edu  
Phone: 785-864-6148 
 
Local Principal Investigator: Dr. James MacKillop 
Department of Psychiatry & Behavioural Neurosciences, McMaster 
University; 
Peter Boris Centre for Addictions Research, St. Joseph's Healthcare 
Hamilton, Hamilton, ON L8N 3K7 
Email: jmackill@mcmaster.ca 
Phone: 905-552-1155, x39492 
  
Study Location: 
 
Peter Boris Centre for Addictions Research 
 
 
 
 
St. Joseph’s Healthcare Hamilton West 5th Site 
 
 
Funding Source: 
 
National Institutes of Health (USA) 
 
 
 
 
Peter Boris Centre for Addictions Research  
 
 

HiREB Project #7458 
 
Protocol Version 1.6 
PI: Michael Amlung, PhD 
LPI: James MacKillop, PhD 
 
 
 
 
 
             Date 22 FEB 2023 
 
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I. 
Lay Project Summary 
Alcohol use disorder is a major public health issue and development of novel treatments and 
improved screening/diagnostic measures depends on advances in understanding the intersection 
between brain and behaviour in this disorder. This study uses techniques from an area of research known 
as neuroeconomics, which integrates concepts and methods from psychology, neuroscience, and 
economics to better understand how people make decisions and how these decisions are supported by 
the brain. One neuroeconomic concept that is especially relevant in the area of addictions is substance 
demand, or how consumption of a commodity (e.g., alcohol, tobacco, or drugs) is influenced by price and 
other factors. Previous studies have shown that alcohol demand is related to severity of alcohol misuse, 
drinking quantity/frequency, and treatment outcomes. In addition, we know that alcohol demand can also 
fluctuate in response to environmental cues such as alcohol-related stimuli (e.g., people report wanting 
to consume more alcohol and placing higher value on alcohol when in the presence of alcohol-related 
beverage cues relative to non-alcoholic beverage cues). This increase in consumption and value is 
clinically significant because it helps us understand how people with alcohol use disorders are negatively 
impacted by environmental stimuli related to drinking and how this prompts increases in craving and 
motivation to drink.  
What remains unclear, however, is how the brain responds in these situations and whether these 
responses differ as a function of severity of alcohol misuse. Therefore, this study will use functional 
magnetic resonance imaging (fMRI) to understand brain activity patterns associated with changes in the 
value of alcohol in the presence of alcohol-related beverage cues relative to neutral-related beverage 
cues. Participants will be non-treatment-seeking adult heavy drinkers who are recruited from the 
community to participate in two testing sessions at St. Joseph’s Healthcare Hamilton: 1) a baseline 
eligibility screening session and 2) an fMRI scan at the Imaging Research Centre. During the fMRI scan, 
participants will make decisions about how many alcohol beverages they would consume (hypothetically) 
at various prices while their brain activity during those decisions is measured. The experimental 
manipulation involves an in-scanner alcohol cue exposure task in which the drinking decisions will be 
made after viewing high-quality images of alcoholic (beer/wine/liquor) beverages or neutral 
(water/juice/soft drinks) beverages. This project has important clinical implications. Determining the 
neural signatures of change in alcohol demand in response to these real-world external influences has 
high potential to increase our understanding of how the brain supports decisions to control drinking (or 
inability to control drinking) in real-world drinking situations. 
 
II. 
Background and Rationale 
Neuroeconomics integrates principles from psychology, economics, and cognitive neuroscience to 
understand the neurobiology of decision making1–3. In alcohol research, neuroeconomics has unique 
potential to increase the ecological validity of functional neuroimaging by investigating cost-benefit 
decisions related to alcohol use disorder4–6. Our group has recently validated a novel functional MRI 
paradigm for measuring a behavioral economic index of reinforcing value of alcohol known as alcohol 
demand7. This refers to the process of making choices about alcohol consumption across a range of 
prices, in order to characterize both trait and state-based variation in alcohol value.  
From a behavioral economic perspective, pathological motivation for alcohol reflects both generally 
high reinforcing value and acute phasic (or state-based) changes in alcohol value. These changes include 
increases resulting from potent environmental triggers, such as alcohol cues. In general terms, the 
working hypothesis is that individuals who are experiencing problems with alcohol may have difficulties 
refraining from or reducing their drinking when they encounter personally-relevant alcohol cues, such as 
their preferred drink or driving past a bar or liquor store. This change in motivation is captured on 
hypothetical alcohol purchase tasks in laboratory studies, whereby people report wanting to consume 
greater amounts of alcohol and are willing to spend more money on alcohol when they are in the presence 
of alcohol cues relative to neutral cues. Prior research has supported this hypothesis, including studies 
showing that demand is increased following exposure to alcohol cues in a simulated bar laboratory, or 
consumption of alcoholic beverages in a self-administration paradigm 8–10.  

HiREB Project #7458 
 
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LPI: James MacKillop, PhD 
 
 
 
 
 
             Date 22 FEB 2023 
 
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Despite increasing evidence from the behavioural literature suggesting that alcohol value 
dynamically increases in the presence of personally-relevant alcohol cues, how the brain responds in 
these situations remains unclear. Therefore, an important question is how do the brain processes 
supporting alcohol-related decisions change when people are making those choices in the presence of 
potent alcohol-related stimuli compared to when the choices are made under neutral conditions. Our 
group has validated a neuroeconomic task to measure brain activity related to alcohol demand 
decisions11.  Our previous study using this task revealed significant neural activation in regions implicated 
in reward salience (ventral striatum), interoception/subjective desire (anterior insula), subjective 
awareness (posterior cingulate), conflict monitoring (anterior cingulate), and executive control 
(dorsolateral prefrontal cortex) in male heavy drinkers.  
The current study will extend these initial findings by examining the neural correlates of changes in 
alcohol demand via an experimental manipulation that models motivational factors in real-world drinking 
decisions. We hypothesize that acute increases in alcohol value will be subserved by changes in areas 
associated with reward salience, interoceptive processing, and perceived value. Furthermore, the 
proposed studies will include both males and females allowing for systematic examination of sex 
differences. Finally, the study will examine whether severity of alcohol misuse moderates behavioural 
and neural responses to the alcohol cues.  
 
III. 
Purpose 
The core scientific purpose of this project is to use our novel fMRI paradigm to investigate the neural 
correlates of increases in alcohol demand resulting from exposure to alcohol cues. The specific aims are 
as follows:  
Primary Aim #1: Characterize neural activity associated with increases in alcohol demand resulting 
from exposure to alcohol cues. Hypothesis: Increases in alcohol value following alcohol cues will be 
associated with significant increases in activity in ventral striatum, anterior insula, and posterior cingulate.  
Secondary Aim #1: Investigate severity of alcohol misuse as a moderator of the manipulations. 
Hypothesis: Based on previous behavioral findings, we predict that increased AUD severity will enhance 
reactivity to cues both in terms of behavioural response and brain activity associated with alcohol 
decisions. 
Secondary Aim #2: Examine patterns of functional connectivity underlying alcohol demand. Based 
on recent evidence supporting network-based perspectives in the neuroscience of decision making, we 
will conduct functional connectivity analyses to characterize the underlying neural networks that subserve 
alcohol demand in general and alterations in connectivity from the alcohol cue exposure. 
 
IV. 
Design 
This study will utilize a within-subjects design to compare heavy drinking individuals (N = 70, 50% 
female) in alcohol demand following an active (i.e., viewing alcohol-related cues) and a control (i.e., 
viewing neutral beverage cues) manipulation. Participation will involve one remote session and two in-
person sessions, including a two-part eligibility screening and an fMRI scanning session. The in-person 
session will also include a validated laboratory alcohol cue exposure in the Peter Boris Centre for 
Addictions Research Simulated Bar Laboratory, although no actual alcohol will be consumed.   
 
V. 
Settings 
This study will primarily be conducted in the Peter Boris Centre for Addictions Research under the 
direction of Dr. MacKillop (LPI). The Peter Boris Centre for Addictions Research (PBCAR) is located at 
the SJHH West 5th site. The PBCAR has several private testing rooms, research assistant work space, 
private washroom, and a kitchenette. Dr. MacKillop’s office is located within the PBCAR.  
The laboratory-based alcohol cue exposure component will be conducted in the simulated bar 
laboratory within the PBCAR. The simulated bar room is equipped with a bar and bar stools, alcohol 
bottles, and alcohol-related artwork. Participants are also monitored via a closed circuit video camera 

HiREB Project #7458 
 
Protocol Version 1.6 
PI: Michael Amlung, PhD 
LPI: James MacKillop, PhD 
 
 
 
 
 
             Date 22 FEB 2023 
 
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system to ensure compliance with study procedures and participant/staff safety. The bar lab component 
is described in detail in Section VIII. Study Procedures. 
MRI data will be collected at the Imaging Research Centre (IRC) at the SJHH Charlton site. The IRC 
is home to a research-dedicated MRI scanner with MRI compatible patient monitoring and 
projection/response systems. The IRC also has a participant waiting room, private assessment rooms, 
an MRI simulator, and an MRI physics lab. The IRC is staffed by multiple licensed MRI technologists and 
an on-site MRI physicist.  
 
VI. 
Sample Characteristics 
Eligibility Criteria 
Heavy drinking adults will be recruited from the Hamilton community. Participants will be required to 
consume alcohol in quantities equal to or above the NIAAA recommended weekly drinking limits of 14/7+ 
drinks for males/females. Participants who are currently in treatment for alcohol problems, or those who 
are currently seeking treatment for alcohol problems are not eligible for this study. Inclusion and exclusion 
criteria are summarized in Table 1.  
 
  Table 1. Eligibility Criteria 
General Inclusion Criteria 
1) 21-55 years old; 2) right-handed; 3) fluent English speaker; 4) heavy drinker (i.e., on average > 14/7 
drinks per week for males/females in past three months; 5) > 1 heavy drinking episode weekly (heavy 
drinking episode = 5+/4+ for males/females) over past three months 
General Exclusion Criteria 
1) Currently receiving treatment, or seeking treatment, for alcohol related problems; 2) Current DSM-5 
substance use disorder other than alcohol or tobacco; 3) Weekly or more frequent use of recreational 
drugs other than cannabis; 4) History of schizophrenia-spectrum disorders, psychotic disorders, 
bipolar disorder, or PTSD; 5) History of neurocognitive disorder or impairment; 6) MRI 
contraindications (e.g., metal in body, history of seizure, etc.); 7) history of serious brain injury; 8) 
currently taking psychotropic medications or medications that could affect cerebral blood flow; 9) 
pregnancy (females); 10) attending any study session with a positive breath alcohol concentration 
(BrAC > 0.00g%) 
 
Sample Size 
Sample size was determined via a power analysis based on our previously conducted proof-of-
concept study. The power considerations pertain to within-subjects contrasts between choices made after 
acute exposure to neutral cues compared to alcohol cues. We based our effect sizes on a previous study 
that most resembles the proposed study cue exposure. Effect sizes for cue effects varied from medium 
to large, fs = .44-.56.A sample size of 70 (35 females) would be sufficiently powered to detect a 
conservative medium effect size (f = .35, α = .05, 1-β = .80). We anticipate oversampling on in-person 
screenings to account for ineligible participants and no-shows (estimated total number of screenings = 
84). We will also oversample scans by 10% to account for the possibility of excessive head motion (N = 
77). 
 
VII. 
Assessments 
Telephone Screening Interview 
Initial eligibility for the current study will be assessed via a telephone interview conducted by a trained 
research assistant using a standardized script. The phone interview consists of the following:  
• 
A brief description of the study. 
• 
Questions assessing the inclusion and exclusion criteria for the study (Table 1).  
• 
Statement concerning outcome (Positive vs. Negative) or follow-up if outcome is ambiguous (i.e., 
responses that require clearance from the study PI).  

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• 
For eligible and interested participants, scheduling of in-person session and providing information 
about lab location and other details pertaining to the study sessions.  
 
Physical Measurements 
 
During the in-person screening and scan session, physical measurements of participants will be 
completed. Physical assessments are provided in Table 2. 
 
Table 2. Physical Measurements 
Variable 
Measure 
Format 
Body Composition 
Bioelectrical Impedance Analysis (BIA) 
Scale: weight, body fat percentage, total 
body water percentage, muscle mass, 
physique rating, BMR, metabolic age, 
bone mass, visceral fat 
Electronic scale 
 
Clinical Interview 
During the in-person screening, participants will undergo a clinical interview assessing drinking 
behaviour, alcohol use disorder symptoms and personality disorder symptoms. Interview assessments 
are provided in Table 3. 
 
Table 3. Clinical Interview Assessments 
Variable 
Measure 
Format 
Drinking Quantity/Frequency 
30-day Timeline Follow Back: 
Participants will report their alcohol 
consumption on a daily basis for the last 
30 days. 
Interview 
Clinical Interviews 
The Diagnostic Assessment Research 
Tool (DART) will be used for AUD 
diagnostic status12. 
 
The Structured Clinical Interview for 
DSM-IV Axis Two Disorders (SCID-II) 
will be used to assess cluster B 
personality disorders13. 
Interview 
 
Questionnaires and Neurocognitive Measures 
The majority of questionnaires will be administered electronically using REDCap software (using the 
McMaster University instance of REDCap), with a few paper-pencil questionnaires. We will also 
administer three neurocognitive tests via REDCap or Inquisit software. The list of questionnaires and 
neurocognitive tests, including the construct being assessed, the measure name (if applicable), and 
format, is provided in Table 4.  
 
Table 4. Questionnaire Measures 
Variable 
Measure 
Format 
MRI Safety / Compatibility 
Imaging Research Centre Screening Form: 
MRI safety and contraindications.  
Paper-Pencil 
Study-Specific Data Sheet 
Paper-pencil data sheet for MRI testing 
session. Used to record information about time 
since last use of alcohol/tobacco/drugs, date of 
last menstrual period, medications, etc. 
Paper-Pencil 

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Demographics 
Self-reported gender identity, sex, age, race, 
ethnicity, education, income, etc. 
REDCap  
Alcohol History 
Self-report questionnaire assessing personal 
drinking history, family history of alcohol 
problems, and prenatal alcohol exposure 
REDCap 
Alcohol Craving 
Penn Alcohol Craving Scale (PACS); self-
report assessment of alcohol craving over the 
last week 
REDCap 
Alcohol Use Disorder Severity 
Alcohol Use Disorders Identification Test 
(AUDIT); 10-item self-report screening for 
alcohol problems 
REDCap 
Nicotine Use 
Fagerstrom Test of Nicotine Dependence 
(FTND); 6-item self-report screening for 
nicotine dependence 
REDCap 
Drug Use Frequency 
NIDA Modified ASSIST; Self-report checklist 
assessing frequency of drug use in last 3 
months  
REDCap 
Drug Use Severity 
Drug Use Disorders Identification Test 
(DUDIT); 11-item self-report screening for drug 
use severity 
REDCap 
Cannabis Use 
Cannabis Use Disorder Identification Test 
(CUDIT-R): self-report screening for cannabis 
use 
REDCap 
Depressive Symptoms 
Patient Health Questionnaire-Depression; 9-
item self-report measure of depression 
symptoms 
REDCap 
Anxiety Symptoms 
Generalized Anxiety Disorder 7-item (GAD-7); 
self-report measure of anxiety symptoms 
REDCap 
COVID-19 Questionnaire 
Self-report measure of the effect of COVID-19 
on daily life 
REDCap 
Sobriety Questionnaire 
5-item self-report measure of sobriety 
REDCap 
Personality Traits 
Personality Inventory for DSM-5 Short Form 
(PID-5-SF); 100-item self-report measure of 
personality traits 
REDCap 
Criminal History 
4-item self-report measure of criminal history 
REDCap 
Traumatic Experiences 
Brief Trauma Questionnaire (BTQ); 10-item 
self-report measure of trauma 
REDCap 
PTSD Symptoms 
PTSD Checklist for DSM-5 (PCL-5); 20-item 
self-report assessment of DSM-5 PTSD 
symptoms 
REDCap 
Neurocognitive Tests 
 
 
Working Memory 
Working Memory Span; Computerized digit 
span test 
Computer 
task 
Verbal IQ 
Verbal reasoning subscale of Shipley Institute 
of Living Scale 
Computer 
task 
Inhibitory Control (Two tasks) 
Go/No-Go Task; computerized response 
inhibition task assessing ability to suppress 
prepotent/automatic behavioural responses to 
visual cues presented in rapid succession on 
the screen.  
Computer 
task 

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Flanker Task: computerized inhibition task 
assessing response selection under conditions 
of visual and cognitive interference.  
 
Cue Reactivity Measures 
During the laboratory cue exposure, we will administer several assessments to measure the effects 
of neutral and alcohol cues on drinking motivation, positive and negative affect, and subjective arousal. 
The list of assessments is provided in Table 5. 
 
Table 5. Cue Reactivity / Motivational Measures 
Variable 
Measure 
Format 
Alcohol Demand 
Alcohol Purchase Tasks-State Versions 
(e.g., “how many drinks would you 
consume right now if they cost $3 each?”. 
All choices are hypothetical. 
REDCap 
Alcohol Craving 
Craving visual analog scales (e.g., three 
items assessing subjective alcohol craving; 
“How much do you want a drink?” “How 
high is your urge for a drink?” and “How 
much do you crave a drink?”; Rated from 0-
100) 
REDCap 
Subjective Affect 
Six 100-point affect circumplex items, from 
−50 to +50: Tense-to-Calm, Sad-to-Happy, 
Nervous-to-Relaxed, Bored-to-Excited, 
Stressed-to-Serene, and Depressed-to-
Elated.  
REDCap 
Physiological Arousal 
Blood pressure; heart rate 
Electronic blood 
pressure monitor 
 
Functional Magnetic Resonance Imaging (MRI) Scan 
Participants will undergo a 60-minute fMRI scan at the Imaging Research Centre at SJHH on a 
research-dedicated 3-Tesla General Electric Discovery 750 MRI system. Scans will be administered by 
a licensed MRI technologist at the IRC. 
1. Functional imaging will comprise T2*-weighted echo planar imaging scans with a gradient echo 
pulse sequence. 
2. Structural imaging will comprise high-resolution T1-weighted fast spoiled gradient echo scan 
3. Resting state functional connectivity scans will comprise T2*-weighted echo planar imaging scans 
with a gradient echo pulse sequence. 
 
 The in-scanner behavioural task is our fMRI alcohol demand paradigm (Alcohol Purchase Task; 
APT). A schematic depiction of the paradigm is presented in Figure 1. On each trial, participants are 
asked how many standard-sized drinks of their preferred alcoholic beverage that they would consume at 
a range of prices (e.g., “How many drinks would you consume if they cost $4 each?”). Each run will 
comprise 22 trials in a randomized order. An important aspect of the paradigm is its fractionation of the 
choice process into two discrete units: a stimulus processing Consider period (4 sec) and an active 
selection Choose period (<6s). In the Consider epoch, participants process the drink price for that trial 
and mentally decide how many drinks they want to purchase. In the Choose epoch participants’ 
behaviorally select their consumption level. This permits dissociation of the cognitive processing part of 
the decision from the motor response of inputting the choice. The Consider period is considered the 

HiREB Project #7458 
 
Protocol Version 1.6 
PI: Michael Amlung, PhD 
LPI: James MacKillop, PhD 
 
 
 
 
 
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primary period of interest. A jittered inter-stimulus interval (ISI) screen is presented in between trials (M 
= 8 sec, range 1-15sec)14. 
 
 
Figure 1. fMRI alcohol purchase task stimuli. 
ISI = interstimulus interval, s = seconds 
 
 
In this study, 4 runs of the paradigm will be administered (run duration = ~7 min). Each of the first 
two runs will be preceded by blocks of cues from one condition (either two runs of alcohol cues or two 
runs of neutral cues), and the final two runs will each be preceded by cues from the other condition. 
Example cues are presented in Figure 2. The order of cue conditions will be counterbalanced across 
participants.  
 
 

HiREB Project #7458 
 
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Figure 2.  Alcohol and neutral stimuli for in-scanner cue exposure. 
Example Neutral Cue 
Example Alcohol Cue 
 
 
 
The paradigm is programmed in E-Prime software and displayed via MRI-compatible stimulus 
presentation system. Participants make their responses using MRI-compatible button boxes. Specifically, 
participants use their dominant (more dexterous) right hand buttons to select the number of drinks and 
submit their choice by pressing a button with their left hand.  
In addition to the APT, participants will complete a 9-minute resting state paradigm. During this scan, 
participants are asked to sit still with their eyes open (focusing on a fixation cross on the screen).  
 
Breathalyzer Test & Urine Screen 
Alcohol sobriety (i.e., breath alcohol concentration = 0.00%) at the beginning of the study visit will be 
assessed via a commercial breathalyzer device (e.g., Alco-Sensor; Intoxometers, Inc). 
We will also assess recent drug use via a commercial urine drug screen (e.g., ToxCup 5-panel urine 
drug screen). Results of the drug screen will be recorded on the data sheet and kept strictly confidential. 
Collection of urine drug screen will follow laboratory SOPs.  
 
VIII. 
Study Procedures 
Participant Recruitment 
Participants will be recruited from the Hamilton, Ontario community via advertisements/tear-off flyers 
posted on bulletin boards in public areas around Hamilton, such as libraries, university campuses, 
bus/train depots, grocery stores, etc. Flyers will also be posted on bulletin boards inside SJHH campuses. 
We will also post advertisements on online classified websites (e.g., Kijiji). We have also had success in 
prior studies with placing professional advertisements on Hamilton city busses and will use those 
methods as needed to increase recruitment.  
 
Participants may also be recruited from the Population Assessment for Tomorrow’s Health (PATH) 
Research Registry research registry in the Peter Boris Centre for Addictions Research (PI: Dr. James 
MacKillop). We will only contact participants in the PATH study who have agreed to be contacted for 
future studies. After identifying viable participants, we will provide a list of PATH subject IDs to the PATH 
Project Coordinator to request names and phone numbers. Then, a research assistant from the current 
study will contact the participants and conduct our telephone screening to formally determine eligibility 
for the current study.  
 
Additionally, participants may be recruited from the Access Research Program at St. Joseph’s 
Healthcare Hamilton (a database of patients who have consented to being contacted for research 

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studies). A research assistant from the current study will contact the potential participants and conduct 
our telephone screening to formally determine eligibility for the current study. 
 
Telephone Screening (10-15 Minutes) 
Prospective participants will contact the PBCAR via telephone and leave a voicemail message with 
their contact information. A research assistant will contact participants to conduct the telephone 
screening. Individuals who screen positive will be scheduled for the in-person screening session. 
Individuals who have an ambiguous outcome will be re-contacted after consultation with Dr. MacKillop. 
Individuals who do not qualify for the study will be thanked, and their data will be destroyed.  
 
In-Person Screening (3 Hours; Peter Boris Centre for Addictions Research) 
 
Figure 3 
 
 
 
 
Participants who pass the initial telephone screening will complete two screening sessions to collect 
baseline data. The first screening session will be conducted remotely using the Zoom app and will last 
approximately 1.5 hours. The session will occur in a private laboratory room. Participant sobriety will be 
assessed at the outset of the session. Participants will then be given a verbal overview of the study, read 
a Participant Information Sheet, and provide electronic informed consent for the screening portion of the 
study. They will complete the clinical interview (Timeline Follow-Back, DART, SCID-II), and 
questionnaires administered via REDCap. 
 
 
 
The second screening session will be conducted in-person and will last approximately 1.5 hours 
(Figure 3). The in-person session will take place in Dr. MacKillop’s lab in the Peter Boris Centre for 
Addictions Research at SJHH West 5th site. The session will occur in a private laboratory room. 
Participant sobriety will be assessed at the outset of the session. They will complete the MRI safety 
screening form, and computerized neurocognitive tests. Final eligibility will be based on participant 
responses during the screening sessions. This decision will be made by the research assistant in 
consultation with Dr. MacKillop.  
Participants will next undergo a standardized neutral and alcohol cue exposure protocol Importantly, 
these procedures (see Appendix A) have been used extensively in over three decades of laboratory 

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alcohol research 15,16, including several studies by Dr. Amlung and colleagues17–19. The protocol is 
identical to a prior study approved by HIREB (Project #1001; PI: Dr. Michael Amlung) and involves 
exposure to neutral (water) cues and alcohol-related cues. Importantly, the present protocol will not 
involve any actual alcohol consumption (see Potential Risks Section IX.3 and Appendix B for procedures 
in the event that participants deviate from protocol and consume alcohol).  
In the neutral cues portion, participants will interact with a neutral water beverage in a neutral 
laboratory room (Figure 4). The participant will be seated at a small table and a bottle of water and glass 
will be placed on the table in front of them. The experimenter will open the bottle and slowly pour the 
water into the glass. Participants are told to not drink the beverage. The experimenter will instruct the 
participant to pick up the glass, hold it up to their nose, and take 5 deep breaths to inhale the small of the 
beverage. The experimenter will then ask the participant to put on a pair of headphones and listen to a 
pre-recorded imagery script using the iPad (recording duration ~5 minutes). The recording will ask the 
participant to periodically pick up the drink, take five deep breaths to inhale the smell of the drink. They 
will also be asked to pay attention to the physical attributes to the drink (e.g., the coolness of the glass, 
the color of the beverage, etc.). After the recording finishes, the experimenter will return and administer 
the post-cue assessments (e.g., blood pressure, craving, alcohol demand, affect).  
In the alcohol cues portion, the participant will be escorted to the Boris Centre bar laboratory where 
they will interact with an alcohol beverage in a simulated bar environment (Figure 4). Participants are 
told that they are not permitted to go behind the bar or handle/drink any of the alcohol in the bottles. The 
procedures for the alcohol cue exposure (e.g., picking up and smelling the drink, listening to the recording, 
etc.) are identical to the neutral cue exposure except that the beverage will be a standard sized drink of 
the participant’s preferred alcoholic beverage. Participants are once again told to not drink the beverage. 
Following the completion of the recording, the experimenter will return and administer the post-cue 
exposure assessments (e.g., blood pressure, craving, alcohol demand, affect). During both cue 
exposures, participants will be monitored for compliance to the instructions via a closed-circuit camera 
system. 
For those participants who qualify for the study, we will provide a detailed description of the full study, 
training on the in-scanner alcohol purchase task, and a description of a typical MRI procedure. Then, if 
they want to continue in the study, a research assistant will schedule the appointment for the MRI session. 
Participants will be given a debriefing, during which they can ask any questions that they may have about 
their experience in the screening. At the conclusion of the debriefing, participants will receive their gift 
card and sign a payment receipt.  
 
Figure 4. Laboratory Cue Exposure Environments 
Neutral Cue Environment 
 
Alcohol Cue Environment 
 
 
 
fMRI Session (2.5-3 hours; SJHH Imaging Research Centre) 
Figure 5 

HiREB Project #7458 
 
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The second laboratory session will ideally be scheduled within 1 week of the in-person screening.  
The session will last approximately 2.5-3 hours and will take place at the Imaging Research Centre at 
the SJHH Charlton site. The session timeline is provided in Figure 5.  
Participants will arrive at the IRC at SJHH Charlton where they will be met by a research assistant 
and escorted to a private multipurpose testing room in the IRC. Participant sobriety will be assessed at 
the outset of the session.  Participants will also provide a urine sample in a private washroom. Participants 
will read a second information sheet and provide informed consent for the full study. 
 Participants will then complete an initial assessment that will ask them about the time since last 
alcohol consumption, time since their last cigarette (if any), time since last drug use (if any), medications 
(if any), and the date of last menstrual period (for premenopausal women).  
The MRI scan will be administered by an MRI technologist following standard IRC procedures. 
Participants will first meet with the technologist who will review the MRI safety form and answer any 
questions about the MRI procedure. The participant will change into a cotton gown in a private changing 
area. Participants will also remove all metal (i.e., jewelry, piercings, hair clips, etc.). The technologist will 
escort the participant into the MRI scanner room, position them on the scanner table, and insert the table 
into the MRI scanner. During the scan, participants will be asked to lay motionless and breathe and 
swallow normally.  Research staff and the MRI technologist will maintain communication with the 
participant via an intercom system. The participant will be given a squeeze ball call alarm to hold during 
the MRI exam.  This can be used to immediately stop the scan and speak to the technologist at any time 
during the procedure. When the scan is completed, the technologist will remove the participant from the 
scanner and participants will change back into their personal clothing.  
The session will end with participants receiving a thorough debriefing about the purpose of the study. 
They will receive their gift card and sign a payment receipt prior to departing the session. 
 
Incentives and Other Costs 
Participants will receive a $20 gift card for completing each screening session of the study and a $40 
gift card for completing the scan session; total compensation for completing both sessions = $80. Gift 
cards will be for local grocery / department stores. Participants will be required to sign a payment receipt. 
Participants will not have to pay anything out-of-pocket to participate in this study. Participants will be 
provided with parking/transportation vouchers, as needed.  
 
IX. 
Potential Risks 
This study does have several potential risks, and we have implemented several procedures to 
minimize these risks. Prior to enrolling in the study, all participants will be given a detailed overview of 
the study and will provide written informed consent for each session. Participants will be reminded that 
taking part in the study is voluntary and that they can withdraw at any time without penalty.  
 
      We anticipate the following potential risks: 
 

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1) Risks associated with MRI scanning: While all forms of diagnostic medical procedures involve 
some risk, the known risks of MRI are very low. However, accidents, injuries, and even deaths have 
occurred during MRI procedures. Serious consequences can occur in people who have metal 
pacemakers, metallic dust in their eyes, metallic prostheses, implants or surgical clips. MRI is also 
dangerous for anyone wearing metal objects (jewelry, hair clips, eyeglasses, metal on clothing, credit 
cards, loose change, etc.) Some participants might experience mild discomfort from the loud noise of 
the scanner and the confined space, which can bring on an anxiety reaction. Occasionally during 
scanning, participants may also experience slight warming of the skin due to increased energy 
absorption from radio waves used in magnetic resonance imaging.  
To reduce these risks, we will implement the following MRI safety and screening procedures:  
1. MRI scans will be administered by licensed MRI technologists at SJHH.  
2. Participants will be screened for MRI safety and compatibility as part of the telephone 
screening, again during the in-person screening, and confirmed with the MRI technologist 
on the day of the scan. 
3. Participants will change into a cotton gown prior to MRI scanning and will remove jewelry, 
hair accessories, piercings, etc. prior to entering the MRI room.  
4. Participants will be given earplugs to reduce risk of hearing damage due to scanner noise. 
5. Participants will be provided with a squeeze ball call alarm and will also be able to 
communicate with staff via the intercom/microphone. If participants have any heating or 
queasy feelings during the study, they can stop the scan by pressing the squeeze ball. 
6. All research staff administering the sessions and conducting the initial MRI safety 
screenings will complete the required MRI safety training course offered by the IRC.  
7. Finally, although there is no known risk to a fetus, it is the policy of the IRC to not scan 
women who report being pregnant. 
2) Risks associated with exposure to alcohol-related cues: The cue exposure involves exposure to 
several types of alcohol-related stimuli (visual cues, olfactory cues, imaginal cues). Exposure to these 
cues could trigger relapse or increased desire to drink in individuals who are in treatment or in 
recovery for alcohol-related problems. To minimize this risk, any participants who report seeking 
treatment for alcohol use disorders will be excluded. In addition, any participants who report actively 
trying to stop or cut down drinking will also be excluded.  
3) Risks associated with consuming alcohol against study protocol: While it is highly unlikely 
based on the PI’s previous experience conducting similar alcohol cue exposure studies, it is possible 
that participants may violate study protocol and drink alcohol and become intoxicated during the cue 
exposure portion of the screening session. This could result in increased risk to the safety of the 
participant, staff, and the public. We will implement a number of safeguards to mitigate this risk. These 
safeguards are described in detail in Appendix B and summarized here. First, the study policy 
prohibiting alcohol consumption will be explained and reiterated multiple times throughout the study 
(telephone screening, informed consent, cue exposures). Second, while in the bar lab, participants 
will be monitored by research staff from an adjacent control room via a closed circuit video system. 
This will allow research staff to immediately intervene in the event that a participant goes behind the 
bar and attempts to consume the alcohol stimuli. If the participant violates instructions and drinks the 
prepared beverage used in the cue exposure, the amount of alcohol that they would consume is likely 
less than they typically consume (i.e., all participants will typically drink heavily on a regular basis). 
Nonetheless, if a participant does become intoxicated during the session, the procedures outlined in 
Appendix B will be implemented.  
4) Risks associated with breach of confidentiality / loss of privacy: A potential risk is loss of privacy 
due to inadvertent disclosure of personal information or which could lead to embarrassment or 
damage to reputation. In addition, some of the questions will ask about illegal behaviours such as 
drug use. We will strictly protect against these risks by keeping all data confidential and stored on 
password-protected servers or in locked file cabinets. Each participant will be assigned a unique 

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subject ID number that will be kept separate from their name. Finally, results will only be presented 
or published in aggregate form with no individual participant names.   
5) Risks associated with discomfort / distress in answering personal questions: Participants may 
experience some discomfort resulting from answering some of the personal questions on the 
questionnaires and psychological tests, including questions about illegal activities (e.g., drug use). 
Participants will be reminded several times that they do not have to answer any questions that they 
do not want to answer. Participants will also be debriefed following both sessions to address any 
concerns that they may have about their experience in the study.  
 
X. 
Incidental MRI Findings Policy 
Procedures concerning incidental MRI findings will adhere to SJHH IRC policy (see IRC-MRI-6 
“Incidental Finding MRI-IRC”, dated 2012/05/08). An incidental finding on an MRI scan would include 
suspected pathology or unusual anatomical features which were not expected. Such findings may or may 
not impact the wellbeing of the individual and may warrant further medical investigation. In the best 
interest of the participant, the acquired images should be relayed to a radiologist for further assessment. 
The following procedures concerning incidental findings will be in place (see IRC Policy for further 
details): 
• 
Participants will be informed that the MRI data collected in this study are for research purposes 
only and no clinical report will be issued for any research MRI scan.  
• 
If in the course of the MRI scan procedure, the technologist notes a possible incidental finding, 
the action steps in the IRC policy above will be taken. Steps include notification of MRI radiologist 
on duty for review of images, contacting the study principal investigator, and relaying information 
regarding the incidental finding to the participant.  
• 
If in the course of data analysis a researcher notes a possible incidental findings, the principal 
investigator will contact the IRC and request review of the images by the radiologist.  
 
 
XI. 
Expected Study Timeline & Dissemination 
 
The study is expected to take 36 months to complete. The study chronology is provided in Table 6. 
Following completion of the study, findings will be disseminated via peer-reviewed publications in 
scientific journals, presentations at local/national/international conferences, and presentations at local 
grand rounds and seminar series.  
 
Table 6. Study Chronology 
 
 
Year 1 
Year 2 
Year 3 
Qtr. 
Activities 
N 
Qtr. 
Activities 
N 
Qtr. 
Activities 
N 
1 
Start-up  
- 
1 
Data Collection 
14 
1 
Data Analysis 
- 
2 
Data Collection 
12 
2 
Data Collection 
14 
2 
Data Analysis 
- 
3 
Data Collection 
12 
3 
Data Collection  
13 
3 
Dissemination 
- 
4 
Data Collection 
12 
4 
Data Analysis 
- 
4 
Dissemination 
- 
  
Year 1 Total 
36 
 
Year 2 Total 
41 
 
Year 3 Total 
0 
   
   
 Overall Total 
77 
 
XII. 
References 
 
1.  
Zak PJ. Neuroeconomics. Philos Trans R Soc B Biol Sci. 2004;359(1451):1737-1748. 
doi:10.1098/rstb.2004.1544 
2.  
Camerer CF. Neuroeconomics: Opening the Gray Box. Neuron. 2008;60(3):416-419. 
doi:10.1016/j.neuron.2008.10.027 
3.  
Glimcher PW, Fehr E. Neuroeconomics: Decision Making and the Brain: Second Edition. London: 

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Academic Press; 2013. doi:10.1016/C2011-0-05512-6 
4.  
Mackillop J. The Behavioral Economics and Neuroeconomics of Alcohol Use Disorders. Alcohol Clin 
Exp Res. 2016;40(4):672-685. doi:10.1111/acer.13004 
5.  
Bickel WK, Miller ML, Yi R, Kowal BP, Lindquist DM, Pitcock JA. Behavioral and neuroeconomics of 
drug addiction: Competing neural systems and temporal discounting processes. Drug Alcohol 
Depend. 2007;90(SUPPL. 1):S85-91. doi:10.1016/j.drugalcdep.2006.09.016 
6.  
Jarmolowicz DP, Reed DD, Digennaro Reed FD, Bickel WK. The Behavioral and Neuroeconomics of 
Reinforcer Pathologies: Implications for Managerial and Health Decision Making. Manag Decis 
Econ. 2016;37(4-5):274-293. doi:10.1002/mde.2716 
7.  
Mackillop J, Amlung MT, Acker J, et al. The neuroeconomics of alcohol demand: An initial 
investigation of the neural correlates of alcohol cost-benefit decision making in heavy drinking men. 
Neuropsychopharmacology. 2014;39(8):1988-1995. doi:10.1038/npp.2014.47 
8.  
Owens MM, Ray LA, Mackillop J. Behavioral economic analysis of stress effects on acute motivation 
for alcohol. J Exp Anal Behav. 2015;103(1):77-86. doi:10.1002/jeab.114 
9.  
Amlung M, Mackillop J. Understanding the effects of stress and alcohol cues on motivation for 
alcohol via behavioral economics. Alcohol Clin Exp Res. 2014;38(6):1780-1789. 
doi:10.1111/acer.12423 
10.  
MacKillop J, O’Hagen S, Lisman S a, et al. Behavioral economic analysis of cue-elicited craving for 
alcohol. Addiction. 2010;105(9):1599-1607. doi:10.1111/j.1360-0443.2010.03004.x 
11.  
Mackillop J, Amlung MT, Acker J, et al. The neuroeconomics of alcohol demand: An initial 
investigation of the neural correlates of alcohol cost-benefit decision making in heavy drinking men. 
Neuropsychopharmacology. 2014;39(8):1988-1995. doi:10.1038/npp.2014.47 
12.  
McCabe RE, Milosevic I, Rowa K, et al. Diagnostic Assessment Research Tool (DART). 2017:1-5. 
13.  
Maples JL, Carter NT, Few LR, et al. Testing whether the DSM-5 personality disorder trait model can 
be measured with a reduced set of items: An item response theory investigation of the personality 
inventory for DSM-5. Psychol Assess. 2015;27(4):1195-1210. doi:10.1037/pas0000120 
14.  
Amlung M, MacKillop J. Consistency of self-reported alcohol consumption on randomized and 
sequential alcohol purchase tasks. Front Psychiatry. 2012;3(JUL):65. doi:10.3389/fpsyt.2012.00065 
15.  
Monti PM, Binkoff JA, Abrams DB, Zwick WR, Nirenberg TD, Liepman MR. Reactivity of Alcoholics 
and Nonalcoholics to Drinking Cues. J Abnorm Psychol. 1987;96(2):122-126. doi:10.1037/0021-
843X.96.2.122 
16.  
Reynolds EK, Monti PM. The Cue Reactivity Paradigm in Addiction Research. In: MacKillop J, de 
Wit H, eds. The Wiley-Blackwell Handbook of Addiction Psychopharmacology. Oxford: Wiley-
Blackwell; 2013:381-410. doi:10.1002/9781118384404.ch14 
17.  
Amlung MT, Acker J, Stojek MK, Murphy JG, Mackillop J. Is Talk “Cheap”? An Initial Investigation of 
the Equivalence of Alcohol Purchase Task Performance for Hypothetical and Actual Rewards. 
Alcohol Clin Exp Res. 2012;36(4):716-724. doi:10.1111/j.1530-0277.2011.01656.x 
18.  
Amlung M, MacKillop J. Further evidence of close correspondence for alcohol demand decision 
making for hypothetical and incentivized rewards. Behav Processes. 2015;113:187-191. 
doi:10.1016/j.beproc.2015.02.012 
19.  
J. M, M.T. A, L.H. S, J. A. The neuroeconomics of alcohol demand: Initial findings. Alcohol Clin Exp 
Res. 2011;35(S1):24A. 
http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=reference&D=emed10&NEWS=N&AN=70597491. 
 
 

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Appendix A 
 
Standardized Alcohol Cue Exposure Protocol used in Peter Boris Centre for Addictions Research 
 
Approximate Duration: 20 minutes per condition (5 minutes preparation/instruction; 5 minutes exposure; 10 
minute assessment); 40 minutes total for neutral + alcohol cue exposure 
 
Note: Participants will be observed for compliance and completion via a video monitoring system installed in 
both rooms that feeds to a computer monitor located in an adjacent control room. Participants are not 
permitted to walk behind the bar and drink/interact with any of the alcohol stimuli. 
 
Imaginal Script Methodology 
 
The standard alcohol cue exposure protocol involves direct exposure to personally relevant alcohol cues, 
including visual, olfactory, gustatory, tactile, and proprioceptive cues. This involves preparation of the 
participant’s typically consumed alcoholic beverage in front of the participant. The alcoholic beverage is a 
standard size beer (12oz.), glass of wine (5oz.), or mixed drink containing one shot (1.5oz.) of liquor. The 
beverage is presented in a prototypical glass for the type of alcohol provided (e.g., pilsner glass for beer, 
stemware for wine). The alcohol cue exposure is typically preceded by a neutral cue exposure involving a 
glass of water. The order of the exposures is typically not counterbalanced (i.e., neutral first, alcohol second) 
due to carryover effects from the alcohol cue exposure.  
 
Following preparation of the beverage, the participant is given brief instructions on the inhalation procedure. 
This involves instructing the participant to pick up the drink and hold the glass 1/2 inch from their nose. They 
are asked to take five deep breaths and inhale the smell of the drink. 
 
Next, the participant is instructed to put on a pair of headphones and listen to a pre-recorded audio script 
directing the cue exposure. The experimenter then leaves the room and the participant starts the recording 
(or the recording can be started by a staff member in an adjacent control room). The audio instructions 
repeatedly ask the participant to raise the beverage up to their nose and to take five inhalations of the smell 
of the beverage (total olfactory exposure = ~20s). 
 
The same imaginal script will be used for both neutral (control) and alcohol cues.  The methodology for the 
script is presented below. The duration of the scripts is approximately 3 minutes. The induction is 238 words 
and written at the 2nd grade level of reading comprehension. 
 
Imaginal Script Structure 
 
1. Introduction and instructions. 
2. Initial olfactory exposure; ~5s direct olfactory exposure.  
3. Second olfactory exposure; ~5s direct olfactory exposure. 
4. Third olfactory exposure; ~5s direct olfactory exposure. 
5. Fourth olfactory exposure; ~5s direct olfactory exposure. 
6. Concluding instructions. 
 
Imaginal Script Delivered by Audio Recording 
 
"In a moment, I’m going to ask you to smell the beverage in front of you. When you are asked, please 
take five deep breaths inhaling the smell of the drink. 
[7 seconds] 

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Please pick up the drink and take five deeps breaths, inhaling the smell of the drink with each breath. 
Keep the drink up to your nose. Take deep breaths and inhale the smell of the drink. Notice the how the 
glass feels in your hand and the color of the beverage. After you’ve taken five deep breaths, put the drink 
back down. 
[7 seconds] 
Please pick up the drink and take five deep breaths of the drink. Take your time and take deep breaths. 
Pay attention to the smell of the drink. Once you’ve taken five deep breaths, put the drink back down. 
[7 seconds] 
Please pick up the drink and take five deeps breaths, inhaling the smell of the drink with each breath. 
Keep the drink up to your nose. Take deep breaths and inhale the smell of the drink. Notice the how the 
glass feels in your hand and the color of the beverage. After you’ve taken five deep breaths, put the drink 
back down. 
[7 seconds] 
Please pick up the drink and take five deep breaths of the drink. Take your time and take deep breaths. 
Pay attention to the smell of the drink. Once you’ve taken five deep breaths, put the drink back down. 
[7 seconds] 
Please remove your headphones now. 
 
 
Sample Step-by-Step Instructions 
 
Note: The experimenter script is essentially identical for neutral and alcohol cue exposure. The key difference 
is the beverage that is prepared and presented to the participant. However, the experimenter should refer to 
the cues as “beverage” or “drink” and not “beer/wine/water/etc”. Instructions/actions are presented in bold; 
verbal script is presented in italics. E = experimenter. 
 
Prior to start of exposure protocol: Experimenter should ensure that both rooms are set up properly and 
that all beverages are out on the table/bar. Prepare audio recording on iPad or computer (also check volume 
level). Prepare iPad REDCap survey and any other assessments prior to participant arriving in cue exposure 
room.  
 
E: Now we’re going to do the portion of the study that has various environmental cues. I’m going to take you 
to different rooms in the lab. 
Escort participant to the neutral cues room or bar laboratory 
 
E: I’m going to give you a moment to get situated (Time 60 seconds, then return).  In a little while you will 
be asked to listen to a recording using these headphones. We will play the recording using the iPad. All you 
have to do is put on the headphones and press play when instructed to do so.  
Open and pour the beverage (water) into the glass while SLOWLY saying the following: 
 
We will be using this beverage in this part of the experiment. However, it is important that you NOT drink the 
beverage under any circumstances. In a little while you will be asked to listen to the recording using the 
headphones. It is very important to listen carefully to the scene described in the recording and follow the 
instructions exactly. In addition to asking you to imagine certain things, the recording will ask you to inhale 
the smell of the beverage from time to time. I’d like to go through smelling the drink with you once before we 
go any further. Please pick up the drink and hold it a half an inch away from your nose. That’s right (when 
they complete it). Now, please take five deep breaths and inhale the smell of the beverage. When you have 
taken five deep breaths, put the glass back down. 
 
Pause and count or at least wait until they are ready for the next instructions. 
  

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In a moment, I am going to ask you to put on the headphones and the recording will begin soon after. Please 
be sure to follow the instructions in the recording exactly, but do not drink any of the beverage under any 
circumstances. 
 
Do you have any questions about anything I’ve told you so far? Answer any questions.  
 
Now, I’m going to leave the room. Once I’ve gone, please put on the headphones and press play on the iPad 
to start the recording.  
 
Leave room and close door. Confirm that participant has put on headphones and started recording. 
Monitor participant on video screen for compliance and completion of exposure activities. After the 
recording finishes and subject removes the headphones, enter room and administer assessment.  
 
 
 
 

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Appendix B 
 
Procedures for Participants who Consume Alcohol during Session 
 
Alcohol consumption is strictly prohibited in the Brain Responses to Environmental Influences on 
Drinking Decisions study. Participants are not allowed to consume the alcoholic beverage used during the 
cue exposure. They are also not permitted to go behind the bar and handle or drink any of the alcohol stimuli.  
Nonetheless, it is possible that participants may violate study protocol and consume alcohol during 
the session. Importantly, the amount of alcohol that participants could potentially consume by drinking the 
cue exposure beverage is relatively modest (1 standard drink) given that participants will all be heavy drinkers 
who often consume much larger quantities of alcohol as part of their usual drinking patterns.  
We will reduce risk of alcohol consumption and intoxication by reminded participants of the alcohol 
policy during the telephone screening interview, on the consent form, and during the cue exposure in the bar 
laboratory. We will also monitor participants via the closed circuit video camera system located in the 
adjacent lab room. This will allow research staff to intervene almost immediately after a participant begins to 
drink any alcohol. 
In the unlikely event that a participant breaks protocol and consumes alcohol, the following 
procedures should be implemented: 
1. Inform the study LPI (Dr. MacKillop) as soon as possible.  
2. Remind the participant that alcohol consumption is not permitted and ask them to stop. If they 
refuse and continue to drink the alcohol, do not intervene further as this may put yourself or the 
participant at greater risk.  
3. The testing session will be terminated immediately as participants will have violated study 
protocol.  
4. If participants consume alcohol, research staff will monitor their blood alcohol concentration via a 
breathalyzer device. The participant will be asked to remain in the lab until their BAC is below 
0.04 g%, which is the recommended safe level for departure from a research study per National 
Institute on Alcohol Abuse and Alcoholism’s Recommended Guidelines for Alcohol Administration 
Studies.  
5. Arrangements should be made for safe transportation home for the participants, including calling 
for a ride from a friend or family member or calling a taxi. 
6. If participants refuse to remain in the lab and have a BAC > 0.04g%, hospital security will be 
notified and they will handle the situation.  
7. If, at any time, participants become agitated, argumentative, violent, or pose any risk to the safety 
of staff or themselves, research staff should activate their personal alarms (signaling a Code 
White in the hospital) or contact the security office at extension 36204.