Reinforcer Pathology 1A: Increasing the Temporal Window
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Virginia Polytechnic Institute and State University

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INSTRUCTIONS: 
●
Use this “TEMPLATE PROTOCOL (HRP-503)” to prepare a study protocol
outlining your research plan.
●
Depending on the nature of your study, some major sections might not be
applicable to your research. If so, simply mark as “N/A.” For example, a simple
survey might have many sections with “N/A.”  For subsections (e.g., 1.x or 8.x)
you can mark as “N/A”if you are certain that the subsection is not applicable.
●
Once the IRB/HRPP approves your submission, your latest approved version of
the protocol will be stored in the IRB Protocol Management online system.
●
If your research plan changes and you need to modify the protocol, please submit
an amendment to Protocol Management with the requested modifications.
Download your current protocol from Protocol Management and indicate the
changes/revisions using the track changes feature in order to make review of the
modifications easier to follow. If you are unable to use track changes, please
create a new paragraph wherever you need to make a change, and indicate
“Amendment: Date” before making a change to any section. Protocol
management will store the older versions of your protocol if the IRB or HRPP
staff need to compare them during the review.
PROTOCOL TITLE: 
Include the full protocol title.  
Episodic Thinking and Alcohol Use 
PROTOCOL NUMBER: 
Include the number assigned in Protocol Management (verify this has been added 
before submitting protocol to HRPP).  
IRB 22-358 
PRINCIPAL INVESTIGATOR: 
Full Name and Degrees: Stephen M. LaConte, PhD 
Department: Fralin Biomedical Research Institute 
Telephone Number: 540-526-2008 
Email Address: slaconte@vtc.vt.edu  
FUNDING: 
Sponsor(s): NIAAA 
Funded already or in the proposal phase?: Funded. 
Is Virginia Tech the primary awardee or the coordinating center of this grant or 
contract? If not, list the primary institution: Yes. 
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VERSION NUMBER/DATE:  
Include the version number and date of this protocol. Versions should start at 1.0. 
 
Version 11.0 - 10/15/2024 
 
REVISION HISTORY:  
Use this table to keep track of changes. Add more rows as needed. 
 
Revision 
# 
Version Date 
Brief Summary of Changes  
(i.e., the different sections) 
Consent 
Change? 
1 
08/04/2022 
Added fMRI to S5; changed compensation to 
match time estimates 
Yes 
2 
09/13/2022 
Changed baseline monitoring drinking days to 
4; changed language to may be pilots 
Consent: clarified time for S5 to match 
compensation and removed BACtrack 
calibration from precautions 
Yes 
3 
10/3/2022 
Updated RAM app description; updated 
compensation 
Yes 
4 
11/30/2022 
Updated inclusion criteria (ln(k) > -4.3 
No 
5 
2/22/2023 
Updated inclusion criteria to remove ln(k); 
moved the in lab screening assessments to post 
consent 
No 
6 
4/24/2023 
Updated recruitment methods; 
Changes in the consent to modify an 
inconsistency  
Yes 
7 
7/19/2023 
Updated recruitment methods to include Build 
Clinical;  
Changes to daily texting procedures;  
Updated compensation 
Yes 
8 
9/26/2023 
Changed language for exclusion criteria 
No 
9 
2/26/2024 
Changed eligibility criteria to lower the 
AUDIT requirement 
 
10 
10/15/2024 
Updated PI 
No 
 
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Table of Contents 
1.0 
Study Summary 
4 
2.0 
Objectives 
5 
3.0 
Background 
5 
4.0 
Study Endpoints 
6 
5.0 
Study Design and Statistical Analysis Plan 
7 
6.0 
Setting 
8 
7.0 
Study Intervention(s)/Investigational Agent(s) 
9 
8.0 
Procedures Involved 
13 
9.0 
Data and Specimen Long Term Storage and Use 
21 
10.0 Sharing of Results with Subjects 
24 
11.0 Study Timelines 
25 
12.0 Inclusion and Exclusion Criteria 
25 
13.0 Vulnerable Populations 
27 
14.0 Number of Subjects 
28 
15.0 Recruitment Methods 
29 
16.0 Withdrawal of Subjects 
34 
17.0 Risks to Subjects 
34 
18.0 Potential Benefits to Subjects 
38 
19.0 Data Management and Confidentiality 
39 
20.0 Provisions to Protect the Privacy Interests of Subjects 
41 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
43 
22.0 Compensation for Research Related Injury 
44 
23.0 Economic Burden to Subjects 
44 
24.0 Consent Process 
45 
25.0 Process to Document Consent in Writing 
48 
26.0 Resources Available 
49 
27.0 Multi-Site Research 
51 
 
 
 
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1.0 
Study Summary 
 
Study Title 
Episodic Thinking and Alcohol Use 
Study Design 
Participants will be enrolled in the study, complete two 
sessions and undergo a one week baseline monitoring phase 
where they provide breath samples to assess for recent 
alcohol use and report their drinks per day. Following this 
baseline period, participants will complete and fMRI then be 
randomized to either the EFT or Control group. Participants 
will then complete two weeks of monitoring, where they 
provide a breath sample three times a day and report the 
number of drinks they consumed. Participants will then 
come back to the lab to generate new EFT/CET cues, then 
complete two more weeks of monitoring. After conclusion 
of the second intervention period, participants will complete 
a post intervention session, including an fMRI, and then a 
one month follow up one month after study completion. 
Primary Objective 
The primary outcome measures of this study are the extent to 
which EFT increases an individual’s temporal window and 
decreases their alcohol valuation, compared to baseline 
and/or the CET condition.  
Secondary 
Objective(s) 
N/A 
Study Population 
Individuals with Alcohol Use Disorder 
Sample Size 
200 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
In the EFT intervention, participants will generate positive 
future events they are looking forward to at 7 time points in 
the future (1 day, 1 week, 1 month, 3 months, 1 year, 5 
years, and 25 years). Participants will be reminded of these 
events using cues throughout the study and instructed to 
think about these cues as they make their decisions. In 
contrast, in the CET intervention, participants will generate 
positive recent past events that have happened to them at 7 
time points from the recent past (last night from 7pm-10pm, 
yesterday between 4pm-7pm, yesterday between 1pm-4pm, 
yesterday from 10am-12pm, yesterday between 7am-10am, 
the night before last between 7pm-10pm, and evening before 
last between 4pm-7pm). Participants will be reminded of 
these events using cues throughout the study and instructed 
to think about these cues as they make their decisions. 
Study Duration for 
Individual 
Participants 
The total study is expected to take up to approximately 15 
weeks. 
Acronyms and 
Definitions  
AUD = Alcohol Use Disorder 
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CET = Control Episodic Thinking  
EFT = Episodic Future Thinking 
 
 
2.0 
Objectives 
2.1 Describe the purpose, specific aims, or objectives of this study: 
 
Test reinforcer pathology via manipulation of the temporal window in the real world.  
 
2.2 State the hypotheses to be tested:  
 
We hypothesize that an intervention involving episodic future thinking (EFT) will 
increase the temporal window and dynamically decrease alcohol valuation (i.e., 
consumption of alcohol in the real world, demand, and craving).  
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study: 
 
Episodic future thinking (EFT) is based on the new science of prospection, which was 
first identified in a Science publication in 2007 and refers to pre-experiencing the future 
by simulation. Considerable evidence suggests that prospection is important for 
understanding human cognition, affect, motivation, and action. Individuals with damaged 
frontal areas, as well as individuals with alcohol use disorder (AUD), show deficits in 
planning prospectively. One systematic method to engender prospection is via EFT. EFT, 
as applied in our prior studies and in this proposal consists of having participants develop 
positive plausible future events that correspond to several future time frames (e.g., 2 
weeks, 1 month, 3 months etc.). For each of these timeframes participants are asked to 
concretize the events (e.g., What are you doing? Who will be there? What will you see, 
hear, smell, and feel?). 
 
3.2 Describe any relevant preliminary data: 
 
We and others have used EFT to decrease delay discounting (DD) in individuals with 
AUD and smokers, as well as normal weight, overweight, and obese populations when 
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compared to the control condition, control episodic thinking (CET). Consistent with 
reinforcer pathology, EFT also reduces alcohol valuation in the purchase task among 
individuals with AUD and decreases alcohol consumption when EFT cues are texted to 
participants during a normal day over the course of 2 weeks.  
 
3.3 Based on the existing literature, provide the scientific or scholarly 
rationale for and significance of your research and how will it add to 
existing knowledge: 
 
In this study, we propose to test an intervention, EFT, which we hypothesize will 
decrease reinforcer pathology measures in the real world over a longer time frame than 
has been done previously; that is, EFT will decrease delay discounting, as well as alcohol 
consumption in the real world, demand, and craving compared to a control episodic 
thinking (CET) condition. Moreover, we hypothesize EFT will enhance activation in 
brain regions associated with prospection (e.g., hippocampus and amygdala) and the 
executive decision system (e.g., DLPFC). Not only will results from these analyses help 
demonstrate the mechanisms by which EFT operates, but also contribute to the 
understanding of EFT as a potential therapeutic behavioral intervention. 
 
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints. See links below for 
discussion of study endpoints and how they may differ from study 
objectives. These are most common in clinical trials but are sometimes 
applicable to other types of biomedical research, as well as social, 
behavioral, or educational research. See link below for a discussion. 
https://docs.google.com/document/d/1Wocz7K7a0hCQJPPO_khh5l1
SQQjhGDDGHzcOPRHR5Tw/edit?usp=sharing  
 
Delay discounting: Change in discounting rates will be compared within-subjects 
between pre intervention and post intervention. In addition, differences in discount rates 
will be compared between groups (EFT and CET). 
Alcoholic Drinks: Change in drinks per day and number of positive breath alcohol 
samples (BrAC) will be compared within-subjects between pre intervention and post 
intervention. In addition, differences in drinks per day and number of positive BrAC 
samples will be compared between groups (EFT and CET). 
Alcohol Demand: Change in demand for alcohol will be compared within-subjects 
between pre intervention and post intervention. In addition, differences in alcohol 
demand will be compared between groups (EFT and CET). 
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Alcohol Craving: Change in alcohol craving will be compared within-subjects between 
pre intervention and post intervention In addition, differences in alcohol craving will be 
compared between groups (EFT and CET). 
 
4.2 Describe any primary or secondary safety endpoints. These should be 
included for all studies that are greater than minimal risk. (Minimal risk: 
The probability and magnitude of harm or discomfort anticipated in the 
research that are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.): 
 
This study’s procedures are not more than minimal risk. 
 
5.0 
Study Design and Statistical Analysis Plan 
5.1 Describe the basic study design/approach (e.g., qualitative study using five 
focus groups of first year students to describe assimilation into the 
university community; randomized controlled trial of a behavioral change 
intervention to increase dietary intake of whole grains; pre- post-test 
evaluation of new pedagogical techniques to improve adult literacy): 
 
Participants will be randomly assigned to experimental or control groups, stratified by 
demographic characteristics (e.g., drinks per day and baseline delay discounting rates). 
Based on our 8 years of experience recruiting this population, we expect approximately 
66% retention among eligible participants. Therefore, we will enroll approximately 200 
participants in order to conclude with 76 completers. We plan to enroll more than our 
average attrition rate because of the increased screening procedures and the time demands 
of the study. Randomization will be stratified on demographic characteristics (e.g., drinks 
per day and baseline delay discounting rate). As a result, any differences observed in our 
primary hypotheses will not be confounded by these variables. 
EFT group participants will be asked to think about and describe the most positive event 
that could realistically happen at a number of delays in the future (e.g., 1 day, 2 weeks, 1 
month, 1 year, 5 years, 25 years). In contrast, participants randomized to the CET 
condition, will be asked to think about and describe the most positive event that occurred 
at a number of time points from the recent past (e.g., last night from 7pm-10pm, 
yesterday between 4pm-7pm, yesterday between 1pm-4pm, yesterday from 10am-12pm, 
yesterday between 7am-10am, the night before last between 7pm-10pm, and evening 
before last between 4pm-7pm).  
 
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5.2 Describe corresponding data analysis plan/approach (e.g., content analysis 
of focus group transcripts; descriptive analysis followed by linear 
regression modeling; nonparametric analysis of pre- and post-test 
measures): 
 
Primary hypotheses: Our primary measure of temporal window is delay discounting 
(DD). Our primary measure of alcohol consumption is self-reported drinks per day. 
Participants are asked to report how many standard drinks they had for the previous 24 
hours on each day of the 7 day baseline and 28 day intervention period. Our secondary 
measure of alcohol consumption is breath alcohol samples from the remote breathalyzer. 
Participants will provide three breath samples daily for the 7 day baseline and 28 day 
intervention period. Our primary measures of demand are alpha and Q0. Alpha and Q0 
are two derived outcomes from a hypothetical alcohol purchase task. Participants are 
asked to report the number of standard drinks they might hypothetically purchase at 
increasing price points. Q0 is a measure of how many drinks a participant might purchase 
when drinks are free (price = $0). Alpha is a measure of the participants sensitivity to 
increasing prices (i.e., how quickly they decide to stop purchasing at higher prices). Our 
measure of craving is the Alcohol Urges Questionnaire (AUQ). Our measure of neural 
activity is BOLD response. We hypothesize that baseline BOLD response will be 
predictive of the efficacy of the intervention. We will model our primary outcome 
measures using a mixed-effects hierarchical model that includes day, time (pre/post 
intervention), and intervention group. A random effect will be included for each 
participant. We will include baseline BOLD response as a fixed-effect covariate in our 
analysis. 
 
6.0 
Setting 
6.1 Describe the sites or locations where your research team will conduct the 
research.  Consider each of the items listed below: 
● 
Identify where your research team will identify and recruit potential 
subjects. 
● 
Identify where the team will perform the research procedures. 
● 
Describe the composition and involvement of any community 
advisory board(s). 
● 
For research conducted in other locations, describe: 
o 
Site-specific regulations or customs affecting the research at 
those locations. 
o 
Local scientific and ethical review structure at those locations.  
Examples include work in other cultures or ethnic groups 
(within or outside of the U.S.) and work with churches. The 
HRPP will provide additional guidance for international 
research. 
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Location of Recruitment:  
Participants will be recruited from the Roanoke-Blacksburg community via posted flyers, 
word of mouth referrals, and electronic advertisements (e.g., Craigslist, Facebook). To 
the extent possible, we will attempt to minimize obstacles to participation. For example, 
travel barriers will be addressed by providing transportation or parking costs to 
participants, and scheduling barriers will be minimized by offering a flexible session 
schedule. 
In addition, we will partner with BuildClinical to accelerate enrollment. BuildClinical is a 
data-driven platform that helps academic researchers recruit participants for research 
studies more efficiently using social media, software, and machine learning. They have 
worked with IRBs in the US to ensure adherence to all the appropriate guidelines and 
procedures. They utilize study-specific advertisements to engage participants on digital 
platforms such as Facebook, Google, WebMD, etc., and redirect them to a study-specific 
landing page should they click it. On the landing page, the person can complete an online 
pre-screen questionnaire that gets routed into BuildClinical's platform. BuildClinical's 
Secure Socket Layer (SSL) software, which encrypts all inputted information is HIPPA 
compliant and keeps potential participant information private. 
 
Location of study: 
All methods and measures will be conducted using standard operating procedures in the 
Addiction Recovery Research Center and LaConte Laboratory at the Fralin Biomedical 
Research Institute at VTC. All staff (including recruitment staff) will be provided with 
cultural sensitivity training. We have a history of successful recruitment of drug and 
alcohol users. All participants will enroll on a voluntary basis and sign an IRB-approved 
consent form prior to study participation. 
 
 
7.0 
Study Intervention(s)/Investigational Agent(s) 
7.1 Describe the study interventions (including behavioral interventions) and/or 
investigational agents (e.g., drugs or devices) to be used in this study.  Consider 
each of the items listed below:  
● 
Drug/Device Handling: If the research involves drugs or devices, 
describe your plans to store, handle, and administer the drugs or 
devices so that they will be used only on subjects, and only by 
authorized investigators. 
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● 
Describe whether any of the following will be used: microwaves, X-
rays, DEXA scans, general anesthesia, or sedation 
● 
If control of the drugs or devices used in this protocol will be 
accomplished by following an established, approved organizational 
SOP (e.g., Research Pharmacy SOP for the Control of 
Investigational Drugs, etc.), please reference the SOP in this section. 
 
 
Episodic Future Thinking: Participants will generate positive future events they are 
looking forward to at a number of time points in the future (e.g., 1 day, 2 weeks, 1 month, 
3 months, 1 year, 5 years, and 25 years) at S3 and S4. Participants will be reminded of 
these events using cues throughout the session and instructed to think about these cues as 
they make their decisions. These cues will be the cues texted to them over the monitoring 
phase. Questions about the cues (e.g., "How vivid is this cue to you, on a scale from 1-5", 
"How real does this cue feel to you, on a scale from 1-5", etc.) will be also texted to the 
participants together with the cues. This procedure is to ensure the participants are 
actually reading their cues when texted to them. A list of question examples is attached in 
the supporting documents.   
Control Episodic Thinking: Participants will generate positive recent past events that 
have happened to them at a number of time points (last night from 7pm-10pm, yesterday 
between 4pm-7pm, yesterday between 1pm-4pm, yesterday from 10am-12pm, yesterday 
between 7am-10am, the night before last between 7pm-10pm, and evening before last 
between 4pm-7pm) at S3 and S4. Participants will be reminded of these events using cues 
throughout the session and instructed to think about these cues as they make their 
decisions. These cues will be the cues texted to them over the monitoring phase. 
Questions about the cues (e.g., "How vivid is this cue to you, on a scale from 1-5", "How 
real does this cue feel to you, on a scale from 1-5", etc.) will be also texted to the 
participants together with the cues. This procedure is to ensure the participants are 
actually reading their cues when texted to them. A list of question examples is attached in 
the supporting documents. 
 
 
7.2 List the name of all drugs (including any vitamins, supplements, herbs, or 
nicotine) to be used in the study.  Indicate whether they have FDA 
approval, and list any limitations for their use:  
 
N/A 
 
7.3 List all devices, how they will be used, their purpose in the study, and if 
they will be used in a manner consistent with their approved uses. If they 
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will be used in ways that are not yet FDA approved, indicate whether they 
need an IDE or a determination that they are exempt from the IDE 
Determination. If a determination of significant risk or non-significant risk 
is needed for any of the devices, include the researcher’s recommendation 
for each of those devices:  
 
We are using a device (BACtrack Mobile breathalyzer) that is under the purview of the 
FDA, but we have not and we believe we are not required to obtain an IDE from the FDA 
for the use of this device because it meets the requirements for IDE exempt in 21 CFR 
§812.2(c)(3).  
These requirements are as follows: 
(3) A diagnostic device, if the sponsor complies with applicable requirements in 
809.10(c) and if the testing: 
(i) Is noninvasive, 
(ii) Does not require an invasive sampling procedure that presents significant risk, 
(iii) Does not by design or intention introduce energy into a subject, and 
(iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by 
another, medically established diagnostic product or procedure. 
 
Our use of this device is noninvasive, does not require an invasive sampling procedure 
that presents sufficient risk, does not by design or intention introduce energy into a 
subject, and is not used as a diagnostic procedure without confirmation of the diagnosis 
by another procedure. Regarding point (iv) specifically, the only diagnosis under 
consideration in our study is alcohol use disorder, but we are not using the device to 
diagnose this disorder. We are using other established questionnaires and assessments as 
uploaded to the IRB to assess whether someone has the symptoms of alcohol use 
disorder, and the breathalyzer device is only being used to monitor ongoing alcohol use. 
Ongoing alcohol use by itself is not sufficient to diagnose alcohol use disorder and we are 
not using it for this purpose. Instead, we are periodically readministering behavioral 
diagnostic surveys to determine if incidence of alcohol use disorder symptoms change 
throughout the study. 
 
The BACtrack Mobile breathalyzer is FDA cleared but confidential, which is why it does 
not appear in a search. The 510(k) number is regulated confidentially, but the listing 
number is D085312 and the premarket submission number is K090067. Additionally, the 
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BACtrack Mobile is not approved to treat or diagnose a disease, but we do not intend to 
use it for this purpose. The use of the BACtrack Mobile is non-diagnostic in this study 
but accurate enough to measure BAC remotely. 
 
The team will be using the BACtrack Mobile for this protocol. The 510(k) number (i.e., 
K090067) is the same as the other model and this information is confidential. Our contact 
at BACtrack confirmed that the device is FDA cleared and also provided the below and 
attached information.  
 
Attached you will find a review from Counterpoint Journal, which compares BACtrack 
Mobile to police and industrial/DOT handheld units: https://www.counterpoint-
journal.com/ 
 
Additionally, here's a link to an abstract from researchers at the Perelman School of 
Medicine at the University of Pennsylvania. While BACtrack performed best relative to a 
police-grade breathalyzer (the Intoxilyzer 240), we've also been informed BACtrack 
outperformed the Intoxilyzer 240 when comparing BAC results to a blood test.  
http://injuryprevention.bmj.com/content/23/Suppl_1/A15.1 
 
Additionally, here are media reviews of BACtrack Mobile compared to police units: 
https://well.blogs.nytimes.com/2015/12/21/turning-your-smartphone-into-a-breathalyzer/ 
https://www.nbclosangeles.com/investigations/Do-It-Yourself-Breathalyzers-
368687801.html 
 
 
 
Functional magnetic resonance imaging (fMRI) is a technique that noninvasively 
measures correlates of neural activity (Ogawa et al., 1992) and allows the identification 
of cerebral substrates associated with processes that shape human awareness and 
perception, such as visual, auditory, emotional, somatosensory. Unlike positron emission 
tomography (PET), fMRI does not require the injection of intravenous tracers or 
exposure of the subject to any ionizing radiation. Another advantage of fMRI is that 
multiple scans can be obtained in a single (or multiple) imaging session(s), which allows 
for acquisition of 1000 scans over a few minutes, while a PET study is limited to 16 scans 
over 2 hours (Friston et al., 1995; Buckner et al., 1996). Thus, fMRI allows us to 
capitalize on increased temporal resolution and repetition of conditions capabilities in an 
effort to study brain function. 
 
The MRI scanner we will use has a magnetic field of approximately 3.0T. Scanners with 
a 3.0T field strength have been approved for clinical use by the FDA and are currently 
available for routine clinical applications. 
 
The MRI imaging experiments will be performed on a Siemens 3T scanner, and we will 
only use structural and functional sequences that conform to FDA guidelines for specific 
absorption rate (SAR) of radio frequency energy. SAR is limited by both hardware and 
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software checks on the MRI scanners. A standard head coil will be used to collect the 
MR data.  
 
The hCG Urine Pregnancy Test Cassettes is a test kit for the determination of hCG 
(Human Chorionic Gonadotropin) in urine specimens. This test kit is used to obtain a 
visual qualitative result for early detection of pregnancy. These tests are Standardized 
with WHO International Reference Standard and FDA Cleared & CLIA Waived. 
 
The QuickTox 5-panel drug test dip card delivers results within 5 minutes. The QuickTox 
is FDA-approved and CLIA-Waived. The 5-panel test detects benzodiazepines, 
marijuana, opiates, meth, and cocaine.  
 
 
7.4 If the drug is investigational (has an IND) or the device has an IDE or a 
claim of abbreviated IDE (non-significant risk device), include the 
following information: 
● 
Identify the holder of the IND/IDE/abbreviated IDE. 
● 
Explain procedures followed to comply with sponsor requirements 
for FDA regulated research for the following: 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
 
 
N/A 
 
 
 
 
 
 
8.0 
Procedures Involved 
8.1 Describe and explain the study design: 
 
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Participants will be enrolled into the study and undergo the informed consent process 
(including signing of the informed consent) during Session 1. Session 2 will be baseline 
assessments, this may be on the same day as Session 1; the baseline monitoring phase 
will follow Session 2. During the baseline monitoring phase, participants will provide 
breath samples to assess for recent alcohol use and report their drinks per day and report 
their alcohol withdrawal symptoms per day. Following the baseline period, participants 
will return for Session 3, where they will undergo fMRI procedures and then be 
randomized to either the EFT or control group (Control Episodic Thinking, CET). 
Participants will complete 2 weeks of monitoring (Monitoring Phase 1) where they will 
provide three breath samples per day and report the number of drinks they consumed per 
day. Participants will then come back to the lab to generate new EFT/CET cues at 
Session 4, and then complete Monitoring Phase 2 for two more weeks. After conclusion 
of the second monitoring phase, participants will complete Session 5 which is composed 
of assessments and an fMRI scan. A one month follow up will be conducted as Session 6. 
 
8.2 Provide a description of: 
● 
All research procedures being performed  
● 
If the study has more than one procedure, session, and/or subject 
population, describe each procedure, session, and/or study 
population separately. For complex studies, you are encouraged to 
include a figure or chart. 
 
 
Participants will be recruited from the community via posted flyers, word of 
mouth referrals, and electronic advertisements (e.g., Craigslist, Facebook). Participants 
will be contacted if they have given prior permission (through previous informed consent 
form) or by completion of a confidential pre-screening questionnaire. 
Participants will be initially pre-screened for eligibility using our RedCap online/phone 
survey.  
Following informed consent (Session 1), participants will complete a second session 
(Session 2). Sessions 1 and 2 may be on the same day. Following this session, 
participants will be asked to provide daily self-report assessments of previous-day 
drinking remotely (see below) and 3 breathalyzer samples per day for 7 days with no 
other study intervention taking place and their alcohol withdrawal symptoms per day. 
The purpose for this baseline period is to quantify baseline drinking patterns and ensure 
that the participant reliably responds to and conveys study information remotely. At the 
end of this baseline period, participants who indicated adequate patterns of drinking on at 
least 4 of the 7 days and successfully reported their level of drinking as requested on 5 of 
the 7 baseline days will be invited to continue in the study.  
Following the baseline period, participants will return to the laboratory for Session 3. 
During Session 3, participants will complete an fMRI. Participants will be 
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counterbalanced to either the active or control group based on alcohol use (e.g., average 
drinks per day) and their baseline delay discounting rate. Both groups will be exposed to 
the same procedures. That is, participants in both groups will generate positive cues at 
either future timepoints (active, Episodic Future Thinking, EFT) or recent timepoints 
(control, Control Episodic Thinking, CET). Following this Session 3, participants will 
begin the first intervention period (Monitoring Part 1). The intervention period will last 
approximately 14 consecutive days, with three breathalyzer screens per day. During this 
14-day period, participants will also self-report their previous-day alcohol use daily 
remotely and their alcohol withdrawal symptoms per day. Following Monitoring Part 1, 
participants will return to the laboratory for Session 4, where they will generate new cues 
and complete assessments. Following Session 4, participants will begin the second 
intervention period (Monitoring Part 2). The intervention period will last approximately 
14 days, with three breathalyzer screens per day. During this second 14-day period, 
participants will self-report their previous-day alcohol use remotely. Session 5 will be 
conducted in the laboratory after the conclusion of Monitoring Part 2. Participants will 
also complete Session 6 (1-month follow-up) one month after the conclusion of the 
intervention. Participants may be provided a cell phone (if necessary) at the beginning of 
the study and a BACtrack breathalyzer at the beginning of the baseline period. 
Participants may receive a $100 study completion bonus at the end of the study provided 
they complete all six sessions (and return the cell phone if applicable). Please note: if 
participants are unable to complete the entire 28-day intervention period, post-
intervention data will be collected regardless of the number of intervention days 
completed.  
Cellular phone communication. All participants will either be allowed to use their own 
personal cell phone for study communications or receive a cell phone with service 
through a nationwide cell phone service provider. If a participant chooses to use their 
personal cell phone for study communications and pays for text messages and/or phone 
calls on a per unit basis, we may reimburse the participant for the cost of those messages 
and calls made for this study.  We have used study-provided cell phones to facilitate 
study communication previously (Athamneh et al., 2021, Koffarnus et al., 2011).  
BACtrack breathalyzer monitoring. The BACtrack breathalyzer 
(https://www.bactrack.com) contains a number of technological advances that make it 
ideally suited for remote breath samplings of alcohol use. To complete scheduled 
breathalyzer assessments, participants will log into the Remote Monitoring app on their 
smartphone, developed by the University of Kentucky. Participants will select to submit a 
breath sample and participants will simply blow into the device for a few seconds. The 
breathalyzer will be provided to the participants for the study. Participants will be able to 
keep their breathalyzer following completion of the study. If the breathalyzer is 
lost/stolen/damaged, the participant will be able to receive a new breathalyzer from the 
study team.  
All participants will be asked to complete breathalyzer screens 3 times per day for 
approximately 35 days (approximately 7 days baseline, and approximately 28 days 
intervention). A period of approximately 28 days of the intervention was chosen to 
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determine if this procedure could result in alcoholic drink reduction using the EFT 
intervention. The breathalyzer screens will be spaced throughout the day, through the 
participants usual bedtime. The first sample of the following day will not be collected 
until 9 hours have passed from their usual bedtime. Throughout the intervention phase of 
the experiment, participants will be required to submit three daily breathalyzer 
assessments at predetermined times. They may be reminded via text message when a 
sample is to be collected. Samples will be accepted 90 minutes after the scheduled time. 
Both groups will receive a $1 payment for each breathalyzer result submitted within the 
allowed submission period, regardless of the result of that test. This payment is to 
encourage participants to complete screens, even if they had consumed alcohol that day. 
Breathalyzer schedules will be similarly arranged for both groups. 
 
Participants will be assigned to either the active Episodic Future Thinking (EFT) 
condition or the control Control Episodic Thinking (CET) condition. EFT participants 
will generate positive future events they are looking forward to and that could happen at 
different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year) and participants 
in the CET condition will list positive recent events (events that have already happened) 
that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours 
ago,1 week ago). Participants will be instructed to use and think about their episodic cues 
as they make decisions.  All participants will be provided with a copy of their episodic 
cues to take home with them and will receive periodic text messages from research staff 
to remind them of their cues. Questions about the cues (e.g., "How vivid is this cue to 
you, on a scale from 1-5", "How real does this cue feel to you, on a scale from 1-5", etc.) 
will be also texted to the participants together with the cues. This procedure is to ensure 
the participants are actually reading their cues when texted to them. To incentivize 
responses to the cue, participants will be paid $1 for each response. Research staff will be 
available throughout business hours and periodically during evening and weekend hours 
to deliver text messages and payments. Participants will have immediate access to these 
payments as soon as they are deposited by research staff (see below).  
Remote delivery of payments. To allow for payments that are both convenient and 
rapidly available, we will pay participants with reloadable prepaid cards through 
Greenphire ClinCard (www.greenphire.com), an FDIC-insured payment provider that 
specializes in clinical trial stipend payments that comply with IRB privacy regulations 
and considerations. At intake, each participant will receive a prepaid MasterCard debit 
card that can be used anywhere that accepts MasterCard. As payments are earned in the 
course of the study, additional funds will be added to the account for that participant. 
Funds are immediately available when added and participants can check their balance as 
desired. This system will allow frequent, immediately available payments without the 
burden of frequent laboratory visits that would negate some of the advantages of remote 
monitoring.  
Daily alcohol use self-reports. Each day, participants will be asked to report how many 
alcoholic drinks they consumed the previous day (from the time they awoke to the time 
they fell asleep). We will ask them about the previous day's alcohol use instead of the 
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current day to best capture all drinks consumed each day without inconsistent response 
times complicating the measurement. Participants will be allowed to report this 
information at any time throughout the day, but will be encouraged through prompts to 
do so in the morning to increase the likelihood of accurate recall of previous day use. 
Participants will be allowed to report this information via the Remote Monitoring app. 
Participants may receive a reminder to report their previous-day drinking with text 
messages, followed by a phone call if they haven’t contacted us appropriately. For 
completing this daily self-report, participants will receive $1 in compensation.  
Daily alcohol withdrawal symptoms. Each day, participants will be asked to report their 
alcohol withdrawal symptoms. Specifically, participants are instructed to report the 
maximum severity of alcohol withdrawal symptoms experienced "today" on a scale of 0 
(no symptoms) to 9 (severe symptoms). Participants are instructed to contact the study 
team immediately if they have concerns about their withdrawal symptoms. Participants 
are provided with common alcohol withdrawal symptoms, including: anxiety, headache, 
insomnia, irritability; and severe symptoms including: convulsions and delirium tremors.  
Participants will be allowed to report this information via the Remote Monitoring app.  
Assessment sessions (sessions 2, 3, 4, 5 and 6). Participants will complete a battery of 
questionnaires and tasks grouped into three general categories: measures of substance use 
(including a urine test for drug and alcohol metabolites and a breath sample to test for 
recent alcohol use), clinically relevant measures including treatment acceptability, and 
measures of alcohol value and sensitivity. At the end of Session 6, participants will be 
provided alcohol treatment resources. 
fMRI Scan. Investigators of the study will review safety issues related to MRI scanner 
with the participant and answer any questions immediately prior to entering the MRI 
scanner (see attached preMRI screening form). The subjects will lie still in the MRI 
scanner for approximately one hour. During the first several minutes acquisition of the 
structural scans will take place (e.g., localizer, T1-, T2-, and/or DTI-weighted), which 
will be followed by acquisition of the functional images. While the participant is inside 
the scanner, an investigator will be in constant visual observation of the participant and in 
between scans will use voice-communication via an intercom to assure the participant 
remains comfortable. The participant will also have a hand-held squeeze bulb to signal 
the investigators at any point in the experiment. In the event the participant wishes to be 
withdrawn, the investigator will take the participant out of the scanner immediately. 
The fMRI session will consist of resting state scan(s). 
Urine samples to assess pregnancy and recent substance use will be collected at the 
Addiction Recovery Research Center in restrooms designated for participant use that 
have built in stainless steel sample pass-throughs. Trained research personnel will 
provide specimen cups labeled only with study ID and will be responsible for testing the 
samples in a designated laboratory space using laboratory procedures to ensure validity 
and safety. To test the urine, specifically, we will utilize the hCG Urine Pregnancy Test 
Cassettes, which is a test kit for the determination of hCG (Human Chorionic 
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Gonadotropin) in urine specimens. This test kit is used to obtain a visual qualitative result 
for early detection of pregnancy. These tests are Standardized with WHO International 
Reference Standard and FDA Cleared & CLIA Waived. We will also use the QuickTox 
5-panel drug test dip card which delivers results within 5 minutes. The QuickTox is 
FDA-approved and CLIA-Waived. The 5-panel test detects benzodiazepines, marijuana, 
opiates, meth, and cocaine.  
 
 
 
 
8.3 Describe: 
● 
Procedures or safeguards intended to reduce the probability and 
magnitude of risks. (For example: Reducing the risk of injury in a 
virtual reality study either by having the subjects sit during the study 
or by providing an obstacle-free space for walking.) 
● 
Be sure to describe all drugs and devices used in the research, when 
they will be administered or used, and their purpose.  
● 
Methods used to collect data about subjects. Please upload all data 
collection forms to Protocol Management. Some common examples 
are: 
● Screening questionnaires  
● Survey(s), including online surveys 
● Demographic questionnaire(s) 
● Interview guide(s), e.g., questions or pool of questions for semi-
structured interviews  
● Focus group guide(s) 
● Other documents used to collect data  
 
Affect Circumplex Measure: Measures positive and negative affect. 
Alcohol Purchase Task: Assesses alcohol demand, where participants report the quantity 
of standard alcoholic drinks they would consume across various prices. 
Alcohol Relative Reinforcement Schedule: Measures substance-related and substance-
free reinforcement. 
Alcohol Urges Questionnaire: Assesses alcohol craving. 
Alcohol Withdrawal Symptoms: Assesses alcohol withdrawal. 
Beck Anxiety Inventory: Assesses symptoms of anxiety 
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Beck Depression Inventory: Assesses symptoms of depression. 
Breath Alcohol Concentration (BrAC): Assesses BrAC prior to and during laboratory 
sessions. 
Brief Assessment of Alcohol Demand (BAAD): Assesses alcohol demand indices 
independent of alcohol purchase task. 
Contemplation Ladder: Assesses readiness to change alcohol use. 
Corsi Block Tapping Test: This task measures working memory capacity. 
Delay Discounting (DD):  DD tasks (a measure of the temporal window) examine the 
devaluation of monetary or alcohol rewards as a function of delay to their receipt. These 
computerized assessments present hypothetical choices between smaller, sooner and 
larger, later rewards available at a range of delays. 
Height: Self report height 
Penn Alcohol Craving Scale: Assesses alcohol craving. 
Reward Responsiveness Scale: Measures responsiveness to reward through a single 
component measure 
Timeline FollowBack Interview (TLFB): Assesses the number of alcoholic drinks and 
other substances daily for the past 30 days, or since the previous assessment, whichever is 
fewer. 
Urinalysis: Assesses substance use and/or pregnancy. 
Weight: Self report weight 
 
 
 
8.4 What data will you collect during the study and how you will obtain them? 
Please include descriptions of electronic data collection, database 
matching, and app-based data collection: 
 
All of the survey and questionnaire data will be collected using  Qualtrics, online survey 
platforms used to develop, administer, and collect participant data in a secure password 
protected database. Only study personnel will have access to the survey and collected 
data.  
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The fMRI tasks will be administered using python-coded tasks, wherein the participant 
data will be securely collected on a password protected shared-drive hosted by FBRI.  
fMRI analyses. GLM-based analysis will be performed using AFNI. We will perform 
slice timing correction, motion correction, and spatial smoothing (Gaussian kernel with 
full-width-at-half-maximum of 2.0 Å~ the voxel size). Linear regression coefficients 
(beta-weights) and t-statistic maps will be calculated. Since fMRI relies on neurovascular 
coupling, which changes due to the vasoactive properties of alcohol, nicotine, and 
caffeine (short term) and for vascular damage (long term for AUD individuals), we will 
model our data with a finite impulse response basis set rather than a “standard” HRF 
model. 
The RAM (Remote Alcohol Monitoring) app was designed and custom built by Co-
Investigator Koffarnus. This application is being used in other funded and approved 
studies, and will be used in this protocol to collect and track breath sample results (BAC) 
and number of drinks per day securely. Participants are provided a username and 
password to login to the app that will be on their phone (or the study provided phone) 
with study personnel help as needed. Participants will open the BAC Measurement 
activity within the app, hold down the button on their BACtrack to turn it on. The device 
will automatically connect, and  a status message in the app will inform the participant  if 
the device connected successfully. When they are ready, participants will press the 
“Measure” button on the screen and follow on-screen instructions to complete the 
measurement submission. To report drinks, participants will have access to a running 
counter you can use to keep track of the number of drinks they have consumed 
throughout the day and they will also be asked to confirm the number of drinks from the 
previous day. This confirmation will meet the requirements for your daily submission of 
drinks per day. To report alcohol withdrawal symptoms, participants will report the 
maximum severity of alcohol withdrawal symptoms that they experienced in the day. 
They are instructed to contact the study team immediately if they are concerned about 
their withdrawal symptoms. 
 
 
 
8.5 Who will transcribe or code audio and/or video recordings?: 
 
N/A 
 
8.6 Include a description of any deception to be used in the study. Include 
justification for the use of deception (why the deception is necessary), 
describe the debriefing process, and describe how the study meets all the 
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following criteria  for alteration of consent (deception is considered an 
alteration of informed consent): 
• The research involves no more than minimal risk to the subjects 
• The alteration will not adversely affect the rights and welfare of the 
subjects 
• The research could not practicably be carried out without the 
alteration/deception 
• (Optional but encouraged in most cases) Subjects will be provided with 
additional pertinent information after participation (i.e., debriefing for 
studies involving deception)  
 
 
N/A 
 
 
8.7 If the study involves long-term follow-up (once all research related 
procedures are complete), describe what data will be collected during the 
follow up period and when it will occur:  
 
N/A 
 
 
 
 
 
9.0 
Data and Specimen Long Term Storage and Use 
9.1 If you will store data or specimens for future use, describe where you will 
store the data or specimens, how long they will be stored, and how and by 
whom the data or specimens will be accessed: 
 
All participant data, including electronic data, will be stored in secure places to protect 
confidential participant information. Secured places will include locked filing cabinets, 
locked rooms accessible only to study personnel, and/or password-protected databases. 
Moreover, all data will be quality controlled in preparation for data analyses. All 
discrepancies in data entry will be checked against the raw data source, and the correct 
data entry will be used. All data entered into spreadsheets and databases will be coded by 
participant ID number and not by name (i.e., first and last name), stored in a master ID 
log. The master ID log will be stored in REDCap, which is HIPAA compliant. 
Additionally, all entered data will be backed up on secure password-protected servers. 
Computers used in the studies will also be password protected, accessible only by study 
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personnel. Computers and  password-protected servers used for this study are Virginia 
Tech secured and managed. We will provide certification of IRB approvals of the study 
protocol to NIAAA prior to screening study participants. VT IRB regulations will be 
strictly adhered to in the conduct of the proposed research. Specifically, prior to 
implementation of any protocol changes, amendments will be submitted to the IRB for 
approval. Data will be stored for three years following publication in accordance with 
NIH policy. Individuals on the IRB approved protocol will have access to data in long 
term storage.  
 
9.2 For specimens, list the data to be stored or associated with each 
specimen: 
 
N/A 
 
9.3 Describe the procedures to release data or specimens outside of the 
research team, including the process to request a release, approvals 
required for release, who can obtain data or specimens, and what data 
will be provided with specimens: 
 
Investigators will adhere to all NIH requirements regarding data sharing. Participant data 
collected in this project will be de-identified and made available if requested. We will 
also share the analysis results. As part of this process, all investigators will be required to 
agree to the following conditions: 1) will adhere to the reporting responsibilities; 2) will 
not redistribute the data beyond the requesting individual and named collaborators; 3) 
will give appropriate acknowledgement; 4) will not use the data for commercial purposes; 
and 5) will obtain appropriate ethical approvals. 
Results from research conducted will be shared and disseminated, including: regular 
project meetings, annual meetings, symposia, workshops, and/or conferences for related 
groups. Manuscripts will be written and submitted for publication in peer-reviewed 
journals/conferences, following the NIH Public Access Policy guidelines. All necessary 
ethical approvals will be obtained. 
Raw data will be made available upon request after dissemination of results. 
Access Criteria:           
Data requests will be reviewed by the principal investigator and data will be shared with 
the expectation of acknowledgment of funding source and primary study team. 
 
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9.4 Describe the identifiers to be included with stored data or specimens, as 
well as any key or code that could be used to make them identifiable. 
Describe where the code will be stored, who will have access to it, and 
when it will be destroyed: 
 
All screened participants are assigned study IDs that are thereafter associated with all 
collected data, whether paper or electronic. The electronic de-identified data is stored on 
the Bickel shared server which is password protected and only accessible to members of 
the research team on the VT IRB approved protocol. Non-electronic data that is collected 
is stored in participant specific binders identified only by study ID. These binders are 
stored in a locked file room inside a locked office within ARRC, accessible to only 
members of the research team on the VT IRB approved protocol. 
Study ID and full name are available together electronically only in REDCap (Harris et 
al. 2009), a widely used secure web-based application that enables us to build and 
maintain a participant database. Specifically, we use REDCap to collect demographic and 
other screening criteria for eligibility for study enrollment. This service is password 
protected and has been approved by Virginia Tech IRB. Personnel with access to 
REDCap will be approved on the IRB protocol and will be limited to personnel directly 
involved in recruitment, enrollment, and eligibility verification. We use a REDCap pre-
screening survey to determine appropriateness for enrollment of ongoing studies within 
our lab. REDCap assigns a number to each survey completer and we use this ID for study 
data. If participants agree to be contacted about future research opportunities, we retain 
their information in the secure REDCap database separate from any study data. 
 
9.5 Please select the identifiers you will obtain (whether directly from 
participants or from another source), including but not limited to: 
 
☒ 
Name 
☒ 
Geographical subdivisions smaller than a state, including street address, 
city, county, precinct, zip code, and equivalent geocodes (note, the initial 
three digits of a zip code are not considered identifiable) 
☒ 
Elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death, and 
single year of age over 89 and all elements of dates (including year) 
indicative of such age (note, such ages and elements may be aggregated 
into a single category of age 90+) 
☒ 
Phone numbers 
☐ 
Fax numbers 
☒ 
Electronic mail addresses (e-mail) 
☒ 
Social Security numbers 
☐ 
Medical record numbers 
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☐ 
Health plan beneficiary numbers 
☐ 
Account numbers 
☐ 
Certificate/license numbers 
☐ 
Vehicle identifiers and serial numbers, including license plate numbers 
☐ 
Device identifiers and serial numbers 
☐ 
Web Universal Resource Locators (URLs) 
☐ 
Internet protocol (IP) address numbers 
☐ 
Biometric identifiers, including finger and voice prints (audio recording) 
☐ 
Full face photographic images and any comparable images (including 
video recording) 
☐ 
Student record number or identification number   
☐ 
User name for online or computer accounts 
☐ 
Any other unique identifying number, characteristic, or code (note this 
does not mean the unique code assigned by the investigator to code the 
data): Click here to explain.   
 
10.0 Sharing of Results with Subjects 
10.1 Describe whether you will share results (study results or individual subject 
results, such as results of investigational diagnostic tests, genetic tests, or 
incidental findings) with subjects or others (e.g., the subject’s primary care 
physician). If so, describe how you will share the results and include this 
information as part of the consent document. Upload materials you will use 
to explain the results to subjects: 
 
We will not share any results with the study participants. In the event of incidental 
findings, we will follow the established protocol highlighted in the NIAAA Data and 
Safety Monitoring Plan (DSMP) for the R01 associated with this project. As an example, 
we will review our current procedure for handling incidental neuroimaging findings 
below: 
Specific to incidental neuroimaging findings: The Human Neuroimaging Lab at Virginia 
Tech has a standardized approach to incidental findings across approximately 60 
currently active protocols (including scanning over 150 individuals with AUD). 
Moreover, our process is consistent with the best practices recommendations of the 
NIMH “MRI Research Safety and Ethics: Points to Consider” whitepaper 
(https://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/mri-
research-safety-ethics_33826.pdf). Furthermore, our procedures conform with those 
reported in the literature as appropriate for our research setting. During the consenting 
process, participants are informed that the scans that will be performed in the study are 
not the same as those that would be used in a clinical setting, and thus have limited 
diagnostic value. Further, some of the scans require subsequent data analysis and would 
never be read by a neuroradiologist. As is common and acceptable in many academic 
institutions, we do not have a neuroradiologist on staff to read every scan. Our policy 
(which is communicated to all participants verbally and written in the consent document): 
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"This is not a study to diagnose these structures. Your brain images will not be read by a 
doctor who specializes in reading brain images. If something abnormal is observed by 
chance, we will tell you. You will then be counseled as to what clinical referral would be 
appropriate. We are not qualified to make any diagnosis, nor is this fMRI of diagnostic 
quality for medical purposes. In the event of an incidental positive pregnancy test finding, 
the study personnel will share the results with you. They will counsel you as to what 
clinical referral might be appropriate." 
We also communicate, however, that we will err on the side of caution in communicating 
with them if we do observe a possible abnormality. The DSMB will review these 
procedures, and their adequacy of protection against risk, at each semi-annual DSMB 
meeting. 
 
11.0 Study Timelines 
11.1 Describe: 
● 
The duration of an individual subject’s participation in the study (for 
example, 1 hour, 2-4 weeks, 3-5 years). 
● 
The amount of time expected to enroll all study subjects (weeks, 
months, years, etc.) 
● 
The amount of time expected for the investigators to complete this 
study including primary data analyses. 
 
The total study is expected to take up to approximately 15 weeks.  The study team has 
projected this study to take approximately 2 years to complete enrollment and data 
analysis.  
 
 
 
12.0 Inclusion and Exclusion Criteria 
12.1 Describe how you will screen individuals for eligibility. When will 
screening occur and what procedures will you use? Upload any screening 
scripts or surveys to Protocol Management:  
 
We have developed and are currently using a separate pre-screening survey (online/phone 
pre-screen), which occurs prior to enrolling participants into our intervention protocols. 
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This pre-screening ensures that participants are likely to meet all inclusion/exclusion 
criteria (e.g., MRI scanner eligibility) prior to enrolling into any randomized study. This 
initial pre-screening (online/phone) may be completed online or over the phone. 
Information is stored in REDCap, which is HIPAA compliant and password protected. If 
participants seem eligible from the online/phone screen, they will be scheduled for the in-
lab screen in the laboratory to further determine eligibility and appropriateness for this 
specific intervention-based study. 
 
12.2 Describe the eligibility criteria that define who will be included and who 
will be excluded from enrollment for each procedure of your study. 
Include any geographic criteria (e.g., Virginia Tech undergraduate 
students, a national sample of adults with engineering degrees, minors 
aged 8-12 in the New River Valley, university faculty in Virginia and 
Paris, France): 
 
Inclusion criteria for signing consent will require that participants: (1) demonstrate high-
risk or harmful drinking (AUDIT>15; i.e., 16 or higher), (2) be between 21-65 years old, 
and  (3) have a desire to quit or cut down on their drinking, but do not have proximate 
plans to enroll in treatment for AUD during the study period. 
Exclusion criteria include: (1) meeting moderate to severe DSM-5 criteria for substance-
use disorders other than alcohol, nicotine, or marijuana, (2) having a current diagnosis of 
any psychotic disorder, (3) having a history of seizure disorders or traumatic brain injury 
they have not fully recovered from, (4) having any contraindication for participation in 
the fMRI session, or (5) reporting current pregnancy or lactation. 
 
12.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of these 
populations as subjects in your research unless you indicate them in the 
description of your subject population.) 
● 
Minors, as defined by state law where the study is performed 
(infants, children, teenagers) 
● 
Pregnant women (can be included in minimal risk studies by 
mentioning in section 13.1) 
● 
Prisoners (including all incarcerated individuals) 
● 
Adults not capable to consent on their own behalf 
 
 
 This project will focus on individuals with alcohol use disorder, aged 21 to 65. We will 
not include individuals under the age of 21 in compliance with Virginia state law.  
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Vulnerable subjects, such as individuals with cognitive impairments, minors, prisoners, 
and pregnant women will be excluded.  
 
 
13.0 Vulnerable Populations 
13.1 If the research involves individuals who are vulnerable to coercion or 
undue influence, please describe additional safeguards you will include to 
protect their rights and welfare. Consider the applicable items listed 
below: 
● 
If the research involves Virginia Tech students, indicate whether 
these are students of any of the investigators. If so, describe whether 
the activities will take place during class time as part of the 
curriculum and the steps you will take to reduce the possibility that 
students feel obliged to participate in order to improve their course 
grade. The HRPP can provide further guidance as needed. Describe 
whether you will request access to student records (e.g., SAT, GPA, 
GRE scores). 
● 
If the research involves employees of Virginia Tech or the research 
sponsor, describe steps you will take to ensure that the employees 
are freely participating and describe how their data will be 
protected from inspection by their supervisors.  
● 
If the research involves Virginia Tech NCAA athletes, you must 
obtain approval from the athletic department.  
● 
For research involving Montgomery County Public Schools, you 
must obtain county approval (after obtaining contingent Virginia 
Tech approval). Other locales have different requirements; please 
check on these and describe here. Approval is typically granted by 
the superintendent, principal, and classroom teacher (in that order). 
Approval by an individual teacher is insufficient. School approval, in 
the form of a letter or a memorandum should be uploaded as a 
supporting document. 
● 
If the research involves pregnant women, review “CHECKLIST: 
Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information in this protocol. 
● 
If the research involves prisoners, review “CHECKLIST: Prisoners 
(HRP-415)” to ensure that you have provided sufficient information 
in this protocol. 
● 
If the research involves persons who have not attained the legal age 
for consent to treatments or procedures involved in the research 
(minors), review the “CHECKLIST: Minors (HRP-416)” to ensure 
that you have provided sufficient information in this protocol. 
● 
If the research involves cognitively impaired adults, review 
“CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure 
that you have provided sufficient information in this protocol. 
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 This research study will not include any vulnerable populations.  
 
 
 
14.0 Number of Subjects 
14.1 Indicate the total number of subjects to be enrolled and how this number 
was determined (e.g., sample size calculation [show], number of available 
subjects in a finite pool, number of tests funding award would allow):  
 
Although we have observed large effect sizes of EFT on DD in AUD participants in our 
preliminary studies (pre-post d=1.6; post-only d = 0.68), we used a more conservative 
medium effect size (f= 0.25) to inform sample sizes to increase power to detect effect on 
the broader range of measures proposed here (e.g., intensity of demand). Using the 
method proposed by Borm, Fransen, and Lemmens, and a pre- and post-measurement 
correlation of 0.70218, 76 total participants would be needed to complete this study (38 
participants per group), assuming a type 1 error rate of 0.01 and 95% statistical power, 
based on an ANCOVA comparing the intervention while using the baseline measure as a 
fixed-effect covariate in the analysis. 
We have been successfully recruiting individuals with AUD in our community for the 
past 8 years. Based on these 8 years of experience recruiting alcohol users into studies of 
comparable length and complexity, we anticipate that over 80% of consented participants 
will be eligible (i.e., randomized) and about 65% of those eligible individuals will 
complete this study. Thus, to achieve a final sample size of 76, we anticipate consenting 
200 participants. We plan to enroll more than our average attrition rate because of the 
increased procedures and the time demands of the study.  
 
14.2 If this is a multi-site study, indicate the number of subjects to be enrolled 
at this site and the total to be enrolled from all sites: 
 
N/A 
 
14.3 If applicable, indicate the number of potential subjects you expect to 
screen for enrollment, and the number of subjects you will need to 
complete the research procedures: 
 
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We have developed and are currently using a separate pre-screening protocol, which 
occurs prior to enrolling participants into our intervention protocols, in order to 
effectively decrease attrition in our studies by ensuring that participants meet most 
inclusion/exclusion criteria (e.g., MRI scanner eligibility) prior to enrolling into the 
randomized study. Given that this separate screening protocol is used for all currently on-
going studies in the lab, we cannot accurately estimate the total number of potential 
participants we expect to screen. However, as described above, we anticipate enrolling 
200 participants in order to complete a total of 76 participants. We plan to enroll more 
than our average attrition rate because of the increased screening procedures and the time 
demands of the study. Additionally the first few participants enrolled into the study may 
be pilots. 
 
14.4 If the study has more than one procedure, indicate the total number of 
subjects to undergo each procedure separately: 
 
 All participants will undergo all sessions unless they withdraw from the study. 
 
15.0 Recruitment Methods 
15.1 Describe when, where, and how you will recruit potential subjects: 
 
Participants will be recruited from the community via posted or mailed flyers/postcard, 
word of mouth, and electronic advertisements (e.g., Craigslist, Facebook). Participants 
will be contacted if they have given prior permission (through previous informed consent 
form) or by completion of a confidential pre-screening questionnaire. Services from 
mailing list companies may be used.  
 
Group posting rules will be checked and followed when posting to community pages. If 
posting requires approval, or if it is unclear if our post meets group rules, the research 
staff will send the following message to a group administrator along with the picture/post 
to be shared: “Hello! My name is ____ and I work for the ____ lab(s) at the Fralin 
Biomedical Research Institute at Virginia Tech Carilion. We are currently recruiting for 
an Institutional Review Board approved study which investigates decision-making in 
individuals who drink alcohol. Would it be alright if I posted the attached ad to this group 
for those who might be interested in participating?” All posted materials, including 
captions and images, will be submitted to and approved by the VT IRB prior to reaching 
out to community pages. In situations where the post would violate group rules or is 
rejected by a page administrator, it will not be shared on that page. If an administrator 
reaches out to the study staff following posting and requests the post be taken down, it 
will be taken down. 
 
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In addition, we will partner with BuildClinical to accelerate enrollment. BuildClinical is a 
data-driven platform that helps academic researchers recruit participants for research 
studies more efficiently using social media, software, and machine learning. They have 
worked with IRBs in the US to ensure adherence to all the appropriate guidelines and 
procedures. They utilize study-specific advertisements to engage participants on digital 
platforms such as Facebook, Google, WebMD, etc., and redirect them to a study-specific 
landing page should they click it. On the landing page, the person can complete an online 
pre-screen questionnaire that gets routed into BuildClinical's platform. BuildClinical's 
Secure Socket Layer (SSL) software, which encrypts all inputted information is HIPPA 
compliant and keeps potential participant information private. 
 
 
15.2 Describe the source of subjects (for example, clinic patients with specific 
conditions, students in the library, community members at a gathering, or 
members of a local gym): 
 
Participants will be recruited from the community via posted or mailed flyers/postcards, 
word of mouth referrals, and electronic advertisements (e.g., Craigslist, Facebook). 
Participants will be contacted if they have given prior permission (through previous 
informed consent form) or by completion of a confidential pre-screening questionnaire. 
Services from mailing list companies may be used. 
In addition, we will partner with BuildClinical to accelerate enrollment. BuildClinical is a 
data-driven platform that helps academic researchers recruit participants for research 
studies more efficiently using social media, software, and machine learning. They have 
worked with IRBs in the US to ensure adherence to all the appropriate guidelines and 
procedures. They utilize study-specific advertisements to engage participants on digital 
platforms such as Facebook, Google, WebMD, etc., and redirect them to a study-specific 
landing page should they click it. On the landing page, the person can complete an online 
pre-screen questionnaire that gets routed into BuildClinical's platform. BuildClinical's 
Secure Socket Layer (SSL) software, which encrypts all inputted information is HIPPA 
compliant and keeps potential participant information private. 
 
 
15.3 Describe the methods that you will use to identify potential subjects: 
 
Participants will be recruited from the community via posted or mailed flyers/postcards, 
word of mouth referrals, and electronic advertisements (e.g., Craigslist, Facebook). 
Participants may contact the lab directly via email, facebook, phone, walk-in, face-to-face 
at tabling events, or completing the online pre-screening questionnaire. Participants will 
also be contacted directly if they have given prior permission (through previous informed 
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consent form) or by completion of a confidential pre-screening questionnaire.  Services 
from mailing list companies may be used. 
 
In addition, we will partner with BuildClinical to accelerate enrollment. BuildClinical is a 
data-driven platform that helps academic researchers recruit participants for research 
studies more efficiently using social media, software, and machine learning. They have 
worked with IRBs in the US to ensure adherence to all the appropriate guidelines and 
procedures. They utilize study-specific advertisements to engage participants on digital 
platforms such as Facebook, Google, WebMD, etc., and redirect them to a study-specific 
landing page should they click it. On the landing page, the person can complete an online 
pre-screen questionnaire that gets routed into BuildClinical's platform. BuildClinical's 
Secure Socket Layer (SSL) software, which encrypts all inputted information is HIPPA 
compliant and keeps potential participant information private. 
 
 
15.4 Describe materials that you will be use to recruit subjects. Attach copies 
of these documents with this protocol in Protocol Management and be 
sure to include the IRB protocol number on each document.  
● For flyers, attach the final copy of printed flyers.  
● For Virginia Tech News, Facebook postings and ads, newspaper ads, 
websites, MTurk/SONA/online survey systems, etc., attach the final 
wording and graphics to be used.  
● For email recruitments, please include the subject line.  
● For advertisements meant for audio broadcast, please submit the 
wording of the advertisement prior to taping (to avoid having to re-
record with approved language) and submit the final recorded version 
for IRB review before use.  
● Describe any compensation to subjects. Separate compensation into 
appropriate categories, such as: reimbursement for expenses, time and 
effort, and additional incentives for study participation.  For each 
category, specify the amount (including any pro-rated amount), schedule, 
and method of payment. 
 
Flyers to be used in community and online posting are attached. 
Compensation. The compensation for this study is based an hourly rate of approximately 
$20/hr. Compensation also includes incentives for participant performance and 
attendance. 
Compensation will follow the following schedule: 
Session 1 = $15    
Session 2 = $25 
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Baseline Monitoring = $1 for daily self-reports and $1 per BAC sample submission (x3). 
During baseline monitoring, participants who submit all required reports in a given day 
will receive a $1 bonus for that day. Thus they can receive $1 per information submitted 
or $5 for submitting all required information.    
= up to $35 (for 7 days; total amount will be more/less depending on 
the exact number of baseline monitoring days completed by participant)  
Session 3 
 
MRI = $15** 
 
Session = $30 
Monitoring Part 1 = $1 for daily self-reports and $1 per BAC sample submission (x3), 
and $1 per reply to cue text (x2). Participants who submit all required reports in a given 
day will receive a $4 bonus for that day. Thus they can receive $1 per information 
submitted or $10 for submitting all required information.   
 
 
= up to $140 (for 14 days; total amount will be more/less depending on the 
exact number of monitoring days completed by participant)  
 
Session 4 
 
Session = $30 
Monitoring Part 2 = $1 for daily self-reports and $1 per BAC sample submission 
submission (x3), and $1 per reply to cue text (x2). Participants who submit all required 
reports in a given day will receive a $4 bonus for that day. Thus they can receive $1 per 
information submitted or $10 for submitting all required information.   
 
 
= up to $140 (for 14 days; total amount will be more/less depending on the 
exact number of monitoring days completed by participant)  
 
Session 5 
 
MRI = $15** 
 
Session = $30 
Session 6 = $50 
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Study Completion Bonus***: $150 
***Participants receive if they complete all six sessions 
As an incentive for session attendance, participants may participate in a fishbowl drawing 
contingent upon arriving on time for the sessions. Some fishbowl drawings may result in 
receipt of either a small, medium, or large prize and some may result in verbal positive 
reinforcement. The prizes may be in the form of $1.00, $5.00, and $10.00 rewards. The 
odds of receiving a prize will be: “Good Job” (odds 13/50), $1 (odds 25/50), $5 (odds 
10/50), $10 (odds 2/50).   
Additionally, participants will be eligible for a $10 Scan bonus** per MRI. Participants 
will receive this bonus if they remain still and awake for the fMRI scan. 
Total Compensation: approximately $700 for completion of all sessions and remote 
reports, plus bonuses. 
We note that compensation will be prorated proportional to the amount of sessions or 
duration of session completed.  
In addition, scheduling barriers will be minimized by offering participants a flexible 
session schedule and travel compensation, if necessary, etc. 
Participants may be compensated for travel expenses (i.e., travel time) if traveling from 
outside of Roanoke to Roanoke for study sessions. For example, traveling from 
Blacksburg to Roanoke for a study session. In these cases, participants will receive 
additional compensation consistent with minimum wage (e.g., approximately $10 per 
hour) for their round trip travel. Currently there are no costs for parking at the FBRI, 
where the study sessions occur. 
 
To allow for payments that are both convenient and rapidly available, we may pay 
participants with reloadable prepaid cards through Greenphire ClinCard 
(www.greenphire.com), an FDIC-insured payment provider that specializes in clinical 
trial stipend payments that comply with IRB privacy regulations and considerations. At 
the beginning of the study, the participant will receive a prepaid MasterCard debit card 
that can be used anywhere that accepts MasterCard. As payments are earned in the course 
of the study, additional funds will be added to the account for that participant. Payments 
will be added to the participant's ClinCard within 24 hours of the session 
completion.  Funds are immediately available when added and participants can check 
their balance as desired. This system will allow frequent, immediately available 
payments. Payments may also be made via check or cash; however remote debit card 
payments and checks will be used most often. 
 
 
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16.0 Withdrawal of Subjects 
16.1 Describe circumstances under which you anticipate subjects could be 
withdrawn from the research without their consent: 
 
Participants may be withdrawn from the research without their consent if they become 
ineligible based on inclusion/exclusion criteria or learning of a contraindication for 
continuing, they demonstrate inconsistent delay discounting rates at the baseline session, 
there is an emergency, and/or they are not adherent with ARRC policies.  
 
16.2 If applicable, describe any procedures for orderly termination (e.g., 
discontinuation of a study drug or debriefing after a behavioral 
intervention): 
 
If a participant is withdrawn from the study, he or she will be informed that we have 
collected all the data required from their participation. If a participant is withdrawn or 
voluntarily discontinue, their compensation for the study will be pro-rated accordingly. 
 
16.3 Describe procedures that you will follow when subjects withdraw from the 
research, including partial withdrawal from procedures with continued 
data collection (e.g., participant declines to continue with regular blood 
draws, but continues with periodic behavioral questionnaires): 
 
If a participant is withdrawn or discontinued, they will be withdrawn from the entire 
study. 
 
 
17.0 Risks to Subjects 
17.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include for the IRB’s consideration a description of the 
probability, magnitude, duration, and reversibility of the risks. Consider 
physical, psychological, social, legal, privacy, and economic risks. Do not 
indicate “No risk” or “N/A.” Instead, for studies with very low risk (e.g., 
anonymous online questionnaire on a mundane topic) indicate “The 
investigators are not aware of any risks from participation in this study.” 
or “No more than risks than are found in everyday life.” The example 
consent form presents a tabular method for risk information, which you 
can also use here. Common risk types include: 
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● Physical (e.g., potential for pain, discomfort, infection) 
● Psychological (e.g., potential for stress, discomfort, and/or 
embarrassment) 
● Social (e.g., potential for discrimination or stigmatization and 
disruption of personal and family relationships) 
● Legal (e.g., potential for disclosure of illegal activity, negligence) 
● Privacy (e.g., potential for personal information being accessed, used, 
or disclosed without the subjects’ knowledge or consent, breach of 
confidentiality/security) 
● Economic (e.g., potential for individuals to lose access to economic 
services, employment, insurability) 
 
There are minimal risks involved in participation, including: 
1. Adverse emotional reactions: These reactions may be related to changes in drinking, or 
to some of the research tasks. Participants may also feel uncomfortable disclosing 
personal information such as drug use history. 
2. Alcohol withdrawal: At sessions not including alcohol, participants may experience 
alcohol withdrawal symptoms such as shaking, sweating, or chills. 
3. Loss of confidentiality: The research team will employ every effort to maintain 
participant confidentiality, however the loss of confidentiality is a potential risk, 
specifically associated with the collection, storage, and transmission of data via an app. 
4. Incidental findings: Incidental findings including positive pregnancy tests and possible 
neuroimaging abnormalities may occur. 
 
17.2  Indicate the measures you will use to minimize risks and monitor subjects 
for safety. (e.g., asking a subject at regular intervals to rate how they are 
feeling from 1 to 10, or to slowly crouch in order to check their balance.) 
 
Informed Consent. All consenting methods will be conducted using standard operating 
procedures, and all staff (including recruitment staff) will be provided with human 
subjects protection training as well as cultural sensitivity training. All participants will 
enroll on a voluntary basis and sign an IRB-approved consent form prior to study 
participation. 
Participants will be provided with a copy of the consent form following phone or online 
screening by email or mail when possible. To accommodate "walk-in" study screens 
and/or participants unable to receive email or physical mail (e.g., "homeless” without 
physical address, email address, or access to a computer), we will provide a hard copy of 
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the consent form to review. In all cases, participants will be given as much time as 
needed to review the consent and ask any questions. Participants will also be informed 
that they may choose to take the consent with them and return at a later date to enroll into 
the study. During the consent process, participants will be given adequate time in a quiet 
room to read (or further review) the written consent form. 
Research staff will review each element of the written consent form with the potential 
participant. The potential participant will be given the opportunity to ask questions and 
will have as much time as they need to decide whether they would like to participate in 
the study. Staff will reiterate that the potential participant can choose to decline 
participation in the study at that time or at any time thereafter without consequence. The 
potential participant and person obtaining consent will sign the consent form after the 
potential participant verbally states that they understand the conditions of the study, have 
no more questions, and chooses to participate. In addition, an Evaluation to Consent will 
be administered to ensure participants have a good understanding of the study. 
Participants unable to provide informed consent for themselves will not be eligible. 
Participants will be informed that the breathalyzer provided to them in this study should 
not be used as a tool to determine whether research participants should operate a motor 
vehicle or other equipment, or perform any other dangerous act. The participants will be 
informed, verbally and in the informed consent document, that the results of any study 
breath samples using the study provided breathalyzer cannot be used in court.  
 
Protections Against Risk: 
Participants will be screened, using medical history and structured interviews, for a 
history of medical contraindications (e.g., recent myocardial infarction, current 
pregnancy), current unstable medical illness, and psychiatric disorders (including other 
substance use disorders). The studies will be conducted at FBRI. Participants will be free 
to withdraw from the study at any time, and their refusal to continue will not affect other 
medical care. In addition, if participants develop medical problems during the course of 
the study, assessments to determine whether participants should continue will be 
conducted by the Study Physician and necessary referrals will be provided. The risks 
enumerated above will be addressed by the following protections against risk, and 
reviewed by the Data and Safety Monitoring Board: 
1. Adverse emotional reactions: Dr. Kablinger will monitor participants’ adverse 
emotional reactions. 
2. Alcohol withdrawal: In addition, participants who are not drinking alcohol may 
experience alcohol withdrawal symptoms during any of the laboratory sessions or if they 
are drinking less than they normally do during the proof-of-concept field study portion of 
this study. At each laboratory session, participants will complete the Alcohol Withdrawal 
Symptom Checklist (AWSC), a validated 17-item checklist of symptoms in which the 
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participant rates their experience from 0 (“Not at all”) to 4 (“Extreme”). A score of >23 
on this checklist requires medical oversight for alcohol withdrawal and will trigger the 
research staff to contact Dr. Kablinger. Dr. Kablinger will speak with the participant to 
determine appropriateness and safety to continue in the study and to provide medical 
consultation and/or a referral to a clinic/primary care physician. If the participant 
produces a score of >23 on the checklist, Dr. Kablinger will be contacted to assess the 
participant’s risk and refer as necessary. We have successfully implemented these 
procedures with Dr. Kablinger in our previous and ongoing studies. 
3. Loss of confidentiality: The use of ID numbers for participants, and keeping all data in 
a locked cabinet in locked offices, will protect confidentiality. Password protected 
computer databases will have coded identifiers, and a Certificate of Confidentiality will 
be obtained. Master files linking subject names to study ID numbers will be kept separate 
from the data. These screening, monitoring, and confidentiality procedures have been in 
effect for decades and for thousands of participants across the various protocols 
employed by our group across various institutions. Although there is a potential risk to 
confidentiality, there are actions taken to reduce the risk to confidentiality via collection 
of data through an app. First, all transmissions from the breathalyzer to the phone and 
from the phone to University of Kentucky are encrypted and secured. The RAM app is 
HIPAA compliant. Additionally, servers are password protected and located behind 
firewalls to minimize the risk to confidentiality. 
 
4. Incidental findings: In the event of an incidental positive pregnancy test finding, the 
study personnel will share the results with the participant, and will counsel the participant 
as to what clinical referral might be appropriate. . Incidental findings are an important 
factor in the risk/benefit analysis of neuroimaging studies. The Human Neuroimaging 
Lab at Virginia Tech has a standardized approach to incidental findings across 
approximately 60 currently active protocols (including scanning over 150 individuals 
with AUD) approved by two separate IRBs (Virginia Tech and Carilion Clinic). 
Moreover, our process is consistent with the best practices recommendations of the 
NIMH “MRI Research Safety and Ethics: Points to Consider” whitepaper 
(https://www.nimh.nih.gov/about/advisory-boards-and-
groups/namhc/reports/mriresearch-safety-ethics_33826.pdf). Furthermore, our procedures 
conform with those reported in the literature as appropriate for our research setting. 
During the consenting process, participants are informed that the scans that will be 
performed in the study are not the same as those that would be used in a clinical setting, 
and thus have limited diagnostic value. Further, some of the scans require subsequent 
data analysis and would never be read by a neuroradiologist. As is common and 
acceptable in many academic institutions, we do not have a neuroradiologist on staff to 
read every scan. Our policy (which is communicated to all participants verbally and 
written in the consent document):  
 
"This is not a study to diagnose these structures. Your brain images will not be read by a 
doctor who specializes in reading brain images. If something abnormal is observed by 
chance, we will tell you. You will then be counseled as to what clinical referral would be 
appropriate. We are not qualified to make any diagnosis, nor is this fMRI of diagnostic 
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quality for medical purposes. In the event of an incidental positive pregnancy test finding, 
the study personnel will share the results with you. They will counsel you as to what 
clinical referral might be appropriate " 
  
 
We also communicate, however, that we will err on the side of caution in communicating 
with them if we do observe a possible abnormality. Finally, we will institute a DSMB 
that includes a radiologist and will, on a semi-annual basis, review our process for 
recognizing and reporting incidental findings in this project. 
 
 
 
17.3 If applicable, indicate which procedures might have risks to the subjects 
that are currently unforeseeable. This will be rare, and usually applicable 
when testing a new drug or device or a new use of an existing drug or 
device: 
 
N/A 
 
17.4 If applicable, indicate which procedures might have risks to an embryo or 
fetus should the subject be or become pregnant: 
 
N/A 
 
17.5 If applicable, describe risks to others who are not subjects (e.g., collection 
of sensitive health data that might affect sexual partners if disclosed, 
mandatory reporting of abuse, DNA testing that might affect family 
members or relationships): 
 
N/A 
 
18.0 Potential Benefits to Subjects 
18.1 Describe the potential benefits that individual subjects might experience 
from participating in the research. Include the probability, magnitude, and 
duration of the potential benefits, as this will be useful to the IRB’s 
risk:benefit analysis. Do not include benefits to society or others. Do not 
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list monetary or non-monetary compensation for participation, as this is 
not a benefit These should be included in section 2 or 3 of this document: 
 
Participants may benefit from possible improvement in self-control from this study, plus 
education about research participation. The project involves minimal risk to 
confidentiality or other personal rights or to physical or emotional health. The results 
from this behavioral economic study will inform the development of new treatments for 
problem drinking. Thus, in general, the expected benefits outweigh the very minimal 
risks to participants. 
 
18.2 If applicable, specify that there are no anticipated direct benefits for 
participants:  
 
There are no anticipated direct benefits for participation in this study. 
 
 
 
 
19.0 Data Management and Confidentiality 
19.1 Describe procedures that you will use for quality control to ensure validity 
of collected data: 
 
The Co-PIs and the IRB will oversee monitoring of the data collection procedures. These 
procedures will be reviewed regularly in a number of settings. For instance, issues 
pertaining to data validity and integrity will be addressed formally during regularly 
scheduled study personnel meeting in which all study personnel, including the Co-PIs, 
will be in attendance. Issues pertaining to participant safety also will be addressed at 
these meetings. Moreover, the Co-PIs and the Senior Research Associate Project 
Manager will meet on a regular basis to discuss these topics further.  
 
19.2 Describe any existing data or biospecimens you will obtain as part of this 
study. Include:  
● 
Variables or samples to be obtained  
● 
Source of the data or specimens 
● 
Your authorization to access or receive the data or biospecimens 
● 
Whether the data or biospecimens are publicly available 
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● 
Whether the data or specimens you receive will contain identifiers  
 
N/A 
 
19.3 Describe the steps that you will take to handle and secure study data 
during data collection, storage, use, and transmission.  Include 
information about training of study staff, authorization of access, 
password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc.: 
 
Access to study data will be limited to study personnel who have completed the IRB 
Human Subjects Tutorial and who have been delegated the responsibility of data 
collection, management, or analyses by the PI.  
All screened participants are assigned study IDs that are thereafter associated with all 
collected data, whether paper or electronic. The electronic de-identified data is stored on 
the Bickel shared server which is password protected. Non-electronic data that is 
collected is stored in participant specific binders identified only by study ID. These 
binders are stored in a locked file room inside a locked office within ARRC. Study ID 
and full name are available together electronically only in REDCap (Harris et al. 2009), a 
widely used secure web-based application that enables us to build and maintain a 
participant database. Specifically, we use REDCap to collect demographic and other 
screening criteria for eligibility for study enrollment. This service is password protected 
and has been approved by Virginia Tech IRB.  
A BuildClinical specific screen form will also be used to collect demographic and other 
screening criteria for eligibility for study enrollment. BuildClinical keeps data secured 
using server authentication and data encryption, and uses the same standard network 
security methods as healthcare institutions. They encrypt all data, whether in transit or at 
standstill. Data is transmitted via HTTPS, and per BuildClinical, the Transport Layer 
Security (TLS) 1.2 has a 2048-bit server key length with industry-leading modern 
browsers. Screening information stored by BuildClinical can be accessed by authorized 
members of the VT research team. The only individuals outside of the research team that 
will have access to these data is the BuildClinical internal team that needs the information 
to help the research team with improvements on the campaign. BuildClinical maintains 
the right to the information prospective participants provide at screening and will retain 
the data in perpetuity. The BuildClinical terms of service and privacy policy are available 
on the landing page when prospective participants first link to the site. All participants 
that screen for the study using the BuildClinical form will also be assigned study IDs that 
are thereafter associated with all collected data, whether paper or electronic. 
In addition, as an NIH funded study, this protocol will include a certificate of 
confidentiality.  
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19.4 For multi-site studies, describe how data or specimens will be handled 
and secured for each site (e.g., central or disseminated data storage, data 
coordinating center): 
 
N/A 
 
19.5 Describe the plan for data disposition following the conclusion of the 
study (e.g., long term maintenance of data, data destruction methods).  
● 
What information will be included in the long term storage of data 
or specimens? 
● 
How long will the data or specimens be stored? 
● 
Where and how data or specimens will be stored? 
● 
Who will have access to the data or specimens during long term 
storage? 
● 
Who is responsible for receipt or transmission of the data or 
specimens? 
● 
How will data or specimens be shared or transported? 
● 
When and how will personal identifiers be destroyed? 
 
 
All data will be securely stored for 3 years following final publication of the study 
results.  Data will be deleted at the designated time. Information included in the long term 
data storage will include eligibility information, survey responses, alcohol use data, and 
demographic information. In addition, informed consents will be stored separately from 
data labeled by study ID. This study will not involve any long term storage of specimens. 
Long term storage of the electronic study data will occur in password protected Virginia 
Tech servers and paper study data will be stored in locked rooms. All data (paper and 
electronic) will only be accessible by study personnel approved by the PI. The receipt or 
transmission of the data will be the responsibility of study personnel designated by the PI. 
Data that does not contain any personally identifying information may be shared with 
other investigators as needed for data analyses. 
 
 
 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20.1 Describe the steps that you will take to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on with whom 
they interact or to whom they provide personal information (e.g., 
collecting the minimal amount of private information required to complete 
the study, protecting the data once it is obtained):  
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Original signed consent forms will be stored in a study specific binder for this protocol. 
This binder is stored behind a locked door in our project manager’s office. Importantly, 
these consent forms are separate from all other study documents, identifying information, 
and data collection.  
All screened participants are assigned study IDs that are thereafter associated with all 
collected data, whether paper or electronic. The electronic de-identified data is stored on 
the Bickel shared server which is password protected. Non-electronic data that is 
collected is stored in participant specific binders identified only by study ID. These 
binders are stored in a locked file room inside a locked office within ARRC. Study ID 
and full name are available together electronically only in REDCap (Harris et al. 2009), a 
widely used secure web-based application that enables us to build and maintain a 
participant database. Specifically, we use REDCap to collect demographic and other 
screening criteria for eligibility for study enrollment. This service is password protected 
and has been approved by Virginia Tech IRB.  
 
20.2 Describe steps that you will take to make subjects feel at ease with the 
research situation in terms of the questions being asked and the 
procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in 
response to questions, examinations, and procedures (e.g., use of a same 
gender investigator to place sensors on the torso, a private changing area 
if clothing must be changed, sensitivity when discussing  pregnancy testing 
with subjects, making it clear on surveys that participants can discontinue 
at any time, not asking questions about private or sensitive issues unless 
necessary for the research): 
 
The Addiction Recovery Research Center (ARRC) has private offices and interview 
rooms, 12 individualized computer testing and/or interview rooms. In all cases in which 
private information is collected, the participant is in a private interview room with a 
trained research staff member. The lab is equipped with white-noise machines to reduce 
excess noise. All participants are informed that their information will be kept entirely 
confidential. 
 
20.3 Describe how you plan to access existing sources of information about the 
subjects (e.g., medical records, grades) and how you will protect 
participant privacy through the data security plan: 
 
All ARRC participants who have previously given consent to be contacted for future 
studies will be searchable in the RedCap database, using the report feature. Eligibility 
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criteria, based on demographics and current use, may be reviewed to contact potentially 
eligible participants for this study.  
 
20.4 Describe any required reporting that might occur as a result of your 
research questions, study populations, and data collection methods. 
Examples for Virginia and Virginia Tech include: 
• Any suspicions (e.g., circumstantial, disclosed) of child abuse (physical, 
emotional, sexual) and neglect  
• Sexual discrimination and/or sexual violence that involves a student 
• Disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan) 
• Disclosure or signs of desire to harm others (i.e., homicidal ideation 
and/or plan) 
• Suspected abuse, neglect or exploitation of vulnerable adults (e.g., 
individuals with a disability, elderly persons) 
 
 
We will report any disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan). In the event of this disclosure study staff will follow ARRC’s SOP related 
to suicidal ideation. This SOP is attached. 
 
 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety monitoring is required when research involves greater than minimal risk 
and is sometimes appropriate for other studies. 
21.1 Describe: 
● 
The plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe  (e.g., 
periodic reporting to the IRB, establishing a data monitoring 
committee, reporting data monitoring committee findings to the IRB 
and the sponsor). 
● 
What data you will review, including safety data, unexpected events, 
and data that show the ability to produce the intended results. 
● 
How the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with subjects). 
● 
The frequency of data collection, including when safety data 
collection starts. 
● 
Who will review the safety data and with what frequency. 
● 
The statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
● 
Any conditions that will trigger an immediate suspension of the 
research (e.g., a serious adverse event). 
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See attached Data Safety and Monitoring Plan associated with the R01 AA027381. 
 
 
 
22.0 Compensation for Research Related Injury 
22.1 If the research involves more than minimal risk to subjects, describe the 
available compensation in the event of research-related injury, if any: 
 
N/A 
 
22.2 Provide a copy of contract language, if any, relevant to compensation for 
research-related injury. At Virginia Tech, this is most common for 
sponsored research: 
 
N/A 
 
23.0 Economic Burden to Subjects 
23.1 Describe any costs that subjects might be responsible for because of 
participation in the research, including any uncompensated costs for items 
such as transportation, missed work, and childcare: 
 
There are no costs to participate in this research study. In some cases, additional 
compensation will be provided for time and travel in order to reduce barriers to 
participation. Participants will be provided with a copy of the consent form following 
phone or online screening by email or mail when possible. To accommodate "walk-in" 
study screens and/or participants unable to receive email or physical mail (e.g., "homeless 
without physical address, email address, or access to a computer), will be given a copy of 
the consent form to review. In all cases, participants will be given as much time as 
needed to review the consent and ask any questions. Participants will also be informed 
that they may choose to take the consent with them and return at a later date to enroll into 
the study. During the consent process, participants will be given adequate time in a quiet 
room to read (or further review) the written consent form. Research staff will review each 
element of the written consent form with the potential participant. The potential 
participant will be given the opportunity to ask questions and will have as much time as 
they need to decide whether they would like to participate in the study. Staff will reiterate 
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that the potential participant can choose to decline participation in the study at that time 
or at any time thereafter without consequence. 
 
24.0 Consent Process 
24.1 Indicate the process by which you will obtain consent for study 
participation. Please upload all consent, parental permission, and assent 
forms, documents, and scripts referenced in this section to Protocol 
Management. 
Describe the following: 
● 
Where the consent process will take place (e.g., clinic waiting area, 
classroom, online) 
● 
The time interval between sharing the consent information with the 
prospective subject and obtaining consent. For lab, interview, and 
focus group studies, the Virginia Tech IRB prefers that subjects have 
at least 24 hours to review the consent form and study information 
before the appointment where consent will be obtained. For simple 
online survey studies, you can typically present the consent 
information immediately before subjects begin participation. 
● 
If applicable, processes to ensure ongoing consent or assent (e.g., 
for multiple sessions; for research in which a minor will turn 18 
during the study; for longitudinal research with minors who will 
later be asked to provide or affirm their assent). 
● 
Please review “SOP: Informed Consent Process for Research (HRP-
090)” for recommended procedure. Describe your process, being 
sure to include: 
o 
The name and role of all study personnel who will be trained 
and certified by the PI to conduct the consent process 
o 
The time that will be devoted to the consent discussion 
o 
Steps that you will take to minimize the possibility of coercion 
or undue influence 
o 
Steps that you will take to gauge or ensure the subjects’ 
understanding 
 
Participants will be provided with a copy of the consent form following phone or online 
screening by email or mail when possible. To accommodate "walk-in" study screens 
and/or participants unable to receive email or physical mail (e.g., "homeless without 
physical address, email address, or access to a computer), will be given a copy of the 
consent form to review. In all cases, participants will be given as much time as needed to 
review the consent and ask any questions. Participants will also be informed that they 
may choose to take the consent with them and return at a later date to enroll into the 
study. During the consent process, participants will be given adequate time in a quiet 
room to read (or further review) the written consent form. Research staff will review each 
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element of the written consent form with the potential participant. The potential 
participant will be given the opportunity to ask questions and will have as much time as 
they need to decide whether they would like to participate in the study. Staff will reiterate 
that the potential participant can choose to decline participation in the study at that time 
or at any time thereafter without consequence.  
Participants will be reminded throughout their study participation that they are 
voluntarily participating in the study as indicated in their original consent form. Research 
personnel are trained to communicate this information during study visits subsequent to 
the initial consent session. 
 
Non-English Speaking Subjects 
● 
Indicate what language(s) other than English are understood by 
prospective subjects or representatives. 
● 
If non-English speakers will be recruited, describe the process you 
will use to ensure that the oral and/or written consent information 
provided will be in a language that they understand.  
● 
If you translate consent forms and study materials, please provide a 
certified translation of the form as well as the certification 
document. 
● 
Indicate the spoken language that study personnel obtaining consent 
will use. Describe how you will assess fluency of personnel obtaining 
consent to ensure that the translation is accurate. 
 
 
N/A 
 
 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 
● 
Review the “CHECKLIST: Waiver or Alteration of Consent Process 
(HRP-410)” to ensure you have provided sufficient information for 
the IRB to make these determinations (i.e., that it meets the criteria 
for a waiver or alteration of the consent process). 
 
N/A 
 
 
Subjects who are not yet adults (minors: infants, children, teenagers) 
● 
Describe the criteria that you will use to determine  legal age for 
consent to treatments or procedures involved in the research under 
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the applicable law of the jurisdiction in which the research will be 
conducted (e.g., in Virginia, individuals under the age of 18 years). 
o 
For research conducted in Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-
013)” to determine which individuals in the state meet the 
definition of “minor.” 
o 
For research conducted outside of the state, please describe 
the legal requirements for the definition of “minor.”  
● 
Describe the process for obtaining parental permission.  
o 
Permission from one parent is acceptable for studies that 
involve no greater than minimal risk OR involve greater than 
minimal risk but present the prospect of direct benefit to the 
minor subject. 
o 
Permission from both parents is required in all other 
cases (unless one parent is deceased, unknown, 
incompetent, or not reasonably available, or when only 
one parent has legal responsibility for the care and 
custody of the minor). 
● 
Describe whether you will obtain permission from individuals other 
than parents or Legally Authorized Representatives, and if so, who 
will be allowed to provide permission. Describe the process you will 
use to determine these individuals’ authority to consent to the 
minor’s general medical care. 
● 
Indicate whether you will obtain assent from all, some, or none of 
the minors. If you will obtain assent from some minors, indicate 
which minors will be required to assent. Consider chronological age 
and intellectual capacity when determining who will be required to 
provide assent (e.g., infants are unable to assent. However, 
teenagers are likely able to read and sign an assent form). 
● 
When assent of minors is obtained, describe whether and how you 
will document it.  Will minors sign an assent form or give verbal 
assent? 
● 
Attach parental permission and minor assent forms or scripts in 
Protocol Management.  
 
 
N/A 
 
 
Adults Unable to Consent  
● 
Describe the process you will use to determine whether an individual 
adult is capable of consent. 
● 
List the individuals from whom you will obtain permission in order 
of priority (e.g., durable power of attorney for health care, court 
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appointed guardian for health care decisions, spouse, and non-
minor child). 
o 
For research conducted in the Virginia, review “SOP: Legally 
Authorized Representatives, Minors, and Guardians (HRP-
013)” to determine which individuals in the state meet the 
definition of “legally authorized representative.” 
o 
For research conducted outside of Virginia, please describe 
the legal requirements for obtaining permission from a legally 
authorized representative in the state where the research will 
occur. 
● 
Describe the process for assent of the subjects. 
o 
Indicate whether you will require assent from all, some, or 
none of the subjects. If some, indicate which subjects will be 
required to assent and which will not. 
o 
If you will not obtain assent from some or all subjects, please 
provide justification for not obtaining assent. 
o 
Describe whether and how you will document assent.  
 
N/A 
 
25.0 Process to Document Consent in Writing 
25.1 Consult “SOP: Written Documentation of Consent (HRP-091)” for 
recommended procedures, and describe whether and how consent of the 
subject will be documented in writing: 
 
The potential participant and person obtaining consent will sign the consent form after 
the potential participant verbally states that s/he understands the conditions of the study, 
has no more questions, and chooses to participate. 
Written consent will include printed name, signature, and date from each of the person 
obtaining consent (e.g., research coordinator/study staff member) and the research 
participant. In addition, a copy of the consent form will be provided to the study 
participant, if they wish. 
 
25.2 If the research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is 
normally required outside of the research context, you can request that the 
IRB waive the requirement to obtain written documentation of consent 
(e.g., consent to participate is indicated by pressing a button for an online 
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questionnaire – after the consent information is presented and before the 
questionnaire begins): 
 
N/A 
 
25.3 If you will document consent in writing, attach a consent document with 
places for signatures. If you will obtain consent, but not document consent 
in writing, please attach the consent script or text. Review “CHECKLIST: 
Waiver of Written Documentation of Consent (HRP-411)” to ensure that 
you have provided sufficient information. You should use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent document or 
script: 
 
Written Consent attached. 
 
 
 
26.0 Resources Available 
26.1 Describe the resources available to conduct the research. For example, as 
appropriate: 
● 
Describe the PI’s availability to supervise the research. 
● 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
● 
Describe the time that you will devote to conducting and completing 
the research. 
● 
Describe your facilities. 
● 
Describe the availability of medical or psychological resources that 
subjects might need as a result of an anticipated or unanticipated 
consequence of participation in the research. 
● 
Describe your process to ensure that all persons assisting with the 
research are adequately informed about the protocol, the research 
procedures, and their duties and functions (e.g., training plans, 
detailed study notebooks). 
 
The organizational structure of the study team involves overall leadership by Principal 
Investigator (PI) Drs. Stephen LaConte, who will assume full responsibility for all 
aspects of the project. Dr. LaConte will oversee recruitment and retention of participants 
with alcohol use disorder. He will also oversee and delegate to the Co-Investigators the 
responsibility of training study personnel, consenting of participants, and data collection. 
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The Research Coordinator(s) will be trained and supervised as appropriate for any 
delegated study procedures. Behavioral data analysis will be overseen by Dr. LaConte 
and conducted by the Co-Is and the Statistician. Dr. LaConte will also oversee the 
collection and analysis of fMRI data. Specifically, Dr. LaConte will work with the Co-Is, 
the Research Associate, the Graduate Student, and the MRI Technician to design and 
program the fMRI stimuli and analyze the neuroimaging data from this project. In 
addition, Dr. James MacKillop (McMaster University) will contribute to the preparation 
and execution of fMRI design and interpretation. Dr. Anita Kablinger (Carilion Medical 
Center) will monitor participant safety throughout the study. Dr. Samuel McClure 
(Arizona State University) will be responsible for developing a computational model of 
reinforcer pathology. 
All staff involved in the conduct and/or monitoring of this study will have completed the 
VT Human Subject Protection Training and Good Clinical Practice Training. 
Documentation of training will be maintained. The Co-PIs and Study Physician will be 
responsible for continuous data and safety monitoring of all participants enrolled in this 
study. In terms of standard operating procedures, trained research staff members will 
administer all assessments. The Study Physician will be directly responsible for 
monitoring risk related to alcohol withdrawal. 
Participants will be recruited from the community via posted flyers, word of mouth 
referrals, and electronic advertisements (e.g., Craigslist, Facebook). To the extent 
possible, we will attempt to minimize obstacles to participation. For example, travel 
barriers will be addressed by providing transportation or parking costs to participants, and 
scheduling barriers will be minimized by offering a flexible session schedule. All 
methods and measures will be conducted using standard operating procedures, and all 
staff (including recruitment staff) will be provided with cultural sensitivity training. We 
have a history of successful recruitment of drug and alcohol users. All participants will 
enroll on a voluntary basis and sign an IRB-approved consent form prior to study 
participation. Note that we have been successfully recruiting individuals with AUD in our 
community for the past 8 years and the demographics of participants have been stable.  
In regards to medical and psychological resources, study personnel have lists of 
psychological resources including resources for people with suicidal thoughts or other 
emergency mental health issues readily available that can be provided to participants 
immediately. In addition, we have a Study Physician, Dr. Anita Kablinger, who can 
communicate with participants regarding medical and psychological issues that arise 
throughout participation in the research. 
 
As far as facilities, the Addiction Recovery Research Center (ARRC; Interim Co-
Directors, Stephen LaConte and Kirstin Gatchalian) is part of the FBRI, located in 
Roanoke, Virginia. Multidisciplinary research projects include examining the effects of 
behavioral, pharmacological, and transcranial magnetic stimulation (TMS) interventions 
as potential therapies for alcohol, cocaine, and nicotine dependence as well as other 
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health behaviors such as obesity. ARRC also develops potential computerized therapies, 
applies principles from behavioral and neuro-economics to the understanding of 
addiction, and assesses nicotine product abuse liability. 
ARRC resides on the 3rd floor of the FBRI and consists of several laboratories for 
clinical research. ARRC has private offices and interview rooms, 12 individualized 
computer testing and/or therapy rooms, a ventilated, negative air pressure smoking 
laboratory that is equipped with computers and five additional behavioral booths, a 
dedicated TMS suite, and a conference room. The research space also includes a 
customized alcohol self-administration “bar lab” space and adjacent male and female 
restrooms with one-way observation windows and connecting stainless steel specimen 
pass-through cabinets. Office space for Multiple PI Bickel, Co-Investigators, Project 
Coordinators, Postdoctoral Associates, and Research Coordinators/Assistants is provided 
in the FBRI. The ARRC office suite has a copy machine, fax machine, network printer, 
scanner, and storage space for participant files and supplies as well as comfortable 
waiting rooms with entertainment (e.g., magazines, television, etc.) for research 
participants. 
The laboratory of Multiple PI LaConte is part of the FBRI located in Roanoke, VA. Dr. 
LaConte has a primary faculty appointment at FBRI as well as a tenure-track 
appointment in the Department of Biomedical Engineering and Mechanics, School of 
Biomedical Engineering and Sciences, in Blacksburg, VA. Projects include fMRI 
methodological development and analyses, including real-time fMRI in substance-
dependent (including alcohol) and traumatic brain injury populations. Moreover, Dr. 
LaConte has been collaborating with Dr. Bickel for five years as Multiple PI’s of an 
existing NIAAA funded grant (R01AA021529) examining executive function training in 
alcohol dependent participants and real time fMRI. 
In addition to his independent office space, Dr. LaConte has full access to the following 
facilities and resources of the FBRI Human Neuroimaging Lab sited in ~10,000 square 
feet divided among: 10 staff offices, 40 open-area Graduate Student and Postdoctoral 
Associates workstations, 18 behavioral testing rooms, 2 observation rooms with 
video/audio recording, 4 conference rooms with 20+ person capacity and AV/video 
conferencing capabilities, 1 data center with 16 rack capacity, 3 fMRI scanning suites 
(includes one on the Virginia Tech Blacksburg campus). Dr. LaConte’s laboratory 
includes two Graduate Students, one Medical Student, two Clinical Coordinators, and one 
Research Programmer. The PI also has access to one MR Research Technician, two full-
time System Administrators affiliated with the FBRI for research support. 
 
27.0 Multi-Site Research 
Contact the HRPP for multi-site research (involving multiple institutions) and 
the details required for this section will be provided. Otherwise, indicate N/A. 
 
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N/A 
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