Clinical trial NCT03449095
Conditions: Alcohol Drinking Alcohol Use Disorder Alcohol Intoxication Alcohol; Harmful Use Alcoholism Binge Drinking
Sponsor: University of Illinois at Urbana-Champaign
Start date: 2017-11-04; Completion date: 2023-07-05
Enrollment: 640 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
In this study, the investigators examine whether emotional and social reward from alcohol varies depending on the social context of consumption.

Detailed description:
Objective: Although the vast majority of alcohol consumption outside the laboratory occurs in social context, experimental studies of alcohol's emotionally reinforcing effects have overwhelmingly examined individuals drinking in isolation. The current study examines motivationally salient elements of everyday social drinking contexts as moderators of alcohol-related reinforcement. More specifically, the present study examine whether alcohol is more reinforcing within the context of unfamiliar vs. familiar social interaction and, further, whether alcohol is more reinforcing within the context of low vs. high quality social relationships. The current study furthermore examine whether individuals with characteristics that put them at risk for developing an alcohol use disorder (e.g., male gender, impulsive/extraverted personality profile, heavy patterns of consumption, family history of AUD, ...) exhibit heightened emotional reinforcement from alcohol within these social drinking contexts.

The current project represents a test of competing theories of alcohol reinforcement. Alcohol myopia theory-which has heretofore represented the most prominent theory of alcohol's effects-predicts that alcohol's ability to relieve stress depends on the nature (positive or negative) of stimuli in the drinker's immediate environment. Alcohol myopia theory might thus predict that alcohol's rewarding effects will be larger within familiar interactions and within secure relationships. In contrast, the social attributional theory of alcohol reinforcement predicts that alcohol-related reinforcement will be most pronounced within the context of unfamiliar social interactions.

In addition to providing an opportunity to test contextual and individual-level moderators of alcohol reinforcement, the current study represents an opportunity to directly test the replicability of research indicating a pronounced reinforcing effect of alcohol specifically within interactions among unfamiliar individuals (Sayette et al., 2012; Fairbairn et al., 2013).

Study Population: Participants will consist of 640 male and female drinkers, aged 21-30, with no reported history of severe alcohol use disorder. Participants will be sampled such that at least 360 of these participants will classify as heavy drinkers.

Design: In the laboratory arm of the study, individuals will be randomly assigned to consume either a moderate dose of alcohol or a control beverage in the company of either familiar or unfamiliar individuals. Of these individuals, a subset will participate in additional tasks post beverage-consumption including a hyperscanning EEG task, while an additional subset will also participate in an ambulatory assessment period over the course of several weeks to examine the interaction of alcohol and social contextual factors in daily life. In the ambulatory study arm, participants will wear transdermal sensors to assess BAC and will further provide information about their mood and their social contexts in response to random prompts.

Outcome Measures: Primary outcome measures include self-reports of positive and negative mood and perceived social reinforcement. The investigators will also examine facial expressions using the Facial Action Coding System, a comprehensive, anatomically-based system for categorizing facial muscle movement. One aim of the current study is to examine whether differential reinforcement from alcohol in unfamiliar social contexts emerges only with respect to self-reports, or is also observable within facial behaviors. EEG/ERP measures will also be examined for a subset of participants engaged in a hyperscanning task.

Arms: arm 1: A moderate dose of alcohol (Target BAC .08%) arm 2: Participants consume a non-alcoholic beverage
Interventions: intervention 1: Alcohol
Intervention descriptions: intervention 1: Alcohol Target BAC .08%

Protocol documents:
Prot_SAP_001.pdf: 
Official Title: Examining the Impact of Stress on the Emotionally Reinforcing Properties of 
Alcohol in Heavy Social Drinkers: A Multimodal Investigation Integrating Laboratory and 
Ambulatory Methods 
NCT number: NCT03449095 
Document Date: 4/24/2024 
 
 


Study Protocol 
Participants in this study will be male and female social drinkers, age 21-30. To be eligible, 
all participants will need to identify at least one eligible same-gender friend. Participants will be 
excluded from participation if they have a history of adverse reaction to the amount of beverage 
employed in the study, if they have a history of alcohol treatment or of major problems 
associated with alcohol, or if they are especially light drinkers or abstainers. Participants must 
also report comfort with the dose of alcohol administered in the study. Individuals will be 
excluded if they have medical conditions that contraindicate alcohol administration, if they are 
illiterate, or if they are non-fluent English speakers. Participants must not be dependent on any 
substance other than nicotine or caffeine, and must not qualify for severe Alcohol Use Disorder, 
as assessed at the time of study screening via DSM-V. Females who are pregnant or trying to 
conceive will be excluded. 
The laboratory portion of this study involves an examination of dyadic interaction. 
Participants will be paid a maximum of $100 for completing the laboratory portion of the study. 
Once at least two members of a friendship group qualify for participation during screening, they 
are invited back for an experimental laboratory session. Study advertisements allow for friend 
groups larger than 2 in order to account for ineligible subjects and/or dropout. Two friend dyads 
are invited to the laboratory for simultaneous beverage administration sessions. On the day of the 
session, they are randomly assigned to consume alcohol in the company of their own friend, or of 
the friend of the other participant (an individual with whom they are unacquainted).We adopt this 
procedure—in which all participants are recruited through a single mechanism—to ensure that 
the populations of individuals in friend and stranger conditions are comparable and unaffected by 
selection bias. Within the stranger condition, we will adopt procedures we have used previously 
to ensure these participants are unacquainted (i.e., all participants are introduced prior to 
beverage administration and backup participants are invited to all stranger sessions in case the 
primary 2 participants are previously acquainted).  
 Dyads will be randomly assigned to receive either a moderate dose of alcohol or a control 
beverage. The dose will be adjusted for participants’ weight and gender and is designed to 
produce a peak BAC of .08% (0.82-g/kg males; 0.74-g/kg females). Alcoholic beverages will be 
administered as a soda/juice-vodka cocktail, and control participants will consume an 
isolvolumic amount of soda/juice. In order to model drinking conditions as they most often 
manifest outside the laboratory (Senchak et al., 1998), both members of the dyad are assigned to 
the same beverage condition. We chose not to deceive participants in the control condition about 
the content of their beverages.  
Participants consume their beverages in 3 equal parts over 36 minutes. Experimenters enter 
the room to refill drinks at 12 and 24 minutes. During the dyadic drink period, video cameras are 
trained on each participant. Participants are initially told that cameras are monitoring their drink 
consumption, and only later provide consent for their behaviors to be analyzed from video using 
FACS. Immediately after the drink administration period, participants are brought into separate 
rooms to complete self-reports, including positive and negative mood, and perceived social 
reinforcement. Participants in the control condition are allowed to leave after completing the rest 
of the laboratory procedures. Participants in the alcohol condition stay until their BAC drops to 
0.00 and are breathalyzed at 15-min intervals. 


 
Participants may also be offered the opportunity to participate in an additional ambulatory 
study. This opportunity may be offered to a subset of individuals who complete the laboratory 
study, as well as individuals recruited from the local community. Participants will sign a separate 
consent form outlining procedures involved in ambulatory assessment.  
          The ambulatory assessment techniques used in this study were selected for their capability 
to reliably and unobtrusively measure key constructs of interest. Data from the SCRAM 
transdermal alcohol monitor will be used to assess alcohol use during the ambulatory assessment 
period, lasting 14 days. Data from transdermal alcohol monitors will be converted into 
estimations of BAC using machine learning algorithms developed by our laboratory (Fairbairn et 
al., 2020). During the ambulatory assessment period, participants will complete self-reports of 
their mood and take photographs of themselves and their surroundings on their smartphones or, 
in the event they do not own a smartphone, on one of our lab’s iPod touch devices. Participants 
will complete self-report surveys regarding their mood, their social surroundings, and their 
alcohol consumption in response to random “pings” or alarms sounding 8 times during their 
waking hours. Participants will be asked to attend 2 additional (brief) laboratory visits during the 
ambulatory assessment period—a total of 3 visits, including the original lab orientation session. 
The first of these visits will take place approximately halfway through the ambulatory 
assessment period. During this visit, the fit of the transdermal sensors will be assessed, and they 
will receive feedback on their compliance with ambulatory assessment procedures. At the end of 
the ambulatory assessment period, participants will review the photographs they took during 
ambulatory assessment and report their level of acquaintance and relationship quality with each 
individual depicted therein. During their final visit, they will return the transdermal equipment. 
Participants will be paid up to $200 for completion of the ambulatory assessment period. 
Statistical Analysis Plan 
 
Analyses will be conducted using Hierarchical Linear Modeling (HLM; Raudenbush & 
Bryk, 2002). Models for facial data will involve 3-levels—within-person, between-person, and 
dyad-level. Raw video frame files—originally recorded for every 1/30th second—will be 
aggregated into bins for analysis to reflect the duration of facial behaviors as the interaction 
progresses (Fairbairn et al., 2013; Sayette et al., 2012). Effects of time within the drink period 
will be entered at level-1 and treated as random at levels 2 and 3. Models for self-reported mood 
data will involve 2 levels –between-person and dyad-level. Alcohol condition and social 
familiarity will be entered at the dyad-level as predictor variables. Self-reported positive and 
negative mood as well as perceived social reinforcement will be each entered at the individual-
level as the dependent variables.  
Analysis of ambulatory data will also involve HLM, accounting for clustering of 
observations (level-1) within individuals (level-2). Note that, although ambulatory data will 
include some complete friendship dyads, we do not anticipate significant clustering at the level 
of these dyads, although ICC's will be calculated to confirm. An index of BAC and familiarity 
will be available for each observation, and these variables will be entered at level-1. Follow-up 
analyses will then parse within-person from between person effects—predictors will be centered 
according to the individual mean at level-1, and then individual averages will be entered at level-
2. Level-1 covariates will include time of day, day of the week, limb of the BAC curve, and 
physical drinking context and level-2 covariates will include basic demographic variables 
(gender, age, and personality) (Miranda et al., 2014; Piasecki et al., 2011).  

ICF_000.pdf: 
 
 
 
Informed Consent 
Form 
NCT03449095 
 
Approved on February 22, 2022 
 


• Experimental Session Consent Friends 
 
University of Illinois at Urbana –Champaign 
Information and Consent for Participation in Research 
 
 
TITLE:  
 
 
 
Alcohol’s Effects on Cognition, Language, and Mood 
 
PRINCIPAL INVESTIGATOR:  Catharine Fairbairn, Ph.D. 
 
   
 
 
 
Assistant Professor of Psychology 
 
 
   
 
 
 
University of Illinois—Urbana-Champaign 
 
   
 
 
 
603 East Daniel Street 
 
   
 
 
 
Champaign, IL 61820 
 
   
 
 
 
Telephone: (217) 265-6767 
 
 
 
 
                                                                                                     
 
What is informed consent? 
 
 
  Federal regulations require that you are informed about research studies.  The following 
information explains the objective, procedures, risks, benefits, restrictions, and requirements of 
this research study.  Signing this form will indicate that this study has been explained to you, and 
that you agree to participate in it.  The process of reading and signing this form is known as 
informed consent. 
 
Why is this research study being done? 
 
 
  The purpose of this research study is to gain a better understanding of the effects that 
alcohol has in social drinkers and to examine how certain factors such as drinking patterns, 
gender, personality, and age may be related to aspects of drinking in social drinkers. Knowledge 
of how these factors may influence alcohol’s effects in social drinkers may contribute to a more 
comprehensive understanding of factors that contribute to drug addiction and its treatment.  In 
addition, the results of this research will be used to validate transdermal technology for the 
measurement of alcohol consumption, which may ultimately be useful for the treatment of 
problematic drinking. Importantly, all information collected from you will be assigned a unique 
coded number.  No data collected will contain your name or other personal information. 
 
Who is being asked to take part in this study? 
 
 
  You are being asked to participate because you are a social alcohol drinker.  People 
invited into this study are males and females, between 21-30 years of age, and fluent English 
speakers.  The study is being performed on a total of 2,000 individuals. 
 
Institutional Review Board 
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IRB #16263


What procedures will be performed for research purposes? 
 
 
 
If you agree to participate in this study, you will take part in one laboratory session, 
during which you will be administered either an alcoholic or a control beverage. You will need 
to refrain from alcohol for 12 hours and other drugs for 24 hours before your session, and refrain 
from eating for 4 hours.  Further, all members of your friendship group who were scheduled for 
the experimental session will need to attend, or the session will need to be rescheduled.  During 
this session, you will wear the Secure Remote Alcohol Monitoring System (SCRAM). The 
SCRAM is a lightweight device that is worn discretely around the ankle and monitors your 
Blood Alcohol Content (BAC) at regular intervals through your skin. Your BAC will not be 
displayed on these devices at any time but is stored securely in a monitoring facility, separate 
from any of your identifying data. Depending on your condition and your rate of alcohol 
absorption, this session will last approximately 6-9 hours. 
 
 
1. When you arrive for the session, a breathalyzer test, which takes approximately 2 minutes, 
will be used to ensure that your BAC is 0.  If your BAC is greater than 0 when you arrive you 
will not be allowed to take part in this study.  If you are female, you will be asked to take a 
urine pregnancy test.  
 
2. Next, you will be fitted with the SCRAM transdermal sensors. While these sensors establish 
baseline readings, you will complete a series of questionnaires about your background, your 
current and past drinking patterns, your mood, and your thoughts and attitudes about drinking 
alcohol and other non-alcohol factors.   
 
4. If you are assigned to the alcohol condition, we will then provide you with a dose of alcohol 
designed to produce a BAC of .075%, which is just under the legal limit for driving a car.  
The drink is one part 100 proof vodka and 3 parts juice/soda.  We will monitor your BAC 
throughout the study using breathalyzer tests, and you will be asked to report how intoxicated 
you feel.  On non-alcohol (control) sessions, you will drink an equivalent volume of juice or 
soda. The beverage administration phase will last approximately 40 minutes. 
 
5.   After the beverage phase, you will complete some tasks and activities relevant to your 
thoughts, attitudes, and social experience. Also, your brainwaves will be recorded while you 
view or listen to stimuli and perform tasks. The electrical responses of the brain can be seen 
in the electroencephalogram (brain waves) recorded from electrodes that make contact with 
your scalp, face, and neck. The brain waves are measured with standard polygraph machines 
which are designed to make this procedure harmless. Some of the electrodes will be 
embedded in an elastic cap that you will wear, and others will be attached individually with 
sticky electrode collars. Your skin will be cleaned beneath each electrode and gently scraped 
using a blunt needle or sack in order to remove any dry skin. A gel (similar to hair gel) will 
then be applied, which allows, the electrode to make contact with your skin. The gel will be 
wiped off of your skin and hair after the experiment, and any residual gel will wash out with 
soap and water. The elastic cap varies in how comfortable it is for different people, we will 
make every effort to make the cap as comfortable as possible for you. If you find it too 
uncomfortable at any time during the experiment, let us know and we will adjust it. 
 
Institutional Review Board 
University of Illinois Urbana Champaign
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Expires 10.27.2022 
IRB #16263


6.  You will be told about the study and be permitted to leave. If assigned to the alcohol 
condition, you will need to remain in the laboratory until your BAC drops below a value of at 
least .03% and your transdermal alcohol levels begin to descend. This means that you’ll have 
to stay in the lab for several hours after alcohol-administration (for example, until 7pm-8pm, 
depending on how long it takes your BAC to descend). Following alcohol sessions, you will 
not be permitted to drive or to operate any machinery following the experiment.  If you do 
not walk, you will receive paid public transportation to and from the experiment. 
 
After your participation in this study is completed, we may contact you with opportunities to 
participate in follow-up interviews and/or additional research activities, involving separate 
informed consent procedures. We may use a variety of means to contact you, including email, 
text, phone, social media, secondary contacts (friends or names provided by you), physical 
mailings, or in-person visits. If you prefer not to participate in follow-up assessments and wish 
not to receive more communications from our lab, you can notify us at any time. 
 
Monitoring/Follow-up Procedures: 
 
Procedures performed to evaluate the effectiveness and safety of the experimental procedures are 
called “monitoring” or “follow-up” procedures.  For this research study, the monitoring/follow-
up procedures include: 
 
Immediately following completion of the experimental procedure, an experimenter will 
repeat the rationale for this study and will give you the opportunity to ask questions 
regarding the procedures in this study and/or express any concerns you may have.   
 
 
 
What are the possible risks, side effects, and discomforts of this study? 
 
 
There are risks for persons who choose to participate in this experiment.  This is because 
the use of any drug, including alcohol, carries risk.  In this case there is a slight risk that our dose 
of alcohol, while targeted to be approximately equal to the legal limit for driving a car, could 
lead you to feel unwell (e.g., nausea). The prevalence of individuals feeling unwell using the 
drinking procedures in this laboratory is rare, occurring in less than 1% of people (less than 1 out 
of 100 people).  A number of steps are taken to reduce what risk remains.  First, we do not allow 
especially light drinkers or persons taking medication that could interact with alcohol, who are 
most likely to experience adverse reactions to alcohol, to participate in this study.  Also, you will 
consume your drink over a 30-min period, rather than the 20-min period often used in similar 
studies.  If you become ill, or if the experimenter judges you to be experiencing nausea, the 
experiment can immediately terminate.  You still will remain in the lab until your BAC reaches a 
minimum of .03%, and be escorted to a nearby hospital (Carle Foundation Hospital, 611 W Park 
St, Urbana, IL), if necessary.  Note that the exact same alcohol administration procedures have 
been used with over 1,000 participants at other institutions, and medical attention has never been 
necessary. The University of Illinois does not provide medical or hospitalization insurance 
coverage for participants in this research study nor will the University of Illinois provide 
compensation for any injury sustained as a result of participation in this research study, except as 
required by law.  
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Another potential risk is that you may drive an automobile in an impaired condition due 
to alcohol consumption.  To minimize this risk, you will be asked not to drive to or from the 
experimental session, and you will not be able to leave the laboratory until your BAC is below a 
minimum of .03%, a level that is half of the level at which it is illegal to drive an automobile in 
the state of Illinois.  You will also be instructed to drink no alcohol, and to use no other drugs, 
after returning home at the end of the experiment, and not to drive a car or operate heavy 
machinery until the morning after you participate.  
 
If you are assigned to receive the electroencephalogram, the tape, gel and scraping 
procedures used to attach the electrodes may irritate some people’s skin slightly, but any residual 
skin irritation will subside within a day or two. 
 
The risks from the experimental procedures are no greater than those ordinarily 
encountered in everyday life. 
 
What are possible benefits from taking part in this study? 
 
 
 
This project will benefit scientific knowledge. In particular, the results of this study will 
help us understand why people consume alcohol and who might be at risk for developing a 
problem with alcohol. There will be no direct benefits to you as a result of participating in this 
study. 
 
If I agree to take part in this research study, will I be told of any new risks that may be found 
during the course of the study? 
 
 
You will be promptly notified if any new information develops during the conduct of this 
research study, which may cause you to change your mind about continuing to participate. 
 
Will my insurance provider or I be charged for the costs of any procedures performed as part 
of this research study? 
 
Neither you, nor your insurance provider, will be charged for the costs of any of the 
procedures performed for the purpose of this research study (i.e., the Screening Procedures or the 
Experimental Procedures).   
 
Will I be paid if I take part in this research study? 
 
 
You will be paid a total of $80 if you and your friends complete this study. You will also 
receive a $20 no-cancel bonus if you don’t cancel or reschedule the initial appointment you made 
with our lab. 
                                                
How will you protect my privacy and the confidentiality of my data? 
 
 
All records related to your involvement in this research study will be stored in a locked 
file cabinet and a password protected computer.  Your identity on these records will be indicated 
by a case number rather than by your name, and the information linking these case numbers with 
your identity will be kept separate from the research records. Your de-identified data may be 
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made publicly available without requesting additional consent. Only the researcher listed on the 
first page of this form and her staff will have access to your research records.   
 
 
     In general, the research team will not tell anyone any information about you. When this 
research is discussed or published, no one but the research team will know that you were in the 
study.  However, laws and university rules might require us to allow one or more of the 
following people or groups to see or copy information about you, including your signed consent 
form – a) The university committee and office that reviews and approves research studies, the 
Institutional Review Board (IRB) and Office for Protection of Research Subjects, and b) 
University auditors and other personnel responsible for oversight of research; and c) State 
auditors. 
 
 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or samples 
that may identify you in any action or suit unless you say it is okay. They also cannot provide 
them as evidence unless you have agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena. 
 
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require reporting 
of child or elder abuse, some communicable diseases, and threats to harm yourself or 
others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations. 
 
 
Researchers may release information about you when you say it is okay. For example, you 
may give them permission to release information to insurers, medical providers or any other 
persons not connected with the research.  The Certificate of Confidentiality does not stop you 
from willingly releasing information about your involvement in this research. It also does not 
prevent you from having access to your own information. The fact that you are participating in a 
research study and that you are undergoing certain research procedures (but not the results of the 
procedures) may also be made known to individuals involved in insurance billing and/or other 
administrative activities associated with the conduct of the study. 
 
Is my participation in this study voluntary? 
 
 
 
Yes!  Your participation in this study is completely voluntary.  You may refuse to 
participate in this study, or you may stop participating at any time, even after signing this form, 
and this decision will not affect you or how you are treated.  If you choose to withdraw after 
you’ve been administered alcohol, we do not recommend that you leave the laboratory before 
your BAC drops below .03%—a threshold which has been set with your safety in mind. You 
may also skip questions on measures if you do not feel comfortable responding to them, 
although, depending on the measure, the decision to skip questions may impact your eligibility 
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for study participation. 
 
May I withdraw, at a future date, my consent for participation in this research study? 
 
You may withdraw, at any time, your consent for participation in this research study. Any 
identifiable research information recorded for, or resulting from, your participation in this research 
study prior to the date that you formally withdrew your consent will continue to be used and 
disclosed by the investigators for the purposes described above.  You may also be removed from 
the study by the investigators in the event that you no longer meet the eligibility criteria. The 
decision to participate, decline, or withdraw from participation will have no effect on your grades 
at, status at, or future relations with the University of Illinois. 
  
To formally withdraw your consent for participation in this research study you should provide a 
written and dated notice of this decision to the principal investigator of this research study at the 
address listed on the first page of this form. 
                                                                                                 
If I agree to take part in this study, can I be removed from the study without my consent? 
 
 
It is possible that you may be removed from the research study by the researchers if, for 
example, you do not follow the instructions given to you by the investigator, or if they learn that 
you have provided inaccurate information concerning your current level of alcohol use or the 
status of your physical health, or that you fall outside of the specified age-range of 21 to 30 
years.  
How can I get more information about this study? 
 
 
 
If you have any further questions about this research study, you may contact the Principal 
Investigator, Dr. Catharine Fairbairn, at (217) 265-6767. 
 
****************************************************************************** 
 
VOLUNTARY CONSENT 
 
All of the above has been explained to me and all of my current questions have been 
answered.  I understand that I am encouraged to ask questions about any aspect of this research 
study during the course of this study, and that such future questions will be answered by the 
researcher listed on the first page of this form.   
 
 
If you feel you have not been treated according to the descriptions in this form, or if you 
have any questions about your rights as a research subject, including questions, concerns, 
complaints, or to offer input, you may call the Office for the Protection of Research Subjects 
(OPRS) at 217-333-2670 or e-mail OPRS at irb@illinois.edu 
 
I certify that I am at least 21 years of age and that I have read and understand the above 
consent form and voluntarily agree to participate in this study.  A copy of this consent form will 
be given to me. 
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_______________________________________________  
________________________ 
Participant’s Signature 
 
 
 
 
 
 
Date 
 
 
_______________________________________________  
 
Participant’s Printed Name 
 
 
 
 
 
 
 
 
 
_______________________________________________  
________________________ 
Person Obtaining Consent Signature  
 
 
 
Date 
 
 
_______________________________________________  
 
Person Obtaining Consent Printed Name 
 
 
 
Institutional Review Board 
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