A Smartphone App to Capture Inhibitory Control as a Novel Moderate Drinking Tool for Young Adults
Phase: NA
Conditions: Drinking, Alcohol, Drinking Behavior
Sponsor: University of Florida

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Protocol 
1. Project Title: 
A Smartphone App to Capture Inhibitory Control as a Novel Moderate Drinking Tool 
 
2. Investigator(s): 
Liana Hone, Ph.D. (PI) 
Robert Leeman, Ph.D. (Co-I) 
William Corbin, Ph.D. (Co-I) 
Mark Fillmore, Ph.D. (Co-I) 
Yan Wang, Ph.D., (Collaborator) 
Frederick Muench, Ph.D. (Consultant) 
Robert Cook, M.D., MPH (Study Physician) 
 
3. Abstract: 
Young adult drinking is a public health issue. Current interventions yield small effect drinking 
reductions, thus new approaches are needed. Smartphone applications (apps) have great 
potential for drinking moderation. Almost all young adults own a smartphone and most are open 
to technology to moderate drinking. There are many drinking apps, but quality varies and there 
is no evidence any apps are more efficacious than a control condition for young adults. Thus, 
there is an evidence gap as to which apps may help. Brief interventions have shown that 
personalized feedback based on motivational interviewing (M.I.) has efficacy, but these 
interventions give feedback about general patterns only, not drinking and impairment in the 
moment. Theory and evidence emphasize that slowing pace of drinking is difficult. These 
findings suggest young adults need more help, preferably while drinking, to slow their pace of 
alcohol use. Apps have potential for in-the-moment intervention, but there are no efficacious, in-
the-moment behavioral interventions for young drinkers. Human laboratory studies support 
perceived impairment as a focus of an in-the-moment, moderate drinking app. Two studies 
using different cognitive tasks found heavier drinking young adults underrated impairment more 
than light drinkers. Simulated driving results in particular suggest serious consequences from 
misperceived impairment. An app that provides accurate feedback on impairment could 
increase perceived impairment and reduce drinking. This study will test an app providing in-the-
moment feedback on impaired inhibitory control as an adjunct to an existing, M.I.-based, brief 
web-based intervention that gives feedback on overall drinking. App feedback will be tied to 
performance on the cued go/no-go task, which tests ability to respond quickly to “go” targets 
(activation) while withholding responses to “no-go” targets (inhibition). Moderate doses to blood 
alcohol content (BAC) of .05-.06% reliably lead to inhibition errors, but higher doses are usually 
needed for “go” reaction time (RT) to slow. Thus, ability to respond remains but ability to inhibit 
is impaired, which has negative implications. Using M.I. - consonant language, feedback will 
compare RT and inhibition failures after alcohol to RT and errors pre-drinking, linking 
performance decrement to consequences like risky sex and driving issues. The experimental 
app, which will be derived from a larger app in a recent study, will be compared to 2 control 
conditions in which the task is completed without this novel feedback.  Heavy drinking young 
adults (N=99) will be randomized to 1 of the 3 app conditions; attend an individual drinking 
session and be dosed to BAC=.06%; during which they will use the experimental or a control 
version of the app. Participants will then attend a group drinking session on a separate day and 
be dosed to BAC=.06% in small groups in a bar lab; then use the experimental or a control 
version of the app, followed by opportunity to self-administer more alcohol. Primary outcomes 
will be differences between study conditions on BAC and alcohol self-administered. During a 4-
week period post-session, all participants will use the experimental app in actual drinking 

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situations for 2 of the 4 weeks, enabling within-subject comparisons of drinking with vs. without 
the app. This study will yield preliminary data for an R01 to test concurrent use of multiple 
mobile tools for combined efficacy in reducing drinking.  
 
4. Background 
High-risk alcohol use by young adults is a public health issue with over 40% reporting recent 
heavy drinking1, which is related to consequences like sexual assault and traffic accidents2, 3. 
Further, heavy drinking at this age can negatively affect the developing brain4-6. Driving under 
the influence (DUI) is more common in 21-25 year olds (18-19% past year prevalence) than any 
other age7. Among 21-30 year-olds killed in crashes, 43% have blood alcohol content (BAC) 
>.08, but risk is not limited to BACs >.08%. Probability of a fatality increases significantly once 
BAC exceeds .05%8, 9 and DUI can be charged with signs of impairment even at BACs <.08%. 
 
Young adult heavy drinking warrants targeted intervention. Reviews/meta-analyses10-14 find 
current interventions yield small effect reductions, making new approaches critical. Smartphone 
applications (apps) have potential to moderate drinking. Young adults spend 3-5 hours/day on 
smartphones36,37 and 98% report using phones during social events8, 9. Fortunately, young 
adults are open to technology use to moderate drinking15, 16. There are many alcohol apps, but 
quality is poor and there is no evidence that any apps are more efficacious than a control 
condition for young adults16-18,40. There are efficacious apps for treatment-seeking19, 20 and 
recovering adults21 to avoid drinking, but not for young adults to reduce drinking: a very different 
indication.  
 
Regarding intervention components, personalized feedback based on motivational interviewing 
(M.I.) has efficacy11, 14. Apps with personalized tailoring are more popular and downloaded 
more40. These interventions give feedback based on general patterns though, not drinking and 
impairment in the moment. With text message interventions22-47, content still tends to be based 
on general patterns23-25 and is limited visually (no graphics)22. General feedback has value, but 
theory and evidence support a need for in-the-moment intervention.  
 
Behavioral economic theory highlights alcohol as immediately available and rewarding26, 27. Self-
control theory posits that resisting rewards can make later exertion of effort more difficult28, 29. 
For heavy drinkers, the impulse to drink is immediate and compelling, making it hard to exert 
control. Self-control theory argues that motivation can make up for limited ability29, but non 
treatment-seeking young adults may not have enough motivation to control drinking on their 
own.30, 31 Accordingly, evidence shows slowing pace of drinking is difficult. Researchers have 
reported difficulty teaching moderate drinking to older adults32-35. Young adults report 
moderating drinking directly (e.g., counting drinks) less often than ancillary strategies (e.g., 
designated drivers)15. Our recent study found that a web-based intervention was efficacious 
when it included ancillary strategies, but not when it gave direct strategies to slow drinkin.g16. 
This suggests young adults need more help, preferably while drinking, to slow the pace of 
drinking and improve decision making while impaired. Apps have great potential in this area. 
 
Past studies suggest actual and perceived impairment are valid targets for an in-the-moment 
app. Two studies using different tasks found that heavier drinkers underestimate impairment 
more than lighter drinkers17-18. In terms of actual performance, heavier drinkers were equally as 
impaired as light drinkers (including on a driving simulator). According to self-efficacy theory, 
decisions are based on perceived ability36, 37 With low perceived impairment, heavier drinkers 
may believe that they can drive effectively after drinking and thus, do so38. An app giving in-the-
moment feedback could increase perceived impairment, and reduce drinking and 
consequences. 
 

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The cued go/no-go (CGNG) task is an ideal choice for in-the-moment impairment feedback. Its 
instructions are simple; practice effects are minimal; and is sensitive to alcohol22-31,39. The 
CGNG tests ability to respond fast to “go” targets (activation) while withholding response to “no-
go” targets (inhibition). Activation/inhibition tension is externally valid. Dual process models40-43 
posit risk behaviors stem from overactive appetitive drives that are compelling and hard to 
inhibit. Poor CGNG performance post-alcohol has been related to poor simulated driving, 
enhancing external validity44. Moderate dosing to .05-.06% BAC reliably increases inhibition 
errors45-51, but slowing reaction time (RT) to “go” cues requires higher doses44, 46, 47, 52. RT to go 
cues often recovers later in a drinking episode (acute tolerance53) but ability to inhibit does not. 
Thus at this BAC, ability to respond remains but inhibition is impaired, which relates to risk 
behaviors like DUI as young adults underrate impairment17. 
 
This study (N=99) will test an app giving in-the-moment feedback on impaired inhibitory control 
as an adjunct to an existing, web-based intervention (US-THRIVE) addressing general drinking 
patterns, based on M.I.54-56-21. US-THRIVE was linked to significant drinking reductions in a 
sample with low baseline motivation16. This new app will give in-the-moment feedback 
comparing pre- and post-drinking RT and inhibition errors, referring to evidence that poor CGNG 
response relates to poor simulated driving and willingness engage in risky behavior. After 
feedback, the app will offer advice on slowing drinking and other options (e.g., a taxi). The 
experimental app—derived from a larger app (RWJF #73293, PIs: Estrin/Muench)—will be 
compared to standard (trial-by-trial RT and error information only) and control versions (no 
information) without feedback. After US-THRIVE, heavy drinking young adults will be 
randomized to 1 of the 3 apps. They will use this app initially and learn about the relevance of 
alcohol’s effects on CGNG. They will then attend an individual alcohol drinking session where 
they will be dosed to .06% BAC, followed by app use. After completion of the first session they 
may be asked to return to the research facility on a different day to take part in a group alcohol 
drinking session where they will be dosed to .06% BAC in groups of 3, followed by app use, 
then 1-hr when they can self-administer alcohol up to .12%57, 58. They will use the app post-
drinking with incentives for fast, accurate performance44 and learn their number of errors and 
fast + correct responses. Performance decrement should motivate subsequent app use. Similar 
to R21AA023368 (PI: Leeman), for 4 weeks post-session, all participants will use the 
experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks. Due to 
the COVID-19 pandemic participants may be asked to complete just the 4 week field use portion 
of this study.  
 
The proposed study will address a critical knowledge gap: there are no evidence-based 
smartphone apps for reducing young adult drinking. There are also no efficacious in-the-
moment behavioral interventions for young adults, despite supporting theory and evidence. Lab 
paradigms, often used to test medications, are under-used for behavioral interventions despite 
their reduced reliance on self-report, time and cost-efficiency59 and NIAAA’s emphasis on their 
use60. The proposed study combines lab with field testing to yield “real world” preliminary 
efficacy and usability data. We have proof-of-concept and feasibility data, but lack data testing 
effects of this novel inhibitory control feedback app on alcohol self-administration. Thus, these 
data are needed for an R01 to test this new app, combined with other mobile tools, for efficacy 
in reducing drinking.  
Preliminary Studies: The studies described below pertain to the validity of the alcohol self-
administration paradigm, along with its safety and feasibility; our ability to recruit the proposed 
sample; and young adults’ interest in intervention components pertinent to the proposed study, 
including a breathalyzer device/app.  

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PS1: Lab research in heavy drinking young adults at University of Florida, the study site. Dr. 
Leeman’s group is conducting an NIH-funded study to test a smartphone breathalyzer 
device/app and 2 other forms of alcohol-related technology in a simulated bar lab. Over 17 
mos., 130 young adults have enrolled (7.7/month). Enrolled participants have been 52% male 
and diverse: 54% non-students, and 32% non-White. This study includes a 2-week field period 
to determine how often participants use the 3 forms of technology in “real” drinking situations. 
Participants have used the technology an average of 8 times overall (SD=5.5) on 63% of 
drinking days (SD=27%). They receive $20 for using each of the 3 technologies at least once. 
No other compensation is tied to technology use. Thus, participants use the technologies “extra” 
times without compensation. These findings provide strong support for non-treatment seeking, 
heavy-drinking young adults’ motivation to use technology to moderate drinking.  Though 
breathing into the breathalyzer only takes about 1 min., the process entails a waiting period of 
15 min. after one’s last drink, much longer than the 3-4 min. required for the experimental app in 
the proposed study. Thus, heavy drinking young adults are willing to use drinking apps even if 
they require several minutes.  
 
PS2: Experience with alcohol administration paradigm. The proposed paradigm is based on a 
study by Co-Investigator Corbin and Dr. Kim Fromme57, 58. They recruited 174 heavy drinking 
young adults (50% female) for a lab study with methods resembling the proposed study 
including administration in a simulated bar lab in small groups; vodka mixed drinks; targeting 
initial BAC of .06% followed by a free-drinking period up to BAC=.12%. Their ad lib period was 
only 20 minutes yet there was a range in drinks self-administered (0-3), which will be 
accentuated due to extension of the free-drinking period to 1 hour in the proposed study.  
  
PS3: CGNG and risk behavior. In a recent pilot study, Dr. Corbin recruited heavy drinking young 
adults for a lab study, again dosing to BAC=.06% (N=21, 43% female). Post-alcohol, 
participants complete the CGNG, then a modified self-report61. CGNG response inhibition 
failures post-alcohol correlated with risk behavior inclination (r=.47), specifically aggression 
(r=.31), drug use (r=.32), delinquency (r=.31) and risky sex (r=.36). Thus poor response 
inhibition post-alcohol relates to risk for negative behaviors. Along with driving, relations 
between CGNG and these risk behaviors will inform personalized feedback in the app for the 
proposed study. 
 
PS4: CGNG Validity. In a placebo-controlled study (N=222, 75% male) by Dr. Corbin, CGNG 
performance post-alcohol (peak BAC=.076%) was related to negative consequences. There 
was a beverage condition by CGNG interaction, β=.35, p=.02. Self-reported consequences were 
associated with inhibition failures on the CGNG after alcohol, β=.26, p=.02, but not placebo, β= -
.10, p=.44. These findings show impaired inhibitory control has “real world” relevance to 
outcomes that could be avoided with feedback given by the proposed app.  
 
PS5: Feedback on task performance & perceived intoxication. Dr. Fillmore led a study in which 
young adult drivers with and without a DUI (N=40, 68% male) completed 2 administration 
sessions with alcohol (peak BAC =.08%) or placebo, then performed simulated driving and 
rated perceived impairment38. They were then given feedback that their driving performance 
was impaired by alcohol. After feedback, they were retested as in the first 2 sessions. 
Paralleling prior findings on heavy vs. lighter drinkers62, 63, those with DUIs initially perceived 
less impairment than those without. However, post-feedback, those with DUIs reported 
increased perceived impairment (p<.01). These results strongly support that perceived 
impairment is meaningful to young adult high-risk drinkers and that task performance feedback 
can have a positive effect in this population.  

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S6: Preliminary findings: app 
version of CGNG 
In a pilot study (N=76, 67% 
female, 25% non-white, M age= 
43[SD=14]), consultant Muench 
compared a standard CGNG with 
the app version in his current 
study, which required 3 min., on 
average. This app version of the 
CGNG will be elaborated in the 
proposed study. Reaction times 
(RTs) in the app and computer 
versions were highly correlated 
(r=.69, p<.01). The trials in the app 
version were divided into thirds 
and mean RTs were correlated to evaluate reliability. RTs among each third were correlated 
between .89-.95, indicating strong reliability. Correlations of inhibition errors on the computer 
version and errors on the app were lower, r=.28 (p=.015). This is not surprising as CGNG 
errors are infrequent when sober. This is actually an advantage as it enhances sensitivity to 
alcohol effects. Given the promising findings and extensive literature on the CGNG45-51, we 
are confident the app version will be sensitive to alcohol. Dr. Leeman included a description 
of the app in a preliminary study of young adult drinkers (N=23). Participants rated the 
likelihood they would use the app 5.1 (SD=1.3) on a 1-7 scale. In a recent web survey of 
young adults in FL (N=72), Dr. Leeman found 66% of heavy drinkers reported scores > 3 on 
a 0-10 scale, indicating agreement they would like to use an app to help reduce drinking, 
suggesting high interest and a degree of motivation. 
 
Summary: These studies show feasibility; young adults’ motivation to use moderate drinking 
apps even if they take several minutes; our experience with relevant methods; external validity 
of the CGNG; and reliability and validity of the app version of the CGNG. Thus, the CGNG is a 
good choice for in-the-moment intervention.  
 
5. Specific Aims 
 
Primary Aim 1: Compare effects of a smartphone app providing feedback on impaired 
inhibitory control to 2 control conditions on BAC (Aim 1a) and number of alcoholic drinks self-
administered (1b) during a 1-hour free drinking period in a naturalistic bar lab that occurs 
immediately after a fixed alcohol dose targeting BAC= .06%.  
 
Primary Aim 2: In a 4-week period post-session, compare, within-subject, number of drinks per 
occasion during 2 weeks when participants use the app during actual drinking situations vs. 2 
weeks when they will not use the app. Also test app satisfaction including number of times used 
and likelihood of future use. 
Hypothesis: Participants will self-administer less alcohol when using the experimental app with 
feedback.  
 
Secondary Aim: Test increased perceived impairment as a partial mediator of the effects in the 
prior Aims.  
Hypotheses: Participants using the experimental app will report higher perceived impairment, 
which will mediate relations between app use and lower alcohol consumption in the lab and in 
the 4-week post period. 
 
Figure 2b 
Figure 2a 

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Exploratory Aim 1: Test study condition during the lab sessions, amount of alcohol self-
administered (operationalized as estimated peak BAC and number of drinks self-administered in 
separate models) in the group alcohol drinking session and during the field period in the 
intervention and non-intervention periods as predictors of self-reported alcohol consumption 
(e.g., drinks per drinking day) and alcohol-related problems self-reported at 6- and 12-months 
post-session on web-based surveys. 
 
Exploratory Aim 2:  Test BACTrack Skyn readings taken during each alcohol administration 
session as predictors of successive breath alcohol readings taken following alcohol 
administration/self-administration periods in the alcohol drinking sessions and to predict number 
of drinks self-administered during the group drinking session.  
 
Exploratory Aim 3: Predict scores on self-reported expected involvement in risky behaviors 
post-alcohol administration based on performance on the app-based cued go/no-go task 
following a .06% fixed alcohol dose in each alcohol drinking session.   
 
6. Research Plan 
Overview 
 
Participants will be otherwise healthy men and women between the ages of 21-25 who 
frequently engage in heavy alcohol use. This study will test an app based on the cued go/no-go 
(CGNG) task giving in-the-moment feedback on impaired inhibitory control as an adjunct to an 
existing, web-based intervention (US-THRIVE) targeting general drinking patterns using M.I. 
principles. This new app will give in-the-moment feedback comparing pre- and post-drinking RT 
and errors, referring to evidence that poor CGNG response relates to poor simulated driving and 
willingness to engage in risky behavior. After feedback, the app will offer advice on slowing 
drinking and other options to avoid harm (e.g., a taxi). The experimental app—derived from a 
larger app (Robert Wood Johnson Foundation grant #73293, PIs: Estrin/Muench)—will be 
compared to standard (trial-by-trial RT and error information only) and control versions (no 
information) without feedback. After US-THRIVE, heavy drinking young adults will be 
randomized to 1 of the 3 apps. After initial use of their randomized app, they will then be dosed 
to .06% BAC during an individual session in a naturalistic lab, followed by app use. After this 
initial session, on a separate day, participants will attend a group session including 2 other 
participants. During this group session; they will again be dosed to .06% BAC, followed by app 
use, then 1-hr when they can self-administer alcohol up to .12%. There will be at least one day 
between the individual and group sessions and the goal will be for the individual and group 
session to occur within 7 days of each other. For 4 weeks post-session, all participants will use 
the experimental app for 2 weeks in real drinking occasions and not use it the other 2 weeks. 
Participants completing both the laboratory alcohol administration and field testing components 
of the study can earn up to $450 during the course of study participation. Participants may also 
be invited to complete only field use of the app due to the COVID-19 pandemic or because they 
cannot physically come to the study location on campus. Among these participants, some will 
be invited to complete the four-week field use period as described above (i.e., 4 weeks total, 2 
weeks with app access, 2 weeks with not and a brief daily questionnaire each day for the 4 
weeks). Maximum possible payment for those chosen to complete only the field use period will 
be $310. A small subset (up to n= 12 participants) will be selected to complete an ecological 
momentary assessment based field period of 10 days in which participants will be prompted 
multiple times per day to either use the app or to complete a brief questionnaire. Maximum 
payment for those completing the ecological momentary assessment will be $200. We 
anticipate enrolling 208 participants, of whom 109 will be eligible with a target of 99 individuals 
completing the study.  

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Participants 
 
Participants will be recruited through a number of means. Flyers and palm cards will be posted 
and handed out in and around the various colleges, universities and technical/trade schools in 
the Gainesville, FL-area as well as in other public areas frequented by young adults. We will 
also post brief messages on multiple sections of Craigslist. Facebook postings will be made 
from our dedicated lab account. These ads will direct participants to the study’s web address 
but will not include an active hyperlink. Ads will also include the study phone number and 
email address. Postings made in response to the ad will be monitored with periodic reminders 
for interested parties to contact the study via phone/text or email. These same brief messages 
will also be disseminated to students at the local colleges, universities and technical schools in 
the area via batch emails and list servs. When permitted, brief recruitment talks will be given 
verbally during class meetings at these local institutions. Verbal recruitment messages will 
contain similar information as flyers and other advertisements. Copies of flyers and palm cards 
will also be provided at the conclusion of these brief recruitment talks. We will also recruit 
participants who have completed the following studies with active protocols: the Smartphone 
Technology Effects on Alcohol Drinking among Young adults (STEADY) study (IRB201600614, 
PI: Leeman), A Quasi-experimental Examination of Alcohol use on Game and Non-game Days 
over Time (IRB201903421, PI: Leeman), and Advancing New Computer-based Health Outreach 
Regarding Sexual behavior (ANCHORS) Study: UH2 Project (IRB201701367, PI: Leeman). 
All enrolled participants will me the following inclusion and exclusion criteria: 
 
Inclusion Criteria: 
Each subject must: 
 
1. Be between the ages of 21-25 
2. Be able to read English and complete study evaluations  
3. Report drinking to an estimated blood alcohol concentration (eBAC) of 0.12% (i.e., the 
maximum allowable BAC in the alcohol drinking sessions in this study) or higher at least once 
in the prior 30 days 
4. Report at least four days with heavy episodic drinking (i.e., 4 or more drinks for women 
and 5 or more drinks for men) out of the prior 30 days* 
5. Report having consumed at least one alcoholic drink during a minimum of 12 days out of 
the prior 30 in order to maximize the likelihood that subjects will choose to drink during the 
self-administration portion of the laboratory sessions.*  
6. Meet, at minimum, DSM-5 criteria for a mild alcohol use disorder (i.e., meet at least 2 
diagnostic criteria) 
7. Perform within 2 standard deviations of normative levels both with regard to reaction time 
and number of errors on the cued go/no-go task at in-person screening. 

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8. Have an iphone/iOS-compatible phone that they are willing to use for study-related tasks 
(field use-only participants from outside of the Gainesville area, only; local participants will 
have an opportunity to borrow a study phone) 
 
 
Exclusion Criteria: 
No subject may: 
1. Be seeking treatment for alcohol or other addictive behaviors or have been in inpatient or 
intensive outpatient treatment within the past 12 months  
2. Have used a smartphone application to facilitate moderate drinking more than 1 time within 
the past 12 months 
3. Provide two positive breath alcohol concentration (BrAC) readings (i.e., > 0.00%) at an in-
person screening appointment or on the day of the alcohol drinking session. After participants 
blow their first positive BrAC, they will be allowed to reschedule and participate at another 
time, however if they blow a second positive BrAC, they will be excluded from this study and 
offered referrals for alcohol treatment. ** 
4. Have positive urine screen results at the in-person screening or on the day of an alcohol 
drinking session for opiates, cocaine, phencyclidine, amphetamines, methamphetamine, 
barbiturates, methadone or benzodiazepines. ** 
5. Meet criteria for current moderate or severe DSM-V Cannabis Use Disorder, or a mild, 
moderate, or severe DSM-V substance use disorder on any other drug, excluding alcohol. 
6. Report current use of psychotropic drugs including anxiolytics and antidepressants. ** 
7. Have received a prescription for any psychotropic drug in the 30 days prior to study 
enrollment ** 
8. Be psychotic or otherwise severely psychiatrically disabled  
9. Report a history of a medical condition that would contraindicate the consumption of 
alcohol (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, neurological 
problems, and gastrointestinal disorders).   
10. Have a history of clinically significant withdrawal from alcohol, defined as any one of the 
following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol 
withdrawal; b) a Clinical Institute Withdrawal Assessment scale (CIWA-Ar, Sullivan et al., 
1989) score > 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; 
or d) a lifetime history of medical treatment for withdrawal.  
11. A woman who is pregnant, nursing, or engages in sexual activity with opposite-sex 
partners and refuses to use a reliable method of birth control. ** 
12. Report disliking vodka or vodka mixed drinks. Vodka is the alcoholic beverage 
participants to be used in the proposed study** 
13. Body weight less than 110 pounds or greater than 220 pounds** 
14. Be colorblind 
15. Be a Foreign National 
 
* These inclusion criteria do not apply to the EMA field testing scenario. There will be no 
requirement of 6 or more heavy drinking days for the EMA scenario. Also, the minimum 
requirement of any drinking days will be only 8 for EMA, rather than 12 in the main study 
 
** These exclusion criteria do not apply to either field testing-only scenario. 
 

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Procedures 
 
Preliminary screening: All recruitment methods will direct participants to either call, text 
message or email the study to find out more information or to go directly to a web page where 
they can learn basic information about the study and complete the web screening questionnaire. 
Research assistants fielding requests for information will provide an overview of the study and 
answer questions.  Individuals interested in participating will be directed to complete the 
confidential web screening questionnaire.  Those who follow the link will be taken to an informed 
consent form for the web screener, which is encrypted and housed at REDCap via UF’s site 
license. They will then proceed to complete the web screen, also housed at REDCap. Neither 
email address nor any other personally identifiable information will be stored on REDCap, which 
is a secure website. REDCap complies with privacy standards set forth by HIPAA, and collected 
data is protected by real-time data replication. If participants do not have web access or would 
prefer to complete the screener by phone, they may do so.  
Interested individuals will indicate consent for the web screener by checking a box or verbally, if 
screened by phone. They will be advised that they can print out a copy of the web screener 
consent for their reference. Only those indicating consent will continue on to the screening 
survey itself.  After providing consent by clicking in a box, participants will be asked to think of a 
code word that would be easy for them to remember but that does not contain any identifying 
information (e.g., their name).  People completing the web screener will be informed of their 
preliminary eligibility via e-mail. Interested individuals who are eligible on a preliminary basis 
can then make an appointment for an in-person screening. These individuals are free to ask any 
questions they would like about the study via phone or email during the time between web and 
in-person screening. 
In-person screening:   
At the outset of the in-person screening appointment, picture identification (i.e., passport, 
driver’s license or state-issued identification card) is examined in order to verify identity and to 
ensure that they are between the ages of 21-25. This ensures that no alcohol consumption on 
the part of individuals under age 21 will take place in this study. At this appointment, the entire 
consent form will be reviewed in detail in a private, one-on-one setting at one of our research 
offices. Participants will be told that the purpose of the study is to test alcohol-related 
smartphone applications designed to provide assistance during actual drinking situations to help 
young adults reduce their drinking. It will be explained to participants that the apps will be tested 
both during a laboratory alcohol drinking session and a 4-week period outside the lab in which 
they can use this technology in actual drinking situations. For those who are asked to complete 
the 4-week field test only, the in-person screening can be done remotely by phone call or 
password-protected UF Zoom meeting. For field use-only participants, we will review the 
informed consent document  remotely and they will sign it via eConsent on RedCap.  
Risks and potential benefits will be described.  Any questions the participant may have will be 
addressed. If the subject wishes, he/she may take the consent form home (or review the 
eConsent, if remote) and consider it further before signing. They may also request to speak to 
anyone on the research team about questions they have. Once the participant has signed the 
consent, s/he may withdraw consent at any time. This informed consent form will serve as 
documentation of the major aspects of the consent process. The informed consent form will be 
signed and dated by the participant, and countersigned and dated by the staff member obtaining 

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consent  .Field-use only participants who are screened entirely remotely will be prompted to 
sign the ICF electronically using RedCap. A copy of the signed informed consent form will be 
given to the participant. Informed consent will be obtained prior to performance of any protocol-
specific procedures at the in-person screening. A breath alcohol concentration (BrAC) reading 
will be taken immediately after signing of the informed consent. The informed consent will be 
considered valid and the in-person screening appointment will proceed only if the participant’s 
BAC = 0.00%.  Following the BrAC reading, participants will also complete drug and pregnancy 
tests (women); timeline followback (TLFB)64 for 30-day alcohol/ other substance use; medical 
history; diagnostic interview36 ; and will complete the cued go/no-go task. The screen will take 
approximately 2 hours, and participants will receive up to $30 via a prepaid debit card.  
Eligible participants who are interested in enrolling will be assigned to the earliest possible 
individual alcohol drinking session. After this individual session, participants may be invited back 
to complete a group alcohol session on a different day along with two other participants with 
similar availability. There is a web-based, REDCap questionnaire for participants to complete in 
conjunction with the in-person screen, however participants complete this questionnaire on their 
own. However, if participants do not do so between the in-person screening appointment and 
the individual alcohol drinking session, we will request that participants complete the web-based 
questionnaire on the day of the individual alcohol drinking session on one of the computers in 
the research office.  
Individual Alcohol Drinking Session: 
Preliminary steps: Participants will be asked not to eat for 3 hours pre-arrival. Alcohol drinking 
will occur in a bar lab located at Yon Hall North in Ben Hill Griffin Stadium at the University 
Florida campus. Participants will be brought to the bar or simulated laboratory for the session 
via study-provided transportation: either a professional service such as taxi or Uber or a UF-
owned automobile driven by a UF employee. However, if a participant lives within a 0.5-mile 
radius of the research facility they may walk to the facility rather than being driven. These 
participants may be walked home by study staff after the end of the alcohol drinking session. 
Upon arrival, BrAC must=.00% and urine tests will be repeated. Participants registering a BAC > 
0.00% or with a positive urine test that leads to exclusion will be dismissed immediately and 
provided transportation directly home by the study. Participants will complete US-THRIVE, an 
efficacious, brief, web intervention based on M.I. (i.e., personalized feedback on drinking 
patterns, behavioral strategies, alcohol facts and resources). Before the alcohol administration, 
participants may be asked to wear the BACTrack Skyn alcohol wristband monitor, which looks 
like a fitness tracker or wristwatch and can detect alcohol as it evaporates through the skin.  
Prior to the session, they will be randomized to 1 of the 3 app conditions. The randomization 
procedure will be managed by a study staff member/collaborator without direct participant 
contact. Staff working with participants will not know app assignment.  
Instructions: After participants learn their app condition, they will view a presentation on the 
CGNG and how to use their assigned app. They will be told the app is based on a cognitive 
game and that they will use it 3 times. They will learn that the task is relevant to real-life as 
moderate amounts of alcohol affect task success and poor performance has been linked to 
driving problems and risky decisions. Dr. Leeman has used similar instructions relating alcohol 
to task performance and pay65, 66 and seen a range of alcohol use in lab drinking sessions. 
Alcohol administration steps: After completing US-THRIVE and using the app, the participant 
will be given vodka mixed drinks targeting a BAC of .06% based on sex, height, and weight 
divided into three parts. The participant will have 10 minutes to complete each drink and after 

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completion of all the drinks they will have a 15-minute absorption period. Participants will 
consume these beverages with a trained research staff member (graduate or undergraduate 
research assistant) to add a social aspect. This individual will be introduced as a staff member 
not a confederate and will not consume any alcoholic beverages 67. After the drinking portion 
has ended the participant will use the app again, be given a glass of water, and a BrAC will be 
taken. After 30 minutes, another BrAC will be taken, followed by self-reports. Drink 
administration will be conducted per NIAAA guidelines75 by 3 staff (supervisor, bartender, 
assistant). The individual drinking session can take place between 11am-7pm and participants 
should expect to remain on site for at least 2 hours after the drinking portion has ended and will 
be released when BrAC≤.02%.  At that, time transportation will be arranged to take participants 
to their home address only. Payment for this session will be $10 an hour and payment will be 
distributed at the follow-up appointment.  
Table 1. Summary procedures involved in individual alcohol drinking sessions in the proposed study 
Time  
Procedures 
    +0 
Arrival. Breath alcohol (BrAC) reading, urine testing, snack, US-THRIVE, app assignment, app 
information, & instructions, use app.  
  +60 
Alcohol dosing period: dose targeting BAC=.06, divided into three parts, 10 minutes to drink each part of 
dose  
  +90 
15 minute absorption period,  participant drinks small glass of water to rinse alcohol from mouth  
+105 
BrAC, use app, self-report of perceived impairment & other measures, then BrAC 
+135 
BrAC, use app, self-report of perceived impairment & other measures.  
+165 
BrAC. Dismissal once BrAC ≤ .02% 
 
Group Alcohol Drinking Session:  
Preliminary steps: Participants who are invited back for a group alcohol drinking session will be 
asked not to eat for 3 hours pre-arrival.  Alcohol drinking will occur either in a bar lab or other 
room located at Yon Hall North in Ben Hill Griffin Stadium at the University of Florida campus.  
At around 3:45pm, participants will be brought to the bar or simulated laboratory for the session 
via study-provided transportation: either a professional service such as taxi or Uber or a UF-
owned automobile driven by a UF employee (Table 2). However, if a participant lives within a 
0.5 mile radius of the research facility they may walk to the facility rather than being driven.  At 
the end of the session, these participants may be walked home by study staff. Upon arrival at 
4pm, BrAC (must=.00%) and urine tests will be repeated (Table 2).  Participants registering a 
BAC > 0.00% or with a positive urine test that leads to exclusion will be dismissed immediately 
and provided transportation directly home by the study. At this appointment, participants will 
receive an abbreviated version of the instructions on how to use the app and its value (see 
below). Participants will also complete baseline self-reports and the cued go/no-go task on the 
app.  Before the alcohol administration, participants may be asked to wear the BACTrack Skyn. 
Each session will be scheduled with 3 people each assigned to a different app, but if 1 cannot 
participate, the session may still occur. While it is our preference that this appointment occur at 
4pm just before the rest of the drinking session activities, if a participant’s schedule does not 
permit it, the 4pm activities may also be scheduled earlier in the day on the day of the session 
or the day before. In the case of an appointment the day before, the urine drug and pregnancy 
test will still occur on the day of the session. Payment for this appointment will be $20 via cash 
card and will be transmitted on the day of the appointment. 
 
Instructions:  The day of the group session participants will be given a brief review of the 
instructions that were given to them at their individual drinking sessions. Participants will be 
asked to not share their results on the app with the other participants. Study staff will explain to 
participants that to incentivize fast, accurate performance (Fig. 2a), they will get $.10 each 

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correct response if <275ms with $.10 penalty per error based on the final CGNG. Dr. Fillmore 
has seen a range of performance post-alcohol with this procedure44. All participants will learn 
their number of errors and fast + correct responses on the final CGNG. This may increase 
motivation to use the app in the 4-wk field-use period. 
 
Alcohol Administration/self-administration steps: Starting at 5pm, each participant will be given 
vodka with juice targeting BAC=.06% based on sex, height and weight divided into 3 parts with 
10 min. for each, 15-min. absorption, then BrAC, app use again and perceived impairment 
rating62 (how impaired they are; how unsafe driving would be). After these steps and another 
BrAC, 1-hr free drinking will begin when they can self-administer more alcoholic drinks up to 
.12% maximum BAC. Drink administration will be conducted per NIAAA guidelines68 (Table 1) 
by 3 staff (supervisor, bartender, assistant). After 1-hr, participants will be given water, another 
BrAC, wait 30 min., BrAC again, then app use, followed by self-reports. Staff will download app 
data onto a computer and inform participants of their number correct and errors on the last 
CGNG. They will rate the assigned app for usability including ease; self-consciousness when 
using; overall value and likelihood of future use69. Procedures for the 4-week field period will be 
explained. In the field period, participants will get the experimental app, regardless of session 
condition.  Participants will remain on-site until at least 11pm and released when BrAC<.02%.  
At that time, transportation will be arranged to take participants to their home address only.  
Participants can earn up to $80 for session participation ($10 per hour for the 6 hours and $20 
for adhering to session rules including accepting study-provided payment to and from the 
session, not completing academic or job-related work during the session, etc.), and payment will 
be distributed at the follow-up appointment. 
 
 
App condition: The control version is a smartphone-compatible CGNG. Each trial has this order: 
fixation cross (250ms); blank (250ms), vertical or horizontal cue (white rectangle) for 1 of 6 
stimulus onset asynchronies (100, 200, 300, 400, 500, 750ms); go or no-go target (green or 
blue rectangle, respectively) until participant responds or 500ms; inter-trial interval (250ms). 
Participants are told to respond fast to green, not to blue. Cues signal a target at 70% 
probability (horizontal: go, vertical: no-go). Activation and inhibitory tendencies develop cue-
dependence70, 71. Go cues speed RT to go targets, which must be overcome for no-go targets. 
Table 2. Summary of procedures involved in group alcohol drinking sessions in the proposed study 
Time 
Procedures 
4pm 
Arrival. BrAC, urine testing, snack, review of instructions, and use app.  
5pm  
Alcohol dosing period: dose targeting BAC=.06, divided into 3 parts, 10 minutes to drink each 
part of dose 
5:30  
15 minute absorption period, participant drinks small glass of water to rinse alcohol from mouth 
5:45 
Breath alcohol (BrAC) reading, use app, self-report of perceived impairment & other measures, 
then BrAC 
6:15 
1-hour free-drinking period when participants can self-administer more vodka mixed drinks to 
max BAC=.12% 
7:15 
Participant drinks small glass of water to rinse alcohol from mouth, then BrAC 
7:45 
BrAC, use app, all participants will get feedback on performance, self-reported 
impairment/other measures 
8pm 
Food provided, participants’ phones returned and staff extracts data from study phones.  
10pm 
Usability ratings of assigned app, 4-week field period explained, experimental feedback app 
provided to all 
11pm 
Earliest possible dismissal once BrAC <.02% 

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Inhibition errors are more common after go cues. The app is the same as a computer version 
except it fits a smartphone (Fig. 2b) with instructions to press the screen directly rather than a 
keyboard and includes 75, not 250 trials. 
  
 
The standard version is the same as the control version with the exception that information 
about performance (correct or incorrect) is displayed along with RT in ms for a correct response 
during each inter-trial interval.  
 
 
The experimental, feedback version includes the standard plus feedback on RT and inhibition 
errors compared to pre-drinking (Fig. 3). Based on past findings45-51, if they react >20ms slower 
and/or make >5% errors, they will get a message summarizing the performance decrement and 
implications for an outcome, picked randomly among trouble driving, risky sex, drug use, 
delinquency, or aggression. The app will state that there are simple alternatives with invitation to 
press a box to view advice,  based on research that risk information may increase risky behavior 
if convenient options are not given72. Feedback will be worded non-judgmentally per 
motivational interviewing tenets. 
 
Post-session field use: 
We will collect data for 4 weeks as people engage in usual drinking. The app will be 
programmed to deploy the CGNG, give related feedback and offer advice for 2 of the 4 wks 
(counterbalanced), enabling within-subject comparison of alcohol use with vs. without the main 
component app. The app will prompt 3 times on typical drinking days. Participants can set the 
app to prompt on other days also. After CGNG and feedback, participants report perceived 
impairment, the number of standard drinks they have consumed to that point and the extent to 
which they want and would like more alcohol. During the 2-weeks when the app does not deploy 
the CGNG task and feedback, participants will answer the questions only. Each morning for the 
4 weeks, the app will prompt recording of number of drinks and time spent drinking the prior 
day. Data collected by the app will not be visible after it is submitted so minimal information 
about participants will be visible in the app if the phone is stolen, lost, “hacked” or in some other 
way made visible to another person. Even though task performance and self-report responses 
are no longer visible after submission we suggest that all participants password protect their 
phone, and change the auto lock to 1 minute so that the application cannot be accidently 
accessed by anyone other than the study participant. Participants completing only the field use 
period will attend a baseline appointment, which can be held remotely via a password-protected 
UF Zoom meeting. During this baseline appointment participants will be walked through how to 
download the smartphone application, and shown how to use the app. They will be asked to use 
the app during the appointment to gather baseline data, and will then be pinged again later that 
evening or the following morning to use the app again. Compensation for this appointment will 
be $10. Following their baseline appointments participants will be asked to attend an orientation 
appointment where they will receive their randomized version of the smartphone application. 
They will receive $10 for this appointment. Participants completing lab sessions will complete 
these appointments in the course of their session participation and receive the same 

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compensation. Participants will be paid $5 per day each day of the field use period for 
completing the morning assessment on the app with a $5 bonus for completing the assessment 
7 out of 7 days ($40 per week). They will also be compensated $10 per week for using the app 
at least once per week. Thus, participants can earn up to $200 during the field use period, and 
payment will be given at the follow-up appointment. Participants will also complete the 6 & 12 
month follow-up surveys making maximum compensation for those chosen to only complete the 
field the use period $310.  
EMA Field Testing Scenario: 
As with main study participants, EMA participants may use their own smartphones or a study 
phone to complete these tasks in the study. Participants will be prompted 5 times per day for 10 
days to complete some type of brief assessment on their phone. On days when participants 
drink alcohol, they may complete up to 7 assessments. EMA participants will complete the same 
morning questionnaire via the app as main study participants do. They will then be prompted to 
use the app including completion of the cognitive task twice (typically, once late morning/early 
afternoon and once in the mid-late afternoon) each day. Participants will receive a reminder an 
hour-two hours before the time when they most often begin drinking on a typical day of the 
week. The reminder will be for participants to complete a brief drinking questionnaire housed on 
REDCap at the conclusion of each of their first 3 drinks, should they have at least that many. 
The reminder will be delivered via text message from a study phone and will include the 
REDCap survey link. This survey will ask about what the participant is drinking, the speed of 
consumption, the subjective effects of alcohol they are feeling, the social context in which they 
are drinking, and their location (i.e. at home, bar, restaurant, friend’s house, etc.). Participants 
will then receive another prompt via text from the study phone to complete the end of the day 
survey just before they go to bed. This prompt will come between an hour to two hours before 
their typical bed time on a given day of the week. This survey will about their total number of 
alcoholic drinks for the day/night, what time they finished drinking, the subjective effects of 
alcohol they are feeling, their perceived impairment, and about perceived impaired control over 
alcohol use (i.e., difficulty in one’s ability to limit drinking). Thus, participants will have input 
regarding when they will receive each of these prompts. Participants will receive $130 if they 
complete ≥ 80% of possible questionnaires. Payment will receive a prorated portion of the $130 
if they complete less than 80%. For instance 50% completion would earn $65. EMA participants 
will earn $20 for the in-person screening appointment; $20 for an appointment to train them how 
to use the app and regarding how the EMA will work, which can occur remotely via Zoom; and 
$30 for an appointment after they complete the 10-day period, which can also occur remotely 
though participants using a study phone will have to return it to the research office. Thus 
maximum compensation for a participant chosen for the EMA scenario will be $200. Typically 
EMA studies are conducted via special EMA software, however, given that we tend to enroll no 
more than 12 participants and the duration will only be 10 days, we will conduct the EMA via 
text messages sent from study staff using a study phone and REDCap surveys.  
 
 
Follow-up appointment: 
After 4 weeks, participants will come to our office for an updated TLFB and give usability and 
acceptability ratings for the CGNG experimental feedback app based on the 4-week field period. 
Staff will extract data from the phones, participants will be paid, and clinical referrals will be 
provided when appropriate. Participants who participate entirely remotely will complete their 
follow-up appointment via Password-Protected UF Zoom.  Participants will receive $30 for 
attending this appointment. They will receive all other earned compensation at this time via a 
prepaid debit card.  
Six- & 12-month follow ups: At six and twelve-months post completion of the study, participants 
will be contacted via electronic mail and will be asked to complete a survey comprised of 

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previously approved measures and items regarding use of alcohol reduction smartphone apps 
and other means of alcohol use reduction. The survey will be completed through the secure 
website www.REDCap.com. Payment for completion of each survey will be $25. 
 
Assessments: 
 
Web/phone screener: 
 
Demographic information:  This questionnaire assesses basic demographic information, 
including age, sex, weight, and whether they are a Foreign National or not. 
 
Frequency and quantity of alcohol consumption: Three multiple choice items will be included, 
which will assess number of drinking days; number of heavy drinking days (5 or more for men, 4 
or more for women) and peak number of drinks in a 24-hour period in the past 30 days.  
 
Liking for different alcoholic beverages: An item will be included concerning participants’ liking of 
beer, wine, vodka (straight or in mixer) and rum (straight or in mixer).  
 
General questions regarding other inclusion criteria: Two questions will list several inclusion 
criteria and ask participants whether or not all of the listed criteria pertain to them. This will 
provide information regarding inclusion and exclusion to study staff while not requiring 
participants to provide specific information along these lines as part of the preliminary screen. 
 
In-Person Screening Appointment: 
 
Vital signs (i.e., blood pressure and pulse readings), height and weight. 
 
Withdrawal: The Clinical Institute Withdrawal Assessment for Alcohol (Revised) (CIWA-AR)29 
will be used to assess withdrawal symptoms.  The CIWA is a reliable 10-item instrument 
designed to assess severity of current withdrawal syndrome. 
 
Medical and psychiatric history: A medical and psychiatric history will be taken from all 
participants, which will cover the following conditions: hypertension, diabetes, high cholesterol, 
cardiac abnormalities, pancreatitis, renal insufficiency, cancer, pulmonary disease, thyroid 
conditions, history of head injury or other neurological problems, stomach or intestinal disorders 
and liver disease. Participants will also be asked whether they have ever been diagnosed with a 
psychiatric condition or received treatment for such a condition. Participants will be asked to 
report all medications, including over the counter medications and those that they are currently 
taking, including psychotropic medications. The Structured Clinical Interview for DSM-5 (SCID) 
will be used to classify patients according to the presence or absence of past or present alcohol 
and other substance use disorders as well as other psychiatric disorders, as needed. 
 
The digits backwards task from the digit span subtest of the Wechsler Adult Intelligence Scale-
III80 will be used to assess working memory. 
 
The Kirby delay discounting measure is a 27-item measure that assesses preferences as to 
whether participants would prefer smaller, immediate or larger, delayed hypothetical monetary 
amount. Length of delay and amount of hypothetical funds vary across items. 
 
 
Web-Based Survey Associated with In-Person Screen 
 
Demographics: Participants will be asked to report their birth sex, gender identity, age, race and 
ethnicity.  
 
Student status: Participants will be asked to report whether or not they are students currently 
and if so, they will be asked about various aspects of their student status, including full-time 
versus part-time status, year in school, type of residence and fraternity/sorority membership. 

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Psychiatric symptoms/conditions: The 42-item Depression Anxiety Stress Scale (DASS85) will be 
administered. This measure assesses several negative emotional states, including depression, 
anxiety and stress to which participants indicate their agreement on a 4-point scale. 
 
Family history of problem drinking:  Family history is measured with a subscale taken from the 
Addiction Severity Index57. Participants are asked to indicate whether or not four classes of 
relatives on both their mother’s and father’s side ever “had a significant problem with alcohol or 
drugs, one that either lead to treatment or should have led to treatment.”   
 
Drinking history: Participants will be asked to report the age when they first started drinking, not 
counting small tastes or sips of alcohol and their age of first intoxication. They will also be asked 
to report the highest number of drinks they have ever consumed over a 24-hour period in their 
lifetimes. 
 
Alcohol-related problems:  Participants will complete the long version of the Young Adult Alcohol 
Consequences Questionnaire (YAACQ), which is comprised of 48 consequences that may have 
occurred within the past three months. 
 
Alcohol expectancies: The Comprehensive Effects of Alcohol (CEOA) measure will be used to 
assess the extent to which participants report experiencing alcohol-related expectancies (e.g., 
“After a few drinks of alcohol, I would be more likely to feel dizzy”).   
  
Subjective response to alcohol: An adapted version of the Self-rating of Effects of Alcohol (SRE; 
Schuckit et al., 199792) will be used at intake to assess the number of alcoholic drinks it took for 
participants to experience a series of subjective effects (e.g., stimulation, arousal) the first time 
they drank alcohol, in the past three months and during their period of heaviest drinking. 
Responses to the adapted SRE will be used to assess self-reported tolerance as well. A tolerance 
score is created by subtracting the score for the first five drinking occasions (α = .83) from the 
score for the recent drinking experiences (α = .86) 93.   
 
Drinking motives:  Drinking motives will be assessed using Cooper and colleagues measure of 
three types of drinking motives (i.e., social, coping and enhancement or the achievement of 
pleasurable affect from drinking).  
 
Drinking-induced disinhibition:  The Drinking-Induced Disinhibition Scale63 (DIDS) is a measure 
comprised of a series of drinking-related experiences to which participants are asked to indicate 
agreement on a six-point scale.  The DIDS assesses four types of disinhibitory experiences 
resulting from alcohol use (i.e., euphoric/social, dysphoric, sexual and aggressive).   
 
Impaired control: The Impaired Control Scale33 (ICS) consists of three parts including 5 items 
concerning actual attempts at limiting alcohol consumption (Part 1); 10 items assessing the 
frequency of past failures at controlling drinking (Part 2) and 10 items assessing beliefs 
regarding future ability to control drinking (Part 3). Parts 1 and 2 will be administered in this 
study. The ICS is reliable and has been validated in clinical and community samples. Items are 
rated on a 0 to 4 scale and summed with higher scores indicating greater difficulty in controlling 
consumption.  
 
The Protective Factors Questionnaire measures frequency of alcohol-related protective strategy 
use on a 7-point scale. This measure has been used with young adult samples in several 
studies. 
 
Facets of impulsivity: Impulsivity and risky decision making will be measured using the UPPS 
Impulsive Behavior Scale: a 59-item measure that assesses five subdimensions of impulsivity 
(premeditation, positive urgency, negative urgency, sensation seeking and perseverance). A 
cued go/no-go task60 will be administered during the in-person screening appointment. This is a 

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8-10 minute computerized task which assesses the ability to inhibit a prepotent response. 
Subjects are instructed to press a key or inhibit pressing a key based on the colors of the 
shapes presented. The orientation of the shape (horizontal or vertical) before the color appears 
signals imperfectly the likelihood that the subsequent stimulus will be “go” or “no-go.” 
Participants receive feedback regarding their accuracy and speed of response. 
 
In-Person Screening Appointment and at Preliminary Appointment Day of the Sessions: 
 
Self-reported alcohol consumption and smoking: The Timeline Followback Interview (TLFB) will 
be administered at the in-person screening and updated at the preliminary appointment. 
Participants will be given a blank calendar including memory prompts (e.g., holidays), which 
covers the designated time interval (the prior 30 days at initial screening) and asked to 
reconstruct their drinking behavior and smoking over that interval. The TLFB has good test-
retest reliability and good validity for verifiable events. 
 
Marijuana use: Participants will be asked on how many days they have used any form or 
marijuana. Participants will be asked to report on the prior 30 days at the in-person screening 
appointment and since the in-person screening appointment at the appointment on the day of 
the session. 
 
Urine drug and pregnancy tests: Urine drug dips will be used to detect opiates, cocaine, 
phencyclidine, amphetamines, methamphetamine, barbiturates, methadone and 
benzodiazepines. Urine pregnancy tests will also be administered to all female participants. A 
positive test for any of the above drugs or a positive pregnancy test will lead to immediate 
exclusion from the study. 
 
Symptoms:  Adverse experiences are collected on standardized forms, using the SAFTEE. The 
SAFTEE includes 1) open-ended questions about any changes in physical or health problems, 
appearance, or activity level, and 2) yes/no responses to a specific list of symptoms for a 
specified time period. For each symptom reported on the SAFTEE a rater also records the 
severity (mild, moderate, or severe) and action taken.  
 
Suicidality: The Columbia Suicide Severity Rating Scale (CSSRS) is a semi-structured interview 
that assesses past and current suicidal ideation, intent, and attempts. It will be used to monitor 
the safety of participants. Any participant reporting current suicidal ideation including intent to 
carry out a suicide attempt will be excluded from the study and the study physician, Dr. Cook, 
will be alerted immediately.   
 
Menstrual cycle data: Self-reports will be obtained from all women on their 
menstrual/gynecological status. We will include women who are cycling normally and/or on birth 
control pills. Three months of self-report data recording the start of their menses will be obtained 
prior to the alcohol drinking session. This information will be obtained initially at the in-person 
screening and updated at the pre-session screening appointment on the day of the alcohol self-
administration session.  
Brief Smoking Questionnaire: The Brief Smoking Questionnaire is a brief self-report survey that 
consists of four questions that evaluate current daily cigarette use and likelihood of nicotine 
dependence. I  
Drinking Reduction Form: This is a brief survey consisting of three Yes/No questions. The first 
question determines whether a potential participant has used a smartphone app to reduce 
drinking in the previous 12 months. The next two questions determine whether a potential 
participant plans to take active steps to stop or cut down drinking in the next three months.  

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Eligibility Checklist: This checklist is used by study staff to determine participant eligibility based 
on measures taken during the screening appointment to make certain that active evaluations of 
eligibility and ineligibility are made.   
 
Screening and at Alcohol Administration Sessions: 
 
Breath alcohol concentration: Breath alcohol concentration will be assessed using a hand-held 
Intoxilyzer breathalyzer unit at the in-person screening; at the preliminary appointment earlier on 
the day of the alcohol drinking session; at the outset of the alcohol drinking session and then at 
several points during the sessions.  
 
Alcohol purchase task:  This is a simulation measure to assess self-reported alcohol 
consumption and expenditure were alcohol to cost varying amounts of money. The measure 
generates a number of variables pertaining to reinforcement from alcohol, including intensity of 
demand. The purchase task will be administered twice during the in-person screening 
appointment. One version will assess how many drinks a participant would consume right now 
at varying amounts of money and a modified version will assess how many drinks a participant 
would consume on a hypothetical weekend evening. At the alcohol drinking session, the “right 
now” version of the measure will be administered multiple times at both at baseline and after the 
drinking period. This will allow a comparison of the amounts of hypothetical money participants 
are willing to spend on alcohol, a priori, upon arrival at the bar or simulated lab and after 
consumption of alcohol. 
 
Risk Taking Behavior: The Cognitive Appraisal of Risk Events (CARE) and its revised version 
(CARE-R; Katz, Fromme, & D’Amico, 2000) assess recent negative consequences and 
expectations that these consequences will occur again in the near future. Of the measure’s 4 
subscales, we will administer at in-person screen a version of the past frequency subscale that 
combines the original with the revised version in order to obtain baseline data. Participants will 
be asked to report how many times in the past 3 months each has occurred. Then after fixed 
dose in the individual session, we will administer the expected involvement subscale. Items are 
rated a 7-point Likert scale ranging from “not at all likely” to “extremely likely”.  
 
Alcohol Administration Sessions: 
 
Measures of the subjective effects of alcohol, craving, mood and perceived impairment will be 
administered at the end of the alcohol self-administration period and every hour afterward until 
the end of the session. Participants will also be asked to estimate their current blood alcohol 
level and number of alcoholic drinks consumed at the end of the alcohol self-administration 
period. Craving and mood will also be assessed at the beginning of the session.  
 
The Probabilistic Choice Questionnaire (PCQ)71 is made up of 30 items comparing certain with 
uncertain hypothetical monetary amounts of varying sizes. 
 
Subjective effects of alcohol: The Biphasic Alcohol Effects Scale, a 14-item self-report, unipolar 
adjective rating scale, will be used to measure the stimulant and sedative effects of alcohol.  
 
Craving: Craving will be assessed using two measures. The Alcohol Urge Questionnaire (AUQ) 
is an 8-item questionnaire, derived from a larger 49-item "Questionnaire of Alcohol Urges" and 
assesses desire for a drink, expectation of positive effect from drinking, and inability of avoid 
drinking if alcohol was available. The AUQ is a reliable and valid scale for the measurement of 
self-reported alcohol urges and scores have been shown to be strongly related to alcohol 
dependence severity and to cognitive preoccupation with alcohol. Its brevity and time frame for 
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Craving will also be assessed with a single item assessed using a 100-point visual analog scale. 
Participants will be asked to report the extent to which they “want alcohol.”  
 
Liking for alcohol: An item from The Drug Effects Questionnaire64 (DEQ) will be used to assess 
the extent to which participants like the effects of alcohol they are experiencing at the time, 
rated on a 100-mm line (from “not at all” to “very much”). The DEQ has been utilized in previous 
alcohol studies65. 
 
Mood: The Positive Affect and Negative Affect Scale (PANAS) provides a measure of current 
mood. Participants indicate their agreement with 20 adjectives, including 10 each to assess 
positive (e.g., attentive, interested) and negative affect (e.g., hostile, scared). The PANAS has 
been found to be both reliable and valid. 
 
Perceived impairment: Participants will also rate their perceived level of impairment with three 
items on 1-10 scales, used by Brumback et al66: 1. “how impaired do you think you are at 
present?”, 2. “how unsafe do you think it would be to drive an automobile at present?”, and 3. “if 
I were at work now, others might think I was intoxicated or behaving unusually” with 10-point 
rating scales for each, anchored at 1 for “not at all” and 10 for “extremely”. The use of these 
items will allow for analyses to address the possibility that misperceived impairment partially 
mediates an association between self-reported impaired control and ad libitum alcohol 
consumption.  
 
Social bonding: The Perceived Group Reinforcement Scale (PGRS) will be used to evaluate the 
degree of social bonding participants believe has occurred during the session for those 
participants who complete alcohol self-administration in a group format. The PGRS is a 12-item 
measure with items (e.g., “I liked this group) rated for agreement on a 9-point scale. The 
measure will be administered twice, once right after the end of the drinking period and then 
again toward the end of the session when the first participant has reached a safe BAC level and 
is able to leave. 
 
“Real Time” Impaired Control Questions: We will ask a series of questions pertaining to 
impaired control that are based on some items in the Alcohol Craving Questionnaire67. The goal 
is to get a sense of participants’ perceived impaired control at that time if they could drink 
alcohol without the limitations on drinking in place due to the study: “If I had access to alcohol 
right now, I would not be able to stop using it;” “I would not be able to control how much alcohol 
I drank if I had some here now;” “I could not stop myself from drinking if I had some alcohol 
here.” Items are rated on 7-point scales anchored by “strongly disagree” and “strongly agree.” 
 
Acceptability and satisfaction with mobile technology: Toward the end of the alcohol drinking 
session, participants will complete a measure regarding the acceptability of the form of mobile 
technology to which they were randomly assigned. These items were adapted from an 
evaluation for computerized cognitive behavioral therapy36. Participants will rate satisfaction with 
their mobile technology; ease of use; self-consciousness while using it; overall value; and 
likelihood they would use it in the future.  
Participant Experience Interview: During the follow-up interview, a study staff member will 
conduct a participant experience interview to obtain participant input regarding aspects of the 
study including aspects they liked, disliked and suggested changes for future studies. Questions 
regarding the drinking session, app use, and advice provided are included in this interview.  
 
EMA Surveys 
 
While drinking survey 
 

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Type of drink: Participants will be asked “What type of drink did you consume?” with the options 
beer, wine, malt liquor, hard liquor shot, and mixed drink. 
 
Speed of Consumption: As soon as possible after completing an alcoholic drink, participants will 
answer the question “How long did it take you to drink [the beverage]?” endorsing one of the 
following time increments in minutes: 1 = <2, 2 = 2 to 5, 3 = 6 to 10, 4 = 11 to 15, 5 = 16 to 20, 6 
= 21 to 25, 7 = 26 to 30, 8 = 31 to 45, 9 = 46 to 60, and 10 = >60. 
 
Location: Participants will be asked “Where is your current location?” with the following options: 
home, work, bar/restaurant, outside, other public place, other location, friend’s house, and 
significant other’s house. 
 
Social Context:  Participants will be asked “In the past 15 minutes, who have you been with?” 
with the following options: no one, romantic partner/spouse, family member, friend/ 
acquaintance, boss/teacher, coworker, roommate, and other. 
 
Liking for alcohol: An item from The Drug Effects Questionnaire64 (DEQ) will be used to assess 
the extent to which participants like the effects of alcohol they are experiencing at the time, 
rated on a 100-mm line (from “not at all” to “very much”). The DEQ has been utilized in previous 
alcohol studies65. 
 
Craving: Craving will also be assessed with a single item assessed using a 100-point visual 
analog scale. Participants will be asked to report the extent to which they “want alcohol”. 
 
Subjective effects of alcohol: The Biphasic Alcohol Effects Scale, a 14-item self-report, unipolar 
adjective rating scale, will be used to measure the stimulant and sedative effects of alcohol.  
 
After Drinking Survey  
 
Drink Amount: At the end of the night participants will be asked about how many drinks they 
have consumed during that day/night, and what type of drinks they were (Beer, wine, hard 
liquor).  
 
End of Drinking: Participants will be asked to indicate when they completed their last drink for 
that day/night  
 
Subjective effects of alcohol: The Biphasic Alcohol Effects Scale, a 14-item self-report, unipolar 
adjective rating scale, will be used to measure the stimulant and sedative effects of alcohol.  
 
Perceived impairment: Participants will also rate their perceived level of impairment with three 
items on 1-10 scales, used by Brumback et al66: 1. “how impaired do you think you are at 
present?”, 2. “how unsafe do you think it would be to drive an automobile at present?”, and 3. “if 
I were at work now, others might think I was intoxicated or behaving unusually” with 10-point 
rating scales for each, anchored at 1 for “not at all” and 10 for “extremely”. The use of these 
items will allow for analyses to address the possibility that misperceived impairment partially 
mediates an association between self-reported impaired control and ad libitum alcohol 
consumption.  
 
“Real Time” Impaired Control Questions: We will ask a series of questions pertaining to 
impaired control that are based on some items in the Alcohol Craving Questionnaire67. The goal 
is to get a sense of participants’ perceived impaired control at that time if they could drink 
alcohol without the limitations on drinking in place due to the study: “If I had access to alcohol 
right now, I would not be able to stop using it;” “I would not be able to control how much alcohol 
I drank if I had some here now;” “I could not stop myself from drinking if I had some alcohol 
here.” Items are rated on 7-point scales anchored by “strongly disagree” and “strongly agree.” 
 

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Liking for alcohol: An item from The Drug Effects Questionnaire64 (DEQ) will be used to assess 
the extent to which participants like the effects of alcohol they are experiencing at the time, 
rated on a 100-mm line (from “not at all” to “very much”). The DEQ has been utilized in previous 
alcohol studies65. 
 
Craving: Craving be assessed with a single item assessed using a 100-point visual analog 
scale. Participants will be asked to report the extent to which they “want alcohol” 
 
Six and Twelve Month Follow-Up Survey:  
Student status: Participants will be asked to report whether or not they are students currently 
and if so, they will be asked about various aspects of their student status, including full-time 
versus part-time status, year in school, type of residence and fraternity/sorority membership. 
 
Psychiatric symptoms/conditions: The 42-item Depression Anxiety Stress Scale (DASS85) will be 
administered. This measure assesses several negative emotional states, including depression, 
anxiety and stress to which participants indicate their agreement on a 4-point scale. 
 
Family history of problem drinking:  Family history is measured with a subscale taken from the 
Addiction Severity Index57. Participants are asked to indicate whether or not four classes of 
relatives on both their mother’s and father’s side ever “had a significant problem with alcohol or 
drugs, one that either lead to treatment or should have led to treatment.”   
 
Alcohol-related problems:  Participants will complete the long version of the Young Adult Alcohol 
Consequences Questionnaire (YAACQ), which is comprised of 48 consequences that may have 
occurred within the past three months. 
 
Alcohol expectancies: The Comprehensive Effects of Alcohol (CEOA) measure will be used to 
assess the extent to which participants report experiencing alcohol-related expectancies (e.g., 
“After a few drinks of alcohol, I would be more likely to feel dizzy”).   
  
Subjective response to alcohol: An adapted version of the Self-rating of Effects of Alcohol (SRE; 
Schuckit et al., 199792) will be used at intake to assess the number of alcoholic drinks it took for 
participants to experience a series of subjective effects (e.g., stimulation, arousal) the first time 
they drank alcohol, in the past three months and during their period of heaviest drinking. 
Responses to the adapted SRE will be used to assess self-reported tolerance as well. A tolerance 
score is created by subtracting the score for the first five drinking occasions (α = .83) from the 
score for the recent drinking experiences (α = .86) 93.   
 
Drinking motives:  Drinking motives will be assessed using Cooper and colleagues measure of 
three types of drinking motives (i.e., social, coping and enhancement or the achievement of 
pleasurable affect from drinking).  
 
Drinking-induced disinhibition:  The Drinking-Induced Disinhibition Scale63 (DIDS) is a measure 
comprised of a series of drinking-related experiences to which participants are asked to indicate 
agreement on a six-point scale.  The DIDS assesses four types of disinhibitory experiences 
resulting from alcohol use (i.e., euphoric/social, dysphoric, sexual and aggressive).   
 
Impaired control: The Impaired Control Scale33 (ICS) consists of three parts including 5 items 
concerning actual attempts at limiting alcohol consumption (Part 1); 10 items assessing the 
frequency of past failures at controlling drinking (Part 2) and 10 items assessing beliefs 
regarding future ability to control drinking (Part 3). Parts 1 and 2 will be administered in this 
study. The ICS is reliable and has been validated in clinical and community samples. Items are 
rated on a 0 to 4 scale and summed with higher scores indicating greater difficulty in controlling 
consumption.  
 

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The Protective Factors Questionnaire measures frequency of alcohol-related protective strategy 
use on a 7-point scale. This measure has been used with young adult samples in several 
studies. 
 
Facets of impulsivity: Impulsivity and risky decision making will be measured using the UPPS 
Impulsive Behavior Scale: a 59-item measure that assesses five subdimensions of impulsivity 
(premeditation, positive urgency, negative urgency, sensation seeking and perseverance). A 
cued go/no-go task60 will be administered during the in-person screening appointment. This is a 
8-10 minute computerized task which assesses the ability to inhibit a prepotent response. 
Subjects are instructed to press a key or inhibit pressing a key based on the colors of the 
shapes presented. The orientation of the shape (horizontal or vertical) before the color appears 
signals imperfectly the likelihood that the subsequent stimulus will be “go” or “no-go.” 
Participants receive feedback regarding their accuracy and speed of response. 
Smartphone app use: Several questions will ask participants about their use of smartphone 
applications during the past 6-months as a way to moderate or reduce their drinking.  
Drinking reduction: Two questions will assess whether participants have taken active (i.e., 
attending self-help group meetings, beginning psychotherapy, medication use or entering an 
inpatient facility) steps to change their alcohol and/or other substance use during the past 6-
months  
 
Data analyses 
 
Normal probability plots will be reviewed to assess normality and need for transformations. 
Paired samples t-tests will be used to confirm an effect of initial dose on CGNG inhibition errors 
but not RT. Our analytic strategy will resemble 3 past studies. The main method will be multiple 
regression with study condition and sex as predictors. Baseline variables that differ significantly 
by condition will be covaried.  
 
Outcome 1a will be BAC during self-administration. Because we will not interrupt alcohol self-
administration with BrAC readings, we will calculate peak estimated BAC (eBAC) based on 
number of alcoholic drinks, time elapsed, weight and sex. eBAC was sensitive to differences in 
consumption between study conditions in a prior study conducted by Dr. Leeman. Results will 
be BrAC-confirmed after the 1-hr free-drinking period. Though not the main focus, we will test 2-
way interactions of study condition by RT and inhibition errors post-alcohol to see if more 
inhibition failures under alcohol predict self-administration. Regressions will be confirmed using 
multilevel models (MLM) in Mplus with random effect of group (people completing a drinking 
session together) and other predictors as fixed effects. Since participants will be randomized to 
different apps, we do not expect strong intra-class correlations, which should result in similar 
findings in regression and MLMs.  In our in-progress study, no group level effects have 
emerged. A similar strategy will be used for 1b (alcoholic drinks self-administered). 
 
Primary Aim 2 will entail comparisons of alcoholic drinks consumed per occasion between the 2 
weeks participants will use vs. not use the app in the 4-week field period post-drinking session. 
We will retain study condition as a predictor (effects of lab-assigned condition are not 
hypothesized here) and a random group effect while adding app use vs. non-use period as a 
within-subjects effect in MLM. ANOVA will compare usability and acceptability ratings at the end 
of the drinking session and 4-week field period across app conditions. For mediation 
(Secondary Aim), we will test for indirect effects of app condition on self-administration via 
perceived impairment using MacKinnon’s products of coefficients approach with bootstrapped 
confidence intervals (CIs). This approach accounts for non-normality of the product of 

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coefficients in calculating indirect effects of IV on DV, operating through a mediator. When the 
CI does not include 0, an indirect effect is significant at the specified alpha level.  
 
For Exploratory Aim 1, we will test between-subjects study condition during the lab sessions, 
amount of alcohol self-administered (operationalized as estimated peak BAC and number of 
drinks self-administered in separate models) in the alcohol drinking session and during the field 
period in the intervention and non-intervention periods as predictors of self-reported alcohol 
consumption (e.g., drinks per drinking day) and alcohol-related problems self-reported at 6- and 
12-months post-session on the web-based surveys using MLM. Baseline reports of each 
alcohol-related outcome and participant sex will be entered as covariates. The web-based 
surveys at baseline, 6- and 12-months post also include measures of several potential 
covariates that may be entered into these models should they differ significantly across study 
conditions. 
 
For Exploratory Aim 2, we will use separate MLMs to test BACTrack Skyn readings during each 
alcohol administration session as predictors of successive breath alcohol readings taken 
following alcohol administration/self-administration periods in the alcohol drinking sessions and 
to predict number of drinks self-administered during the group drinking session. Sex and 
participant weight will be entered into these models as covariates as well.  
 
For Exploratory Aim 3, we will use MLM to predict expected involvement scores on the CARE 
measure post-alcohol administration based on performance on the app-based cued go/no-go 
task following the .06% fixed dose as the predictor variable. Baseline expected involvement 
scores and scores on the other CARE subscales will be held constant in these models. Since 
the .06% dose will be administered at each session along with cued go/no-go task performance 
and the CARE, these measures will be entered into the same models as repeated measures. 
Participant sex and study condition will also be entered as covariates in these models  
 
Sample, power & effect size 
 
Our goal was to power the study for the Primary and Secondary Aims. Roberts and Fillmore’s 
findings speak to the potential impact of task-based feedback (Preliminary Study 5 [PS5]). 
Perceived ability to drive post-alcohol declined from M=46.8(4.7) to 29.7(5.5) in the higher risk 
DUI group and only M=25.8(5.5) to 21.2(4.8) in the no-DUI group: a large effect difference 
(d=1.5). While not the same as a control condition, the no-DUIs were a subgroup in which the 
intervention had minimal impact, as with a control condition. Our alcohol study in-progress 
(Preliminary Study 1 [PS1]) is relevant as a test of effects of an app on alcohol self-
administration though the methods are not identical. Since our ongoing study does not begin 
with a fixed dose targeting a specific BAC, results involving number of alcoholic drinks self-
administered are more comparable to the proposed study and more appropriate for power and 
effect size estimation. In our in-progress study, the smartphone breathalyzer device/app was 
associated with significantly less alcohol self-administration (M=3.5 drinks, SD=1.3) than a 
control condition (M=4.8, SD=1.5), d=.89. Considering these findings, we project a large effect 
size.  
  
Aim 1 power is based on ability to detect a between-subjects effect of app condition. We used 
an effect size equivalent to our in-process smartphone breathalyzer study for effect of condition 
(experimental vs. control groups). This estimated effect is much smaller than in Roberts and 
Fillmore’s prior study providing feedback regarding cognitive impairment to a sample of drinkers 
with and without a prior DUI. Assuming an effect (d=.89) at α=.025 (to account for comparisons 
between the experimental app and each of the other study conditions: standard and control), the 
proposed sample of 99 completing the lab session and follow-up period yields .90 power. For 
Primary Aim 2, the goal will be to compare alcohol use in the 2 weeks participants use vs. do 

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not use the experimental app. No study condition effect is hypothesized, thus the focus will be 
on within-subjects comparison. As such, assuming α=.05 at 90% power, we can detect an effect 
of .33 (small-to-medium). The secondary aim of testing the indirect effect of app condition on 
drinking via perceived impairment will require the largest sample size as it entails tests of 
between group differences and tests of indirect effects are underpowered relative to tests of 
direct effects. In a Monte Carlo simulation, assuming small-to-medium correlation (.35) between 
perceived impairment and drinks self-administered (DV), power to detect an effect of the IV 
(study condition) on the mediator and an effect of the mediator on the outcome was >.90 and 
power to detect an indirect effect was .80 with 33 per condition (N=99 total).  
 
7. Possible Discomforts and Risks 
Potential risks in this study were identified in accordance with the recommended guidelines on 
ethyl alcohol administration in human experimentation put forth by the National Advisory Council 
on Alcohol Abuse and Alcoholism (2005) and two reviews on this subject (Dolinsky & Babor, 
1997; Wood & Sher, 2000). Steps taken to minimize these risks were also developed in 
accordance with these documents. 
Alcohol consumption: A number of medical conditions could potentially be worsened by acute 
alcohol administration (e.g., liver disease, cardiac abnormality, pancreatitis, diabetes, 
neurological problems, and gastrointestinal disorders). As a result, participants with such 
medical problems as revealed by a medical history taken during the in-person screening will be 
excluded from the study. 
Alcohol self-administration in a research study by individuals who are severely alcohol 
dependent as evidenced by current withdrawal or a history of withdrawal may pose a risk to 
their health and safety. Alcohol self-administration in a research study by individuals who are 
seeking treatment for alcohol use disorder or who have recently engaged in intensive treatment 
for alcohol dependence may compromise their efforts to reach or to maintain abstinence or 
moderate levels of alcohol use.  
Alcohol may cause nausea in high doses, however, nausea is not expected at the doses that 
will be consumed in this sample of frequent heavy drinkers. Only frequent heavy drinkers are 
selected for the study, thus ensuring that any amount of alcohol consumed during an alcohol 
drinking session is less than or equal to an amount of alcohol they consume on their own on a 
regular basis. Also, beyond the initial fixed dose targeting a blood alcohol content of .06%, the 
subjects determine the amount of alcohol consumed. Subjects can choose not to drink any 
alcohol at all beyond the fixed dose if they prefer. 
Another area of potential risk to subjects under the influence of alcohol involves their safety 
during the experimental procedures. All subjects will be under the close supervision of the 
experimenters to prevent possible accidents such as falls. Alcohol is a reinforcing agent, which 
may cause changes in behavior including repetitive or excessive alcohol consumption.  
Breath screening and urine collections: Breath screening and urine collections are performed 
primarily as safeguards and should add no risks other than those normally associated with these 
procedures. 
BACTrack Skyn: The wrist biosensor poses virtually no risk as it is a noninvasive device and is 
shaped like a fitness tracker with a sensor for alcohol. Utilizing this product will add no risks other 

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than those normally associated with these procedures, for example, wearing the wrist band too 
tightly. The device is adjustable for different wrist sizes, and participants will not be required to 
wear the wrist sensor if they do not want to. Data collected by the Skyn will not include 
participant identifiers. Readings from the biosensor will be downloaded as a CSV/Excel file and 
stored on a secured server at UF after each lab session. Data from these devices may be 
combined with data from another ongoing study (IRB201801188) without identifiers to address 
relationships between Skyn readings and key variables such baseline self-reported alcohol use 
and participant sex and weight. These data would be combined to create a larger dataset 
including parallel measures to yield enhanced statistical power for analyses related to Skyn 
readings. Data will not be matched to data from individual participants in IRB201801188. The 
study populations from the two studies are non-overlapping. RB201801188 enrolls participants 
with a much wider age range and wider range of drinking behavior including a high percentage 
of lighter social drinkers. Further, approximately half of participants enrolled in RB201801188 
are HIV-positive. In contrast, HIV-positive individuals would likely not be eligible for the current 
study, which enrolls a narrow age range of young adults who engage in frequent heavy drinking 
behavior. Dr. Wang and Dr. Leeman are investigators on both studies. They are the only 
investigators privy to identifiers of participants from the two studies. 
Interviews, rating scales and questionnaires: The assessments used in this study deal with some 
sensitive issues including family history of high-risk alcohol use and participants’ own experience of 
alcohol-related problems. The major disadvantages of these assessments are the time taken to 
complete them and possible breach of confidentiality. Our past experience with these measures 
indicates that they are acceptable to participants.  
Smartphone app use: We will use smartphone apps as a form of moderate drinking intervention 
and a data collection tool in the proposed study. During the alcohol drinking sessions, participants 
will use study-provided smartphones only, however for the 4-week field use period after the 
drinking session, participants will use smartphone apps on their own personal smartphone or they 
can continue to use a study smartphone if they prefer. We prefer that participants use their own 
smartphone during the field use period since it will be easier and more natural for them to utilize the 
app on their own phone. However, we want to include participants who do not own their own 
smartphone and we respect the possibility that some individuals may not want to utilize their own 
phone for study purposes. The apps to be tested in this study will obtain minimal information from 
users (e.g., study ID number; date and time of logins to the app), however they do not obtain 
protected health information (e.g., the user’s phone number). Consequently, the developers of the 
apps to be used in the study receive only limited information (not protected health information) 
about study users. At the follow-up appointment, taking place at the end of the field use period, we 
will extract data regarding use of the app from participants’ own smartphones or the study 
smartphone, depending on which they used during this period. Study staff will extract the data in 
the presence of study participants. During the informed consent process, study staff will inform 
participants about smartphone apps obtaining minimal user data and our extraction of use data 
from their smartphones after the field use period. 
Possible breach of confidentiality: In addition to a breach of confidentiality risk associated with data 
collected in the study, that alcohol drinking sessions will involve 2-3 participants at a time 
introduces possible breaches of confidentiality.  

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Procedures to protect against or minimize potential discomforts and risks 
Alcohol consumption: Participants will only be enrolled in the study if they self-report consuming 
the requisite level of alcohol use. This minimum level of alcohol consumption greatly decreases 
the likelihood that any individual in this study will consume alcohol at a level greater than to 
which they are accustomed. Participants will also be excluded should they self-report any 
condition that contraindicates alcohol consumption (e.g., a history of clinically significant 
withdrawal detected at the in-person screening). Females will be screened for pregnancy at the 
in-person screening, as well as during the pre-session appointment on the day of the alcohol 
drinking session. 
Alcohol drinking sessions will be conducted by the P.I. and by research staff who are 
experienced with these methods and have been carefully trained. As described above, all 
subjects will be under supervision to prevent possible accidents. Several steps will be taken to 
ensure that alcohol consumption in this study occurs in a safe manner, in accordance with the 
recommended guidelines on ethyl alcohol administration in human experimentation, set forth by 
the National Advisory Council on Alcohol Abuse and Alcoholism (2005).  
Participants will not be permitted to drive themselves to alcohol drinking sessions, which will 
decrease the likelihood that individuals will attempt to drive after consuming alcohol as part of 
this study. Participants will not leave the laboratory facility on the University of Florida campus 
where the study will be taking place during the self-administration procedure. Given that 
smoking is not allowed in restaurants and bars in Gainesville, FL or in the surrounding 
cities/towns, this necessitates exclusion of individuals who are currently nicotine dependent as 
we will not be able to allow them smoking breaks during the alcohol self-administration period 
and nicotine deprivation may present a confound to the results of this study. All alcohol 
consumption will end at 7:15pm. Also, no alcohol consumption will be allowed that would lead to 
an estimated BAC  > 0.12% at any point during the session. Estimated BAC will be monitored 
using an estimated blood alcohol level chart developed for each individual, based on their sex 
and weight. Participants will be retained at the laboratory faculty until at least 11pm and until 
their breath alcohol concentration (BrAC) drops to the safe level of 0.02% or lower (according to 
2 breathalyzer readings). Participants will wait in the laboratory space while their BrAC goes 
down. When it is time for dismissal, participants will be placed in transportation provided by the 
study and taken directly home. Participants will not be allowed to drive themselves home from 
the lab or to otherwise arrange their own transportation home (e.g., from a friend or family 
member). 
Several protocol features diminish the chance that study participants will leave the lab before 
dismissal by study staff and we have plans in place in case this occurs. As part of the informed 
consent process, we advise all participants of study requirements, including the requirement to 
stay until their BrAC falls to a safe level. We also ask participants to refrain from consuming 
more alcohol and from driving or operating heavy machinery the rest of the night after their 
dismissal from the session. We reiterate these requirements on the day of the session, just 
before the beginning of the alcohol administration period.  
Finally, several aspects of the study’s methods discourage early departure from the lab, 
including their acceptance of study-provided transportation to the lab. The pay structure of the 
study also discourages early departure. We pay participants on an hourly basis during the 
alcohol drinking sessions, thus persons leaving early would forfeit payment for the remainder of 

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the session. Any participants who depart early would also forfeit a portion of their pay devoted to 
adherence to study rules. While there is some benefit to participants in the form of personalized 
information about their drinking and the opportunity to use smartphone apps designed to 
facilitate moderate drinking, participants in laboratory studies take part primarily for the 
monetary compensation, making it unlikely that they will intentionally engage in behaviors that 
reduce their payment. 
Nonetheless, it is possible that a participant could elect to leave the lab early. We have 
procedures in place should this occur. Study staff will ask individuals who wish to end their 
participation early to remain in the lab until their breath alcohol reaches the safe level of 0.02% 
or lower. Study staff will offer these participants transportation by cab to their home, paid for by 
the study, regardless of whether or not they comply with requests to remain in the lab. Given 
that participants arrived by cab and will not have a car available, we expect that they will accept 
study-provided transportation to their home.  
During a follow-up phone call on the day after the alcohol drinking session, study staff will verify 
with participants that they have experienced no adverse events related to the alcohol 
consumption they engaged in for the study. At a follow-up appointment at the end of the field 
use period, participants will receive brief counseling and information about their drinking. A 
master’s or doctoral-level clinician will provide participants with a summary of their typical 
frequency and quantity of alcohol use and related consequences. In addition, treatment referrals 
will be offered to participants as needed based on their level of drinking and stated concern 
about their drinking levels. These may include relevant randomized, controlled treatment trials; 
student health services available at the local colleges and universities along with other local 
treatment resources. Web-based behavior change options will be offered as well, including 
NIAAA’s “Rethinking Drinking” website.  
Administration of alcohol to individuals in treatment for addictive behaviors could potentially 
impede the progress of their recovery. As a result, we will not enroll individuals who have taken 
part in inpatient or intensive outpatient treatment for alcohol use or other addictive behaviors in 
the past 12 months. Further, we will not enroll individuals with a lifetime history of clinically 
significant withdrawal from alcohol; a lifetime history of medical intervention for withdrawal or 
who currently present in a manner suggestive of withdrawal, based on the Clinical Institute 
Withdrawal Assessment for Alcohol (CIWA-Ar; Sullivan et al., 1989), to be conducted by trained 
study staff. These steps regarding withdrawal will also have the benefit of excluding individuals 
who are severely dependent on alcohol, for whom alcohol consumption in this study may not be 
safe. 
Interviews, rating scales and questionnaires: The major risk of the assessments is potential loss 
of confidentiality, which we address below. To minimize any discomfort associated with reporting 
sensitive behaviors, participants will be informed that they may refuse to respond to questions 
that they are not comfortable answering. Questions related to eligibility determination and 
monitoring of safety and treatment response are not optional. If a person declines to answer 
these questions, we will advise them that they will not be able to participate. 
Smartphone app use: We anticipate that smartphone app use will be acceptable to participants 
since most young adults own a smartphone and utilize multiple smartphone apps in a day. For 
these reasons, we also anticipate that the vast majority of participants will opt to utilize their own 
personal smartphones during the 4-week field use period, however the option to use a study 

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smartphone is available for those who prefer to do so and for those who do not own a smartphone. 
Any participants using a study smartphone during the field use period will be asked to use the 
study phone only in association with drinking occasions. During other parts of their day, they should 
use their own cell phone. Participants will be advised that any data from their personal use of the 
study smartphone (e.g., personal text messages, records of recent personal phone calls) will be 
deleted from the study smartphone at the end of their study participation. During the consent 
process, participants will also be advised of possible breach of confidentiality associated with loss 
of the study smartphone during the 4-week field use period and that $50 (approximately half the 
replacement cost of the phone) will be deducted from their payment should they lose a study 
smartphone. Only participants who acknowledge this potential confidentiality breach and agree to 
this penalty will be able to use a study smartphone during the field use period. While study staff will 
extract use data for the experimental app, we will do so in participants’ presence, which should 
allay any concerns they might have about study staff seeing any personal information on their 
phones.  
Confidentiality: Whenever possible, research participants will be referred to by study-assigned ID 
numbers rather than by their name or other personal information. Accordingly, results of clinical 
interviews, vital signs, breath alcohol and urine drug/pregnancy screening are recorded by staff 
members on paper forms using study IDs only. Urine testing will take place only at our research 
offices. Urine samples will be used for the purposes of this testing only and will be discarded 
after tests are completed. 
However, some private identifiable information about individuals will be collected to enroll and 
contact participants. This information will be collected primarily via paper forms, which will be 
stored in locked filing cabinets at the research facility and only be accessible by study staff and 
other authorized individuals (e.g., members of the University of Florida Institutional Review 
Board). This includes a master list connecting participant study identification numbers to 
participant names.  
Electronic mail is an invaluable means of communicating with prospective and enrolled study 
participants. All email communication with participants in this study will be via secure email 
accounts administered by UF. In the proposed study, electronic mail is an option for prospective 
participants to self-identify as being potentially interested in the study. Prospective participants 
also have the option of communicating with study staff by phone or text message. Email 
communication will be used primarily to schedule appointments and to respond to questions 
about the study. Telephone and in-person are the preferred methods for conversations 
regarding protected health information (PHI). Conversations via email regarding PHI will occur 
only after participants consent to engaging in these conversations via email after being advised 
of potential risks of breach of confidentiality, which will be minimal given our use of secure email 
accounts administered by UF. 
Some self-report data will be collected via the web, however no protected health information 
(PHI) will be collected via web-based forms. Participants will be identified on web-based forms 
either by self-selected code words that do not contain PHI or by a study-issued identification 
number. Even though no PHI will be collected on these forms, steps will be taken to maintain 
the confidentiality of this information. A preliminary screening questionnaire to contribute to the 
determination of eligibility and self-reports by enrolled participants will be completed using a 
secure web survey software (REDCap), which ensures that data will be kept confidential. Data 
transmitted from the server will be encrypted and secured within a password-protected file that 

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will only be accessed by study staff. In order to contact individuals completing the web screener 
to inform them of their eligibility, participants will identify themselves in the web-based form with 
the use of an innocuous code word that is personally meaningful but contains no PHI. They will 
be instructed subsequently to send an email message to a secure UF email account for the 
study in which they list this code word. This allows study staff to link participant identity to the 
web-based self-report data. These steps will provide the highest level of security for web-based 
data in this study.  
Data sets not containing any PHI will be stored on the P.I.’s desktop computer in his office at the 
Florida Gymnasium facility on the UF campus and on space in a secure server maintained by 
UF HHP. Data for this study that are stored on the secure server will be maintained by the 
Research Assistant and the P.I. Any data from this study that is shared with collaborators or 
other qualified individuals from institutions outside UF will first be de-identified. Thus, no 
investigators outside UF will have access to any protected health information collected in this 
study. This includes consultants on the proposed study. 
To reduce possible breach of confidentiality resulting from multiple participants being involved in 
each alcohol administration session, steps will be taken to avoid participants knowing the other 
participants completing the sessions with them. For instance, efforts will be made to avoid 
scheduling participants who attend the same college/university. As part of the consent process, 
participants will be told that they will be participating in alcohol administration sessions with 
other participants and will be asked not to disclose the identities of other individuals who 
complete the study along with them, nor to disclose the behaviors that these other individuals 
demonstrate during the sessions (e.g., how much alcohol they consume).  
All NIH-funded studies collecting sensitive date are now considered to be granted a Certificate of 
Confidentiality. This certificate will protect the confidentiality of all research records generated 
by this study. Individually identifiable health information will be protected in accordance with the 
Health Insurance Portability and Accountability Act of 1996. All research personnel will be trained 
on human subjects’ protection and HIPAA procedures.  
In Case of Injury: If a participant is injured as a direct result of participation in this study, 
treatment will be provided. The participant and/or his or her insurance carrier will be expected to 
pay the costs of this treatment. No additional financial compensation for injury or lost wages is 
available. Participants will not waive their legal rights by participating in this study. 
 
8. Possible Benefits: 
 
Participants may benefit from an awareness of problematic behaviors in which they are 
engaging, through completion of the interviews and self-reports in this study. They may also 
benefit from use of the experimental app and moderate their alcohol use. Information about 
counseling/treatment options will be provided to them as needed. The results of this study could 
benefit society at large because of the potential public health impact of the proposed app, 
should it have efficacy in reducing alcohol drinking and related consequences.  
 
9. Conflict of Interest: 
None 
 
10. Data Safety and Monitoring Plan: 

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Designation of Serious Adverse Events: 
Dr. Liana Hone, the PI, has primary responsibility for monitoring the data, assuring protocol 
compliance, and conducting regular safety reviews after each alcohol drinking session has been 
completed. Dr. Hone will be responsible for distinguishing serious from non-serious adverse 
events. Dr. Hone has sufficient clinical research expertise to make this distinction. 
Reporting of Serious Adverse Events 
Dr. Hone will report serious adverse events in writing within 48 hours to the UF IRB 01 following 
their policies. The investigator will apprise fellow investigators and study personnel of all 
adverse events that occur during the conduct of this research project through regular weekly 
study meetings. An annual report will be submitted to UF IRB 01 summarizing all adverse 
events. 
Female subjects:  
Women who are pregnant or nursing, or who report engaging in sexual activity with an opposite 
sex partner and refuse to use a reliable method of birth control (e.g., condoms +spermicide; 
birth control pills, diaphragm) will not be allowed to participate in this study. Urine pregnancy 
tests will be completed at the in-person screening appointment and at an appointment at the 
research office just prior to alcohol self-administration. 
Supervision of Alcohol Administration Sessions:  
The National Advisory Council on Alcohol Abuse and Alcoholism - Recommended Council 
Guidelines on Ethyl Alcohol Administration in Human Experimentation - Revised May 2005 will 
be followed. All alcohol drinking sessions will be supervised by Dr. Hone herself or by a 
graduate student or other senior research staff member who will be carefully trained in alcohol 
self-administration methods and this specific protocol.  Dr. Hone will either be present at the 
alcohol drinking session themselves or be readily available on call to make any determination 
regarding serious versus non-serious adverse events. In addition, the Study Physician Dr. Cook 
will be available for consultation as needed. In cases of illness or injury where medical treatment 
is needed, the necessary treatment will be provided. 
Follow-up:   
At a follow-up phone call the day after both alcohol drinking sessions, study staff will verify with 
participants that they have experienced no adverse events related to the alcohol consumption 
they engaged in for the study. Dr. Hone will review reports of all adverse events interviews. In 
the case of any medical concerns, participants will be seen by the Study Physician or other 
medical personnel. Participants will then be directed by these clinicians to obtain further 
treatment as needed. Participants are screened carefully prior to alcohol administration and all 
prospective participants who present as psychotic or otherwise severely psychiatrically disabled 
are excluded, along with those who report psychotropic medication use or a prescription for 
such medications within the prior 30 days. Given these exclusions, the likelihood of serious 
psychiatric symptoms arising at this appointment is slight, however if such issues arise, 
participants will be evaluated immediately by the Study Physician and directed for further 
treatment as needed. Any Serious Adverse Events that occur during this period will be reported 
as indicated above. 

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Procedures for Data Quality Assurance and Confidentiality:   
Data quality will be ensured through training of research staff, the development of data 
collection tools, and monitoring of data quality. Study staff will monitor the quality of data after 
completion of each participant. Right to privacy for participation in this research will be protected 
through coding of data using study-assigned identification numbers and proper storage of research 
records. Access will be limited to the P.I. and his designates involved in the study. Data storage 
and analysis will occur at Yon Hall North or Florida Gymnasium on the UF campus. All private 
identifiable information about individuals will be stored in locked filing cabinets in a locked room 
in the research facility in Yon Hall North. A master list linking participants’ names to their study ID 
numbers will be maintained, but it will be stored in a locked cabinet separate from other study 
materials. Identifiers will be destroyed when all study activities are completed. Protected health 
information will not be collected or stored electronically. Web-based data collection will be 
encrypted and stored on secure servers, but will not contain any identifiers. Data from the app will 
be stored on the Amazons AWS database with no personal identifiers beyond randomly assigned 
study ID. Amazon’s AWS is approved by UF IT as secure and currently has a Business Associate 
Agreement with the University of Florida. Intermittently, these data will be downloaded by study 
staff and stored on our secure server and secure desktop computers in the P.I.’s office or lab 
space. Individually identifiable health information will be protected in accordance with the Health 
Insurance Portability and Accountability Act of 1996. All research personnel will be trained on 
human subjects’ protection and HIPAA procedures. 
ClinicalTrials.gov Requirements 
This study will be registered on clinicaltrials.gov. 
 
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