Alcohol Approach Bias Modification Effects on Alcohol Consumption: A Pilot Human Laboratory Study
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: University of California, San Francisco

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PROTOCOL VERSION 
4/12-18-19 
FILE NAME 
STUDY TITLE 
STUDY NUMBER 
CLINICAL PHASE 
RAP AABM + ADP Protocol 
ALCOHOL APPROACH BIAS MODIFICATION 
EFFECTS ON ALCOHOL CONSUMPTION: A PILOT 
HUMAN LABORATORY STUDY  
18-25069/NCT03898323
Phase 2 

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1. INTRODUCTION 
This document is a protocol for a human research study. The purpose of this protocol is to ensure that this study is to be 
conducted according to ICH GCP guidelines (CRF 21 Part 312), applicable government regulations and Institutional 
research policies and procedures. 
 
2. BACKGROUND 
 
2.1 Background Prevalence of Research Topic 
Alcohol use disorder (AUD) remains a critical public health problem and requires more efficacious behavioral and 
pharmacologic treatments.  Existing behavioral and pharmacologic treatments have major limitations. Currently approved 
medications have only modest efficacy and are therefore underutilized. They have only small to moderate effect sizes and 
are limited by availability, while behavioral treatments have limited access and adherence.  Neither behavioral nor 
pharmacologic treatments by themselves are likely to provide maximal/optimal outcomes. While pharmacotherapies can 
be effective as long as medications are provided, they may lose effectiveness after discontinuation of treatment, whereas 
neurocognitive training interventions such as AABM have been shown to have more lasting effects. New treatments are 
needed – in particular, treatments that could lead toward combinations of behavioral interventions and pharmacotherapy. 
 
The project will conduct a pilot human laboratory feasibility study of alcohol approach bias modification as a potential 
treatment in heavy-drinking individuals. The purpose of the trial is to assess and establish the feasibility of conducting 
controlled trials of AABM in human laboratory alcohol drinking studies.  The pilot data and feasibility demonstration will 
allow for future funding proposals to be submitted to allow larger studies of AABM alone and combined with 
pharmacotherapy for AUD. 
 
Importantly, early clinical studies by other investigators have shown that Alcohol Approach Bias Modification (AABM) 
training may reduce relapse to alcohol use in patients with AUD who have already stopped drinking.  
One potential AUD treatment modality is to reduce automatic alcohol approach tendencies through alcohol approach bias 
modification (AABM) training. AABM has effects on reducing alcohol use and relapse to AUD. However, few treatment 
trials have been conducted with AABM and little is known about its efficacy in reducing drinking in human laboratory 
alcohol consumption, especially in non-treatment-seeking, heavy-drinking individuals. 
 
2.2 Prior Experience 
 
2.2.1 Clinical Experience 
 
Behavioral and neural correlates of implicit alcohol-approach behavior 
Patients with substance use disorders exhibit an automatic tendency to approach rather than to avoid drug cues1,2,3-6. The 
associative process central to alcohol-approach behavior can be measured with a relatively new joystick task called the 
Approach-Avoidance Task (AAT) developed by Rinck et al. (2007)6. Differences in pulling an image toward one vs. 
pushing it away in relation to the content (e.g., alcohol pictures) are interpreted as automatic action tendencies7. 
Responses to appetitive cues typically occur outside of awareness8. The alcohol AAT taps implicit automatic approach 
tendencies9-11.  To assess implicit responding or unconscious bias12, participants are asked to respond to an irrelevant 
feature of the picture – its format (left- or right-tilt) rather than to the alcohol or non-alcohol content of the picture 
(explicit responding). The first study of alcohol approach-bias using the AAT was conducted by Wiers et al., (2009)12. In 
this study, heavy drinking students exhibited an alcohol approach-bias toward alcohol but not to generally 
positive/negative pictures (e.g., people and animal images)12.   
 
Modification of implicit alcohol-approach tendency: Alcohol Approach Bias Modification 
Implicit alcohol approach-bias is related to changes in the motivational system in alcohol dependence and in heavy 
drinkers. Implicit alcohol-approach bias represents a target for clinical intervention. Wiers et. al., (2010)13 adapted the 
implicit alcohol AAT to be used as an intervention by manipulating the percentage of pictures of alcohol or soft drinks, 
which were to be pulled or pushed. To train participants to avoid alcohol, 90% of the alcohol pictures were presented in 
push-format and 90% of the soft-drink pictures were presented in pull-format. Wiers et. al., (2010)13 demonstrated that 
this alteration in task resulted in reductions in alcohol approach-bias (measured with the original implicit alcohol AAT), 
and in reduced drinking behavior in “hazardous drinkers” (not AUD) compared to those who were trained to approach-
alcohol. This was the first study to show that retraining automatic approach processes could help to regain control over 
addictive impulses. A training version of the implicit alcohol AAT, named Alcohol Approach Bias Modification (AABM), has 
been studied in a handful of RCTs targeting alcohol dependent patients in in-patient treatment settings. 

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RCTs of Alcohol Approach Bias Modification  
The first randomized controlled trial of AABM for alcohol was completed by Wiers et. al.(2011)14. An inpatient cohort of 
214 AUD patients (not active heavy drinkers) were assigned to one of two experimental conditions; an explicit and implicit 
condition in which they were trained to make avoidance movements (pushing joystick) or to one of two control conditions 
in which they received sham or no training.  Results showed successful alcohol approach-bias modification14. 
Furthermore, clinical outcomes were obtained from 87% of the patients one year later. Patients in the experimental 
condition showed better treatment outcomes; only 46% of the experimental group relapsed (resumed drinking >2 days) 
vs 59% of the control group14. Eberl et al,15 extended the AABM work to determine the optimal amount of training 
needed to maximize the change in alcohol approach bias. Based on these responses, the recommended number of 
training sessions is 6, 9, or 12, dependent on resources15.  We will provide 6 sessions over 2 weeks. 
 
The Role of Pilot Feasibility Studies 
The term ‘pilot study’ is widespread in clinical and translational research16.  UCSF biostatistician  Kraemer17, asserts that 
pilot studies should be conducted to assess feasibility, rather than attempt to establish the sample size for a future larger 
study.  “Pilot studies are important in the preparation of proposals for hypothesis-testing studies,” because they can 
“check on the availability of … subjects using the recruitment methods proposed, “test the feasibility of the treatment and 
measurement protocols, train researchers, and to set up data… capabilities”.  The present proposal is designed to do so. 
 
3. RATIONAL SIGNIFICANCE 
 
3.1 Problem Statement 
We will combine AABM with a human laboratory methodology of assessing alcohol consumption – the Yale Alcohol 
Drinking paradigm (ADP) –  to assess the feasibility of these combined methods for use in future studies to test AABM 
efficacy in alcohol use reduction and abstinence initiation in actively drinking individuals with AUD --  not only for relapse 
prevention in already abstinent individuals (as previous trials have done) -- and not just to rely on self-reports of 
drinking/relapse behavior, but to obtain actual measures of alcohol use. 
 
3.2 Purpose of Study/Potential Impact 
We will conduct the first pilot trial of AABM effects on alcohol consumption in the human laboratory in non-treatment-
seeking, heavy-drinking individuals and the first trial of AABM effects on the Yale Alcohol Drinking Paradigm - a method of 
rapidly assessing the potential efficacy of putative pharmacologic and possibly behavioral treatments for AUD. Participants 
will be 12 non-treatment-seeking heavy-drinking male volunteers. After baseline assessment, participants will undergo 
Human Lab session 1, in which we will administer the Alcohol Approach-Avoidance Task (AAT) (not AABM training) to 
measure baseline (pre-treatment) alcohol approach bias tendency, and then conduct the ADP to measure baseline alcohol 
consumption. After Human Lab/ADP Session 1, participants get 2 weeks of a total of 6 sessions of training; they will have 
been randomly assigned to undergo AABM or a sham training condition. Outcomes will be various measures of feasibility, 
including recruitment, retention, safety, and adverse effects and assessment of measurement burden, and the tolerability 
of ADP and AABM interventions 
 
3.3 Potential Risks and Benefits 
 
3.3.1 Potential Benefits 
There is no direct benefit to these participants besides referral to treatment, which will be provided at the end of the study. 
They will be able to withdraw from the study at any time. The direct benefit is not great for participants, but given the 
potential benefit to developing effective treatments for alcoholism, the risk-benefit ratio appears favorable. 
 
Participants may benefit somewhat from the extra physical examination, laboratory tests, and attention. In the informed 
consent form, participants are instructed:  “Taking part in this study may not make your health better. If you are in this 
study, you may benefit from the physical examinations, blood tests, and review of your symptoms. Others may benefit from 
the overall conclusions drawn from the results of this study.” 
 
AUD is major public health problem that contributes prominently to the global burden of disease [58].  While there are 
several approved medications for the treatment of AUD, the available pharmacotherapies are hampered by small effect 
sizes, adverse effects, and limited adoption into practice. Currently available FDA-approved pharmacological agents have 
major limitations and there is a critical need to identify novel medication strategies for AUD treatment. Despite the large 
numbers of patients who suffer from AUD, medications are greatly underutilized and only a small minority of adults in the 

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United States who have AUD are treated with medications. This low utilization is thought to be in part due to a perception 
of AUD medication ineffectiveness. The potential knowledge to be gained in this study is judged to be highly significant.  
This research seeks to expand the knowledge base regarding the treatment of alcohol use disorder.  Because of the known 
low to moderate risk profile of the study medications and the close monitoring afforded by the study design, the level of 
risk for prospective participants is judged to be modest, and therefore, is considered to be reasonable, in comparison with 
the potential knowledge to be gained. 
 
The results of this laboratory-based drinking paradigm will provide an important initial signal regarding the potential efficacy 
of Alcohol Approach Bias Modification in reducing alcohol drinking. There is a great need for the development of new 
methods to treat alcohol use disorder. This laboratory paradigm will also provide information regarding the mechanism of 
action of this novel method and thus significantly contribute to the literature.  
 
3.3.2 Potential Risks and Procedures to Minimize Risks 
 
The major potential risks in this study are related to administration of alcohol, blood drawing during the physical exam and 
the alcohol drinking period, and risks to privacy.  
 
Alcohol 
A number of medical conditions could potentially be worsened by acute alcohol administration (e.g., liver disease, cardiac 
abnormality, pancreatitis, diabetes, neurological problems, diabetes, and gastrointestinal disorders). During screening, the 
study physician will conduct a medical history and physical exam and review laboratory findings.  As a result, participants 
with medical problems that are judged by the study physician/PI (Dr. Batki) will be excluded from the study. 
 
Alcohol may also cause nausea in high doses; however, nausea is not expected at the dose being used in this sample of 
heavy drinkers. Participants will not be drinking to levels more than they typically consume in their own drinking context, 
and, with the exception of the priming dose, they determine the amount of alcohol consumed. 
 
Another area of potential risk to participants under the influence of alcohol involves their safety during the experimental 
procedures. Although impairment of gross motor coordination in heavy drinkers is rare at the alcohol dose used in this 
study, all participants will be under the supervision of the experimenters to prevent possible accidents such as falls. 
Participants will not leave the laboratory during the self-administration procedure,  
 
Alcohol is a reinforcing agent, which may cause changes in behavior including repetitive or excessive alcohol consumption. 
Because of this, the administration of alcohol to alcoholics in treatment could potentially impede the progress of their 
recovery. In addition, the administration of alcohol to sober alcoholics living in the community presents a possible risk of 
relapse. As a result, we will be recruiting non-abstinent non-treatment-seeking alcoholics in keeping with the National 
Advisory Council on Alcohol Abuse and Alcoholism's recent update of its 198941 recommended guidelines on ethyl alcohol 
administration. At completion of the study, we will make a serious and concerted effort to link the participant with treatment 
for their alcohol problems. This will be done by giving the participant objective feedback about the fact that their drinking 
exceeds standards for avoiding hazardous drinking, providing a brief one-session motivational intervention for their drinking, 
and by arranging for alcohol treatment services if they are interested. In our previous and ongoing work, several participants 
quit drinking and many others reduced their drinking in the three months following this intervention. 
 
***Protection against risks of alcohol challenges*** 
The alcohol challenges will be conducted by Dr. Batki and research staff, using methodology adopted from the Yale group, 
and trained by our Yale colleague, Dr. Suchitra Krishnan-Sarin.  
 
We provide a number of safeguards to reduce the risk of physical injury by supervising all sessions and having participants 
stay in the CRC until they are alert and do not show signs of psychomotor impairment. We also exclude participants for 
whom physical or psychological problems contraindicate alcohol consumption. By selecting non-treatment-seeking 
participants who are currently drinking heavily on a regular basis, we are not exposing participants to alcohol consumption 
levels that differ from their normal drinking context. Although this has not happened in the Yale group’s experience, should 
a participant insist on leaving the research setting prematurely, we will provide transportation back to their residence. This 
contingency will be explicitly addressed in the consent form.  
 

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Clearly, participants are free to discontinue the experiment at any time, although we would strongly encourage them to 
remain in the research setting until their blood alcohol level is below .02 and alertness and psychomotor status are judged 
to be safe.  
 
Because participants are not in treatment, participation in an alcohol challenge study will not interfere with efforts to achieve 
abstinence. At the end of the study, however, a potential benefit is that participants will be provided with a professional 
evaluation and treatment will be arranged if they express interest. 
 
***Protection against the risk of heavier alcohol use, suicidality, or other medical or psychiatric problems that may arise 
over the course of the study*** 
To protect against this risk, we will do the following: 
-We will closely monitor alcohol use at each visit. 
-Participants will be withdrawn from the study if, in the opinion of the PI or the DSMB, there is: sustained clinically significant 
increase in alcohol use between ADP sessions 1 and 2, suicidal ideation consisting of suicidal intent or plan, unacceptable 
adverse events judged by the study physician (the PI, Dr. Batki) to be related to study interventions, or any other clinically 
significant medical, psychiatric, or substance use related poor outcome that makes continued study participation unsafe. 
 
Blood and Urine Collections 
Screening blood and urine collections are performed primarily as safeguards to participants and should add no risks other 
than those normally associated with these procedures. Participants will have approximately 8 mL or 2 tsp of blood drawn 
at the intake appointment to determine liver and kidney functioning, and during the self-administration portions of the study 
we will draw approximately 3 mL or ½ tsp of blood at each of the 2 visits. Therefore, the total amount of blood drawn 
during the study (17 ml or 3.5 tsp) poses minimal risk in healthy participants. We will advise participants against donating 
blood for six weeks following study participation. 
 
Blood Drawing (Venipuncture) Risks 
Participation in the study requires participants to have their blood drawn 3 different times over the course of study 
(screening and human laboratory ADP sessions 1 and 2).  Having blood drawn may cause pain (common), fainting/passing 
out (not very often), a bruise where the needle goes in (not very often), and infection at the same place (rare). 
 
***Protection against blood drawing (venipuncture) risks*** 
To protect against this risk, we will do the following: 
1) Professionally trained phlebotomists at the CTSI Clinical laboratory will perform all phlebotomies.  
 
Risk of Privacy/Confidentiality 
Participation in the study presents a risk to the participant of loss of privacy and confidentiality regarding research material, 
particularly with respect to potentially embarrassing or harmful personal health  information, 
particularly 
related 
to 
mental health and alcohol and substance use. This includes detailed and sensitive information regarding alcohol and drug 
use, and psychiatric symptoms.  For example, urine drug testing will be conducted.  Potential release of information 
regarding drug use, in particular, could have serious implications if made known, for example legal ramifications, 
jeopardizing insurability or employability.   
 
In order to ensure the safety of the participant and others, information may be shared between research staff and the 
clinical team only under the following circumstances: 1) If in the judgment of the study physician, the participant has a 
psychiatric or medical condition that requires urgent attention to protect the safety of the participant or others; and 2) If a 
participant has missed several study appointments, and research staff needs to verify the participant's whereabouts and/or 
verify the participant's safety.  These above circumstances will be clearly outlined in the informed consent form, and be 
discussed and clarified with prospective participants at the start of the study. 
 
***Protection against risks to privacy/confidentiality***  
To protect against this risk, we will do the following: 
 
In the informed consent form, participants are instructed: “Participation in research may involve a loss of privacy, but 
information about you will be handled as confidentially as possible.  If you do not already have a medical record at the VA 
Medical Center, San Francisco, one will be created because of your participation in this study.” 
 
HIPAA regulations will be followed throughout this study. Several methods will be used to decrease the risk of loss of 
confidentiality to participants.   
o 
First, all study forms will be labeled with a unique, identifying code number, and maintained in a locked cabinet. Those 

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that contain the names of participants or other identifying information will be stored in a locked cabinet, separate from 
other study forms.   
o 
Second, research material will not be shared between the research team and clinical staff - with the exception of 
information to be shared only to ensure the safety of the participant and others.   
o 
Third, no names will be used in any published reports about this study.   
o 
Fourth, most of the questionnaire data will be collected using an online survey instrument called Qualtrics: 
All collected research data will be referenced by unique study identification codes only, stored in an electronic database 
(SQL server) on a password-protected secure VA server behind a secure VA firewall at SFVAMC available to study staff only. 
After receiving CHR and R&D approval, we will be collecting most of our questionnaire measures in digital format, so that 
this questionnaire data can be collected using an online survey instrument called Qualtrics, which meets strict IRB and 
HIPAA data security requirements. Data will be entered into SQL Server tables using MS Access as a front-end or batch load 
from an external file.  At a point of entry, form values are subjected to consistency edit checks (e.g. range and type 
verification, missing data). Scoring algorithms are applied where appropriate. Once data is entered into the database, edit 
checks are run for accuracy. 
 
Unknown Risks 
Participants may experience side effects that are not known yet.  
 
***Protection against unknown risks*** 
To protect against this risk, we will do the following: 
-During the informed consent process, participants will be notified about the possibility of unknown risks associated with 
taking lacosamide or their combination with alcohol.  
-During the informed consent process, the possibility of unknown risks are explained and that researchers will let participants 
know if new information about risks and side effects becomes available over the course of the study.  
-Adverse effects will be carefully monitored during each ADP lab session. 
 
4. STUDY OBJECTIVES 
 
4.1 Hypothesis 
Include a clearly defined hypothesis, if relevant, and list the key questions the study is expected to answer. Be detailed, 
clear and as specific as possible. 
 
4.2 Primary Objective 
As this is a small pilot study, the Primary Aims are process- rather than outcome-oriented:   
 
1. To establish the feasibility and safety of giving alcohol to human participants in a laboratory alcohol self-
administration procedure;  
 
2. To establish the feasibility and safety of administering AABM training sessions; and  
 
2. To allow our research team to gain experience with these procedures and fine-tune them.   
 
4.3 Secondary Objectives 
The Secondary Aim is to obtain a preliminary assessment of the effects of Alcohol Approach Bias Modification training on 
alcohol consumption and related behaviors in individuals with AUD.  
 
5. STUDY DESIGN 
 
5.1 General Design 
We will conduct the first pilot trial of AABM effects on alcohol consumption in the human laboratory in individuals with 
AUD and the first trial of AABM effects on the Yale Alcohol Drinking Paradigm - a method of rapidly assessing the 
potential efficacy of putative pharmacologic and possibly behavioral treatments for AUD. Participants will be 12 non-
treatment-seeking heavy-drinking male volunteers. After baseline assessment, participants will undergo Human Lab 
session 1, in which we will administer the Alcohol Approach-Avoidance Task (AAT) (not AABM training) to measure 
baseline (pre-treatment) alcohol approach bias tendency, and then conduct the ADP to measure baseline alcohol 
consumption. After Human Lab/ADP Session 1, participants get 2 weeks of a total of 6 sessions of training. Outcomes will 

7 
 
be various measures of feasibility, including recruitment, retention, safety, and adverse effects and assessment of 
measurement burden, and the tolerability of ADP and AABM interventions. 
 
5.1.1 Study Duration 
The study begins with a screening visit that is expected to last approximately 4 hours. If it is deemed safe for the 
participant to enroll in the study and they meet all eligibility criteria, then the participant will be scheduled for 2 human 
lab sessions, each 12 hours long. The human lab sessions will take place on Week 2 (1st human lab session) and Week 5 
(2nd human lab session). After each human lab session, a study coordinator will conduct a phone visit which is estimated 
to take 10 minutes. In addition to the human lab sessions, participants will come to the Ft. Miley campus 3 times per 
week for 3 weeks to complete Alcohol Approach Bias Modification (AABM) training sessions. These computerized training 
sessions last 20-30 minutes and will occur during Weeks 3 and 4 of the study. A follow-up visit will be scheduled 7 days 
after the 2rd and final human lab session. In total, participants can expect to spend about 32 hours over the course of 6 
weeks. 
 
5.2 Outcome Variables 
This section describes the primary and secondary outcome variables, which are the endpoints that will be used to assess 
the study. 
 
5.2.1 Primary Outcome Variables 
The primary outcome variables are measures of feasibility: 
1. Time needed to recruit, screen, and run the study procedures for 12 participants. 
2. Retention rates at the various in the study process (screening, Human Lab ADP session 1 + 2, AABM training 
sessions 1 – 6, and follow-up). 
 
5.2.2 Secondary Outcome Variables 
Secondary outcomes: 
1. Alcohol craving 
2. Alcohol consumption during each of the 2 Human Lab ADP sessions. 
 
5.3 Study Population 
A total of 12 male non-treatment seeking healthy community volunteers will be enrolled. 
 
5.3.1 Number of Participants 
The study will enroll 12 men participants. We anticipate needing to start up to 15 participants to get 12 to complete 2 
human lab sessions and the majority of the 6 AABM training sessions. 
 
5.3.2 Eligibility Criteria 
 
Inclusion Criteria: 
1. 
Men, ages 21-50; 
2. 
Able to read English and to complete study evaluations; 
3. 
Heavy (also known as risky, high-risk, or hazardous) alcohol use, defined as 15-70 standard drinks per week on 
average over the past 30 days; 
4. 
No more than 3 days/week of alcohol abstinence in the past 30 days, to maximize likelihood that participants will 
choose to drink during the laboratory sessions. 
5. 
At least 1 heavy drinking day (> 5 drinks/day) per week on average during the 30 days prior to screening. 
 
Exclusion Criteria: 
1. 
Individuals who are seeking AUD treatment or have been in treatment within the past 6 months; 
2. 
Current DSM-V non-alcohol substance use disorder other than tobacco and marijuana; 
3. 
Positive urine drug test results at more than one baseline appointment for opioids, cocaine, 
benzodiazepines, or barbiturates; 
4. 
Regular use of psychoactive drugs including antipsychotics, anxiolytics and antidepressants 
during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous 
system stimulants or depressants, or other drugs that cause excessive sedation; 
5. 
Psychosis or any other serious mental illness as judged by MINI and study physician assessment; 

8 
 
6.  
Medical conditions that in the judgment of the study physician contraindicate the consumption of 
alcohol or would make study participation hazardous; 
7. 
History of serious alcohol withdrawal (e.g. seizures, DTs, hospitalization) or a Clinical Institute 
Withdrawal Assessment Scale (CIWA-AD) score > 8; 
8. 
Participants who report disliking beer will be excluded because beer will be provided during the 
alcohol self-administration periods. 
 
6. METHODS 
 
The study will consist of the following steps, replicating the Yale ADP methods:  
(1) Recruitment;  
(2) Pre-screening: Brief telephone or in-person to determine eligibility for full screening beginning with establishing non-
treatment seeking status;  
(3) Full Screening/baseline visit: 1-3 in-person visits to obtain consent and to evaluate eligibility (e.g. to reject participants 
with medical conditions): participants who meet heavy drinking criteria, and by confirming that the individual is non-
treatment seeking. If these criteria are met, physical examination and laboratory testing will be conducted. Eligible 
participants then proceed to the main part of the study, which includes participation in 2 human lab sessions and 6 AABM 
training sessions. 
(4) Human Lab ADP Sessions 1 and 2: There will be two sessions, Human Lab/ADP Session 1 (Pre-training), and Human 
Lab/ADP Session 2 (post-training). Alcohol Drinking Paradigm (ADP): After the alcohol cue-induced craving, subjects will 
be given the opportunity to self-administer alcohol using the ADP.  (Table 1) Subjects are first given a moderate Priming 
Drink of alcohol at 11 AM, designed to raise blood alcohol to ~0.03 mg%, and are instructed to drink it within 5 minutes. 
At 1 PM, and again at 2 PM, subjects undergo two 1-hour long alcohol Self-Administration (SA) periods. For each SA 
period, a tray of 4 beer drinks (each containing an amount of alcohol calculated to increase blood alcohol concentration 
by 0.015 mg%) will be brought into the Lab room along with a "tab" sheet worth $12. Participants are told that these 4 
drinks will be available for the next 60 minutes, and they can choose to drink or keep the money; each drink will cost $3. 
The money will be given by check at the end Human Lab Sessions. This monetary cost for each drink was determined to 
reliably reflect the trade-off between desire to drink and cost20,21. The main measure is the number of drinks 
consumed over the course of two 1-hour-long SA periods. Dr. Krishnan-Sarin at Yale University helped to develop 
the ADP, and it has been adopted by other prominent research groups22-33. 
(5) Phone Visits 1 and 2: After each Human Lab ADP session, a study coordinator will call the participant to check in by 
phone.  
(6) Alcohol Approach Bias Modification (AABM) training: Immediately following completion of Human lab Session 1, 
patients will be randomly assigned to receive 6 sessions of AABM training over 2 weeks beginning 2-7 days after Human 
Lab/ADP Session 1. We will use a training version of the Alcohol Approach-Avoidance Task: patients are asked to respond 
to the format of presented pictures using a joystick (push right-tilted pictures, pull left-tilted pictures), irrespective of the 
pictures’ content. Pushing a picture away decreases picture size; pulling a picture closer increases size (zoom effect). 
There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages. Training effect is 
achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. 200 trials are 
presented per session (~20 minutes) with a short break halfway through.  
(7) Participants then undergo a Follow-up visit 1 week after the last ADP session, where adverse events and alcohol use 
will be assessed and a research clinician will provide a motivational enhancement session to encourage these non-
treatment seeking participants to consider treatment and provided with referral materials.  

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6.1 Treatment – Computerized Training 
 
6.1.1 Identity of Investigational Treatment 
The Alcohol AAT is a joystick-task that measures automatic approach tendency toward alcohol. The proposed Alcohol AAT 
was developed based on the previous work of Wiers et. al., (2009) 10,12 and Rink et al., (2007)50.  
 
6.1.2 Dosage, Administration Schedule 
Patients are instructed to respond to the format of presented pictures using a joystick (push right-tilted pictures, pull left-
tilted pictures), irrespective of the pictures’ content. Pushing the picture away decreases picture size, while pulling a picture 
closer increases size (zoom effect). There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic 
beverages (soft drinks). Patients are instructed to either push or pull for left-tilted images and to perform the alternative 
response for right-tilted images. All images are presented in both formats. The difference in reaction times (RT) between 
push and pull is the approach bias. The task starts with 10 practice trials showing neutral objects (containers), followed by 
80 test trials. A standardized d-score is calculated which represents differences in reaction time for pushing vs. pulling75. 
Negative values indicate less alcohol-approach bias75.  
 
6.1.3 Method of Assignment/Randomization 
All participants will receive the active AABM training intervention. 
 
6.1.4 Blinding and Procedures for Unblinding 
Not applicable 
 
6.1.5 Packaging/Labelling 
Not applicable 
 
6.1.6 Concomitant Therapy 
Participants will be informed that they cannot use psychoactive drugs including antipsychotics, anxiolytics and 
antidepressants during the 30 days prior to entry, as well as anticonvulsants, beta blockers, central nervous system 
stimulants or depressants, or other drugs that cause excessive sedation in the judgment of the study physician/PI. 
Additionally, if participants engage in treatment for alcohol use disorder while enrolled in the study, then they will be 
withdrawn as they are no longer considered eligible. 
 
6.1.7 Restrictions 
As per Exclusion Criteria, above. 
 
6.2 Assessments 
Please see the list of study measures below, Sec. 6.3.5 

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6.2.1 Efficacy 
This is a pilot feasibility study, not an efficacy study. The primary outcome variables are measures of feasibility: 
1. Time needed to recruit, screen, and run the study procedures for 12 participants. 
2. Retention rates at the various in the study process (screening, Human Lab ADP session 1 + 2, AABM/sham 
training sessions 1-6, and follow-up). 
 
6.2.2 Safety 
Please see the study procedures, below, Sec. 6.3.5, and steps to minimize risks, above, in Sec.3.3.5. 
 
6.2.2.1 Adverse Events Definition and Reporting 
 
Adverse Events 
During the study, site personnel will note any change in the condition(s) and the occurrence and nature of any adverse 
events. Important clinical information that comes to light during study participation will be communicated by research 
coordinators to the study physician in real time. 
  
The study physician (either the PI, Dr. Batki) will review each participant’s safety at each study visit. 
-Lab results will be reviewed on the same day that the results are received. 
-Adverse effects reported by participants will be reviewed on the same day as they are reported by the study participant. 
-Adverse effect assessment will be done by the research coordinators and discussed with the study physician on a daily 
basis, immediately after these adverse effects are reported by the participant to the study coordinator. 
  
As with our current, CHR-approved clinical trials, the study physician, if not immediately present at the time of adverse 
effect data collection, will be contacted in real time by the study coordinator by phone, pager, or text message, so that 
adverse effects can be discussed with the study physician. The study physician, based on examination of the participant 
and/or review of the participant’s data, will make a clinical judgment at each visit regarding whether it is safe to proceed 
with study medications. 
  
The PI will report to the IRB, DSMB and study sponsor his assessment of the potential relatedness of each AE to protocol 
procedure, studied disease state, study drug via the CRF. For each adverse event recorded on the Adverse Event CRF, the 
PI will make an assessment of seriousness, severity, and causality. 
  
According to the ICH guideline for Good Clinical Practice, an adverse event is any untoward medical occurrence in a 
clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An adverse event 
can therefore be any of the following: 
 
Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a medicinal product, whether or not considered related to the medicinal product. 
 
Any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a 
known condition). 
 
Recurrence of an intermittent medical condition (e.g., headache) not present at baseline. 
 
Any deterioration in a laboratory value or other clinical test (e.g., ECG, X-ray) that is associated with symptoms or 
leads to a change in study treatment or concomitant treatment or discontinuation from study drug. If a 
participant’s dosage is reduced or treatment is discontinued as a result of an AE, the PI will report to the study 
sponsor via CRF the circumstances and data leading to any such dosage reduction or discontinuation of 
treatment. 
  
Events leading to the clinical outcome of death from progressive disease will not be recorded as adverse events unless 
the PI believes that the event may have been caused by the study drug. 
  
Serious adverse event (SAE) collection begins after the participant has signed informed consent and has received study 
drug. If a participant experiences an SAE after signing informed consent, but prior to receiving study drug, the event will 
NOT be collected unless the PI feels the event may have been caused by a protocol procedure. 
  
The PI will alert the study sponsor of any SAE within 24 hours of the PI’s awareness of the event. Alerts issued via 
telephone will be immediately followed with official notification on study-specific SAE forms. 
  

11 
 
An SAE is any adverse event from this study that results in one of the following outcomes: 
 
death (excluding death due to progression of study disease, unless related to study drug); 
 
initial or prolonged inpatient hospitalization; 
 
a life-threatening experience (that is, immediate risk of dying); 
 
persistent or significant disability/incapacity; 
 
congenital anomaly/birth defect; 
 
considered significant by the PI for any other reason. 
  
Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered 
serious adverse drug events when, based upon appropriate medical judgment, they may jeopardize the participant and 
may require medical or surgical intervention to prevent one of the outcomes listed in this definition. 
  
Serious adverse events (SAEs) occurring after a participant has taken the last dose of study drug will be collected for 7 
days after the last dose of study drug, regardless of the PI’s opinion of causation. Thereafter, SAEs will not be reported 
unless the PI feels the events were related to either study drug, or drug delivery system, or a protocol procedure. Any 
SAE occurring prior to enrollment that the PI believes may have been caused by a protocol procedure will be reported to 
the study sponsor within 24 hours of the PI’s awareness of the event and recorded on the CRF. 
  
Study-specific clinical outcomes of death from progressive disease will be reported as SAEs only if the PI deems them 
related to use of the study drug. 
  
Immediate Reporting Requirements From 
 
PI to Sponsor: 
Certain events will be immediately reported to allow the Sponsor to take appropriate measures to address potential new 
risks in a clinical trial. The PI will report such events to the Sponsor immediately; under no circumstances will be reporting 
take place more than 24 hours after the PI learns of the event. The following is a list of events that the PI will report to 
the Sponsor within 24 hours after learning of the event, regardless of relationship to study providers: 
Serious adverse events 
Non-serious adverse events of special interest 
Pregnancies 
  
The PI will report new significant follow-up information for these events to the Sponsor immediately (i.e., no more than 
24 hours after becoming aware of the information). New significant information includes the following: 
 
New signs or symptoms or a change in the diagnosis; 
 
Significant new diagnostic test results; 
 
Change in causality based on new information; 
 
Change in the event’s outcome, including recovery; 
 
Additional narrative information on the clinical course of the event. 
  
Emergency Medical Contracts  
 
Medical Monitor Contact Information: 
Any life-threatening (i.e., imminent risk of death) or fatal AE that is attributed by the PI to the investigational product will 
be telephoned to the Medical Monitor immediately, followed by submission of written case details on an CRF within 24 
hours. 
  
The following is the contact information that will be utilized by the PI: 
MEDICAL MONITOR 
Anne Richards, MD, MPH 
SFVAMC/UCSF 
4150 Clement Street 
San Francisco, CA 94121 
Telephone:415/221-4810 x 23312 
Email: anne.richards@va.gov 
 
  

12 
 
Follow-up of Participants after Adverse Events 
 
PI Follow-Up: 
The PI will follow all unresolved treatment-related adverse event until the event has resolved to baseline grade or better, 
the event is assessed as stable by the PI, new therapy is initiated, the participant is lost to follow-up, or the participant 
withdraws consent.  
  
Every effort will be made to follow all serious adverse events considered to be related to study procedures until a final 
outcome can be reported. During the study period, resolution of adverse events (with dates) will be documented on the 
Adverse Event CRF and in the participant’s medical record to facilitate source data verification (SDV). If, after follow- up, 
return to baseline status or stabilization cannot be established, an explanation should be recorded on the Adverse Event 
CRF. 
  
Data Review - For Phase II or III Sponsor Studies 
PIs will conduct continuous review of data regarding participant safety at weekly study group meetings where the results 
of each participant’s treatment are discussed, as is currently done for the PI’s other UCSF CHR approved clinical trials. 
The discussion will include the number of participants, significant toxicities as described in the protocol, doses 
adjustments, and observed responses. 
 
6.3 Study Procedures 
 
6.3.1 Study Schedule 
WEEK 
STUDY VISIT 
TIME PER VISIT^ 
Week 1 
Screening visits 
2.5 hours 
Week 2 
ADP Session # 1 
12 hours 
Phone visit #1 
10 minutes 
Week 3 
AABM training session #1 + #2 
1.5 hours 
AABM training session #3 + #4 
1 hour 
AABM training session #5 + #6 
1.5 hours 
Week 4 
ADP Session #2 
12 hours 
Phone visit #2 
10 minutes 
Week 5 
Follow-up visit 
30 minutes 
TOTAL 
12 study visits 
approximately 31-32 hours 
^The amount of time is an approximation 
 
6.3.2 Informed Consent 
The process of informed consent will minimize undue influence or coercion and offer sufficient time for review. Typically 
study coordinators will receive thorough training on the correct way to conduct informed consent. On a rare occasion, a 
study physician or project manager will conduct informed consent. All staff conducting informed consents have at least a 
Bachelor of Arts or Science in a health-related field and/or have 2 years of research-related experience.  Training for the 
administration of informed consent teaches study staff how to move through the consent, assessing participant’s 
comprehension along the way. A staff member in training will (1) shadow a trained staff member conducting informed 
consent 2 times, then (2) practices informed consent with other lab members, and finally (3) conducts informed consent 
with a participant while another trained lab member watches. Once the staff member-in-training satisfactorily conducts 
informed consent under the supervision of another trained staff member, the staff-in-training becomes authorized to 
conduct informed consent. 
 
6.3.3 Screening 
After consent, participants will be scheduled for screening assessments. The screening phase is accomplished over a total 
of 1 to 3 visits. 
 
6.3.4 Enrollment 
Once a participant has completed all screening/baseline measures and procedures and it has been determined that the 
participant is eligible and it is safe to participate, then they will be enrolled in the study.  
 
 

13 
 
 
6.3.5 On study visits 
Baseline/screening visit 
4 hours 
Informed consent + HIPAA 
Participant Locator form 
Demographics 
Eligibility form 
Medical History 
Physical Exam 
Lab tests 
Height/weight 
Concomitant Medications 
Columbian Suicide Severity Rating Scale 
AE Spontaneous 
Breath alcohol test 
Structured Clinical Interview for DSM-5 (SCID) 
Timeline Followback (TLFB) 
Clinical Institute Withdrawal Assessment (CIWA-AD) 
Urine Drug Screen (UDS) 
Barratt Impulsiveness Scale (BIS-11) 
Alcohol Use Disorders Identification Test (AUDIT) 
Alcohol Purchase Task (APT) 
Obsessive Compulsive Drinking Scale (OCDS) 
Vitals 
Balloon Analogue Risk Task (BART) 
Delay Discounting (DD) 
Iowa Gambling Task (IGT) 
Salience Task 
Phone Visits 1 and 2 
10 minutes each 
AE Spontaneous 
Timeline Followback (TLFB) 
Human Lab Sessions 1 and 2 
12 hours each human lab 
Weight 
AE Spontaneous 
Concomitant Medications 
Breath alcohol test 
Timeline Followback (TLFB) 
Clinical Institute Withdrawal Assessment (CIWA-AD) 
Urine Drug Screen (UDS) 
Blood alcohol level (BAL) 
Vitals 
Alcohol Urge Questionnaire (AUQ) 
Biphasic Alcohol Effects Scale (BAES) 
Balloon Analogue Risk Task (BART) 
Delay Discounting (DD) 
Ratings of Drinking Behavior During the Alcohol Self-
Administration Period 
AABM/Sham Training Sessions 1-6 
30 minutes each visit 
Concomitant medications 
AE Spontaneous 
Breath alcohol test 
TLFB (Sessions 2, 5, and 8 only) 
CIWA-AD 
AABM/Sham training 
AABM/Sham Training Sessions 1 and 6 
an additional 1.5 hours 
Obsessive Compulsive Drinking Scale (OCDS) 
Alcohol Purchase Task (APT) 
Iowa Gambling Task (IGT) 
Delay Discounting (DD) 
Balloon Analogue Risk Task (BART) 

14 
 
Barratt Impulsiveness Scale (BIS-11) 
Stop Signal Task (SST) 
Follow-up Visit  
1 hour 
Breath alcohol test 
Timeline Followback (TLFB) 
Concomitant medications 
AE Spontaneous 
Medical Management (MM) 
Participant End of Study Questionnaire 
 
Assessments at Study Entry and During and After Human Lab Sessions 
 
At Entry:  
These are adapted from previous/ current clinical studies at the UCSF/SFVAMC Addiction Research Program. 
▪ Demographic data, will be assessed with data on age, race, socioeconomic status, marital status, educational and 
occupational levels, and significant medical history.   
►A number of safety evaluations are included: Medical history and physical examination; Suicide Risk Assessment:  The 
Columbia Suicide Severity Rating Scale [101]. It is a standard, thorough, frequently used method to screen for suicidal 
ideation, used by our group in alcohol use disorder clinical trials;   
 Clinical Laboratory Tests for Health/Safety Monitoring: Blood samples will be collected for chemistry, liver panel, renal 
panel and complete blood count (CBC); urine will be collected for urinalysis.  
▪ Structured Clinical Interview for DSM5, (SCID) [96]: the SCID will be used to determine DSM-V diagnosis of current 
(current year) Alcohol Use Disorder, and the DSM-V current psychiatric diagnoses for anxiety, mood, psychotic, and non-
alcohol substance use disorders in order to determine study eligibility.  
▪ Study Physician Review: All health measures, medical history/exams and labs will be reviewed by a study physician to ensure 
that the subject meets all the eligibility criteria and are ready for randomization 
▪ Alcohol Approach Task (AAT): A way to measure pre-treatment alcohol approach bias tendency.  Salience Task: A survey 
that measures the salience of each stimulus image for participant. 
 
At Entry and at various times throughout the study:  
▪ Clinical Institute Withdrawal Assessment for Alcohol, DSM-IV Version (CIWA-AD): at entry and before each Human Lab 
Session and at each Follow-up; 
▪ Urine Drug Screen: For opioids, benzodiazepines, cocaine, amphetamines, cannabis, barbiturates:  at entry and before 
each Human Lab Session.  
▪ Breath alcohol concentration (BrAC); at entry and before each Human Lab Session; and during each Human lab Session  
▪ Vital Signs: Temperature, heart rate, and blood pressure will be measured at study entry and multiple times during each 
Human Lab Session. 
▪ Concomitant Medications Review:  at entry and before each Human Lab session: thorough review of all concomitant 
medications (prescription or over-the-counter) in the past 30 days, as well as those started during the study. 
▪ Concomitant Treatment Log: At Entry and  A way to track any type of alcohol treatment at baseline/screening and 
throughout the study. 
▪ Adverse Effects: Spontaneous: At Entry and at Human Lab Session 1 and 2; Phone visits 1 and 2; AABM Sessions 1-6; 1-
wk FU. This form is designed to collect information about adverse health events. We will ask about emergent AEs, follow-
up with AEs reported at previous study visits, and ask if there has been a hospital admission since the last study visit.  
▪ Timeline Followback (TLFB):  at study entry, then Human Lab Session 1 and Human Lab Session 2. TLFB will be used to 
calculate standard drinks consumed per week in the past 30 days prior to consent and at the two Human Lab Sessions, and 
the 1-week follow-up. The TLFB will be used to determine whether subjects meet minimum alcohol consumption criteria at 
entry. Other substance use will also be collected by TLFB.  
▪ Barratt Impulsiveness Scale (version 11) (BIS-11)  [98]: This provides a trait measure of impulsiveness and will be used 
to characterize the study cohort at study entry.  
 
At AABM Training Sessions: 
▪ Alcohol Use Disorders Identification Test (AUDIT): The AUDIT [97] is valid and reliable self-report measure of alcohol-
related problem severity.  
▪ Obsessive Compulsive Drinking Scale (OCDS): At AABM sessions 1 and 6. A questionnaire that measures cognitive aspects 
of alcohol craving. 

15 
 
▪ Alcohol Purchase Task (APT): At AABM sessions 1 and 6. A questionnaire uses hypothetical choices regarding alcohol 
purchases at varying prices to generate several indices of alcohol-related reinforcement.  
 
At Follow-up visit: 
▪ Motivational Enhancement Therapy: at the follow-up visit, research clinician will provide a motivational enhancement 
session to encourage the non-treatment seeking participants to consider treatment.  
 
Measures of Alcohol Effects:  
▪ Breath alcohol concentration (BrAlc) [99] at each visit, and multiple times in ADP Sessions 1 and 2. BrAlc will be measured 
at each session to detect recent alcohol use with the Intoximeters Alco-Sensor IV instrument.  
▪ Blood Alcohol Levels: Human Lab Sessions 1 and 2 (Table 1): Blood samples will be drawn to measure plasma levels of 
blood alcohol (BAC) during the priming dose and during the alcohol self-administration paradigm.   Blood samples will be 
stored at -4°C and will be analyzed at the San Francisco VA.  
 Time-line Follow-back (TLFB): To collect alcohol and drug use in the 90 days prior to entry and all days included in the 
11 weeks of the study. TLFB will be used to calculate standard alcohol containing drinks consumed per week in the past 
90 days prior to consent and then throughout the 11 weeks of the study. Cigarette and substance use will also be collected 
by the TLFB. 
▪ Biphasic Alcohol Effects Scale (BAES) [81]: Human Lab Sessions 1 and 2 (Table 1).  This 14-item self-report rating scale 
measures alcohol stimulant/ sedative effects and is used regularly in the Yale ADP.   
▪ Alcohol Urge Questionnaire (AUQ): At study entry; multiple times in Human Lab Sessions 1 and 2 (Table 1); 1-wk FU; 1-
mo FU: The AUQ is an 8-item questionnaire assessing desire, expectation of positive effect, and inability to avoid drinking 
if alcohol is available. The AUQ is a reliable and valid scale for the measurement of self-reported alcohol urges. Its brevity 
and time frame for ratings (i.e. right now) makes it suitable for the ADP.  
▪ Yale Craving Scale (YCS): multiple times during ADP Sessions 1 and 2. A measure of craving for alcohol.  
▪ Ratings of Drinking Behavior During the Alcohol Self-Administration Period: multiple times in in Human Lab Sessions 1 and 
2. Subjects will be videotaped during the alcohol self-administration portion of ADP 1 and ADP 2. Videotapes will be rated 
by two independent for the onset and offset of each sip of alcohol. Dependent measures will be constructed including time 
until the first sip and average time to consume each drink. 
▪ Vital Signs: Human Lab Sessions 1 and 2 (Table 1).  These will include heart rate, blood pressure, and skin. The blood 
pressure cuff will be on subject's dominant arm while the probe of will be attached to the middle finger of the subject's 
non-dominant arm.   These data will be further used to examine the safety of using the study medications during alcohol 
self-administration.  
 
Neurocognitive Assessments: 
The battery was developed to assess performance in cognitive domains commonly affected by heavy alcohol use and 
contains standardized instruments with good-to-excellent norms administered (~1.5 hours) at AABM sessions 1 and 9. Raw 
scores will be converted to z-scores. Domain-specific summary scores will be calculated by averaging z-scores of the 
individual constituent measures. When feasible, alternate forms will be used for repeated administrations. 
Domains and constituent measures: 
a) Risk Taking, Decision-making, and Motor/Choice Impulsivity: Balloon Analogue Risk Task86; Iowa Gambling Task87; 
Stop-signal88, Delayed Discounting89;  
 
Cognitive Training – Alcohol Approach Bias Modification (AABM) Training: 
Immediately following ADP Session 1, heavy drinking participants will begin to receive 6 sessions of AABM training taking 
place over 3 weeks. We will use a training version of the Alcohol Approach-Avoidance Task: patients are asked to respond 
to the format of presented pictures using a joystick (push right-tilted pictures, pull left-tilted pictures), irrespective of the 
pictures’ content. Pushing picture away decreases picture size; pulling a picture closer increases size (zoom effect). There 
are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages (soft drinks). Training effect is 
achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Two hundred 
training trials are presented per session (~20 minutes) with a short break halfway through. 
 
 
 
 
 
 
 

16 
 
Participant Incentives 
 
WEEK 
ATTEND STUDY VISIT 
TOTAL PER 
VISIT 
Screening 
$55* 
$55 
ADP Session #1 
$200 (+ $24 for tab)** 
$224 
Phone visit #1 
AABM 1 + 2 
$50 
$50 
AABM 3 + 4 
$40 
$40 
AABM 5 + 6 
$50 
$50 
ADP Session #2 
$200 (+ $24 for tab)** 
$224 
Phone visit #2 
Follow-up @ 1 Week 
$40 (+ $50 bonus if attended all study visits)*** 
$90 
TOTAL 
$733 
 
*At the screening/baseline visit, participants are paid per task they complete. At the end of screening, they will earn $55. 
 
**Participants will receive $200 for each ADP Lab Session they complete. They could earn an additional $24 per ADP Lab 
Session, depending on how many drinks they consume per session. At each session, participants are offered 8 drinks, 
each worth $3. They will receive $3 per drink for every drink that is not consumed.  
 
6.3.6 Removal of participants 
 
Stopping Rules 
 
Discontinuation of participants: 
Participants for whom there has been at least 2 weeks without participant contact will be discontinued from the study. 
Exceptions may be made after discussions with the PIs, approval by the Medical Monitor, and consistency with the 
regulations of the Institutional Review Board/Ethics Committee (IRB/EC). 
  
Discontinuation of study: 
The study will be stopped if, in the judgment of the DSMB or the PI, there are sufficient safety concerns that arise during 
the conduct of the study that would indicate that participants are being harmed by the study interventions. Examples of 
such safety concerns would be: 
-Other events that pose unacceptable risks to participants, e.g., multiple SAEs that are judged to be related to study 
interventions. 
  
Withdrawal Rules 
 
Discontinuation of Participants: 
If a participant who does not meet enrollment criteria is enrolled, the study sponsor will be contacted. In such cases, the 
PI will provide information on the participant´s anticipated benefit or current benefit from being enrolled in the study or 
continuing to receive study drug respectively. In addition, the PI will discontinue participants from the study drug or the 
study or both in the following circumstances: 
 
 
Participant has evidence of progressive disease. 
 
The participant, for any reason, requires treatment with another therapeutic agent that has been demonstrated 
to be effective for treatment of the study indication. In this case, discontinuation from the study occurs prior to 
introduction of the new agent. 
 
The PI decides that the participant should be withdrawn from the study. If a SAE or a clinically significant 
laboratory value is the basis for this decision, the PI will discontinue the study therapy and take appropriate 
measures. The PI will immediately notify the study sponsor or its designee. 
 
The participant or attending physician requests withdrawal of the participant from the study.  
 
The investigator or the study sponsor stops the study or stops the participant’s participation in the study for 
medical, safety, regulatory, or other reasons consistent with applicable laws, regulations, and good clinical 
practice (GCP).  

17 
 
 
The study therapies have shown unacceptable side effects. 
 
The participant is noncompliant with study procedures. 
 
In the clinical judgment of the investigator, the participant requires acute detoxification from the alcohol.  
 
When a participant withdraws before completing the study, the reason for withdrawal will be documented in the CRF and 
in the source document. 
 
6.4 Statistical Method 
Descriptive statistics will be used to summarize the data set. Measures of central tendency and measures of variability will 
be reported for the chief variables of interest as noted below in 6.4.3.   
 
6.4.1 Statistical Design 
As this is a pilot feasibility study, no inferential statistics will be used.  
 
6.4.2 Sample Size Considerations 
Not applicable. 
 
6.4.3 Planned Analyses 
Descriptive statistics will be used to describe the data set. Measures of central tendency and measures of variability will 
be reported.  Chief variables of interest are listed below in 6.4.3.1, 6.4.3.2, and 6.4.3.3. 
 
6.4.3.1 Primary Analyses 
Primary analyses will consist of descriptive statistics. These measures of feasibility are:  
1. Time needed to recruit, screen, and run the study procedures for 4 participants 
2. Retention rates at the various timepoints in the study process (screening, Human Lab ADP session 1,2,3, and 
follow-up). 
 
6.4.3.2 Secondary Objectives Analyses 
Descriptive statistics will be used to summarize the data set. The variables analyzed will include: 
1. Alcohol craving 
2. Alcohol consumption during each of the 2 Human Lab ADP sessions. 
3. Alcohol – medication interaction effects on BAES and computer tasks (AAT, BART, and DD) 
 
6.4.3.3 Safety 
Descriptive statistics will be used to summarize the data. The SAFTEE will be used to assess adverse effects.  Descriptive 
statistics will be used. 
 
7. TRIAL ADMINISTRATION 
 
7.1 Institutional Review Board (IRB) Review 
The Human Research Protection Program (HRPP) reviews and monitors research involving human participants at UCSF 
and affiliate institutions to ensure the ethical and equitable treatment of the research participants. Within the HRPP, the 
Institutional Review Board (IRB) reviews all research that involves human participants performed by UCSF faculty. 
 
7.2 Unanticipated Problems 
[Explain how unanticipated problems that may occur during the study will be handled, communicated to the IRB, sponsor, 
and FDA, if applicable.] 
 
7.3 Study Monitoring 
Study monitoring will be conducted by the DSMB. 
 
7.4 Data Safety Monitoring Plan 
 
Plan to monitor study progress and safety: The Data and Safety Monitoring Plan (DSMB)  
The DSMP for this project consists of: 
- a Data and Safety Monitoring Board (DSMB) 
- a schedule of DSMB meetings to review study data and events 

18 
 
- a list of study data and event items to be reviewed by the DSMB 
- procedures for communicating DSMB findings to the CHR, the study sponsor (Department of Defense) and other 
appropriate entities 
- a plan for conducting and reporting interim analysis 
- stopping rules 
- rules for withdrawing study participants from the study interventions 
 
These elements of the DSMP are described below: 
 
The Data and Safety Monitoring Board (DSMB) 
The Data and Safety Monitoring Board (DSMB) is a group of 3 physicians who are not study investigators and who are 
experts in the area of clinical research and substance use disorders.  The current composition of the PI’s DSMB is:  William 
Wolfe, M.D., a clinical investigator and Medical Director, PTSD Clinic, SFVAMC; Anne Richards, M.D. [medical Monitor], an 
experienced human clinical investigator, Assistant Professor of Psychiatry at University of California, San Francisco and 
Steven Lieske, M.D., Ph.D., an experienced basic neuroscience investigator and attending psychiatrist, SFVAMC. 
 
The DSMB will meet biannually to review data reports prepared by the PI regarding the progress of the study and will 
monitor patient enrollment, retention, outcomes, adverse events, and other issues related to patient safety.  The DSMB will 
make recommendations to the PI as to whether the study should continue or be modified or terminated.  The DSMB can 
consider patient safety or other circumstances as grounds for early termination.   Any member of the DSMB can ask for a 
meeting of the group if he/she feels that it is necessary, based upon the data. 
 
During the course of the study, reports will be prepared and distributed to the Data and Safety Monitoring Board on a 
biannual basis. In order for the Data and Safety Monitoring Board to discharge their duties for overseeing the study and 
the rights of the patients, they will receive analyses of the primary outcome measures and the important secondary 
measures on a quarterly basis. The DSMB will receive reports of serious adverse events (SAEs) within 72 hours of their 
occurrence. 
 
DSMB Minutes will be prepared by the Study Coordinator within 5 working days after each biannual DSMB meeting. 
 
Medical Monitor  
Anne Richards, M.D., Medical Director of the PTSD Clinic at San Francisco VA Medical Center will serve as the Medical 
Monitor. As Medical Monitor, Dr. Richards will review all unanticipated problems involving risk to subjects or others, serious 
adverse events and all subject deaths associated with the protocol and provide an unbiased written report of the event.  At 
a minimum, the medical monitor will comment on the outcomes of the event of problem and in case of a serious adverse 
event or death, comment on the relationship to participation in the study. The Medical Monitor will also indicate whether 
she concurs with the details of the report provided by the principal investigator.  Reports for events determined by either 
the investigator or medical monitor to be possibly or definitely related to participation and reports of events resulting in 
death will be promptly forwarded to the IRB and other governing authorities. 
 
7.5 Study Discontinuation 
If a serious adverse effect occurs and is considered by the PI and DSMB to be study-related, the study will be stopped 
until study procedures can be reassessed and modified as needed, with concurrence by the DSMB. 
 
7.6 Study Completion 
We will conduct the following procedures to close-out the study: 
Submit a close-out report to the UCSF CHR 
Submit a notification to the Biosafety Committee to close-out the Biological Use Authorization (BUA).  
Submit notification to the SF VA R&D Committee to close-out the project. 
Once all close-out reports have been processed, we will submit a notification to the study sponsor (UCSF RAP) with all 
other close-out reports.  
 
7.7 Funding Source 
The study is funded by the University of California, San Francisco (UCSF) Resource Allocation Program (RAP). 
 
 
 

19 
 
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21. Griffiths, R.R., Troisi, J. R. II, Silvermian, K., Miumford, G. K. , Multiple choice procedure: An efficient approach for 
investigating drug reinforcement in humans. Behavioural Pharmacology, 1993. 4: p. 3-13.  
22. Krishnan-Sarin, S., S.S. O'Malley, N. Franco, D.A. Cavallo, M. Morean, J. Shi, B. Pittman, and J.H. Krystal, N-methyl-D-
aspartate receptor antagonism has differential effects on alcohol craving and drinking in heavy drinkers. Alcohol Clin Exp 
Res, 2015. 39(2): p. 300-7.  
23. Leeman, R.F., W.R. Corbin, C. Nogueira, S. Krishnan-Sarin, M.N. Potenza, and S.S. O'Malley, A human alcohol self-
administration paradigm to model individual differences in impaired control over alcohol use. Exp Clin Psychopharmacol, 
2013. 21(4): p. 303-14.  
24. O'Malley S.S., K.-S., S., Farren, C., Sinha, R., Kreek, M.J., Naltrexone decreases craving and alcohol self-
administration in alcohol-dependent subjects and activates the hypothalamo-pituitary-adrenocortical axis. 
Psychopharmacology, 2002. 160(1): p. 19-29.  
25. Krishnan-Sarin, S., Krystal, J.H., Shi, J., Pittman, B., O'Malley, S.S., Family history of alcoholism influences naltrexone-
induced reduction in alcohol drinking. Biological Psychiatry, 2007. 62: p. 694-697. 

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26. Krishnan-Sarin, S., Cavallo, D., Shi, J., Franco, N., Pittman, B., O'Malley, S., et al., Memantine effects on human 
ethanol consumption: Initial impressions. Alcoholism: Clinical and Experimental Research, 2009a. 33(6s): p. 290A.  
27. replacement on alcohol responses and alcohol self-administration. Psychopharmacology 2008. 196(2): p. 189-200.  
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Estevez, I.L., Balchunas, E., Varenicline reduces alcohol self-administration in heavy-drinking smokers. Biological 
Psychiatry, 2009. 66(2): p. 185-90.  
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30. Anton, R.F., Voronin, K.K., Randall, P.K., Myrick, H., Tiffany, A., Naltrexone modification of drinking effects in a sub-
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Res, 2012. 36(11): p. 2000-2007.  
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on alcohol consumption: naltrexone and nalmefene. Neuropsychopharmacology, 2003. 28(4): p. 755-64.  
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221-227.  
33. Myrick, H., Xingbao, L., Randall, P.K., Henderson, S., Voronin, K., Anton, R.F., The effect of aripiprazole on cue-
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35. Bujarski, S., Ray, L.A.. Experimental psychopathology paradigms for alcohol use disorders: Applications for 
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K.E.K.R.D. Batt, Editor. 1989, CRC Press: Florida. p. 44-66.  
39. Sinha, R., Catapano, D., O'Malley, S.S., Stress reactivity and stress-induced cocaine craving. Paper presented at the 
Annual Meetings of the College on Problems of Drug Dependence, Nashville, TN, 1997, June 12-17.  
40. Miller, W.R., Zweben, A., DiClemente, C.C., Rychtarik, R.G., Motivational Enhancement Therapy manual: A clinical 
research guide for therapists treating individuals with alcohol abuse and dependence. National Institute on Alcohol Abuse 
and Alcoholism, Rockville, MD, 1992.  
41. First, M.B., Williams, J.B.W., Karg, R.S., Spitzer, R.L., Structured Clinical Interview for DSM-5, Research Version 
(SCID-5, Research Version; SCID-5-RV). Arlington, VA,. American Psychiatric Association, 2015.  
42. Saunders, J.B., Aasland, O.G., Babor, T.F., de la Fuente, J.R., Grant, M., Development of the Alcohol Use Disorders 
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- II. Addiction, 1993. 88: p. 791-804.  
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Effects Scale. Alcoholism: Clinical and Experimental Research, 1993. 17: p. 140-146.  
46. Posner, K., Brown, G.K., Stanley, B., Brent, D.A., Yershova, K.V., Oquendo, M.A., Currier, G.W., Melvin, G.A., 
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findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011. 168: p.1266-77. 

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Department of Veterans Affairs
INFORMED CONSENT FORM
Subject Name:  
Date:
Title of Study:   ALCOHOL APPROACH BIAS MODIFICATION EFFECTS ON ALCOHOL 
CONSUMPTION: A PILOT HUMAN LABORATORY STUDY
Principal Investigator:  Steven L. Batki, M.D.
San Francisco VAMC
CONSENT TO PARTICIPATE IN RESEARCH
This is a research study investigating the benefits of a “cognitive training program” – a training program to 
improve your thinking – designed to help you to reduce your alcohol use. The principal investigator, Steven 
L. Batki, M.D. or Co-investigators and Dr. David Pennington, Ph.D. from the San Francisco VA Medical 
Center and UCSF Department of Psychiatry, or a designated research staff associate, supervised by Dr. 
Batki, will explain the study to you.
Research studies include only people who choose to take part. The purpose of this form is to give you the 
information you will need to help you decide if you want to be in this study. Read this form carefully and 
ask questions about anything you do not understand. Take your time to make your decision about 
participating. You may discuss your decision with your family and friends and with your health care team. 
When all your questions have been answered, you can decide if you want to be in this study.  If you do 
decide to be in the study, you will get a copy of this signed and dated form to keep for your records. 
1. Why is this study being done?
The purpose of this study is to discover if a “cognitive training program” called “alcohol approach 
bias modification (AABM)” can help reduce alcohol use and improve your thinking. 
AABM is a computer training program that has been well-studied and shown to reduce alcohol use.
This study is funded by the University of California, San Francisco (UCSF). 
 
2. How many people will take part in this study?
About 12 men will be enrolled in this study. 
3. Are there some people who should not be in this study?
The study doctor or a member of the study staff will talk with you about the requirements to participate in 
this study. It is important that you are truthful with them about your history. You should not be in this study 
if you do not meet all the qualifications. 
You should not be in this study if:

You are younger than 21 years of age or older than 50 years of age.

You are seeking treatment for alcoholism, or if you would like to receive treatment to help reduce 
alcohol use. 

You are currently receiving treatment for alcoholism, or have received treatment for alcoholism in 
the past 6 months.

You are currently receiving medication for alcoholism, including disulfiram (Antabuse), naltrexone 
(Depade, Revia or Vivitrol) or acamprosate (Campral).

You are already in another alcohol treatment study or study involving medication as a treatment for 
alcoholism. 

You have liver disease, heart disease, pancreas problems, diabetes, neurological problems, or if 
you have gastrointestinal problems that are worsened by drinking alcohol. 

You regularly used opioids, cocaine, benzodiazepines or barbiturates in the past 30 days. 
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
You regularly used medications that can affect your brain and nervous system in the past 30 days, 
such as medicines used to treat psychiatric conditions like psychosis, anxiety, depression or 
medications to treat epilepsy (seizures).
4. How long will I be in the study?
In total, you will be asked to commit approximately 35 hours of your time over the course of 6 weeks.  
5. What will happen if I take part in this study?
All study procedures will take place at the San Francisco VA Medical Center. The study can be divided 
into 4 parts:
a. Screening: 1-3 visits over approximately 1 week.
b. Main – ADP sessions: 2 all-day Alcohol Drinking Paradigm (ADP) sessions.
The 2 all-day ADP sessions will be at the San Francisco VA Medical Center. At each of these 2 all-
day study visits, you will participate in an alcohol drinking session under observed conditions. We 
refer to each of these all-day alcohol drinking sessions as the “Alcohol Drinking Paradigm (ADP)”.
c. Main – AABM sessions: 6 sessions over 2 weeks of Alcohol Approach Bias Modification (AABM) 
computer training. 
The AABM is a computerized training session during which you will interact with a computer by 
pushing and pulling a joystick. During the task you will be asked to respond to the format of a 
presented picture, irrespective of the pictures’ content. Pushing a presented picture away will 
decrease picture size, whereas pulling a picture closer will increase size (zoom effect). The duration 
of the training is approximately 20 minutes, and you will be given the option of a break halfway 
through the task.
d. Follow-up: 1 visit 1 week after the last ADP session.
5a. Procedures for the Screening:
To see if you are eligible to participate in the study, we will ask that you take part in the following exams, 
tests and procedures. Any information that we collect will be kept confidential (as detailed later in this 
Consent Form).
Breath alcohol test + informed consent: 
The study will be discussed with you, and you will be asked to sign this consent form after you blow a 
0.00 on your breath alcohol test.  If you have ANY alcohol on your breath, as measured by the 
breathalyzer, you will be asked to wait until you have no alcohol on your breath or to complete your visit 
at another time.
•
You can also ask to be referred to other treatment if you wish.
•
If you are legally intoxicated, you will be offered transportation home.
Contact information: 
You will be asked to provide the names and phone numbers of people we may contact in case you miss 
a study appointment. Research staff will confirm your personal contact information, as well as that of 
your alternate contact, before you can continue in the study.
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Medical history and physical exam: 
The study doctor will take your medical history and review the medication you use. You will also have a 
brief physical examination. The history and physical exam are similar to those done for regular medical 
care. 
Vital signs: 
A study staff member will measure your blood pressure, heart rate, height and weight. 
Concomitant medication: 
A study doctor will review all the other medications you are currently taking to make sure it is safe for you 
to participate in the study.
Blood drawing (venipuncture): 
You will be asked to give a blood sample for routine laboratory tests to check your health.  Approximately 
2 teaspoons of blood (8 ml) will be drawn by inserting a needle into a vein in your arm for these tests. 
Blood will be taken for routine medical tests. 
Urine sample: 
You will be asked to give a urine sample to test for drug use, including recreational and illegal drugs and 
alcohol. 
Medical and psychiatric diagnoses: 
You will be evaluated for current and previous diagnoses.
Substance use assessments: You will be asked to report your use of alcohol and other substances 
(cigarettes, marijuana, cocaine, etc.) and possible alcohol withdrawal symptoms.
Questionnaires: You will be asked to complete questionnaires about your education, work, and other 
aspects of life. Some of the questionnaires ask that you answer detailed questions about your alcohol 
use, alcohol craving and family history of alcohol use. 
Cognitive testing: 
You will be asked to complete tests of your thinking ability that measure your thinking and decision-
making. Some of these tests are paper and pencil tests and some are completed on the computer. We 
will repeat these tests at the end of the study so that we can try to understand how alcohol and the 
AABM (computerized training) affects your use of alcohol, your craving for alcohol, and your thinking.  
5b. Procedures for the main phase – ADP Sessions: 
After the Screening tests have been reviewed by a study doctor, and if you continue to meet the eligibility 
requirements, you will begin the main part of the study.  
Overview: 
You will be asked to attend 2 all-day study visits at the San Francisco VA Medical Center for the main 
part of the study. At each of these 2 all-day study visits, you will participate in an alcohol drinking session 
under observed conditions. We refer to each of these all-day sessions as an Alcohol Drinking Paradigm 
(ADP).  
At each of these 2 ADP sessions, you will be offered alcoholic beverages and allowed to drink them 
within a certain period of time, under observed conditions. Study staff will be measuring how much 
alcohol you drink at each of these 2 ADP sessions. Each ADP session starts at 8 AM and finishes 
around 8 PM, for a total of 12 hours. 
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Details: 
We ask that you not consume alcohol after 5 pm on the evening prior to each ADP session. When you 
arrive at the San Francisco VA Medical Center (SFVAMC), we will check your breath alcohol level by 
asking you to blow into the breathalyzer. If you arrive with a positive breath alcohol level and your breath 
alcohol level is above 0.00 and/or is increasing, indicating recent alcohol use, then the session will have 
to be rescheduled. If your breath alcohol level is above 0.05 and the session has to be rescheduled, we 
will have to keep you at the SFVAMC and advise you not to drive until it comes down to 0.02. 
Alternatively, we could provide you with transportation. 
We will also collect a urine sample to screen for the use of drugs (e.g. cocaine, opiates, marijuana, 
benzodiazepines). 
Then we will measure your height and weight, your heart rate and blood pressure, and ask you to 
complete some assessments and computer tasks. You will be given a light breakfast around 9:00 am, 
and a late lunch/early dinner around 3:30pm. If you are a smoker, you will be provided with 2 “smoke-
breaks” during which you will be escorted out and allowed to smoke up to 2 cigarettes. Non-smokers will 
also be given the option of taking ‘breaks’ at certain intervals. When you are not completing 
assessments, you will be able to relax, read a book or be on your cell phone.
Later that same day, you will participate in the ADP. A video camera will be recording this session to 
monitor your drinking behavior.  Prior to the start of this session, you will be asked to complete some 
questionnaires and rating scales. We will test your breath alcohol level over the course of the ADP and 
we will test your blood alcohol level once during the ADP. To test your blood alcohol level, about a half-
teaspoon of blood (3 ml) will be drawn by placing a needle into a vein in your arm.
At 12 noon, you will be given your first alcohol drink. The amount of alcohol in this drink will vary 
depending on how much you weigh and will be the same as a typical mixed drink. You will be asked to 
drink it in 5 minutes. You must consume this drink in order to remain in the study.  If you do not wish to 
consume the drink, you will be discharged from the study.  You will then be monitored for the next 55 
minutes and asked to complete some measurements. 
At 1:00 pm you will be given a tray with 4 drinks, each worth $3, for a total of $12. During the next 50 
minutes, you can either choose to drink or keep the money value of the drinks ($3 per each drink that 
you do not drink).  If you choose the money, it will be given to you after the session is completed.  
At 1:50 pm, the old drinks will be removed.
At 2:00 pm you will be given a tray with 4 fresh, new drinks, each worth $3. These will be available to you 
for the next 50 minutes. Again, you can choose to drink them or keep the money. The drinks will be 
removed at 2:50 pm at which time the alcohol drinking part of the session is over. Your breath alcohol 
level, blood pressure and heart rate will be checked until your breath alcohol level returns to 0.02 or less. 
You will also be asked to complete various measurements during the rest of your stay.  
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It is important to note that during the ADP sessions phone use, watching TV, and sleep will be restricted 
as follows:
TIME
PHONE USE
TV
SLEEP
8:30 AM 
– 9:30 AM
NO
NO
NO
9:30 AM 
– 10:00 AM
YES
NO
NO
10:00 AM 
– 11:00 AM
NO
NO
NO
11:00 AM 
– 11:30 AM
YES
NO
NO
11:30 AM 
– 3:00 PM
NO
NO
NO
3:00 PM 
– 8:00 PM
YES
YES
NO
At 8:00 pm you will be discharged and paid in return for your time and effort. If your breath alcohol level 
is above 0.02 at 8:00 pm, then a study doctor will conduct a brief examination to make sure it is safe for 
you to go home. If in the judgment of the study physician you are too intoxicated to safely go home, you 
will be taken to SF VA Emergency Department by the study physician for further evaluation and 
treatment, if needed.
You will repeat the ADP session 1 more time, for a total of 2 ADP sessions.  There will be 2 weeks 
between the 1st and 2nd ADP session. Both ADP sessions are identical in nature. The day after each ADP 
session, a member of the study team will call you to conduct a 10-minute study visit by phone. During the 
conversation, you will be asked how you feel and if you are experiencing any side effects. 
5c. Procedures for the main phase – AABM training:
After you complete your first ADP session, you will be receive AABM training.
At each of the 6 AABM training sessions, the following will take place:
Breath alcohol test 
A breath alcohol test (“breathalyzer”) test will be performed and you must have a blood alcohol 
concentration of 0.00%. If you have ANY alcohol on your breath, as measured by the breathalyzer, you 
will be asked to wait until you have no alcohol on your breath or to complete your visit at another time.
Substance use assessments: You will be asked to report your use of alcohol and other substances 
(cigarettes, marijuana, cocaine, etc.) and any alcohol withdrawal symptoms you may have.
Medications: 
You will be asked if you have started taking any new medications since your last visit. 
AABM training: 
You will complete 6 sessions of an AABM training over the course of 2 weeks. Each session takes about 
20 minutes to complete.  You will be asked to complete 2 sessions of the AABM training per AABM study 
visit for a total of 3 AABM study visits.  During this task you will work with a computer by pushing and 
pulling a joystick. During the training sessions you will be asked to respond to the shape of a picture, 
regardless of the picture’s content, by pushing or pulling on a joystick.  Pushing a picture away will make 
it smaller, while pulling a picture closer will make it bigger.  Each training is about 20 minutes, and you will 
have a chance to take a break halfway through the session. 
During AABM Session 1 and AABM Session 6:
To measure the effects of the AABM training, we will ask you to complete several extra questionnaires and 
tests of your thinking at your first (Session 1) and last (Session 6) AABM sessions. 
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5d. Procedures for the follow-up visit:
There is one follow-up visit – 1 week after your 2nd and final ADP session. 
Follow-up visit: 
You will be asked to describe any side effects you may have had since the last study visit. You will be 
asked questions about substance use and possible alcohol withdrawal symptoms since the last visit. You 
will also be asked to complete questionnaires that you took at the beginning of the study, as well as 
undergo the same tests of your thinking. A psychiatrist or psychologist will talk to you about your alcohol 
use, and if you are interested, will provide you with treatment referrals. This appointment will be 
conducted with all participants, even those who do not complete the entire study, and will take 
approximately 1 hour.
5e. Study Plan:
Another way to find out what is being asked of you if you decide to participate in the study is to read the 
chart below. Start reading on the left side of the paper, and follow the lines and arrows.
Consent & 
Screening 
Visit(s)
Consent & 
Screening 
Visit(s)
Prescreening: 
Phone and 
In-person 
Prescreening: 
Phone and 
In-person 
Human Lab 
Session 1
 
6 AABM
Training 
Sessions
Human Lab 
Session 2
1 Week 
Follow-Up 
1 Week 
Follow-Up 
Telephone  
Check-in 24 
hours after 
Human Lab 
Session 1
Telephone  
Check-in 24 
hours after 
Human Lab 
Session 2
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6. How long will I be in the study?
After you complete the screening visits, the study is 6 weeks total. There are 7 visits over the course of 5 
weeks. Please refer to the Study Visit Schedule below.
Study Visit Schedule
WEEK
STUDY VISIT
TIME PER VISIT^
Week 1
Screening visits
2.5 hours
ADP Session # 1
12 hours
Week 2
Phone visit #1
10 minutes
AABM training session #1 + #2
1.5 hours
AABM training session #3 + #4
1 hour
Week 3
AABM training session #5 + #6
1.5 hours
ADP Session #2
12 hours
Week 4
Phone visit #2
10 minutes
Week 5
Follow-up visit
30 minutes
TOTAL
12 study visits
approximately 31-32 hours
^The amount of time is an approximation
7. Can I stop being in the study?
Yes, you can decide to stop at any time. It is important to tell the study research staff if you are thinking 
about stopping. Also, the study PI or co-investigators may stop you from taking part in this study at any 
time if they believe it is in your best interest, if you do not follow the study rules, or if the study is stopped.
8. What side effects or other risks can I expect from being in the study?
The study visits and procedures are designed to limit risks to your health and limit your discomfort as much 
as possible. These procedures closely monitor your safety throughout the study. 
You may have side effects while in the study. Everyone taking part in the study will be watched carefully 
for any side effects. However, doctors don't know all the side effects that may happen.  Side effects may 
be mild or very serious. You should talk to your study doctor about any side effects you experience while 
taking part in the study.
Risks associated with alcohol: 
A number of medical conditions could potentially be worsened by acute alcohol administration, such as 
liver disease, heart disease, pancreas problems, diabetes, nervous system problems, or stomach and 
intestine problems.  If you have any of these medical problems, you should not participate in this study. 
Alcohol may also cause nausea in high doses; however, nausea is not expected at the dose being used 
in this study. In order to ensure that you do not fall and hurt yourself after consuming alcohol, we will ask 
you to stay at the SF VA Medical Center until your breath alcohol level returns to 0.02 or less. Alcohol 
can be addictive. We do not recommend that you continue drinking alcohol in the quantities that will be 
used in this research study.
Risks associated with alcohol withdrawal: 
We are not going to ask you to change your drinking behavior while you are participating in this study. 
However, you should know that some individuals who suddenly reduce or stop their drinking can 
experience alcohol withdrawal symptoms such as nervousness, shaking, loss of appetite, difficulty 
sleeping or more severe symptoms like extreme restlessness, confusion, hallucinations (hearing and 
seeing things that are not there) and seizures -- but these are extremely rare. We will monitor you very 
closely for withdrawal symptoms during your daily visits to our clinic. If you experience worsening of 
withdrawal symptoms, you may have to be hospitalized and will be given the standard medications that 
are used to treat and manage withdrawal. 
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Risks of tests of your thinking, and AABM training: 
Risks related to answering questions about your medical/psychiatric history, reporting of drug use, taking 
part in tests of your thinking, or taking part in AABM training may include fatigue and distress. You are free 
to decline to answer any questions or to stop the assessments/training at any time.  Tests of your thinking, 
interview sessions, and computer training will include breaks. In the event that you appear to be under 
undue strain, the session will be immediately discontinued. 
Blood drawing (venipuncture) risks: Drawing blood may cause temporary discomfort from the needle 
stick, bruising, infection and fainting. We expect to draw 17 mL amount of blood (about 3.5 teaspoons) 
over the course of the study.
STUDY VISIT
AMOUNT OF BLOOD
Screening
8 mL or 2 tsp
1st ADP session
3 mL or ½ tsp
2nd ADP session
3 mL or ½ tsp
TOTAL
14 mL or 3.5 tsp
Risk of distress/fatigue due to psychiatric and other assessments:
Risks related to answering questions about your medical/psychiatric history, reporting of drug use, taking 
part in assessments of your thinking may include fatigue and distress. You are free to decline to answer 
any questions or to stop assessments at any time. Assessments and interviews will include breaks. If you 
are uncomfortable, let us know and the session will be immediately discontinued.
Risks of loss of privacy:
Other risks of being a study participant include a loss of privacy.  In this study, you will be asked about 
drug use and other possibly illegal activities. The researchers will keep information about participants as 
confidential as possible, but complete confidentiality cannot be guaranteed.  All information we obtain 
about you will be de-identified, meaning your name will not be used in any reports or publications resulting 
from this study and your name will not be recorded on any test materials or other research-related records. 
An identification number will be used instead of personally identifiable information. Your identification 
number will be kept in a secured database. Other sites associated with this study, and other University of 
California institutions may review or receive information about you. De-identified data, that is data that has 
been stripped of any information that could be used to identify you, will be shared with collaborating 
investigators.  
Unknown risks: 
The study intervention may have side effects that no one knows about yet. The researchers will let you 
know if they learn anything that might make you change your mind about participating in the study.
For more information about risks and side effects, ask your study doctor. 
9. Are there benefits to taking part in the study?
Taking part in this study may or may not make your health better. If you are in this study, you may benefit 
from the psychological assessments and review of your symptoms. You may respond favorably to the 
training and reduce your drinking, but there is no guarantee that this will happen.  
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10. What other choices do I have if I do not take part in this study?
You do not have to be in this study. 
You may choose to seek treatment services.
You can obtain FDA-approved medications for alcoholism through your general medical care provider. 
You are free to seek treatment through your general care providers. 
You may also choose not to seek treatment for your use of alcohol.
11. Will my information about me be kept private?
Participation in research involves some loss of privacy. We will do our best to make sure that information
about you is kept confidential, but we cannot guarantee total privacy. Because you are a volunteer from 
the community, a medical record will be created for you at the San Francisco VA Medical Center. A note 
about your participation in the study, along with the results from your urine drug screen and blood alcohol 
level tests, will be added to the medical record. 
The information that will be collected includes demographic information (for example: name, address,
age, date of birth, social security number) and health information (psychiatric information, alcohol and
drug use, and medical information). 
If you begin the screening period but are found to be ineligible, the research team will keep the 
information collected, as required by VA rules and regulations. This information will be kept in a locked 
room, in a locked storage unit or on a password-protected computer, depending on how the information 
was collected. This data will be saved for the entirety of the study and will not expire.
Every effort will be made to protect the confidential nature of your identifying information by assigning
you a unique identification code during the study. All information and data collected by the study staff
during this study will contain this identification code instead of any identifying personal information. This
identification code will be stored in an electronic database on a password-protected, secure web server
managed through the SFVAMC. The data manager will download study data from the server that will be
needed for analysis and store it in a password-protected database, stored on a VA server behind a
secure VA firewall at the SFAVMC. The written log that connects your identification code to the
demographic information you give us will be kept in a file separate from the collected data. This log will
have restricted access and will be stored in locked cabinets when not in use. Any data sent via email
messages or delivery service will be encrypted and password-protected.
Video recordings will be stored on a password-protected, secure web server managed through the 
SFVAMC and will not be deleted in accordance with VA research rules. 
To ensure your safety and the safety of others, information may be shared between research staff and 
your clinical team only under the following circumstances: 1) If in the judgment of the study physician, 
you have a psychiatric or medical condition that requires urgent attention to protect your safety and that 
of others; and 2) If you have missed several study appointments, and research staff needs to verify your 
whereabouts and/or verify your safety.
Progress notes related to your participation in this study indicate that you have been in enrolled in a
research study, and the name and contact information for the investigator conducting the study. Details 
like urine drug test results, any mention of alcohol, the study name or number will not be included in the 
progress notes.
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Except for the results of your urine drug screen and blood alcohol level test, study tests that are 
performed by non-VA research labs and information gathered directly from you by the study staff will be 
part of your research study records but will not be added to your medical record. Your personal 
information may be given out if required by law. If information from this study is published or presented at 
scientific meetings, your name and other personal information will not be used.
Authorized representatives from the following organizations may review your research data for the 
purpose of monitoring or managing the conduct of this study: 
•
Representatives of the Sponsor (University of California, San Francisco)
•
Representatives of the University of California
•
Representatives of the Veterans Affairs
•
Members of the study’s Data and Safety and Monitoring Board
In this study, you will be asked questions about illegal drug use and your urine will be tested
for illegal drugs. The researchers will keep information about you as confidential as possible, but
complete confidentiality cannot be guaranteed. On rare occasions, research records have been
subpoenaed by a court.
12. Are there any costs to me for taking part in this study?
No. The sponsor has agreed to pay for all items associated with this research study; you or your insurer 
will not be billed.
13. Will I be paid for taking part in this study?
You will be compensated in return for your time and effort to attend study visits. Payment is also intended 
to cover, or partially cover, the cost of public transportation/gas/parking.  You will not be paid for any missed 
visits. If you complete all study visits and procedures, you will be paid as follows:
WEEK
ATTEND STUDY VISIT
TOTAL PER 
VISIT
Screening
$55*
$55
ADP Session #1
Phone visit #1
$200 (+ $24 for tab)**
$224
AABM 1 + 2
$50
$50
AABM 3 + 4
$40
$40
AABM 5 + 6
$50
$50
ADP Session #2
Phone visit #2
$200 (+ $24 for tab)**
$224
Follow-up @ 1 Week
$40 (+ $50 bonus if attended all study visits)***
$90
TOTAL
$733
*Payment for screening visits depends on the completion of tasks at each visit. You will earn up to $55 
total if you complete all screening measures.
**Please note that you could earn up to $24 per ADP session depending on how many drinks you consume 
per session. At each session, you will be offered 8 drinks, each worth $3. You will receive $3 per drink for 
any drinks that you do not consume.
***If you attend all possible study visits, then you will receive an extra $50 at the last study visit.
Payments will be made in check or cash upon the completion of each visit.  
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Check reimbursement 
For ADP sessions you have the potential to earn up to $224 per visit. You will be paid $200 by check for 
each of the completed ADP sessions. The check will be issued by UCSF, mailed to the address you 
provide, and should be received within 2 weeks after your visit.
Cash reimbursement
You will receive cash for attending the AABM training sessions, the phone visits, the follow-up visit and an 
additional bonus payment if you attend all study visits. The cash reimbursements will be dispersed at the 
end of the corresponding study visits. 
Depending on how many drinks you consume per ADP session, you could receive up to $24 in cash. This 
cash payment will be issued at the end of each drinking session.
Because this study offers participants total payments equal or greater than $600 in a calendar year period, 
then the payments are considered tax reportable income. This means that we will share your home address 
and Social Security Number with the Accounts Payable Manager, using a secured file via email. You will 
also be asked to fill out a W-9 form. 
14. What happens if I am injured because I took part in this study?
It is important that you tell your study doctor, Steven L. Batki, MD, if you feel that you have been injured 
because of taking part in this study. You can tell the doctor in person or call him at 415-221-4810 x 
23671.
Treatment and Compensation for Injury: If you are experiencing a medical emergency, please call 
9-1-1. If you incur an injury or illness as a result of being in this study, the Department of Veterans 
Affairs (VA) will ensure that treatment is made available at a VA medical facility or non-VA facility, as 
appropriate. If you were following study instructions, the costs of such treatment will be covered by 
the VA or the study sponsor (if applicable). If you were NOT following study instructions, the costs of 
such treatment may be covered by the VA or the study sponsor (if applicable), or may be billed to you 
or your insurer just like any other medical costs, depending on a number of factors. The VA and a 
study sponsor do not normally provide any other form of compensation for injury or illness. For further 
information about this, call the study team at the number(s) provided.
15. What are my rights if I take part in this study?
Taking part in this study is your choice. You may choose either to take part or not to take part in the 
study. If you decide to take part in this study, you may leave the study at any time. No matter what 
decision you make, there will be no penalty to you and you will not lose any of your regular benefits. 
Leaving the study will not affect your medical care. You can still get your medical care from our 
institution. 
We will tell you about new information or changes in the study that may affect your health or your 
willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek payment by 
signing this form.
16. What are my responsibilities as a study participant?
•
As a participant in this study, your responsibilities are as follows:
Following the instructions given to you by the study staff and study doctor.
•
Attending all study visits as scheduled.
•
Communicating with study staff if you will not be able to attend a study visit as scheduled.
•
Reporting any side effects, injuries, or other changes in your health to the study doctor.
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•
Reporting all medicines, vitamins, recreational drugs, herbal products, supplements, or over-the-
counter products you use during the study.
•
Speaking with the study doctor if you would like to stop participation in the study.
IMPORTANT: We request that you abstain from driving to the VA Medical Center for study visits if you 
have been drinking. If you do drive and your breath alcohol level is above a 0.08, then a clinician will 
assess your safety before you will be allowed to leave. This is a VA protocol established to ensure your 
safety.
17. Clinical Trial Registry Data Bank
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time.
18. Who can answer my questions about the study?
You can talk to your study doctor about any questions or concerns you have about this study. At the San 
Francisco VA, please contact you study doctor, Steven L. Batki, M.D. at 415-221-4810 x 23671 or page 
him at 415-313-6537.
For questions about your rights while taking part in this study, call the office of UCSF’s Institutional 
Review Board (a group of people who review the research to protect your rights) at 415-476-1814.
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CONSENT
You have been given copies of this consent form and the Experimental Subject's Bill of Rights to keep.
You will be asked to sign a separate form authorizing access, use, creation, or disclosure of health 
information about you.
PARTICIPATION IN RESEARCH IS VOLUNTARY.  You have the right to decline to participate or to 
withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.
Optional Procedures: Please indicate if you agree to participate in the following optional procedures by 
placing your initials on the lines below: 
-------------------------------------------------------------------------------------------------------------------------------
______   I agree to be contacted after this study is done or to be asked to be in other studies.
______   I do not agree to be contacted after this study is done or to be asked to be in other studies. 
-------------------------------------------------------------------------------------------------------------------------------------------
If you wish to participate in this study, you should sign below.
Signature of Participant
Date
__________________________________________________
Printed Name of Participant
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