Clinical trial NCT02885311
Conditions: Alcohol-Related Disorders Alcohol Drinking Alcoholism Alcohol Abuse Alcohol Use Disorders
Keywords: Drinking Excessive drinking Alcohol use disorders Primary Care
Sponsor: Northwell Health
Start date: 2017-01-01; Completion date: 2018-10-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.

Detailed description:
Excessive drinking (ED) and alcohol use disorders (AUD) remain one of the nation's leading public health problems, yet this problem is largely under-recognized and undertreated. Although many people with ED/AUD see a primary care physician annually, there has been limited research and implementation of models to treat ED/AUD in primary care. Important changes in the healthcare system and advances in alcohol research offer new and potentially transformative opportunities to integrate ED/AUD treatment into primary care practices. In particular, these changes have led to the development of new patient-centered, integrated care models that facilitate the treatment behavioral health issues in primary care. Experts have repeatedly called for the development of a chronic care model to treat alcohol problems in primary care, similar to models now used to treat other chronic illnesses, including depression. Yet, research to develop and test such models has been surprisingly limited. The primary aim of this study is to develop and test a chronic care model to treat ED/AUD in the patient-centered model home (PCMH) using the NIH stage model of intervention development. Specifically, using a mixed methods approach, this study proposes to adapt and test the collaborative care (CC) model for depression to treat ED/AUD in a high volume PCMH. Importantly, we will build the CC model onto a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program that is already in place in the PCMH. Notably, this SBIRT model currently refers those with ED/AUD out to specialty treatment providers. The proposed study will be conducted in two phases. Phase I will involve initial adaptation of the CC model for depression. During this phase, relevant depression CC protocols and measures will be adapted for ED/AUD and piloted tested on participants (n = 25) recruited in a PCMH. Phase II will involve model refinement based on iterative cycles of patient and PCMH staff feedback and examination of drinking outcome data. During this phase, participants (n = 60) will be assessed and followed for three months. Iterative development will focus on: 1) utilizing a stepped-care model of treatment which will include outpatient detoxification, behavioral interventions, and medication intervention and management, 2) maximizing patient engagement, and 3) balancing the resource and expertise constraints of treating ED/AUD in a PCMH. Participants in Phases 1 and 2 will be followed at 1 and 3 months and primary outcome data on drinking outcomes will be examined.

Arms: arm 1: AR will receive feedback about their drinking and brief advice along with follow up assessments. arm 2: PD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments. arm 3: AD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy \[MBSCT\]) adapted from our two prior protocols. These participants will also receive follow up assessments. arm 4: AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
Interventions: intervention 1: Motivation Enhancement Therapy intervention 2: Modified Behavioral Self-Control Therapy intervention 3: Naltrexone intervention 4: Brief Advice intervention 5: Referral to specialty substance use disorder treatment
Intervention descriptions: intervention 1: Motivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan). intervention 2: Motivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers. intervention 3: Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day). intervention 4: Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide. intervention 5: Participants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders.

Protocol documents:
ICF_002.pdf: 
 
Version Date: 12/12/16 
IRB #: 15-0743 
 
 
 
 
 
 
 
Page 1 of 8 
 
Northwell Health 
 
Campus: Zucker Hillside Hospital 
 
Behavioral Intervention Consent for Participation in a Research Study 
 
Title: Project ReDUCE (Collaborative Care for Alcohol Use Disorders in the Patient-Centered 
Medical Home: Phase I & Phase II) 
 
Principal Investigator: Jon Morgenstern, PhD  
 
Sponsor: National Institute on Alcohol Abuse and Alcoholism 
 
Introduction 
You already agreed to participate in a research study and have chosen to receive a behavioral 
intervention.  
 
This consent form will explain: 
 the purpose of the overall study 
 the purpose of behavioral interventions in the study 
 information about the behavioral interventions available to you in this study  
 what you will be asked to do if you decide to receive a behavioral intervention as 
part of this study 
 the potential risks and benefits of the behavioral interventions available in this 
study  
 
It will also explain that you do not have to be in this study to receive a behavioral intervention. 
You do not have to agree to receive a behavioral intervention to participate in the study. You 
should ask questions before you decide if you want to receive a behavioral intervention as part of 
this study. You can also ask questions at any time during the study.  
 
Why is this research study being done? 
The purpose of this research study is to develop and test a care model to treat problem drinking 
and alcohol use disorders in the primary care setting. You are being asked to participate in this 
study because routine screening and assessment conducted at your primary care clinic indicates 
that you have recently exceeded healthy drinking limits as outlined by the National on Alcohol 
Abuse and Alcoholism. A behavioral intervention is available as one treatment option for you, 
and this consent form will review this option so that you can determine whether you would like 
to pursue this option. Whether or not you choose to receive a behavioral intervention will not 
affect your participation in the overall study.   
 
How many people will take part in this study?   
The overall research study hopes to enroll 85 individuals. 
 


 
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How long will you be in this study?  
The study will last for 12 weeks. All of the procedures described in the main study consent form 
will apply to you. If you choose to receive a behavioral intervention in this study, you will 
undergo an assessment at your initial appointment to evaluate your level of need for treatment. 
Depending on this assessment, you may be offered any of the behavioral interventions (described 
in the next section) that will occur either for four sessions over the 12 weeks of the study or 
weekly. These behavioral intervention sessions will occur in addition to the research assessments 
you have already agreed to in the main study consent. 
 
What will happen in this research study? 
You have already provided verbal consent to be screened for risky alcohol use as a standard of 
care at the 865 Northern Boulevard General Internal Medicine site, and you received a brief 
counseling session based on your screening results. After that counseling session, you were 
asked to participate in the overall research study.  
 
If you chose to participate in the study by signing the main study consent form, you were further 
assessed and provided medication and behavioral treatment options based on your need. At that 
time, you chose to receive a behavioral intervention, and, therefore, undergoing this consent 
process to learn more there interventions available to you and the associated risks and benefits. If 
you choose to consent, a Behavioral Health Specialist (BHS; which is a licensed mental health 
professional) will begin the first session of the behavioral intervention you are offered.   
  
You will be offered ONE of the below behavioral treatment options based on your level of need: 
 
Motivational Enhancement Therapy includes four, 45-minute sessions with a BHS, 
occurring at weeks 1, 2, 4 and 8 of the study. During this treatment, you will discuss 
potential reasons and ways to reduce your drinking to safe levels.  
 
OR 
 
Modified Behavioral Self-Control Therapy includes twelve, 45-minute session with a 
BHS, occurring weekly since week 1. During this treatment, you will discuss potential 
reasons to reduce your drinking as well as ways and skills you can use in order to do so. 
 
 
At week 4, your progress in treatment will be assessed by your BHS and your health coach. You 
may be offered medication treatment, if it appears that an alternative may be more suitable than 
the behavioral intervention you have been receiving for the first 4 weeks. This treatment would 
involve taking naltrexone (50mg) daily. If you agree to receive medication, a medical 
professional (i.e., a Registered Nurse, a Nurse Practitioner, or a Medical Doctor) will meet with 
you separately to perform the consenting process for the medication. During that time, you will 
learn about the medication, including possible side effects and risks and benefits to taking it. 
Then, you will be able to decide if you want to consent to take the medication. 


 
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Decisions regarding additional treatment options will be made by your BHS, who is part of this 
study, in consultation with you and this study staff and the primary care clinical team. 
 
What are the risks of the research study? What could go wrong? 
All the risks reviewed in the main study consent form still apply to you. There are some risks 
associated with this study. It is possible that your condition may worsen while receiving the 
behavioral intervention and being in this study. If this occurs, your BHS will discuss this with 
you and review other treatment options. Also, the topics discussed in the therapy sessions are of 
a sensitive nature. You may feel uncomfortable in answering some questions or discussing issues 
that are distressing. If you feel uncomfortable, you may choose to refuse to discuss topics that 
may be difficult for you. You may refuse to any answer questions that you find hard to talk 
about.  
 
What are the benefits of this research study? 
The possible benefits you may experience from the procedures described in this study include a 
reduction in problem drinking; however, this cannot be guaranteed. We expect that the findings 
of this research will help your primary care team recognize and treat excessive drinking and 
alcohol use disorders in primary care settings in the future.  
 
If you do not want to take part in this research study, what are your other choices? 
If you do not choose to participate in the behavioral interventions of this study, you will still be 
able to participate in the main study. Your alternative treatment options would include 
medication or referral to treatment elsewhere. If you choose to receive medication, a Registered 
Nurse, Nurse Practitioner, or a Medical Doctor will meet with you to undergo a separate consent 
for medication where you will learn about the important risks and benefits associated with that 
treatment. 
 
Are there any costs for being in this research study?  
This research study is funded by the National Institute on Alcohol Abuse and Alcoholism. All 
study related visits will be given to you at no additional cost to you. If you choose to receive a 
behavioral intervention as a part of this study, your insurance company will not be billed, and 
your treatment sessions will occur at no cost to you.  
Will you receive any payments for participating in this research study? 
You will receive $20 for each study interview you complete, as discussed in the general consent 
for the study. Therefore, if you participate in all study sessions, you will be paid up to a total of 
$80 for your time. Payment will be made at the end of each study assessment or when you end 
your participation. The behavioral interventions sessions are not compensated.  
 
If the total payment you receive from Northwell Health, during this year, is equal to $600 or 
more, the payment is required to be reported to IRS.  Although this study does not pay $600, if 
you participate in other Northwell Health studies, it is possible your payment could end up 
totaling $600.  If this occurs, the payment you receive on this study will be reported to the IRS.   
In this case, you will be issued a 1099 form and be required to provide your social security 
number at that time for reporting purposes.  You will also be responsible for reporting this 
income while filing your tax return. 


 
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What are your rights as a research participant? 
Your participation in this project as well as in receiving a behavioral intervention as part of your 
treatment is voluntary. The quality of your medical care will be the same, whether you join, 
refuse to join, or decide to leave the study or to receive a behavioral intervention.  
 
If you do not join the study or do not wish to receive a behavioral intervention, you will not be 
penalized or lose benefits to which you are entitled. If you join the study you may withdraw at 
any time or discontinue the behavioral treatment without prejudice to your future care at 
Northwell Health. Follow-up examinations may be needed to assure your well-being.   
 
Could you be taken off the study before it is over? 
It is also possible that your participation in the behavioral intervention may end without your 
consent. This decision may be made by a researcher, study sponsor, or the Institutional Review 
Board (IRB—the committee that oversees research at this institution).    
 
Reasons for withdrawal may include:   
 failure to follow instructions,  
 failure to show up for study visits, 
 it is not in your best interest to continue the behavioral intervention, or  
 the study is stopped.   
 
If you are withdrawn from being able to receive a behavioral intervention, any data already 
collected will continue to be used, and you will be offered alternative treatment in the study or 
referred to treatment outside of the study. You will still be monitored in the research assessment 
portion of the study, unless you choose to withdraw, which you are free to do at any time without 
any effect on your care at Northwell Health. 
 
What happens if new information is learned? 
You will be told of any new findings that may change your decision to continue to participate. 
Your consent to continue to take part in this study may be obtained again.   
 
What information will be collected and used for this study? 
If you agree to be in this study, we will collect information about your health and your alcohol 
use. We may collect the results of questionnaires and interviews. This information may include 
questions about the amount of alcohol you drink, how often you drink, any problems you have 
experienced because of drinking, and any reasons why you may have trouble accessing treatment 
services. If you drop out of treatment, we may ask you why so that we can learn from your 
experiences. We will only collect information that is needed for the research. This information 
has been described in this consent form. If you sign this consent form, you are giving us 
permission to collect, use and share your health information. This permission is called 
authorization. If you do not want to provide authorization, then you cannot participate in this 
research study. 
 
 


 
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Who else will see your information?  
Study records that identify you will be kept private. You will not be identified in study records or 
publications disclosed outside the Northwell Health System, except as detailed below.  
 
Investigators will share de-identified information collected from this research study with: 
 study sponsor and/or its agents,  
 data safety monitoring board, 
 clinical staff not involved in the study who may be involved in the participant's treatment 
 
The following reviewers may access your study and medical records to make sure that this study 
is being done properly:  
 Representatives from federal and state government oversight agencies, such as National 
Institutes of Health, US Department of Health and Human Services (DHHS), or the New 
York State Department of Health. If these representatives request study records, 
identifiers will be redacted from the documents prior to release. 
 Representatives from the Northwell Health System Human Research Protection Program 
(a group of people that oversee research at this institution) 
 
We will do our best to protect the privacy of your records, but it is possible that once information 
is shared with people listed on this form that it may be released to others. If this happens, your 
information may no longer be protected by the federal law. 
 
In the future, we may publish results of this study in scientific journals and may present it at 
scientific meetings. If we do, we will not identify you.  
 
If the researchers learn about potential serious harm to you or someone else or other public 
health concerns, it will be shared with the appropriate authorities. 
 
Will you be able to access your records? 
If your research records are used for decisions related to your clinical care, then you have the 
right to review this information and request changes. This is limited to information about your 
treatment and does not include information related to procedures or tests that are for research 
purposes only. You may access this information only after the study analysis is complete. You 
have the right to know who has and who will see your records. To request this information, 
please call the Human Research Protection Program at 516-321-2100. 
 
How long will your health information be kept?  
There is no limit on the length of time we will keep your information for this research because it 
may be analyzed for many years. We will keep it as long as it is useful, unless you decide you no 
longer want to take part or we close the study.  You are allowing access to this information 
indefinitely.   
 
Can you change your mind? 
If you change your mind about being in the study or about receiving the behavioral intervention, 
you may withdraw at any time or discuss alternative treatment options with study staff. If you 


 
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want us to stop collecting your health information, you can send a letter to the researcher at the 
following address: 
Dr. Jon Morgenstern. 
1010 Northern Blvd. Suite 311 
Great Neck, N.Y., 11021 
 
Your letter needs say that you have changed your mind and do not want the researcher to collect 
and share your health information. You may also need to leave the research study if we cannot 
collect any more health information. We may still use the information we have already collected. 
We need to know what happens to everyone who starts a research study, not just those people 
who stay in it. 
 
Will information about this study be available to the public? 
We may write about this study and publish it in a scientific journal; however, you will not be 
named and all participants’ data will be combined such that no one participant is written about. 
Also, a description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At most 
the website will include a summary of the results. You can search this website at any time.  
 
Does the investigator of this study receive money if you take part?   
Funding for this research study is provided by the National Institute on Alcohol Abuse and 
Alcoholism. The investigators on this study receive money to conduct the study but do not 
financially benefit from your participation. The money they receive is to pay them back for the 
costs of conducting the research study. If your doctor is an investigator for this study s/he is 
interested in both your healthcare and the conduct of this research. You do not have to take part 
in a research study conducted by your doctor. 
 
Who can answer your questions about this study? 
If you have any questions about the study, you may call Dr. Jon Morgenstern at (516) 837-1694. 
If you have questions about side effects or injury caused by research you should call Dr. Jon 
Morgenstern at (516) 837-1694. If you need emergency care, dial 911 or go to the nearest 
Emergency Room. If you have questions about your rights as a research participant, concerns 
about being in the study, or would like to offer input, you may contact the Office of the 
Institutional Review Board (the committee that oversees research at this institution) at (516) 321-
2100.  
 
A signed copy of this consent form will be given to you. 
 
 
 
REVIEW QUESTIONNAIRE TO FOLLOW 
 
 
 
 
 


 
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Research Review Questionnaire 
 
 
After reviewing the consent form for this study please answer the following questions by circling 
“True” or “False”. The researchers doing this study want to be sure that you know what is 
involved in being in this research study. This questionnaire will help them make that decision. 
You may ask questions of the researcher and review the consent form again at any time. 
 
You do not have to be in this study or receive the behavioral interventions in the study in order to 
receive treatment for drinking. 
 
True   False 
 
If I decide to receive a behavioral intervention, I will choose from two different options.   
 
 
 
 
 
 
 
 
 
 
 
True   False 
 
I can withdraw from participating in this study at any time.  
 
 
True   False 
 
There are no risks to me from participation in this study.  
 
 
 
True   False 
 
 
 
 
 
 
 
[Signature Page Follows] 
 


 
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Summation/Signature 
 
You have read the above description of the research study. You have been told of the risks and 
benefits involved and all your questions have been answered to your satisfaction. A member of 
the research team will answer any future questions you may have. You voluntarily agree to join 
this study and know that you can withdraw from the study at any time without penalty. By 
signing this form, you have not given up any of your legal rights. 
  
____________________________________________________________ 
Printed Name of Participant   
 
 
___________________________________________________             ______________ 
Signature of Participant 
   Date 
 
_______________________________             ____________________  __________ 
Witness’s Printed Name 
 
 
    Witness’s Signature 
  Date 
(Note: A witness can be a member of the research team, but cannot be the same person signing 
consent as the investigator) 
  
 
 
Investigator’s Statement  
In addition to advising the above participant of other forms of treatment and therapy which are 
appropriate, I have offered an opportunity for further explanation of the risks and discomforts 
which are, or may be associated with this study and to answer any further questions relating to it. 
 
_________________________________               ____________ 
Investigator’s signature                                                Date  
  
_____________________________________________ 
Investigator’s printed name                                              
 
 
 

Prot_SAP_000.pdf: 
 
v. 3/30/2018 
 
1 
 
 
RESEARCH PROTOCOL 
 
Protocol Title:  
 Collaborative Care for alcohol use disorders in the patient-
centered medical home (short title: Project ReDUCE) 
Principal Investigator: 
Jon Morgenstern, Ph.D. 
Primary Contact Name: Svetlana Levak, Ph.D. 
Primary Contact Phone: (516) 837-1675 
Primary Contact Email: slevak@northwell.edu 
Date Revised: 
 
3/30/2018 
IRB Number: 
 
15-0743 
 
1) 
PREVIOUS STUDY HISTORY 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to submission 
to this IRB? 
NO 
YES—if yes, please explain: N/A 
 
2) 
BRIEF SUMMARY OF RESEARCH 
 
Excessive drinking (ED) and Alcohol Use Disorders (AUDs) remain one of the nation’s leading 
public health problems, yet this problem is largely under-recognized and undertreated. Although 
many people with ED/AUD see a primary care physician annually, there has been limited 
research and implementation of models to treat ED/AUD in primary care. Important changes in 
the healthcare system and advances in alcohol research offer new and potentially 
transformative opportunities to integrate ED/AUD treatment into primary care practices. In 
particular, these changes have led to the development of new patient-centered, integrated care 
models that facilitate the treatment of behavioral health issues in primary care. Experts have 
repeatedly called for the development of a chronic care model to treat alcohol problems in 
primary care, similar to models now used to treat other chronic illnesses, including depression. 
Yet, research to develop and test such models has been surprisingly limited. The primary aim of 
this proposal is to develop and test a chronic care model to treat ED/AUD in the patient-
centered model home (PCMH) using the National Institutes of Health (NIH) stage model of 
intervention development. Specifically, using a mixed methods approach, this study proposes to 
adapt and test the collaborative care (CC) model for depression to treat ED/AUD in a high 
volume PCMH. Importantly, we will build the CC model onto a Screening, Brief Intervention, and 
Referral to Treatment (SBIRT) program that is already in place in the PCMH. Notably, this 
SBIRT model currently refers those with ED/AUD out to specialty treatment providers.  
 
The purpose of the study is to develop and test a collaborative care model to treat ED and 
AUDs in a primary care practice. We plan to conduct this study in two phases using the NIH 
stage model. A third stage that includes a randomized controlled trial will be conducted later and 
will be submitted as a separate IRB protocol after we adapt protocols based on what is learned 
in the first 2 phases 
 
The proposed study will be conducted in two phases. Phase I will involve initial adaptation of the 
CC model for depression. During this phase, relevant depression CC protocols and measures 
will be adapted for ED/AUD and pilot tested on participants (n = 25) recruited in a PCMH. Phase 


 
v. 3/30/2018 
 
2 
 
II will involve model refinement based on iterative cycles of patient and PCMH staff feedback 
and examination of drinking outcome data. During this phase, participants (n = 60) will be 
assessed and followed for three months. Iterative development will focus on: 1) utilizing a 
stepped-care model of treatment which will include outpatient detoxification, behavioral 
interventions, and medication intervention and management, 2) maximizing patient 
engagement, and 3) balancing the resource and expertise constraints of treating ED/AUD in a 
PCMH. Participants in Phases I and II will be assessed at weeks 1, 4, 8, and 12 and primary 
outcome data on drinking outcomes will be examined. 
 
3) 
INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
 
Public Health and Excessive Drinking. ED and Alcohol Use Disorders (AUD) remain one of 
the nation’s leading public health problems. One in six Americans exceeds recommended 
guidelines for healthy drinking (Center for Disease Control & Prevention, 2014) and about one 
in twelve (8.45%) meet criteria for AUD (Grant, et al., 2004). Annual costs to society related to 
alcohol problems are estimated to be $223.50 billion (Bouchery, Harwood, Sacks, Simon & 
Brewer, 2006), a figure similar to that of other major diseases like diabetes ($245 billion) and 
cancer ($216 billion). Despite the magnitude of the problem, ED/AUD are under- recognized 
and undertreated. For example, studies indicate that only 12% of those with an AUD ever 
received treatment (Cohen, Feinn, Arias, & Kranzler, 2007). Barriers to treatment include 
stigma, impaired motivation among those with alcohol dependence (AD), inadequate insurance 
coverage, and the delivery of AUD treatment in specialty care settings that exist outside of 
mainstream medicine. The alcohol research community has long recognized this problem 
(Institute of Medicine, 1990). Progress has certainly been made in the last 25 years, but the 
problem of delivering care to the vast majority of those with ED/AUD remains unresolved.  
 
New Opportunities to Integrate Treatment of ED/AUD into Mainstream Healthcare: 
Improved understanding of alcohol problems and changes in the healthcare system offer new 
and potentially transformative opportunities to expand access to alcohol treatment. AD is now 
widely understood as a chronic illness, similar to that of other chronic medical conditions 
(McLellan, et al,, 2014). Effective treatments have been developed that can be feasibly 
delivered in primary care settings including brief advice (Center for Substance Abuse 
Treatment, 1999), time-limited behavioral interventions (Babor, et al., 2007), and 
pharmacotherapies (Park, et al., 2015). Epidemiology studies provide new support for the 
public health argument that alcohol treatments should be made accessible to those with mild to 
moderate alcohol problems, in part as a strategy to avert the development of chronic illness 
(Town, Naimi, Mokdad, & Brewer, 2006). For example, an analysis of NESARC data found that 
over half of those diagnosed with AD reported relatively intact psychosocial functioning and low 
rates of mental health comorbidities. These subgroups appeared to have a less severe course 
of AD and had the lowest rates of treatment seeking (<5%). Study findings support the 
argument that primary care might be a more suitable setting to treat a large segment of those 
with AD who currently remain untreated, if such treatment was widely available (Lenaerts, et al., 
2014; Willenbring, 2007). Similarly, studies indicate about 16% of Americans binge drink four 
or more times a month, most binge drinkers are not alcohol dependent, and binge drinking 
accounts for 75% of alcohol’s estimated costs to society (Town, et al., 2006; Centers for 
Disease Control and Prevention, 2012). These findings highlight the population health and 
economic benefits of screening and intervention in primary care. Overall, recent research 
findings substantially strengthen the argument for expanding ED/AUD treatment to primary care 
settings. Evidence supports the treatment of AUD as a chronic illness similar to other chronic 
conditions; the effectiveness of interventions that can be feasibly delivered in primary care 
settings; and the public health benefits of widespread access to alcohol treatment, especially 
early intervention, as an important strategy to reduce healthcare costs. 


 
v. 3/30/2018 
 
3 
 
 
Changes in Healthcare Delivery: The last decade has witnessed a dramatic and accelerating 
transformation of the healthcare delivery system driven by the twin goals of improving quality of 
care and reducing costs (Mechanic, 2012). Two developments of special import for the 
integration of alcohol treatment into mainstream healthcare are: 1) the paradigm shift from a 
focus on acute to chronic illness and 2) the passage of healthcare reform legislation that when 
fully implemented will greatly increase insurance coverage for treating alcohol problems 
(McLellan, et al., 2014; Ghitza & Tai, 2014).   (Lewis, et al., 2014) 
 
As noted above, ED/AUD substantially contributes to the burden of chronic illness. Alcohol 
screening and early intervention has been shown to be one of the most cost effective 
preventative medicine strategies for use in primary care (Solberg, Maciosek, & Edwards, 
2008), and effective interventions exist that can feasibly be implemented to treat a wide 
spectrum of alcohol problems from at-risk drinking to uncomplicated AD within the primary care 
setting. There is reason to anticipate that identification and access to treatment in primary care 
will lead to greater engagement and reduced drinking for problem drinkers and those with 
uncomplicated AD; groups who rarely receive care in the current system. These developments 
present a new and exciting window of opportunity to address a longstanding, seemingly 
intractable public health challenge: integration of alcohol treatment into mainstream medicine 
as a way to reduce the number of untreated or undertreated Americans who drink excessively 
or are afflicted with AUD. 
 
Gap in Model Development and Testing: Wagner’s Chronic Care Model (CCM) has been an 
influential template for designing and implementing most of the above mentioned integrated 
care models. Addiction experts have repeatedly called for the development of a CCM to treat 
AUD (McLellan, et al., 2014; Lenaerts, et al., 2014; Butler, et al., 2008; Saitz, Larson, Labelle, 
Richardson, & Samet, 2008; Saitz, 2013). CCM features as implemented in primary care 
include: patient-centeredness, multi-professional teamwork, continuity of care, evidence-based 
practice, and continuous quality improvement (Lenaerts, et al., 2014; Ouwens, Wollersheim, 
Hermens, Hulscher, & Grol, 2005). A review published in 2014 by a NIDA Consensus panel 
concluded that despite the clear clinical need for a CCM model and the extraordinary 
opportunity for integration created by ACA, implementation of such a model would prove 
difficult for two reasons (McLellan, et al., 2014). First, few practical models exist to provide 
guidance. Second, there is a striking absence of empirical evidence comparing CCM to other 
SUD treatment models. Thus, there is a consensus among experts that a CCM model of 
ED/AUD is needed to capitalize on the dramatic changes in healthcare, but such a model and 
evidence to support its efficacy does not yet exist. 
 
Research on Models that Integrate AUD Treatment into Primary Care Settings: 
Screening, Brief Intervention and Referral to Treatment (SBIRT) has been extensively studied 
as a model for treating alcohol problems in primary care. Reviews have found that SBI is 
effective for at-risk drinkers, that multi-component brief interventions (BI) are more effective 
than single encounters, but that SBIRT appears ineffective among harmful drinkers and those 
with mild to moderate AD (Jonas, et al., 2012; McCambridge & Rollnick, 2014; Saitz, 2010). 
These widely accepted results (i.e., modest effects on consumption for at-risk drinkers and an 
absence of evidence of efficacy for heavier drinkers) have led a number of senior alcohol 
scientists to call for new research to test the efficacy of behavioral interventions and 
medication in primary care for those with mild to moderate AD as well as harmful drinkers as 
an important next step in building a stronger evidence-base for treating AUD in primary care 
(McCambridge & Rollnick, 2014; Heather, 2014; Saitz, 2014). 
Two recent studies examined integrated treatment of AD in primary care. First, Oslin et al. 
(2014) compared treating veterans with AD using naltrexone plus medical management in 
primary care versus referring them to specialty care. The study found superior outcomes for 
the group treated in primary care. Saitz and colleagues (2013) tested a CCM for SUD in a 


 
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primary care clinic. The study focused on one important subgroup of patients: those with SUD 
dependence who had significant social, medical, and mental health problems. The majority of 
participants (75%) were recruited following residential drug detoxification. The study found no 
significant differences between CCM and a referral to primary care but did find a small positive 
effect for a subgroup with AD only. In commenting on the negative findings, the authors note 
that the efficacy of treatments for multi- problem individuals with chronic SUD may be limited. 
Thus, delivering such treatments in primary care may not improve outcomes. 
 
Overall, with the exception of the Saitz and colleagues (2013), no study has rigorously 
examined a CCM for AUD in primary care. As noted above, research supports the use of 
screening as a strategy to identify those with alcohol problems in primary care and the efficacy 
of brief interventions to treat at-risk drinkers. Findings from Oslin et al. (2014) support the use 
of naltrexone to treat AD in primary care, but findings may be limited to the VA. For example, 
half of participants in the Oslin et al. study (2014) already had a prior episode of alcohol 
treatment. In addition, a number of experts have suggested that future research in primary care 
should focus on testing treatments for harmful drinkers and those with mild to moderate AD. 
 
Model and Setting Considerations: We propose to develop our model in the context of a 
Patient Centered Medical Home (PCMH) and to adapt model features from the Collaborative 
Care (CC) model for the treatment of depression in primary care (Unutzer, Harbin, & Druss, 
2013). The PCMH (also referred to as medical homes) is at the center of efforts to reinvent 
primary care to address the burden of chronic illness. Among the key features of PMCH are: a 
comprehensive approach to care, a personal relationship with a physician-led team that has 
collective responsibility for the patient in a manner that is coordinated and continuous, and a 
reimbursement approach that pays for the cost of these systems. Since 2008, the National 
Committee for Quality Assurance (NCQA)  has been evaluating and certifying practices’ ability 
to function as a PCMH. NCQA PCMH Recognition is the most widely-used way to transform 
primary care practices into medical homes. More than 10 percent of U.S. primary care practices 
(almost 7,000) are recognized as NCQA PCMHs (National Committee for Quality Assurance, 
2014). A recent study found that the transition of primary care practices to PCMHs is rapidly 
accelerating. PCMH projects are now found in 44 states and are strongly supported by 
commercial, state, and federal funders (Neilsen, Buelt, Patel, Nichols, & Fund, 2014). In 2014, 
the American Academy of Family Physicians and other leading medical societies issued a 
statement that integrated behavioral health is a core principle of PCMH (Baird, et al., 2014). 
Subsequently, NCQA joined this movement by issuing a new set of PCMH standards that 
include integration of behavioral health. Thus, PCMHs have been identified by leading medical 
groups as a setting where the integration of medical and behavioral health care should occur. 
 
There is a strong rationale to develop a CCM for ED/AUD in a PCMH setting. PCMHs already 
have many of the critical organizational, technology, practice, and staffing features needed to 
develop CCM for alcohol. The newly developed model can capitalize on those features, rather 
than seek to create them. PCMHs do vary across a wide range of dimensions, but NCQA 
requirements provide a core set of features that will facilitate adoption of the model. In 
addition, because PCMHs are designed to address chronic illness, there will be increasing 
pressure on them to expand coverage of behavioral health issues, including alcohol. Thus, 
PCMHs represent an important stakeholder constituency who over time will be motivated to 
include CCM for alcohol problems, if such an intervention proves effective. 
 
Collaborative Care (CC) Model: CC is an evidence–based approach for integrating 
depression treatment as part of routine medical care. CC was developed using the Wagner 
model and contains the five CCM core principles (Ouwens, et al., 2005). CC has been widely 
recommended for adoption by state Medicaid agencies as part of ACA in the context of the 
expansion of medical and health home programs (Unutzer, et al, 2013). CC includes: care 


 
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coordination, regular proactive monitoring and treatment- to-target using validated clinical 
rating scales, and regular systematic caseload reviews for patients not showing improvement. 
A number of reviews have found that CC for depression consistently demonstrated greater 
effectiveness relative to usual care (Gilbody, Bower, Fletcher, Richards, & Sutton, 2006; 
Bower, Gilbody, Richards, Fletcher, & Sutton, 2006). 
 
There are several reasons for our decision to adapt CC to ED/AUD. First, features of the 
model provide a good fit for adaptation to existing evidence-based alcohol interventions (cf. 
section below). Second, CC has a strong evidence base. One attractive feature is that the CC 
attempts to treat problems in primary care rather than referring out. As stated above, 
provisional evidence supports intervening for alcohol problems within the PCMH, rather than 
referral out, as a first-line approach. Second, CC appears likely to become the dominant model 
for the treatment of mental health problems in the PCMH. Developing a parallel model for 
alcohol could greatly facilitate dissemination to PCMHs. 
 
Core Features of CC and their Adaptation for Excessive Drinking/AUD: Knowns and 
Unknowns: CC has four core features: 1) standardized assessment to enable identification, 
diagnosis, and risk stratification. In addition, protocols are required for pro-active ongoing 
monitoring, tracking, and support to assess treatment response and adjust treatment as 
needed; 2) risk stratification of patients and use of treatment algorithms for selection of the 
initial evidence-based treatment; 3) Stepped care and treatment-to-target (TTT) protocols are 
needed to respond in a timely manner to treatment non-response and modify or step-up 
treatment; 4)Teamcare (described below) consisting primarily of Primary Care Practitioners 
(PCPs), a non-physician care manager/behavioral health clinician, and easy access to a 
consultative specialist(s) to advise the PCP on care issues. In the following sections, we 
describe the issues related to adapting CC for ED/AUD. We identify known elements in alcohol 
assessment/treatment that can be easily adapted as well as unknown factors that require 
exploration and development: 
 
(1) 
Standard Assessment and Ongoing Monitoring and Support to Assess Treatment 
Response: There is a well-established literature on screening and assessment for alcohol 
problems in primary care using validated self-report measures (Fiellin, Reid, & O’Connor, 
2000). Unknowns: Self-report measures fail to detect a portion of those with alcohol problems.  
It is not clear whether other methods such as biological assays (e.g., liver enzyme tests) or 
medical record reviews in combination with standard screening would substantially increase the 
number of patients identified and whether such individuals would engage in alcohol treatment. 
Extended care interventions have developed protocols for pro-active monitoring and 
intervention but these have largely been limited to aftercare (McKay et al., 2005).  Unknowns: 
We have limited knowledge about how best to structure pro-active monitoring, education, and 
support for patients and families or the development of a patient registry to track care in the 
PCMH. 
 
(2) 
Risk Stratification & Treatment Algorithms (cf. Approach for a more detailed description 
of four mutually exclusive risk groups): Evidence supports stratification and treatment 
assignment based on severity of alcohol problems and the presence of co-occurring problems 
(United States Department of Health and Human Services, 2005; Cavacuiti, 2012; Harris, 
Kivlahan, Bowe, Finney, & Humphreys, 2009). As noted above, brief interventions in primary 
care have proven effective for at-risk drinkers, but not for those with more severe problems 
(Saitz, 2010; Kaner, et al., 2009). A number of brief behavioral interventions including 
Motivational Enhancement Therapy (MET) (Morgenstern & McKay, 2007; Morgenstern, et al., 
2012; Walters, 2000) have proven effective for problem drinkers (i.e., heavy drinkers including 
those with mild to moderate AD seeking drink reduction rather than abstinence goals). In 
addition, several medications including naltrexone and topiramate have also proven effective 
(Morgenstern, et al., 2012a; Kranzler, et al., 2009; Kranzler, et al., 2014)  to treat problem 


 
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drinkers. General clinical research guidelines tend to exclude participants with severe AD 
(often defined as evidence of physiological withdrawal) from problem drinker studies 
(Morgenstern, et al., 2012b; Kranzler, et al., 2014). Numerous clinical trials of patients with 
moderate-to-severe AD, but without significant co-occurring problems, support the efficacy of a 
similar set of behavioral and pharmacological treatments as those listed above, but in the 
context of abstinence goals (Miller & Longabaugh, 1995; Anton, et al., 2006; Johnson, et al., 
2007). Notably, trials such as Project MATCH (Project MATCH Research Group, 1998) or 
COMBINE (Anton et al., 2006) have tended to exclude individuals with current other Axis I or II 
disorders or significant social instability and clinical practice guidelines tend to recommend 
more intensive treatments such as intensive outpatient care for this group (Cavacuiti, 2012; 
Harris, et al., 2009). Unknowns: With very few exceptions (Oslin, et al., 2014), evidence for the 
efficacy of treatment for problem drinkers and AD is based on treatment seeking samples. 
Thus, we have limited knowledge about whether such patients will engage or benefit from AUD 
treatment delivered in primary care. 
 
(3) 
Stepped Care and TTT: Stepped care in the CC model refers to pro-active monitoring of 
the patient during the initial care episode to assess adherence and response to the initial 
treatment. Patients who fail to respond are offered a stepped-up care option. Typically, 
stepped care involves consultation with a specialist consultant 
(e.g., psychiatrist) and provision of an alternative evidence-based treatment that may be more 
intensive than  the initial treatment. Patients who fail to respond to this treatment are offered a 
third option, typically a referral to specialty care treatment (e.g., mental health care setting). In 
CC models, evidence-based treatments are organized in a hierarchy with interventions that 
involve the least burden to the patient and staff being the first option. In the case of CC for 
depression, use of treatment algorithms allows the primary care team to initiate treatment 
without involving specialty mental health consultants. If the initial treatment fails, then the 
specialist consultant gets involved and a second treatment option is implemented. If the patient 
continues to be symptomatic, a third option is offered and so on. At each step-up, more 
specialized treatments and specialized expertise become involved. Unknowns: There is an 
evolving literature on stepped care in AUD in the context of AUD clinical trials (Kranzler & 
McKay, 2012). However, we are not aware of peer-reviewed literature on treatment of AUD in 
primary care using stepped care/TTT options. 
 
Teamcare: Teamcare refers to the realignment of roles of the PCPs, specialists, and allied 
health professionals, so that they function more as a team and less as independent and 
uncoordinated sources of patient care (Katon, et al., 2010). Teamcare can be characterized by 
the professionals on the team, their defined roles, and the workflow of the program (Advanced 
Integrated Mental Health Solutions Center, 2015). Typically, the team is comprised of PCPs, 
care managers, and specialists (e.g., psychiatrists). Care managers typically help screen and 
identify patients and work closely with the PCP on engaging the patient in care. Care managers 
provide education, support and monitoring and are responsible for developing a registry that 
tracks patients. In CC for depression, a consulting psychiatrist is available to provide as-needed 
advice to the PCP and conduct regular case supervision for complex patients. Teams have 
been used in prior studies of CC for SUD in primary care (Saitz, et al., 2013; Alford, et al., 
2011) and the broad features are clearly applicable to AUD treatment. Unknowns: The 
appropriate team composition, their respective roles, and workflow have to be developed and 
tested for feasibility. In addition, estimated resource allocation for staff time to operate the 
model is unknown. 
 
Summary of Significance: ED/AUD is a major public health problem but remains under-
recognized and undertreated in the healthcare system. While progress has been made, the 
problem of integrating ED/AUD treatment into mainstream healthcare remains largely 
unresolved. Legislative mandates for SUD treatment reimbursement and ongoing initiatives to 


 
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transform primary care provide a new climate and unprecedented opportunity to address this 
problem (McLellan, et al., 2014) . Experts have repeatedly called for the development of a CCM 
to treat ED/AUD in primary care, but (as reviewed above) research in this area has been 
limited. This study builds on the new understanding about the strengths and limitations of 
SBIRT (Saitz, 2010), the development of effective interventions for PD and AD that could be 
delivered in primary care (Oslin, et al., 2014; Morgenstern, et al., 2012a, 2012b), and the 
success of the CC model for integration of depression treatment into primary care. If study aims 
are achieved, important and necessary first steps – development of the model and provisional 
support for its efficacy – towards establishing an evidence-based, workable model to treat 
ED/AUD in the PCMH will be taken. 
 
4) 
OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
 
 
We conducted an extensive review of the published literature and currently funded NIH studies 
but found surprisingly limited research on development of a CCM model to treat ED/AUD in 
PCMHs. Thus, to the best of our knowledge, this would be among the first studies in this area. 
In addition, while the general assumption is that early intervention in primary care can be 
effective, there is very limited knowledge about whether patients will engage in more than a 
brief intervention or how best to accommodate important aspects of patient-centered care such 
as patient preferences. Finally, little is known about non- response to ED/AUD treatment in 
primary care and what stepped care approaches can feasibly be implemented in PCMHs using 
a team-care approach. 
 
 
The primary aim of this proposal is to develop and test a chronic care model (CCM) to treat 
excessive drinking and Alcohol Use Disorders (ED/AUD) in a patient centered medical home 
(PCMH) setting using the stage model of intervention development. The study proposes to 
adapt the collaborative care model (CC) for treating depression in primary care to use with 
ED/AUD and then test the adapted model for feasibility, acceptability, and clinical utility.  If 
evidence supports the model, the long-term aim of the study is to develop the necessary 
protocols, site preparation, and design specifications to proceed to submitting an RO1 
application.  
 
The study will be conducted in two phases using a mixed methods approach. Phase I (5 
months) will involve initial adaptation of the CC model for depression to ED/AUD (referred to 
hereafter as CC-AUD).  During this phase, relevant CC for depression protocols, measures, 
and procedures will be adapted for ED/AUD and piloted test on 15-20 participants recruited in a 
PCMH. Phase II (6 months) will involve model refinement based on iterative cycles of patient 
and PCMH staff feedback. During this phase, participants (n=60) will be recruited, assessed, 
and followed for three months. Iterative development will focus on two themes: 1) maximizing   
patient engagement while balancing this feature with 2) the resource and expertise constraints 
of treating ED/AUD in a PCMH. Study results will be analyzed and lessons learned will be used 
to develop a refined model. a small randomized controlled trial (RCT) of the model.. 
Aim I. Adapt the CC model for depression to treat ED/AUD and implement the model (CC-AUD) 
in a PCMH.  
Aims II. Use iterative, recursive, and bidirectional features of the stage model to refine CC-AUD 
using a mixed methods approach. 


 
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8 
 
 
Specific hypotheses are not provided for Phases I and II of the study as we are exploring and 
refining possible model options. For Phase III of the study, which is the randomized controlled 
trial and will be submitted as a separate IRB protocol, will provide specific hypotheses on what 
we expect to see from the models. 
 
5) 
RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
 
Subjects will be recruited as part of normal SBIRT procedures already being conducted at the 
865 Northern Boulevard General Internal Medicine site in Great Neck, NY. Normal SBIRT 
procedures include the pre-screening of all scheduled patients by medical assistants to identify 
initial substance use risks, and then further assessment to identify risk classification of the 
patient based on their substance use patterns and counseling by an SBIRT Health Coach for 
patients as needed based on this assessment. Patients identified as excessive drinkers during 
the standard SBIRT procedures will be asked by the SBIRT Health Coaches (HCs) about their 
interest in a study on treatment for problematic alcohol use in the primary care setting. As all 
clinic patients are being routinely screened for alcohol, we will have a large pool of patients 
screened from which to identify excessive drinkers. Based on SBIRT data collected, we 
estimate that 75% of the patients or about 33 per month have a primary alcohol problem and 
would not be excluded for other reasons. We estimate that about 2/3 of eligible participants 
would be classified as at-risk drinkers with the remainder in the other categories (i.e., Problem 
Drinkers, Alcohol Use Disorder with Physiological Withdrawal, and Alcohol Use Disorder with 
Chronic or Complex Presentation). Thus, assuming that 50% consent to participate, we 
estimate n=24 participants per month would be available to enroll in the study and about eight of 
these would meet problem drinking criteria. We note that of the 526 participants screening 
positive and offered a brief intervention at the 865 Northern Boulevard site, only 3 refused. 
Thus, we anticipate a positive response from participants and consider our recruitment 
projections as conservative estimates.  
 
6) 
RECRUITMENT METHODS 
Participants will be recruited via the SBIRT program at the 865 Northern Boulevard General 
Internal Medicine Clinic. In addition, patients of other Northwell Health Department of General 
Internal Medicine (DGIM) sites may be referred to the 865 Northern Boulevard practice to 
participate in this study. All patients receive SBIRT screening, conducted by the Health 
Coaches (HCs). During the screening, HCs will identify potential participants for this study 
based on study eligibility criteria. For individuals who screen positive and meet study criteria, 
the HC will offer the opportunity to participate in the study and conduct further assessment if 
the individual is interested. In cases where individuals are ambivalent about participation, they 
will be handed an informational card about the study with a way to contact study staff. This 
card will be submitted to the IRB for approval prior to distribution to patients.  
 
7) 
ELIGIBILITY CRITERIA 
We expect to recruit a total of 85 participants for Phase I and II of this study based on the 
following inclusion/exclusion criteria: 
 
Inclusion Criteria: Participants must: 1) receive care at the 865 Northern Boulevard General 
Internal Medicine clinic and/or other Northwell Health DGIM sites; 2) have an estimated 
weekly consumption of greater than 14 drinks for men and 7 drinks for women or experience 


 
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at least one binge drinking day (i.e., 5 or more drinks for men and 4 or more drinks for 
women) per week; 3) demonstrate observable fluency in English language; 4) have no 
recognizable cognitive impairment. 
 
Exclusion Criteria: Participants will be excluded from the study if they: 1) report substance 
use other than cannabis, nicotine, or caffeine in the last year; 2) report using cannabis “daily 
or almost daily” and that this use is problematic and the primary concern compared to their 
alcohol use, as indicated in the SBIRT screening; 3) present with a serious psychiatric illness 
or substantial suicide or violence risk, as assessed via a chart review, reported by the primary 
care treatment team (e.g., the Primary Care Physician [PCP]), and/or reported by the 
potential participant in the initial screen; 4) are on probation or parole as reported in the initial 
screen; 4) have an organic mood/mental disorder; 5) is pregnant, breastfeeding, or trying to 
become pregnant as reported in the initial screen; 6) report being enrolled in current 
substance use treatment in the initial screen. 
 
8) 
NUMBER OF SUBJECTS 
In the 865 Northern Boulevard primary care setting from where participants will be recruited 
and seen, approximately 526 patients are pre-screened per week for alcohol use problems. 
Of these patients, approximately eight receive alcohol use brief interventions. It is estimated 
that all 526 patients will be pre-screened for our study and the eight who receive brief 
interventions will be offered to participate, if they meet initial eligibility criteria. We expect that 
50% of these patients or 4 individuals per week will be consented into our study. Other DGIM 
sites from where staff can refer patients to the study, the number of pre-screens for alcohol 
use problems are comparable. As a result, we expect to enroll a total of 85 participants, which 
includes 25 for Phase I of the trial and 60 for Phase II. 
 
9) 
STUDY TIMELINES 
Enrollment for the proposed study is expected to last for approximately one year. Each 
participant will be in the study for 12 weeks. We expect to complete this study (Phases I and 
II) in Fall 2017. 
 
10) 
ENDPOINTS 
Over the 12 weeks of the study, there will be five assessment points at weeks 0, 1, 4, 8, and 
12, which all participants will receive. Participant response and safety will be assessed at 
each assessment point. In addition, participants will be monitored daily via Ecological 
Momentary Assessment data (EMA) comprising a brief questionnaire about their drinking. 
The HC will monitor participants’ adherence to these surveys and their study visits and make 
outreach as needed. Notably, participant response to treatment will be assessed at week 4 
and a stepped-care approach will be applied in the case that the participant has not 
responded to the initial treatment that he or she chose. For instance, participants who chose 
to receive a behavioral intervention will be offered medication (i.e., naltrexone) if they have 
not shown progress in their treatment as evident by a significant reduction in drinking.  
 
Some participants will also attend treatment appointments in the 12 weeks of this study, some 
of which will overlap with the assessment appointments. Participants will have biweekly 
medication management appointments and/or potentially 4 to 12 sessions of behavioral 
treatment. 


 
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10 
 
 
11) 
RESEARCH PROCEDURES 
During Phase I (Initial Model Implementation), we will prepare all relevant new materials, adapt 
existing treatment and assessment protocols, fine-tune all new procedures, and train the primary 
care treatment team (including HCs, Medical Doctors [MDs], Nurse Practitioners [NPs], 
Registered Nurses [RNs], and Behavioral Health Specialists [BHSs]) on the new intervention 
protocols. Because all staff are currently either working as part of SBIRT or in other roles in 
Psychiatry and Medicine, we anticipate a rapid start-up. In addition, the BHSs are already 
trained in the delivery of the proposed interventions.  
 
 
During Phase II (Iteration and Model Refinement), we will iterate and refine the model that was 
tested in Phase I. We will focus on key issues of patient engagement, balancing treating 
patients within the PCMH versus need to refer complex cases to specialty care as well as 
issues related to staff burden, workflow and resources. We will focus on examining the utility of 
medical record screening, refining the content and methods to deliver personalized feedback 
on alcohol consumption and health and assessing their impact of increasing patient motivation 
as well as PCP receptivity to including alcohol interventions as part of PCMH care. We will pay 
special attention to tracking non-adherence, and adjusting interventions for non-responders. 
We will also carefully examine workflow and resources required to manage patients. For 
example, how much time is required from specialist consultants and what types of consultation 
(e.g., caseload supervision, patient consults) are most informative. We will use these data to 
generate an estimate of staff resources required to treat eligible participants. 
 
Below we describe the procedures to be conducted at each endpoint in both phases of the 
study, in addition to specific procedures related to our stepped-care approach and risk/safety 
monitoring. 
 
Week 0: Pre-enrollment: Participants will be recruited through the Screening, Brief 
Intervention, and Referral to Treatment (SBIRT) program that is already a standard practice in 
the primary care site, where they are patients or to which they are referred to from other 
Northwell DGIM sites. As part of SBIRT standard practice in this setting, all patients are 
systematically screened for risky alcohol use by a medical assistant and a health coach, using 
the Alcohol Use Disorders Identification Test (AUDIT), a self-report validated screening tool. In 
addition, for patients who screen positive for risky alcohol use, the HC provides a brief 
intervention, which includes feedback about their drinking, a discussion about motivation to 
reduce use, and planning around reducing or stopping alcohol use. During this interaction, HCs 
will assess if patients are eligible for the study based on the criteria. The HC will provide a brief 
explanation of the study to patients who appear initially eligible to participate. Further eligibility 
screening will be provided either that day or another day when the patient is available, if he or 
she expresses interest in participating. 
 
Week 0: Eligibility Screening: Participants will be recruited for this study based on our 
inclusion/exclusion criteria described above. Those participants who are interested in the study 
will be initially consented (General Consent) by the HC and will complete further measures (i.e., 
the Timeline Follow Back [TLFB] for the past 60 days and the Composite International 
Diagnostic Interview-Alcohol Module [CIDI-Alcohol]), assessing for drinking criteria and 
establishing risk classification for treatment options. Other inclusion/exclusion criteria (i.e., drug 
use, mental/organic disorders, suicide/violence risk, legal involvement, and pregnancy) will be 
evaluated at this point via self-report, chart review, and/or in consultation with the primary care 
clinical team (e.g., the primary care physician). Patients who endorse withdrawal criteria on the 


 
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CIDI-Alcohol (i.e., endorse experiencing at least two withdrawal symptoms in the last year after 
not drinking for a few hours or days, if any of those symptoms include hallucinations or seizures, 
or if they report drinking to reduce withdrawal symptoms in the last year) will also meet with a 
Registered Nurse (RN; supervised by an MD), Nurse Practitioner (NP), or a Medical Doctor 
(MD) to assess active withdrawal symptoms and appropriateness of outpatient detoxification 
treatment. In such cases, the RN/NP/MD will complete the Clinical Institute Withdrawal of 
Alcohol Scale, Revised (CIWA-Ar) and assess for medical (e.g., brittle diabetes, unstable heart 
failure, advanced liver disease) and compliance (e.g., no family support at home to assist) 
issues with which outpatient detoxification would be contraindicated. Those participants who do 
not have medical or social contraindications and score below 15 on the CIWA-Ar will be offered 
outpatient detoxification as part of standard care at the 865 Northern Boulevard Internal 
Medicine Clinic. These participants will be grouped in the AD-W group and offered treatment as 
per the description below. Participants’ insurance will cover the cost of the detoxification 
treatment. Participants who score above15 on the CIWA-Ar or experience medical and/or social 
contraindications for outpatient detoxification will be referred for inpatient detoxification or other 
warranted treatment and classified into the AD-CMPLX group, as described below.  
 
Eligible participants will be classified (i.e., random assignment will not be used) into one of four 
groups by the HC after the above assessment is completed:  
 
At-Risk Drinkers (AR). AR will include individuals who exceed NIAAA guidelines for 
weekly consumption (>14 standard drinks [SD] for men or 7 drinks for women), those who 
exceed NIAAA daily limits (>5 SD for men or >4 SD for women), or those whose medical 
conditions contraindicate any alcohol consumption. AR will be followed up at week 4, 8, and 12 
assessments and will not be offered additional treatment after the brief advice they receive as part of 
SBIRT. 
 
Problem Drinkers (PD). PD will be defined based on weekly consumption (> or = 24 SD 
for men or > or = 14 SD for women) or a pattern of regular binge drinking (>3 times per month). 
PD will be offered a choice of either four sessions of Motivational Enhancement Therapy (MET) or 
12 weeks of daily naltrexone with medication management. 
 
Alcohol Use Disorder with Physiological Withdrawal Drinkers (AD-W): Participants 
meeting criteria for DSM-5 Alcohol Use Disorder with physiological withdrawal will receive 
outpatient detoxification as part of standard care, unless medically or socially contraindicated 
(described above). Upon completion of outpatient detoxification, participants will be offered 12 
weeks of daily naltrexone plus medication management or 12, weekly sessions of M o d i f i e d  
B e h a v i o r a l  S e l f - C o n t r o l  T h e r a p y  ( M BSCT). 
 
Alcohol Use Disorder with Chronic or Complex Presentation Drinkers (AD-CMPLX): 
Participants in this group will include those who meet criteria for DSM-5 Alcohol Use Disorder, 
report inpatient treatment for alcohol use and/or other mental health issues within the last five years, 
experience social problems (i.e., unstable housing) that would suggest the need for more 
intensive psychosocial treatment, or are deemed not appropriate for outpatient detoxification 
treatment and in need higher-level of care as assessed by the NP/MD performing the CIWA-Ar 
assessment. Participants classified at AD-CMPLX will be referred to specialty substance use 
treatment based on the SBIRT protocol, where participants are referred to an outpatient 
treatment program that best fits their needs. In the case that these participants refuse a referral 
to speciality care, a second attempt will be made to do so at week 1. In the case that the second 
attempt is not successful, they will be offered MBSCT, abstinence-based treatment, focused on 
connecting them with specialty care, as part of the study.  


 
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Once participants are grouped and offered treatment options for their risk classification, they will 
choose a preferred treatment course and be scheduled for their next appointment with an 
RN/NP/MD to administer naltrexone or a Behavioral Health Specialist (BHS) to conduct the 
behavioral interventions. Each respective clinician will complete either the Medication 
Intervention Consent or the Behavioral Intervention Consent with the participant at their next 
appointment. Notably, participants are free to change their treatment choice during the consent 
process (described below) with the clinician. If they do so, they will be scheduled for another 
appointment with the appropriate clinician. All participants will be informed that they are being 
asked not to pursue any other formal substance use treatment until after the week 12 
assessment of the study, unless they are in the AD-CMPLX group and referred to treatment as 
part of this study. If they decide to pursue alternative treatment, study staff will facilitate 
referrals. The participant will continue to be followed in the study via follow up assessments in 
order to learn about the progress of the participant which is valuable in our effort to test a 
feasible treatment model. 
 
Weeks 1-12: During this period, participants in the PD and AD-W groups will receive treatment 
(see procedure as follows) and assessments, while the AR and AD-CMPLX groups will be 
followed in assessments only. All groups will be assessed for appropriateness of stepped-care 
at week 4.  
 
Participants, who choose the medication intervention, will attend medication management in-
person at the primary care clinic. Appointments would be conducted by a NP, an MD, or an RN, 
who is supervised by an MD,. These appointments will occur weeks 1, 2, 4, 6, 8, 10, and 12. At 
their week 1 appointment after consent has been signed, the medical professional will assess 
the participant for appropriateness to take medications. They will conduct a medical exam, 
review the participant’s chart, and may consult with his/her primary care clinical team.  
 
Participants who choose behavioral interventions will have appointments conducted at the 
primary care clinic or via televideo, based on the preference of the participant. Behavioral 
Health Specialists (BHSs), who are licensed therapists or therapists supervised by licensed 
clinicians, will conduct the treatment. Participants receiving MET will have four sessions at 
weeks 1, 2, 4, and 8. Participants receiving MBSCT will receive weekly sessions from week 1 to 
12. 
 
In addition to regular treatment appointments, follow up assessment appointments will occur 
with the HC at weeks 4, 8, and 12. Each assessment appointment will occur after the treatment 
session scheduled for that day. These appointments can occur in-person or via televideo based 
on each participant’s preference and will be conducted by the HC. At each appointment, the 
participant will complete the Timeline Follow Back (TLFB), a treatment addendum, and patient 
satisfaction measures. Participants will be monitored for risk and safety at each of these 
appointments as described below. 
 
Furthermore, at week 1, participants will meet with a HC to complete a demographics 
questionnaire and receive training and instruction on the Ecological Momentary Assessment 
(EMA; described below). Because participants will be using smartphones, we will show them 
how to use their phones in a way that increases the security and confidentiality of the online 
surveys and the texts they receive. Based on our experience in previous studies, participants 
complete about 80% of the required surveys, which is significantly higher than expected. Note 
that EMA data is in electronic format and available in real-time to the HC. We will monitor EMA 
diary completion continuously to increase compliance and will have the required data available 


 
v. 3/30/2018 
 
13 
 
for safety monitoring. Participants will have the option to participate in the study even if they do 
not have a smartphone or refuse to use it to complete EMA. In such cases, participants will not 
complete EMA. 
 
At week 4, participants will be assessed for response to the treatment intervention that they 
chose and offered an alternative treatment via the stepped care procedure below in the case 
that they do not respond. Response will be defined as drinking below study drinking inclusion 
criteria and demonstrating adequate progress in treatment without adverse response (based on 
clinician’s assessment of participants’ drinking, attendance, engagement, and effort and/or 
possible side effects if receiving naltrexone). A participant will be deemed a non-responder if his 
or her drinking exceeds NIAAA guidelines for weekly (>14 SD for men or 7 drinks for women) or 
daily (>5 SD for men or >4 SD for women) limits. 
 
Stepped Care: Participants will be offered stepped care if they are deemed to be a treatment 
non-responder at their week 4 appointment. During their treatment visit at week 4, they will 
be assessed by the HC and their clinician for treatment response based on the criteria 
described above. The HC will assess participants’ drinking based on NIAAA guidelines and 
the clinician will assess participants’ progress in treatment. If a participant is deemed a non-
responder, the clinician will discuss alternative treatment options with him or her. Stepped 
care options will be offered to the AR, PD, and AD-W risk classification groups at their week 
4 assessments in the following way: 
 
For the AR group, participants who are deemed non-responders will be offered an additional 
session of Brief Advice similar to what they received as part of the SBIRT protocol. This 
additional session will occur at the same time as their assessment appointment at week 4. 
 
For the PD and AD-W groups, participants, who chose a behavioral intervention, will be 
offered naltrexone and medication management. These participants will be scheduled for an 
appointment with the respective clinician, preferably in the same week, in order to undergo 
consent, to evaluate medication appropriateness, and, if appropriate, to commence with the 
alternative treatment. Participants, who chose naltrexone and medication management, will 
be offered either a behavioral intervention (i.e., MBSCT) in addition to naltrexone or 
topirimate as an alternative medication for reducing drinking. This medication will be started 
on the same day, while the behavioral intervention would be scheduled for a different 
appointment with a BHS, where an additional consent would be completed. Participants will 
have the option to deny alternative treatment if they believe it is still the appropriate course of 
action during these phases of the study as long as it appears safe for them to continue (e.g., 
no adverse side effects to the medication are noted). The goal is to learn about the 
effectiveness of these different treatment models in these phases of the study through an 
ecological application of the models in a clinical setting, where patients would otherwise be 
free to deny an alternative treatment. 
 
Risk/Safety Monitoring: Participants of this study will be patients who are receiving care at 
the 865 Northern Boulevard Internal Medicine Clinic or another Northwell Health DGIM site 
Therefore, their health is actively monitored by the Primary Care Physician (PCP) at the 
clinic, who will be notified of the participant’s participation throughout the study. In addition to 
this monitoring, the clinicians meeting with the participants for treatment will assess their well-
being at each assessment (at weeks 4, 8, and 12) along with the HC drinking assessments 
and the daily EMA data monitoring. At the week 4, 8, and 12 assessments, the clinicians will 


 
v. 3/30/2018 
 
14 
 
perform a risk and safety assessment. Significant deterioration of note is defined as a 
significant increase in drinking since the baseline interview (more than 25%); a significant 
increase in depression, anxiety, or other mental health symptoms; instability in life 
circumstances that would suggest a need for immediate treatment; or suicidal or homicidal 
ideation. If any of these indicators are present, as a first-line of treatment, participants will be 
referred to the clinical team at the primary care clinic for additional treatment or evaluations. 
If a higher level of care is warranted, participants will be referred to appropriate care, such as 
intensive outpatient treatment, inpatient detoxification, or outpatient psychiatric treatment, 
and continued to be monitored at their assessment visits. For participants who present an 
imminent risk of harm to self or others, or an inability to care for themselves, the primary care 
clinical team will evaluate the patient to determine the need to activate EMS, who will then 
take the patient to the emergency room to be evaluated for possible inpatient psychiatric 
admission. 
 
Visit Scheduling and Follow-up: In our experience with longitudinal psychotherapy 
intervention studies, participants often need to reschedule appointments for various reasons. 
In order to maintain integrity of the data, when a participant needs to reschedule, every 
attempt will be made to schedule the visit within the same week (i.e., if the participant cannot 
attend a visit on the first day of week 4, we will attempt to reschedule them at some other 
point within week 4). In an effort to reduce retention, we will also offer televideo and/or 
telephone options for all visits. In addition, if a participant misses an appointment (e.g., loss 
of contact, participant had an unexpected conflict, etc.), study staff will attempt to follow up 
with that participant and collect data for the missed appointment as soon as we are able to 
reach the participant and/or reschedule; ideally, this would occur within a week of the missed 
appointment. However, since our primary outcome measure (Timeline Follow Back) is 
continuous throughout the 12 weeks of the study and our data analytic methods (e.g., 
Generalized Estimating Equations) can accommodate uneven intervals between visits, if we 
are unable to reschedule a participant within a week of their original appointment date, we 
will continue to attempt to reschedule their visit until the participant withdraws consent for 
participating in the study or until the Principal Investigator determines that it is no longer 
feasible to attempt to locate the participant (if out of contact). Our primary aim when a 
participant misses a visit and/or falls out of contact is to determine whether the participant is 
at risk due to heavy drinking or other factors and to help the participant find the appropriate 
resources if necessary. Thus, we feel it is important to continue to follow up with participants 
who have missed visits for as long as is necessary to determine that they are safe. This plan 
is clearly communicated to participants during their enrollment and is verbally reinforced 
during the scheduling of visit appointments. 
 
Daily online questionnaires: Ecological Momentary Assessment (EMA) is a global term 
used to describe techniques to collect data in the real world. For example, filling out a daily 
data diary would be considered a kind of EMA. For this study, EMA involves brief internet-
based surveys. Participants will be asked to complete a brief, online survey every morning for 
the 11 weeks of participation (i.e., weeks 1 to 12). Participants will use their personal 
smartphone. Smartphones will be utilized for receiving text messages to prompt participants 
to complete the online survey. Each morning survey requires approximately one minute to 
complete and will ask about daily use of alcohol. We have used similar scripts previously (in 
our R01 study of MI), and they are attached to this protocol. Participants, who do not have a 
smartphone or wish to not use their smartphone as part of this study, will be free to opt out of 
this part of the study. 


 
v. 3/30/2018 
 
15 
 
 
Study Setting. Whether participants are recruited from the 865 Northern Boulevard Primary 
Care Clinic or referred from another Northwell Health DGIM primary care site, this study will 
be conducted at the 865 Northern Boulevard site. It is located in Great Neck, NY, has been 
designated a Level 3 Patient Centered Medical Home (PCMH) since 2009. It was one of the 
first medical homes in the lower New York State region and includes both a faculty and 
resident practice with approximately 32,000 visits per year. Patients from a variety of 
socioeconomic band ethnic backgrounds are cared for by 16 faculty providers and 72 internal 
medicine residents. In addition to medical staff, the practice includes a clinical psychologist, 2 
nurse practitioners, 2 social workers, a certified diabetes educator, a clinical pharmacist and a 
nutritionist. Medical assistants, nurses, and administrative staff support clinical staff members. 
These practitioners are part of the clinical team at this practice, and they provide regular 
monitoring/care for participants of this study. The practice uses the Allscripts electronic health 
record (EHR) and has since pioneered many of the innovations and enhancements including 
the use of e-calculators for SBIRT screens and generation of clinical alerts. 
 
The National Center on Addiction and Substance Abuse (CASA) will contribute to the 
theoretical development of the study as well as data management and analyses. This will 
include participation in project meetings, performance of data analyses, and preparation of 
manuscripts. There will be no consenting or data collection that will occur at CASA. All 
recruitment, consenting, and subject data collection will be conducted at Northwell Health. 
Notably, the SBIRT project is being conducted in collaboration with CASA. 
 
12) 
SCHEDULE OF EVENTS 
The table below indicates the measures that will be administered in this study and the time 
points at which each will occur. 
 
Admin 
method 
Measure 
Wk 
0 
w
k 1 
w
k 4 
w
k 8 
w
k 
12 
HC 
Screening for inclusion/exclusion criteria 
X 
  
  
  
  
HC 
General Consent 
X 
  
  
  
  
NP/MD/BH
S 
Medication OR Behavioral Intervention Consent 
  
X 
  
  
  
HC 
Enrollment note 
  
X 
  
  
  
HC 
Locator information 
X 
  
  
  
  
HC 
Demographic Questionnaire 
  
X 
  
  
  
HC 
CIDI-SAM (Composite International Diagnostic Instrument, 
Alcohol Module) 
X 
  
  
  
  
RN/NP/MD 
CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol 
Scale, Revised), if report withdrawal on CIDI-SAM 
X 
  
  
  
  
HC 
TLFB (Time-Line Follow-Back Interview) 
X 
  
X 
X 
X 
HC 
Treatment Addendum 
  
  
X 
X 
X 
HC 
Patient Feedback Questionnaire 
  
  
X 
RN/NP/MD 
Blood draw to assess liver function, if pt. chooses to receive 
medication 
  
X 
X 
X 
X 


 
v. 3/30/2018 
 
16 
 
NP/MD/BH
S 
Study progress note 
  
  
X 
X 
X 
EMA 
Daily text messaging surveys on drinking 
  
X 
X 
X 
X 
HC 
Study Termination note--time of completion depends on 
participant trajectory 
  
  
  
  
X 
 
13) 
INTERVENTIONS 
Brief Advice (BA). BA will consist of a 20-minute session delivered by a health coach, 
closely adhering to the NIAAA's Clinician Guide to PD (National Institute on Alcohol Abuse 
and Alcoholism, 2005). This includes normative feedback based on NIAAA drinking norms 
(using data from AUDIT), goal selection, instructions on self-monitoring, discussion of drink 
reduction strategies, and distribution of NIAAA biblio-therapy guide. The rationale for using 
the NIAAA guide is that it contains elements that have been empirically linked to brief 
intervention success (Morgenstern, Kuerbis, Chen, et al., 2012; Morgenstern, Kuerbis, 
Amrhein, et al., 2012), and its use will foster generalization of study results to mainstream 
healthcare settings. Participants will have one session of brief advice provided by the HC 
during the pre-screening for the study. An additional session may be offered to the AR group 
as part of stepped care, if warranted. 
 
Motivational Enhancement Therapy (MET): MET (Miller & Tonigan, 1992) is a motivational 
intervention shown to be effective in treating a broad spectrum of drinking problems in both 
abstinent (Project Match Research Group, 1997), and non-abstinent goal conditions (Miller, 
1995). As adopted from Project MATCH, MET in this study focuses on resolving ambivalence 
about and increasing commitment to positive behavior change. MET in this study will be 
delivered as in a previous study (Morgenstern, et al., 2012a) over the 12-week treatment 
period with sessions scheduled for weeks 1, 2, 4 and 8. This treatment will be provided by a 
Behavioral Health Specialist (BHS), who is a licensed mental health clinician or is being 
supervised by a licensed clinician. 
 
Modified Behavioral Self-Control Therapy (MBSCT): MBSCT was developed and 
implemented for a previous study, (Morgenstern & McKay, 2007) in which we provided twelve 
weeks of psychotherapy for problem drinking men who have sex with men focused on 
reduction both of alcohol consumption and HIV risk behaviors. It is a combination of 
Motivational Interviewing and Behavioral Self-Control Training (Miller, Leckman, Delaney, & 
Tinkcom, 1992; Walters, 2001). In that study, treatment was focused on the dual problems of 
problem drinking and HIV risk behavior. For the present study, treatment will address only 
problem drinking. MBSCT is based on cognitive behavioral principles and is designed to 
modify critical behavior patterns that maintain excessive drinking. MBSCT aims to provide a 
more complete application of CBT theory by addressing motivational issues and by including 
a functional analysis of drinking behavior. The first stage of MBSCT is motivation 
enhancement therapy and is closely modeled on the MET intervention as described above. 
The second stage of treatment focuses on teaching the client the cognitive behavioral model 
of substance misuse, completing a functional analysis of drinking, and addressing specific 
coping skills for moderation of or abstinence from drinking behavior. This treatment will be 
provided by a Behavioral Health Specialist (BHS), who is a licensed mental health clinician or 
is being supervised by a licensed clinician. 
 


 
v. 3/30/2018 
 
17 
 
Naltrexone+Medication Management (NTX): Those selecting medication will receive 12 
weeks of daily naltrexone (50 mg) with medication management. Naltrexone is FDA-approved 
for the treatment of alcohol dependence at 50 mg/day. It has been effectively applied in 
previous studies (Kranzler et al., 2009; Morgenstern, et al., 2012b). To minimize any potential 
side effects, initiate treatment using a 25-mg dosage for the first week and as long as the 
medication is well tolerated will then increase to 50 mg daily. Participants will be instructed to 
call their study RN/NP/MD with any side effects or medication related concerns. A follow-up 
PCP visit at week 12 will be scheduled. Visit scheduled will be adjusted upward if there are 
reports of side effects or problems with non-adherence. Blood tests will be administered at 
baseline and week 4 to guard against liver toxicity (i.e., one 5 cc tube, the equivalent of one 
teaspoon, will be drawn monthly). Additional blood tests (i.e., one 5 cc tube, the equivalent of 
one teaspoon, will be drawn monthly) may be drawn if it is clinically indicated any time during 
the study. Unless a return to social drinking is contraindicated, participants will be offered a 
choice of moderation or abstinence goal treatment. Naltrexone treatment will be prescribed by 
an NP/MD or an RN, under the supervision of an MD. A medical exam and review of the 
patient’s medical history will be conducted and, if deemed appropriate, the participant will 
receive a prescription. Then, they will then be seen by the RN/NP/MD weekly for the first two 
weeks of treatment, or until the participant’s medication dose has been stabilized with minimal 
side effects. After stabilization, visits will take place biweekly. Participants will have 
medication management appointments at weeks 1, 2, 4, 6, 8, 10, and 12. At these medication 
management visits, the RN/NP/MD will assess participants’ medication compliance, potential 
side effects, and their current drinking. 
 
14) 
STATISTICAL ANALYSIS The specific aims of Phases I and II of this study are: Aim 
1: Adapt the collaborative care model for depression to treat excessive drinking and alcohol 
use disorders and implement the model, to be called CC-AUD, in a primary care practice. 
Aim 2: Use iterative, recursive, and bidirectional features of the National Institutes of Health 
stage model to refine the CC-AUD model. In both phases iterative analysis and 
experimenting with new approaches will be ongoing. However, at the end of Phase II we will 
conduct a formal study of model implementation and results using a mixed methods 
approach.  We describe the quantitative portion here and the qualitative portion below.  We 
will calculate descriptive statistics such as means, medians, SD, range and frequencies to 
create a baseline description of the sample, examine various measures of treatment 
compliance (e.g., sessions attended, medication adherence), and drinking outcomes reported 
on the TLFB to include: number of heavy drink days, number of abstinent days, and weekly 
sum of standard drinking.  Alcohol use data are often not normally distributed; therefore, we 
will examine outcome distributions using graphs (e.g., histograms) in order to inform model 
selection. Depending on the nature of the outcome variable distribution and the data, we will 
use multiple regression or Generalized Estimating Equations (GEE) models with the best 
outcome distribution (e.g., normal, Poisson, negative binomial) to examine predictors of 
treatment compliance and drinking outcomes. We will examine characteristics of the sample 
who participated relative to those who refused using screening and brief intervention study 
data using statistics to estimate differences between groups (e.g., t-test and chi-square). We 
will analyze qualitative data collected from patients and staff notes.  Qualitative data will be 
input into NVivo 9 software.  Qualitative themes around patient engagement and staff burden 
will guide the analysis.  First, Dr. Morgenstern (PI) will develop meta-themes and sub-themes 
based on the literature and the data.  These themes will be reviewed by Dr. O’Grady (co-PI). 
Next, a research assistant will code the transcripts for themes. These will be reviewed by Dr. 
O’Grady and discrepancies will be resolved.  We will triangulate data across qualitative and 
quantitative sources to examine whether patients respond to alcohol treatment in a PCMH 


 
v. 3/30/2018 
 
18 
 
and whether the alcohol collaborative care model features implemented are compatible with 
PCMH staff resources, workflow, and expertise. 
 
15) 
DATA MANAGEMENT AND CONFIDENTIALITY 
To avoid breach of confidentiality, participants' data will be primarily maintained in HIPAA-compliant 
applications, such as our platform and REDCap. Any other electronic data will be stored only on 
computers with a BIOS password to prevent access by unauthorized users and users must login following 
10 minutes of inactivity. Each file will be password protected and will only be stored on network-encrypted 
drives. If any data has to be printed for monitoring or tracking, it will be kept double locked (i.e., in a 
locked cabinet, in a locked room) to maintain their security. All study data forms will contain only the 
participant's unique study identification number, using a reference system maintained by the PI. 
Completed study charts will be kept in a locked cabinet. The key to such data and access to any of the 
above-mentioned data will be available only to the PI and study research staff. Lastly, participant visits 
will be scheduled, and no information about the participant will be provided to anyone (except in 
emergencies as defined above) in person or by telephone.  
 
There is no personal health information that could identify an individual by seeing their web-
based assessment data and the codes that match participant information to their unique 
codes are kept secure. 
To avoid breach of confidentiality, participants' names will appear only on a consent form, a 
telephone screening form and a "key" form that is password protected maintained on 
Northwell Health’s REDCap servers. All forms that contain identifying information will be kept 
double locked (i.e., in a locked cabinet, in a locked room) to maintain their security. All study 
data forms will contain only the participant's unique study identification number, using a 
reference system maintained by the PIs. Completed study charts will be kept in a locked 
cabinet, the key to which will be available only to the PIs and study research staff. Participant 
visits will be scheduled, and no information about the participant will be provided to anyone 
(except in emergencies as defined above) in person or by telephone. The study will be 
conducted in an outpatient clinical trials clinic at a site in which treatment is provided to 
participants who have a variety of psychiatric problems, not limited to substance abuse. 
 
Identifiable information will be retained for seven years post study completion. All de-
identified data will be retained for use under the PIs’ discretion. Only individuals who are 
listed as study personnel will have access to the data collected. The PIs will monitor 
appropriate handling of data to secure confidentiality and integrity. 
 
16) 
DATA AND SAFETY MONITORING PLAN 
• 
The PIs of the study will monitor study data and safety of participants every six 
months or more often via regular study team meetings. They will be responsible 
for:Reviewing the research protocol and planning for data and safety monitoring. 
• 
Monitoring that will take place on a regular basis (every 6 months or more often).  
• 
Evaluating the progress of the trial, including periodic assessments of data quality 
and timeliness, participant recruitment, accrual and retention, participant risk 
versus benefit, and other factors that may affect study outcome. Monitoring may 
also consider factors external to the study when interpreting the data, such as 
scientific or therapeutic developments that may have an impact on the safety of the 
participants or ethical issues related to the study. 


 
v. 3/30/2018 
 
19 
 
• 
Inquiring for further information as necessary to accomplish their mission. 
• 
Maintaining confidentiality during all phases of the trial including the monitoring, 
preparation of interim results, review and response to monitoring 
recommendations.  
• 
Generating a report that will be provided to the PI, the IRB, and NIAAA 
 
Specifically in regard to safety monitoring, participants of this study will be patients who are 
receiving care at the 865 Northern Boulevard Internal Medicine Clinic or another Northwell 
Health DGIM site. Therefore, their health is actively monitored by the Primary Care Physician 
(PCP) at the clinic, who will be notified of the participant’s participation throughout the study. 
In addition, the clinicians meeting with the participants for treatment will assess their well-
being at each assessment (at weeks 4, 8, and 12) along with the HC drinking assessments 
and the daily EMA data monitoring. In the case of significant deterioration in drinking and/or 
mental health (as outlined in study procedures), participants will be referred to the clinical 
team for additional treatment or evaluations. If a higher level of care is warranted, participants 
will be referred to appropriate care, such as intensive outpatient treatment, inpatient 
detoxification, or outpatient psychiatric treatment, and continued to be monitored at their 
assessment visits. For participants who present an imminent risk of harm to self or others, or 
an inability to care for themselves, the primary care clinical team will evaluate the patient to 
determine the need to activate EMS, who will then take the patient to the emergency room to 
be evaluated for possible inpatient psychiatric admission.  
 
17) 
WITHDRAWAL OF SUBJECTS 
The goal of Phases I and II is to provide a treatment-team based approach to care for 
individuals with Alcohol Use Disorders that would be inclusive all those in the primary care 
setting in order to truly craft a feasible model. Therefore, during these phases of the study, 
rather than withdrawing participants who may have experience deterioration, we would 
provide them with alternative treatment via the in-house clinical team (as would be the 
standard for any primary care patient; e.g., referral to social work) or refer them to outside 
intensive treatment, while still offering them in-house monitoring as part of the study. The 
RN/NP/MD/BHSs will provide regular monitoring of participants to assess for possible 
deterioration and need for alternative treatment. Likewise, participants will be seen and 
regularly monitored in the primary care clinic as part of standard care. 
 
18) 
RISKS TO SUBJECTS 
General Procedures: There is some risk that participants will be identified as participants in 
a study of the treatment for heavy drinking or that clinical assessments will adversely affect 
participants’ well-being. Inadvertent breach of confidentiality concerning drinking behavior is 
also a risk. To protect against any breach of confidentiality, study procedures will be 
conducted in a private and confidential clinical setting. All data will be collected and stored on 
secured computers in secure databases or in locked file cabinets with patient identity being 
kept separate from their research materials. Participants will only be identified with a number, 
and the key for matching these numbers to the participant name/contact information will be 
kept in a separate locked location.  
 
Behavioral Interventions. The proposed behavioral interventions are evidence-based and 
patient-centered. They have been used with those who drink excessively in a variety of 
settings. Psychological risks are minimal and not different from those of equivalent non-study 
treatments. All counseling will be conducted in a private and confidential setting. Subjects will 


 
v. 3/30/2018 
 
20 
 
be able to end behavioral counseling at any time, if they experience any discomfort.  
 
Rating Scales and Questionnaires: While the proposed assessments are all non-invasive 
and add no special risks, they do cover sensitive areas. Participants may feel uncomfortable 
answering questions about and discussing their drinking. Study personnel will be training to 
create a non-judgmental and comfortable environment to allow participants to share freely; 
participants will also be allowed to decline to answer and/or discuss topics in the situation 
that they are not at ease. The major disadvantage is the time taken to complete them, and 
the potential for breach of confidentiality. We will also provide participants will time 
expectations to complete their appointments, as well as allowing them to be completed via 
REDCap while at home whenever possible. Additionally, careful efforts to maintain 
confidentiality that have been effective in our previous research will be continued. 
 
Daily Questionnaires: The primary concern to confidentiality is that there may be an 
inadvertent breach of confidentiality concerning problem drinking behavior. It is possible that 
since participants will be receiving messages on their personal mobile phones, another 
person may view a message specific asking about alcohol use from an unguarded phone. 
While unlikely, it is possible that there may be a breach of confidentiality if a participant’s cell 
number is obtained through the REDCap computer database. We have a similar protocol that 
is currently approved by the IRB (14-299) and we have had no adverse events with this 
protocol which sent 100s of messages about drinking to participants. Already approved 
protocol 14-299 uses an outside vendor and therefore this study will be even more secure 
because we are using REDCap. There have been multiple studies using text message as a 
means to communicate patient information of much more sensitive information. To reduce 
any possible breaches of confidentiality, participants will be offered instructions on how to: 1). 
Change message settings to alert individuals that an SMS message has been received but 
do NOT display or preview any of the message. This ensures that a third party cannot 
passively see the message on a participants phone because no information is provided. 2). 
Inform individuals to add a security code to their phone in which one must enter the security 
code to view a message. 3). Inform individuals to create a contact to which they would feel 
comfortable receiving a message. For example, they can program their phone to display the 
name, Bob Jones every time we send them a message. 4). Inform the participants that they 
should keep their phone on their person or in a secure location at all times. 5). Inform 
participants on how to delete all messages from a particular sender. 
 
Medication: Participants identified as problem drinkers may choose to receive a medication 
intervention that includes naltrexone (50 mg per day). According to the package insert for 
naltrexone,the medication has been associated with liver toxicity at very high doses (up to 
300 mg/day); however, a number of clinical trials and published studies suggest there are few 
serious adverse effects, including minimal hepatotoxicity, associated with 50 mg of NTX 
daily. Notably, naltrexone is an FDA-approved for alcohol use disorder and is not an 
experimental drug. The most common side effects patients report experiencing from taking 
naltrexone are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty 
sleeping, fatigue, irritability, and decreased appetite.  
 
In the present study protocol, we propose to monitor self-reported side effects weekly for the 
first two weeks or until the participant’s medication dose has been stabilized, and then 
biweekly. Monitoring and medication management will be conducted by an RN/NP/MD, and 
the PCP will also see the patient at baseline and at 12 weeks post-prescription for 
monitoring. We will monitor liver function monthly, and we will conduct more frequent medical 
monitoring as appropriate. These measures should ensure that any potential risk to 


 
v. 3/30/2018 
 
21 
 
participants is minimized.  
 
For participants who need stepped up care as previously described, one option is a trial of 
Topiramate for those who fail to respond to Naltrexone. Topiramate is an FDA-approved 
medication for the prevention of seizures and migraine headaches. It is also recommended 
and often used clinically as a second line medication for treatment of alcohol use disorder, 
however, it is not FDA-approved for alcohol use disorder at this time. The most common side 
effects are fatigue, difficulty concentrating, paresthesia’s, memory impairment, dizziness, and 
weight loss.  
 
To avoid breach of confidentiality, participants' names will appear only on locator form and a 
"key" for these forms will be kept by the PI in a locked cabinet. All forms that contain 
identifying information will be kept double locked (i.e., in a locked cabinet, in a locked room) 
to maintain their security. All study data forms will contain only the participant's unique study 
identification number, using a reference system maintained by the PI. Completed study forms 
will be kept in a locked cabinet, the key to which will be available only to the PI and study 
research staff. All electronic files (e.g., database, spreadsheet, etc.) containing identifiable 
participant information are password protected. All computers hosting such files have a BIOS 
password to prevent access by unauthorized users. Research staff will have a secure login to 
access study data. All research staff that will be involved in the proposed study are 
knowledgeable and experienced in dealing with confidentiality issues and any new staff will 
be trained rigorously. Ongoing training will be provided on human subjects issues. 
 
Benefits. Participants will benefit from the study by being able to receive treatment for their 
problematic alcohol use within their regular primary care practice, rather than needing to 
procure services from an external treatment facility or opt not to pursue treatment at all. They 
will receive additional monitoring and connection with healthcare staff rather than potentially 
disconnected treatment between healthcare and substance abuse care. 
 
19) 
RESEARCH RELATED HARM/INJURY 
As part of their participation in the study, participants who choose medication treatment may 
experience side effects from the medications (i.e., naltrexone and/or topirimate). Participants’ 
response to these medications will be closely monitored by an RN/NP/MD in this study. In 
addition, all participants in this study are patients of the 865 Northern Boulevard Primary 
Care Clinic (or another Northwell DGIM site), where their overall health is regularly monitored 
by their PCP. For participants who receive outpatient detoxification before starting treatment 
in this study, they will have access to an on-call physician in the clinic at all times and will be 
closely monitored by the RN/NP/MD performing the detoxification. These on-call physicians 
will assess participants’ status and recommend scheduling a visit or instructing participant to 
call 911 or go to the nearest emergency room in cases of deterioration or non-compliance 
with detoxification protocol and urgent care is warranted. 
 
In the case that participants’ drinking increases and they appear to need a higher level of 
care, they will be referred to inpatient or outpatient treatment outside of the clinic, which will 
also be the case for participants who appear to require inpatient detoxification. Participants 
will continue to be followed in the study but will be responsible for the cost of such care. 
 
20) 
POTENTIAL BENEFIT TO SUBJECTS 
Direct benefits to participants include careful evaluation of their alcohol use and potential 
reduction in alcohol consumption, which may improve their health and well-being. In addition, 
there are benefits that this research will contribute to public health. Alcohol Use Disorder 


 
v. 3/30/2018 
 
22 
 
(AUD) is a highly prevalent and costly health condition that disproportionately affects young 
people and is among the leading causes of disability worldwide for individuals ages 18-45. A 
number of effective psychosocial and pharmacological interventions exist to treat AUD. 
However, these interventions are modestly effective, and there is a surprising absence of 
empirical research to guide treatment selection based on individual need. In addition, 
although there is a significant need to provide treatment for individuals with AUDs, it appears 
little is known about providing this treatment in primary care. Participation in this study could 
contribute to the development of a model of monitoring and treatment of AUDs in a primary 
care setting.  
 
21) 
PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
Participants will be recruited as part of normal SBIRT procedures at the 865 Internal 
Medicine practice site or referred from another Northwell Health DGIM primary care practice. 
SBIRT Health Coach (HC) will provide Brief Advice with patients identified as excessive 
drinkers or having AUD as noted above, the HC will then describe the study and determine 
the patient’s interest, and if the patient is interested, the HC will conduct further assessment 
and complete the initial plan for treatment. The HC will also consent the participant to the 
general study procedures by explaining the study protocol, study risks, potential benefits, and 
alternative treatment options. This recruitment will be conducted in a private setting (i.e., in a 
private office at the 865 Northern Boulevard Internal Medicine Clinic or another Northwell 
Health DGIM primary care site). Information obtained from the patient is kept confidential as 
all clinic staff is trained to maintain HIPAA compliance. If a participant will express interest in 
the study, his or her information will be input into REDCap to maintain confidentiality of 
identifiable data. Once in the study, all assessments, treatment visits, and study 
communications will be conducted in a confidential and private setting (e.g., at the primary 
care setting or via Webex, which is a HIPAA-compliant software). Identifiable information will 
not be shared and will only be stored in REDCap. Participants will be trained on protecting 
their smartphones when using them for the study.  
 
22) 
COSTS TO SUBJECTS 
Study-related visits will be given at no additional cost. For participants who choose to receive 
medication as part of the study, their insurances will be billed to cover the costs of this 
treatment and the lab work. The study will pay for their co-pays. If a participant does not have 
insurance or does not want their insurance to be used, the study will pay for the medication 
and lab work in full. 
 
23) 
PAYMENT TO SUBJECTS 
Incentives will be provided to patients to complete assessments at baseline, one-month 
follow-up and three-month follow-up at $20 per time point. Thus, participants could potentially 
earn up to $80. They will receive compensation on the ClinCard that will be provided at their 
week 1 appointment. Individuals who are screened but not eligible for the study will receive a 
$20 Amazon gift card for their screening assessment. 
 
24) 
CONSENT PROCESS 
Consenting for this study will be conducted as a two-step process—the first of which is 
General Consent to be conducted by the HC at week 0 and the second is a Medication and/or 
Behavioral Intervention Consent to be conducted by the clinician performing the relevant 
treatment intervention (i.e., RN/NP/MD conducting naltrexone and medication management 
or a BHS conducting the behavioral interventions) at week 1 prior to starting treatment. All 
participants who are eligible will sign the General Consent with the HC at their Week 0 
appointment. During that time when the participant is classified into a treatment group, he or 


 
v. 3/30/2018 
 
23 
 
she will choose a medication or behavioral intervention treatment option that is offered for his 
or her risk classification in the study. Once a participant chooses a treatment option, he or 
she will be scheduled for an appointment with the clinician (RN/NP/MD for medication or a 
BHS for a behavioral intervention). At this following appointment, the participant will undergo 
consent for treatment with the relevant clinician. Notably, participants will be given the 
opportunity to change their treatment option to the other treatment offered for their risk group 
in the case that they do not wish to consent to the treatment they chose. For example, a 
participant in the Problem Drinkers group may choose to receive naltrexone and medication 
management in their initial appointment with the HC and will be scheduled to meet with the 
RN/NP/MD at the next appointment to consent and start treatment. At that appointment, they 
may still decide to not consent to the medication treatment and alternatively choose to receive 
the Motivational Enhancement Therapy (MET). They will be allowed to do so and a new 
appointment with a BHS, providing this treatment, will be scheduled in order to consent for 
and undergo MET instead. 
 
 
 
 
 


 
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24 
 
 
 
 
 
25) 
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ICF_001.pdf: 
 
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Northwell Health 
 
Campus:  
Division of General Internal Medicine:  
865 Northern Boulevard Office 
 
 
Medication Consent for Participation in a Research Study 
 
Title: Project ReDUCE (Collaborative Care for Alcohol Use Disorders in the Patient-Centered 
Medical Home: Phase I & Phase II) 
 
Principal Investigator: Jon Morgenstern, PhD  
 
Sponsor: National Institute on Alcohol Abuse and Alcoholism 
 
Introduction 
You already agreed to participate in a research study and have chosen to receive medication.  
 
This consent form will explain: 
 the purpose of the overall study 
 the purpose of using medication in the study 
 information about the medication available to you in this study  
 what you will be asked to do if you decide to take medications as part of this 
study 
 the potential risks and benefits of the medications available in this study  
 
It will also explain that you do not have to be in this study or take the study medications to 
receive medical care. You do not have to agree to take medications to participate in the study. 
You should ask questions before you decide if you want to take medications as part of this study. 
You can also ask questions at any time during the study.  
 
Why is this research study being done? 
The purpose of this research study is to develop and test a care model to treat problem drinking 
and alcohol use disorders in the primary care setting. You are being asked to participate in this 
study because routine screening and assessment conducted at your primary care clinic indicates 
that you have recently exceeded healthy drinking limits as outlined by the National on Alcohol 
Abuse and Alcoholism. Medication is available as one treatment option for you, and this consent 
form will review this option so that you can determine whether you would like to pursue this 
option. Whether or not you choose to take medication will not affect your participation in the 
overall study.   
 
How many people will take part in this study?   
The overall research study hopes to enroll 85 individuals. 
 
 
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How long will you be in this study?  
The study will last for 12 weeks. All of the procedures described in the main study consent form 
will apply to you. In addition, as part of your initial visit, you will see a medical professional 
(i.e., a Registered Nurse [RN] supervised by a Medical Doctor [MD], a Nurse Practitioner [NP], 
or an MD), who will perform a medical exam, review your medical history, and discuss with 
your primary care team (e.g., your Primary Care Physician) to be sure you are a good candidate 
for medication.  
 
If you choose to take medication as part of this study, you will be given a prescription for 
naltrexone during your initial study visit, and you will take the naltrexone daily for 12 weeks as 
long as you do not experience any side effects.  
 
During the first two weeks, you will meet with the medical professional once per week, so that 
we can monitor potential side effects. Starting in week three, you will meet with the medical 
professional every other week, unless you are still experiencing side effects and need to be seen 
more frequently.  
 
Lab work will be performed prior to enrollment, at your week 4 assessment, and additional times 
throughout the 12 weeks, IF there is clinical indication that liver enzymes should be assessed an 
additional time.  to make sure that the medication is not affecting your liver. These medication 
management and lab visits will be part of your treatment visits and will not require you to take 
part in research surveys, except for your week 4, 8, and 12 appointments where you will have a 
treatment appointment and research assessment in the same visit, as described in the overall 
study consent that you already signed. 
 
What will happen in this research study? 
You have already provided verbal consent to be screened for risky alcohol use as a standard of 
care at the 865 Northern Boulevard General Internal Medicine site, and you received a brief 
counseling session based on your screening results. After that counseling session, you were 
asked to participate in the overall research study.  
 
After you agreed to participate in the study by signing the main study consent form, you were 
further assessed and provided medication and behavioral treatment options based on your need. 
At that time, you chose to pursue medication treatment, and, therefore, undergoing this consent 
process to learn more about the medication, its side effects, and other relevant information. If 
you choose to consent, a medical professional will perform a medical exam, review your medical 
history, and consult with your primary care clinical team to determine if you are appropriate for 
taking this medication.  If you agree to receive medication, the medical professional will write 
you a prescription.  
 
If you select medication as your treatment options, you will receive 12 weeks of daily naltrexone 
(50 mg) with medication management appointments. Naltrexone is FDA-approved for the 
treatment of alcohol problems at 50 mg/day. To minimize any potential side effects, we will 
 
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initiate treatment using a 25-mg dosage for the first week, and as long as the medication is well 
tolerated by you, we will then increase to 50 mg daily. 
 
You will be seen by the medical professional weekly for the first two weeks until the medication 
dose is stable and then meetings will continue biweekly. At these visits, you will be asked about 
your drinking and experience with the medication, including compliance and side effects. 
Additional physician or nurse visits may be scheduled if you experience side effects or do not 
follow the recommended medication guidelines. We will monitor liver function by doing blood 
tests to be sure that there is no damage to your liver and to make sure it is functioning properly. 
Lab work (i.e., 5 cc of blood, the equivalent of one teaspoon) will be performed prior to 
enrollment, at your week 4 assessment, and additional times throughout the 12 weeks, IF there is 
clinical indication that liver enzymes should be assessed an additional time  
 
At week 4, your progress in treatment will be assessed by the medical professional and your 
health coach. You may be offered the below options, if it appears that an alternative may be 
more suitable than the naltrexone treatment you have been taking the first 4 weeks: 
 daily topiramate (200mg) with medication monitoring and management as described as 
above; OR 
 behavioral treatment while taking naltrexone.  
 
Decisions regarding additional treatment options will be made by the medical professional, who 
is part of this study, in consultation with you and this study staff and the primary care clinical 
team. 
 
Birth Control 
The drugs in this study may affect a baby, before or after the baby is born. As a result, women 
should not be in this study if they are: 
 pregnant,  
 breast-feeding, or 
 trying to become pregnant. 
 
If you are a woman of childbearing age, you should use birth control for the entire time you are 
in the study and for at least one menstrual cycle after stopping the study. Hormonal methods 
(birth control pill, etc.), double-barrier methods (condoms with spermicidal, sponge with 
spermicidal, or diaphragm with spermicidal), or not having sex may be used. Your doctor will 
discuss these with you. 
 
What are the risks of the research study? What could go wrong? 
All the risks reviewed in the main study consent form still apply to you. Using medications in 
ways other than prescribed by your study doctor (including taking too much or abruptly 
stopping) can be dangerous. At the end of the study, you will be given a tapering schedule if you 
do not wish to remain on your study medication (either naltrexone or topiramate) under the care 
of your own PCP. If you are taking naltrexone, the dose of naltrexone does not need to be 
tapered at the end of the study but can simply be stopped. If you are taking topiramate, it will be 
suggested that you decrease your daily dose of topiramate by 50 mg each week until you are off. 
 
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Based on studies using topirimate for either seizure or migraine prevention, there is a risk of 
rebound seizure or headache when the medication is stopped suddenly. It is unknown if the same 
risk applies when using topiramate to help reduce drinking.  To be safe, the same slow decrease 
in dose should be followed.   
Please consult with a member of the study team before abruptly stopping either topiramate or 
naltrexone. 
Naltrexone 
There are some potential side effects from taking naltrexone at the dose of 50mg per day. The 
most common side effects are nausea, vomiting, anxiety, headache, abdominal discomfort, 
difficulty sleeping, fatigue, irritability, and decreased appetite. Naltrexone has rarely caused 
serious liver disease; however, persistent nausea/vomiting, severe stomach/abdominal pain, dark 
urine, yellowing eyes/skin should be reported to your doctor immediately. There are no known 
effects of naltrexone on liver function that are not reversible upon stopping the medication. 
Naltrexone can interfere with certain medications, such as opioids.  
 
Naltrexone is an FDA-approved treatment for alcohol use disorder; it is not an experimental 
drug. We have put several safeguards in place to reduce the risk of serious side effects. For 
example, you will undergo a medical exam and your medical history will be reviewed by nurses 
and doctors before you start the medicine. You will meet with a nurse weekly for two weeks and 
then every other week for the following10 weeks to monitor your self-reported side effects, and 
the frequency of these visits can be increased if needed. We will monitor liver function monthly 
to be sure that there is no damage to your liver. We will conduct more frequent medical 
monitoring as appropriate.  
 
Because naltrexone can interfere with opioids, you will be urged to delay elective procedures, 
such as dental procedures or elective surgery, requiring opioid treatment until after the study 
treatment. If you cannot delay such procedure, you will not be eligible to receive naltrexone as a 
treatment option. If you have a history or evidence of recent opiate use, you will not be eligible 
to receive naltrexone.  In addition, if you have any serious illnesses, including liver disease 
and/or a known sensitivity to naltrexone, in order to minimize the risk of a serious reaction to 
study medication, you will not be eligible to receive this medication.  
 
Topiramate 
If naltrexone is not working for you, we will be offer topiramate (200 mg per day). Although 
topiramate is FDA-approved for the treatment of other conditions (i.e., for migraine headaches 
and prevention of seizures), the use of the drug in this study for the treatment of alcohol use 
disorders is not FDA-approved and is considered investigational. The target dosage for 
topiramate will be 200 mg/day and will be increased only if tolerated. It may be reduced if 
necessary (i.e., patients experiencing side effects will have their dosage decreased gradually to 
the highest tolerated dosage).  
 
We will start you on a lower dosage and then slowly increase it to make sure you do not have 
any negative effects. The schedule is as follows:  
 Week 1: 25mg once per evening;  
 
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 Week 2: 50mg once per evening;  
 Week 3: 25mg once per morning + 50 mg once per evening;  
 Week 4: 50mg once per morning and once per evening;  
 Week 5: 50mg once per morning and 100mg once per evening;  
 Week 6-12: 100mg once per morning and evening.  
 
The most common side effect of topiramate is numbness and tingling. The other most common 
side effects include: change in sense of taste, tiredness/sleepiness, fatigue, dizziness, loss of 
appetite, nausea, diarrhea, weight decrease, difficulty concentrating, and memory-related 
difficulties.  
 
Less common side effects include: nervousness, slow thinking, abnormal vision, confusion, 
anxiety, abdominal pain, dry mouth, involuntary muscle contractions, and language problems. 
Depression and mood problems have also been reported.  Some patients have had suicidal 
thoughts or actions. Kidney stones and effects on the levels of acid in your blood may occur, 
though this is less likely.  
 
To safeguard from the above side effects, patients will be informed that, if they feel a change in 
their mood, feel depressed, or feel they may harm themselves, they should contact the study 
team. Drinking adequate fluids will be recommended to reduce the risk of kidney stones.   
 
If you have significant suicidal risk, you will not be offered topiramate as part of this study and 
ongoing monitoring throughout the study will serve to reduce the risk of intentional overdose. If 
you have cirrhosis and/or significant liver enzyme elevations or histories of significant liver 
disease, you will not be offered topiramate as part of this study. 
 
The study treatment team physicians will provide guidance for you as you increase your dosage 
level of medication, if adverse effects occur.  A medical professional (i.e., a medical doctor or 
nurse practitioner) will monitor you closely for side effects weekly for the first two weeks or 
until your medication dose has been stabilized, and then biweekly for the remainder of the study. 
We will monitor your liver function monthly by conducting lab work, and we will conduct more 
frequent medical monitoring as appropriate. 
 
Blood-Drawing 
If you choose to take medications as part of this study, you will have blood drawn prior to 
enrollment, at your week 4 assessment, and additional times throughout the 12 weeks, IF there is 
clinical indication that liver enzymes should be assessed an additional time. Blood draws will 
include extracting 5 cc of blood, the equivalent of one teaspoon. Having your blood drawn can 
be uncomfortable and can sometimes cause a bruise. In some people, it can cause fainting. In 
very rare cases, and infection can occur. Only trained people will draw your blood. You should 
discuss any problems with blood draws with the study medial professional, who will be meeting 
with you.  
 
The study treatment team will meet weekly during the study to ensure that adequate monitoring 
of your medical stability is being conducted and will communicate closely with your primary 
 
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care clinical team. If you develop serious adverse side effects, the medication will be stopped, 
and you may be offered alternative treatment in the study.   
 
Unknown Side Effects 
As with any drug, there might be side effects that are unknown at this time. You will be closely 
watched for side effects.  You should report any unusual events to the study staff. 
 
Women of Childbearing Potential and Pregnant Women  
Naltrexone and topiramate may have adverse effects on fertility or a fetus.  Both naltrexone and 
topiramate are excreted in breast milk. For this reason, if you believe you are pregnant or have a 
chance of becoming pregnant, not take part in the medication arm of the study.  During the initial 
screening appointment, you will be asked if you are pregnant.  If you are pregnant, you will not 
be allowed to participate in the medication arm of the study. 
 
If you do take part in this study and are of childbearing potential, you must use a medically 
recognized form of birth control for one month before entering the study, while in the study, and 
for at least one menstrual cycle after stopping the study.  If you become pregnant during the 
study and are receiving medication, you will be immediately withdrawn from the medication arm 
of the study and closely monitored through your entire pregnancy. 
 
Due to the potential for serious adverse reactions in the nursing infant, you should not take part 
in the study if you are breastfeeding. 
 
What are the benefits of this research study? 
The possible benefits you may experience from the procedures described in this study include a 
reduction in problem drinking; however, this cannot be guaranteed. We expect that the findings 
of this research will help your primary care clinical team recognize and treat excessive drinking 
and alcohol use disorders in primary care settings in the future.  
 
Drug Availability After Completion of Study  
At the end of the study, the study doctor will give you a prescription for the medication you have 
been taking if you would like to continue taking it and you have been taking the medication as 
directed by the study doctor. If you would like to discontinue the medication, the study doctor 
will discuss with you how to safely stop taking it.  
 
If you do not want to take part in this research study, what are your other choices? 
If you do not choose to participate in the medication portion of this study, you will still be able to 
participate in the main study. Your alternative treatment options would include behavioral 
counseling or referral to treatment elsewhere. If you choose to receive a behavioral intervention, 
a behavioral health specialist will meet with you to undergo a separate consent for those 
interventions. 
 
Your doctor can also tell you the important risks and benefits associated with the alternative 
treatment 
 
Are there any costs for being in this research study?  
 
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This research study is funded by the National Institute on Alcohol Abuse and Alcoholism. All 
study related visits will be given to you at no additional cost to you. If you choose to receive 
medication treatment as a part of this study, your insurance company may be billed for the cost 
of the medication and potential lab work costs. If you do not have insurance, or do not wish to 
have your insurance billed, the study will cover the costs of medication and bloodwork during 
the 12 weeks of the study. In this case, you will have to obtain medications from a specific 
pharmacy associated with Northwell Health where we will send your prescription at no cost to 
you.  
Will you receive any payments for participating in this research study? 
You will receive $20 for each study interview you complete, as discussed in the general consent 
for the study. Therefore, if you participate in all study sessions, you will be paid up to a total of 
$80 for your time. Payment will be made at the end of each study assessment or when you end 
your participation. 
 
If the total payment you receive from Northwell Health, during this year, is equal to $600 or 
more, the payment is required to be reported to IRS.  Although this study does not pay $600, if 
you participate in other Northwell Health studies, it is possible your payment could end up 
totaling $600.  If this occurs, the payment you receive on this study will be reported to the 
IRS.   In this case, you will be issued a 1099 form and be required to provide your social security 
number at that time for reporting purposes.  You will also be responsible for reporting this 
income while filing your tax return. 
 
What are your rights as a research participant? 
Your participation in this project as well as in receiving medication as part of your treatment is 
voluntary. The quality of your medical care will be the same, whether you join, refuse to join, or 
decide to leave the study or to take the medication.  
 
If you do not join the study or do not wish to take the medications, you will not be penalized or 
lose benefits to which you are entitled. If you join the study you may withdraw at any time or 
discontinue taking the medications without prejudice to your future care at the Northwell Health 
System. Follow-up examinations may be needed to assure your well-being.   
 
Could you be taken off the study before it is over? 
It is also possible that your participation in taking medication may end without your 
consent. This decision may be made by a researcher, study sponsor, or the Institutional Review 
Board (IRB—the committee that oversees research at this institution).    
 
Reasons for withdrawal may include:   
 failure to follow instructions,  
 failure to show up for study visits, 
 side effects from medications  
 it is not in your best interest to continue with the medications, or  
 the study is stopped.   
 
 
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If you are withdrawn from being able to take medications, any data already collected will 
continue to be used, and you will be offered alternative treatment in the study or referred to 
treatment outside of the study. You will still be monitored in the research assessment portion of 
the study, unless you choose to withdraw, which you are free to do at any time without any effect 
on your care at Northwell Health. 
 
 
What happens if new information is learned? 
You will be told of any new findings that may change your decision to continue to participate. 
Your consent to continue to take part in this study may be obtained again.   
 
What information will be collected and used for this study? 
If you agree to be in this study, we will collect information about your health and your alcohol 
use. We may collect the results of questionnaires and interviews. This information may include 
questions about the amount of alcohol you drink, how often you drink, any problems you have 
experienced because of drinking, and any reasons why you may have trouble accessing treatment 
services. If you drop out of treatment, we may ask you why so that we can learn from your 
experiences. We will only collect information that is needed for the research. This information 
has been described in this consent form. If you sign this consent form, you are giving us 
permission to collect, use and share your health information. This permission is called 
authorization. If you do not want to provide authorization, then you cannot participate in this 
research study. 
 
Who else will see your information?  
Study records that identify you will be kept private. You will not be identified in study records or 
publications disclosed outside the Northwell Health System, except as detailed below.  
 
Investigators will share de-identified information collected from this research study with: 
 study sponsor and/or its agents,  
 data safety monitoring board, 
 clinical staff not involved in the study who may be involved in the participant's treatment 
 
The following reviewers may access your study and medical records to make sure that this study 
is being done properly:  
 Representatives from federal and state government oversight agencies, such as National 
Institutes of Health, US Department of Health and Human Services (DHHS), or the New 
York State Department of Health. Representatives from the Northwell Health System 
Human Research Protection Program (a group of people that oversee research at this 
institution) 
 
We will do our best to protect the privacy of your records, but it is possible that once information 
is shared with people listed on this form that it may be released to others. If this happens, your 
information may no longer be protected by the federal law. 
 
In the future, we may publish results of this study in scientific journals and may present it at 
scientific meetings. If we do, we will not identify you.  
 
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If the researchers learn about potential serious harm to you or someone else or other public 
health concerns, it will be shared with the appropriate authorities. 
 
 
 
Will you be able to access your records? 
If your research records are used for decisions related to your clinical care, then you have the 
right to review this information and request changes. This is limited to information about your 
treatment and does not include information related to procedures or tests that are for research 
purposes only. You may access this information only after the study analysis is complete. You 
have the right to know who has and who will see your records. To request this information, 
please call the Human Research Protection Program at 516-321-2100. 
 
How long will your health information be kept?  
There is no limit on the length of time we will keep your information for this research because it 
may be analyzed for many years. We will keep it as long as it is useful, unless you decide you no 
longer want to take part or we close the study.  You are allowing access to this information 
indefinitely.   
 
Can you change your mind? 
If you change your mind about being in the study or about taking medications, you may 
withdraw at any time or discuss alternative treatment options with study staff. If you want us to 
stop collecting your health information, you can send a letter to the researcher at the following 
address: 
Dr. Jon Morgenstern. 
1010 Northern Blvd. Suite 311 
Great Neck, N.Y., 11021 
 
Your letter needs say that you have changed your mind and do not want the researcher to collect 
and share your health information. You may also need to leave the research study if we cannot 
collect any more health information. We may still use the information we have already collected. 
We need to know what happens to everyone who starts a research study, not just those people 
who stay in it. 
 
Will information about this study be available to the public? 
We may write about this study and publish it in a scientific journal; however, you will not be 
named and all participants’ data will be combined such that no one participant is written about. 
Also, a description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This website will not include information that can identify you. At most 
the website will include a summary of the results. You can serach this website at any time.  
 
Does the investigator of this study receive money if you take part?   
Funding for this research study is provided by the National Institute on Alcohol Abuse and 
Alcoholism. The investigators on this study receive money to conduct the study but do not 
financially benefit from your participation. The money they receive is to pay them back for the 
 
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costs of conducting the research study. If your doctor is an investigator for this study s/he is 
interested in both your healthcare and the conduct of this research. You do not have to take part 
in a research study conducted by your doctor. 
 
 
 
Who can answer your questions about this study? 
If you have any questions about the study, you may call Dr. Jon Morgenstern at (516) 837-1694. 
If you have questions about side effects or injury caused by research you should call Dr. Jon 
Morgenstern at (516) 837-1694. If you need emergency care, dial 911 or go to the nearest 
Emergency Room. If you have questions about your rights as a research participant, concerns 
about being in the study, or would like to offer input, you may contact the Office of the 
Institutional Review Board (the committee that oversees research at this institution) at (516) 321-
2100.  
 
A signed copy of this consent form will be given to you. 
 
 
Research Review Questionnaire 
 
 
After reviewing the consent form for this study please answer the following questions by circling 
“True” or “False”. The researchers doing this study want to be sure that you know what is 
involved in being in this research study. This questionnaire will help them make that decision. 
You may ask questions of the researcher and review the consent form again at any time. 
 
You do not have to be in this study or take the study medications to receive medical care.  
True   False 
 
Naltrexone can interfere with certain medications, such as opioids.  
 
True   False 
 
I can withdraw from participating in this study at any time.  
 
 
True   False 
 
There are no risks to me from participation in this study.  
 
 
 
True   False 
 
 
 
 
 
 
 
[Signature Page Follows] 
 
 
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Summation/Signature 
 
You have read the above description of the research study. You have been told of the risks and 
benefits involved and all your questions have been answered to your satisfaction. A member of 
the research team will answer any future questions you may have. You voluntarily agree to join 
this study and know that you can withdraw from the study at any time without penalty. By 
signing this form, you have not given up any of your legal rights. 
  
____________________________________________________________ 
Printed Name of Participant   
 
 
___________________________________________________             ______________ 
Signature of Participant 
   Date 
 
_______________________________             ____________________  __________ 
Witness’s Printed Name 
 
 
    Witness’s Signature 
  Date 
(Note: A witness can be a member of the research team, but cannot be the same person signing 
consent as the investigator) 
  
 
 
Investigator’s Statement  
In addition to advising the above participant of other forms of treatment and therapy which are 
appropriate, I have offered an opportunity for further explanation of the risks and discomforts 
which are, or may be associated with this study and to answer any further questions relating to it. 
 
_________________________________               ____________ 
Investigator’s signature                                                Date  
  
_____________________________________________ 
Investigator’s printed name                                              
 
 
 
 
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Page 1 of 10 
 
Northwell Health 
 
Campus: Zucker Hillside Hospital 
 
General Consent for Participation in a Research Study 
 
Title: Project ReDUCE (Collaborative Care for Alcohol Use Disorders in the Patient-Centered 
Medical Home: Phase I & II) 
 
Principal Investigator: Jon Morgenstern, PhD  
 
Sponsor: National Institute on Alcohol Abuse and Alcoholism 
 
Introduction 
You are being asked to join a research study called, “Collaborative Care for Alcohol Use 
Disorders in the Patient-Centered Medical Home” or Project ReDUCE. Being in a research study 
is different from being a patient. When you are a patient, you and your doctor have freedom in 
making decisions about your healthcare. When you are in a research study, the researcher will 
follow the rules of the research study as closely as possible, while monitoring your health. The 
purpose of this research study is to explore different alcohol use treatment options, including a 
combination of medication and different types of counseling on drinking, in a primary care 
setting.   
 
This consent form will explain: 
 the purpose of the study 
 what you will be asked to do  
 the potential risks and benefits 
 
It will also explain that you do not have to be in this study to receive medical care. You should 
ask questions before you decide if you want to participate. You can also ask questions at any 
time during the study.  
 
Why is this research study being done? 
The purpose of this research study is to develop and test a care model to treat excessive drinking 
and alcohol use disorders in the primary care setting. The goal of this research study is to 
increase the identification and treatment of problem drinking in the primary care setting. You are 
being asked to participate in this study because routine screening and assessment conducted at 
your primary care clinic indicates that you have recently exceeded healthy drinking limits as 
outlined by the National Institute on Alcohol Abuse and Alcoholism.  
 
How many people will take part in this study?   
This research study hopes to enroll 85 individuals. 
 
 


 
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How long will you be in this study?  
The study will last for 12 weeks. If you choose to take part in this study, the first survey will last 
for approximately 30 minutes. You will then have follow up assessments also lasting 
approximately 30 minutes and occurring at weeks 4, 8, and 12 of the study. These research 
assessments can be completed in-person or via televideo based on your preferred method. We 
will also monitor your alcohol use in order see if the treatment is working via daily 
questionnaires. These questionnaires will be sent to your phone via text message. These 
treatment monitoring questions will take about 1 minute to complete. Depending on the 
treatments offered to you and your response to treatment, over the 12 week course of the study, 
you may be asked to make additional office visits for further assessment, counseling sessions, lab 
work, or consultation with study staff. These visits will not occur more than once per week. 
These visits will be to manage your treatment and will not require you to take part in research 
surveys.    
 
What will happen in this research study? 
You have already provided verbal consent to be screened for risky alcohol use as a standard of 
care at the 865 Northern Boulevard General Internal Medicine site, and you received a brief 
counseling session based on your screening results. Now, we are requesting written informed 
consent for your participation in this study, including confirming your eligibility. You have 
received and will receive the standard services detailed above, while at this clinic, regardless of 
your participation in this study.   
 
If you agree to participate in this study, you will undergo an assessment in order to confirm your 
eligibility for this study and determine if this study is appropriate for you.  For example, this 
study is for people who drink regularly, have concerns about their drinking, and who are willing 
to engage in efforts to reduce their drinking to safe levels. Once we determine that you are 
eligible to participate in this study, we ask that you not participate in any other type of formal 
substance abuse treatment outside of the study for the 12 weeks of the study so that we may be 
able to isolate the effects of our treatments as much as possible. 
 
You may withdraw from the study at any time. If you choose to not participate in this study and 
at any time you feel that what is offered in this study is not addressing your problems 
sufficiently, you will be provided with referrals to community organizations or private 
practitioners for further treatment.  
 
Depending on your level of need, you will be given the option to receive behavioral, medication, 
treatments or referral to a community alcohol treatment provider. In addition to the Brief Advice 
about your drinking that you already received as part of standard care at this primary care clinic, 
you may be offered other behavioral treatments, including four sessions of Motivational 
Enhancement Therapy or 12 sessions of Modified Behavioral Self-Control Therapy. You may be 
able to choose to receive medication treatment, which would include daily naltrexone (50mg) 
and bi-weekly meetings with a licensed medical professional to monitor appropriateness and 
safety of the medication treatment. You will be asked to choose a treatment from the options 
provided to you at the end of this appointment, and the treatment will be discussed in detail with 
a clinician at your next appointment as the second part of the consent process. During that time, 


 
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if you do not wish to continue with the treatment you chose, you will be free to choose a 
different option of the treatment choices provided for your level of need.   
 
You will also be asked to complete a total of three assessments at week 4, 8, and 12, after your 
initial assessment. Assessments and behavioral treatments may be scheduled in-person or via 
televideo, depending on your preference. Each assessment entails completing questionnaires. 
Medication visits will occur in-person. 
 
A summary of the study is provided in more detail below:  
 
Week 0 Assessment: If you choose to participate in the study by signing this consent form, a 
trained research staff member will conduct a survey asking you questions about your alcohol use 
and a review of your medical chart as well as discuss your participation with your primary care 
clinical team (e.g., your primary care physician). The survey that you complete will last 
approximately 30 minutes. During this assessment, you will be evaluated for eligibility and, if 
you are deemed eligible, you may be offered treatment options in addition to the assessments 
based on your need. Treatments are described in more detail below. Once you choose from the 
treatment options available to you, you will be scheduled to meet with a clinician providing that 
treatment the following week (week 1). 
 
Week 1-12 Treatment: At your week 1 appointment, you will learn in detail about the treatment 
option and can choose to participate or change your treatment choice to another option that was 
provided to you. If you choose to continue with your treatment choice, you will be asked to sign 
a separate consent form specific to the treatment that you will be doing with the clinician 
providing the treatment.  
 
If you choose to receive medication treatment, you will meet with a licensed medical 
professional who will conduct a medical exam and review of your medical history as well as 
consult the primary care clinical team. You will learn about the medication, its side effects, and 
other relevant information. Participants enrolled in medication treatment will be seen weekly for 
the first two weeks until the medication dose is stable at 50mg, and then meetings will occur 
biweekly. Additional physician visits may be scheduled if you experience side effects or do not 
follow the recommended medication guidelines.  
 
All participants already received one session of Brief Advice to discuss information about their 
drinking, which occurred as part of standard care at the primary care clinic. Some participants, 
who may also receive additional behavioral interventions, will meet with a Behavioral Health 
Specialist, who will be a licensed mental health professional, for treatment starting at week 1. 
Those who receive four sessions of Motivational Enhancement Therapy will have sessions at 
weeks 1, 2, 4, and 8. This treatment will focus on discussing reasons to reduce drinking and ways 
to do so. Those who receive 12 sessions of Modified Behavioral Self-Control Therapy will have 
weekly sessions starting at week 1. This treatment will focus on reasons and strategies to reduce 
drinking.  
 
 
 


 
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Week 4, 8, and 12 Assessments:  
At week 4, 8, and 12 of the study, you will meet with a research assistant to assess your changes 
in drinking and progress in the study. These assessments will be approximately 30 minutes and 
can occur in-person or via televideo, based on your preference.  
 
At your week 4 assessment, you may be offered alternative treatment depending on your 
progress and need. For instance, if you initially chose to receive medication, you may have the 
option to switch to a different medication or receive a behavioral intervention in addition. If you 
chose to receive a behavioral intervention, you may be able to switch to receiving a medication. 
You will be able to discuss these options with the study clinician providing your initially chosen 
treatment and make a decision on whether or not you wish to change your treatment choice.  
 
Daily Online Questionnaires: 
Starting at week 1, all participants will receive daily questions via text message to assess the 
previous day’s drinking. As part of this study, you are agreeing to send and receive text messages 
on your mobile phone. You will receive text messages once a day. The texts you receive will 
contain a link that will direct you to a survey that will ask you questions about your drinking and 
will require a response from you. It will take approximately one minute to complete. You may 
not appreciate receiving a text message or its content at a particular time. If you do not wish to 
answer a particular question at the time you receive the message, you may skip it. The text 
messages will not identify you as someone who is taking part in a study on drinking reduction. 
The survey can only be opened by you using a unique code number. This unique code number 
will open the survey in your mobile web-browser. We will review all the ways to keep your 
phone secure if you decide to participate and are eligible. 
 
In case we have trouble contacting you: To be in the study, we will ask you to provide the 
names and contact information of two people. The only reason we will contact them is to help us 
locate you if you move or are otherwise non-responsive to our outreach. No other information 
about you will be given to them nor will we ask your contacts any questions. 
 
What are the risks of the research study? What could go wrong? 
There is the risk of a breach of confidentiality of the study data.  The study team has put 
measures in place to protect the confidentiality of study data to minimize risk. 
 
We will be collecting minimal personal data. Only your contact information will be recorded and 
it will be kept separate from the study data collected. All study data will kept on the Northwell 
Health password-protected, secured computers in secure databases or in locked file cabinets.    
 
Interviews/Questionnaires 
Some of the questions we will ask you are personal. You may feel embarrassed or stressed. You 
may ask to see the questions before deciding whether or not to take part in this study. All 
questionnaires will be conducted in a private and confidential setting. You will be able to end the 
questionnaire at any time if you experience any discomfort.  
 
 


 
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Daily Online Questionnaires 
If you do not have an unlimited text messaging plan, you may be charged for the text messages 
you send and receive in this study.  We will not compensate you for any charges you incur for 
text messages. As with any mobile phone, there is a risk that messages that you send and receive 
can be read by unintended individuals.  It is your responsibility to ensure your phone is 
appropriately secured and managed; however, we will provide you with ways to keep your 
messages confidential and your phone secured. 
 
Permission to contact you once the study is over (Optional): 
Sometimes, once the study is over, we realize we may have additional questions about your 
experience of change and being in the study. We are asking your permission to re-contact you 
after the study to ask you questions about your experience of change and being in the study. You 
may withdraw permission at any time—it will not affect your participation in the study. 
 
I consent to being re-contacted after my participation in the study is completed: 
□ Yes □ No                         Initials: __________  Date: __________ 
If you have any questions or believe that you have suffered an injury related to this research as a 
participant in this study, you should contact the Principal Investigator of the study, Dr. Jon 
Morgenstern at telephone number (516) 837-1694. 
 
What are the benefits of this research study? 
The possible benefits you may experience from the procedures described in this study include a 
reduction in problem drinking; however, this cannot be guaranteed. We expect that the findings 
of this research will help your primary care clinical team to recognize and treat excessive 
drinking and alcohol use disorders in primary care settings in the future.  
 
If you do not want to take part in this research study, what are your other choices? 
If you do not join this study, you have other choices for treatment. Talk to your doctor about 
your choices. Your other choices may include: 
 Standard treatment 
 Medication 
 Counseling 
 No treatment 
 
Currently, there are agencies that provide information about drinking to the public. A variety of 
types of treatment for alcohol use, including inpatient and outpatient rehabilitation programs, 
outpatient counseling, self-help groups, and medications, may be available to you through 
community organizations, treatment centers, or private practitioners. Medications such as 
disulfiram (Antabuse) and naltrexone (ReVia) are approved by the FDA to help reduce alcohol 
use and are available by prescription from a physician. If you would like, we can provide you 
with a list of available services in the community for more information about drinking or 
treatment for alcohol use. 
 
 


 
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Are there any costs for being in this research study?  
Because you will be receiving text messages as part of this study and may complete assessments 
using your smartphone, you may be subject to data overage usage charges per your smartphone 
data plan. If you choose to receive medication treatment as a part of this study, your insurance 
company may be billed for the cost of the medication and potential lab work costs. If you do not 
have insurance, or do not wish to have your insurance billed, the study will cover the costs of 
medication and bloodwork during the 12 weeks of the study.  
All assessment and behavioral intervention visits and procedures will be given to you at no cost. 
Neither you nor your insurance company will be billed for these visits.   
Will you receive any payments for participating in this research study? 
You will be paid up to a total of $80 for your time for being in this study. If you do not complete 
the entire study, you will be paid $20 for each study assessment session that you have completed. 
Payment will be made at the end of each assessment or when you end your participation.  
 
If the total payment you receive from Northwell Health, during this year, is equal to $600 or 
more, the payment is required to be reported to IRS.  Although this study does not pay $600, if 
you participate in other Northwell Health studies, it is possible your payment could end up 
totaling $600.  If this occurs, the payment you receive on this study will be reported to the IRS.   
In this case, you will be issued a 1099 form and be required to provide your social security 
number at that time for reporting purposes.  You will also be responsible for reporting this 
income while filing your tax return. 
 
What happens if you are injured while participating in this study? 
If you are hurt from being in the study, you will receive medical care and treatment as needed 
from Northwell Health. However, you will be responsible for the costs of such medical 
treatment, directly or through your medical insurance or other forms of medical coverage. No 
money will be given to you.  
 
What are your rights as a research participant? 
Your participation in this project is voluntary. The quality of your medical care will be the same, 
whether you join, refuse to join, or decide to leave the study. 
 
If you do not join the study you will not be penalized or lose benefits to which you are entitled. If 
you join the study, you may withdraw at any time without prejudice to your future care at 
Northwell Health. Follow-up examinations may be needed to assure your well-being.   
 
Could you be taken off the study before it is over? 
It is also possible that your participation in this study may end without your consent.  This 
decision may be made by a researcher, study sponsor or the Institutional Review Board (IRB—
the  committee that oversees research at this institution).    
 
Reasons for withdrawal may include:   
 failure to follow instructions,  
 failure to show up for study visits,  


 
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 it is not in your best interest to continue on this study, or  
 the study is stopped.   
 
If you withdraw from this study or if you are withdrawn from the study, any data already 
collected will continue to be used.  However, no new data will be collected.   
 
What happens if new information is learned? 
You will be told of any new findings that may change your decision to continue to participate. 
Your consent to continue to take part in this study may be obtained again.   
 
What information will be collected and used for this study? 
If you agree to be in this study, we will collect information about your health and your alcohol 
use. We may collect the results of questionnaires and interviews. This information may include 
questions about the amount of alcohol you drink, how often you drink, any problems you have 
experienced because of drinking, and any reasons why you may have trouble accessing treatment 
services. If you drop out of treatment, we may ask you why, so that we can learn from your 
experiences. We will only collect information that is needed for the research. This information 
has been described in this consent form. If you sign this consent form, you are giving us 
permission to collect, use and share your health information. This permission is called 
authorization. If you do not want to provide authorization, then you cannot participate in this 
research study 
 
Who else will see your information?  
Study records that identify you will be kept private. You will not be identified in study records or 
publications disclosed outside Northwell Health, except as detailed below.  
 
Investigators will share de-identified information collected from this research study with: 
 study sponsor and/or its agents,  
 data safety monitoring board, 
 clinical staff not involved in the study who may be involved in the participant's treatment 
 
The following reviewers may access your study and medical records to make sure that this study 
is being done properly:  
 Representatives from federal and state government oversight agencies, such as National 
Institutes of Health, US Department of Health and Human Services (DHHS), or the New 
York State Department of Health. Representatives from Northwell Health Human 
Research Protection Program (a group of people that oversee research at this institution) 
 
We will do our best to protect the privacy of your records, but it is possible that once information 
is shared with people listed on this form that it may be released to others. If this happens, your 
information may no longer be protected by the federal law. 
 
In the future, we may publish results of this study in scientific journals and may present it at 
scientific meetings. If we do we will not identify you.  
 


 
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If the researchers learn about potential serious harm to you or someone else or other public 
health concerns, it will be shared with the appropriate authorities. 
 
Will you be able to access your records? 
If your research records are used for decisions related to your clinical care, then you have the 
right to review this information and request changes. This is limited to information about your 
treatment, and does not include information related to procedures or tests that are for research 
purposes only. You may access this information only after the study analysis is complete. You 
have the right to know who has and who will see your records. To request this information, 
please call the Human Research Protection Program at 516-321-2100. 
 
How long will your health information be kept?  
There is no limit on the length of time we will keep your information for this research because it 
may be analyzed for many years. We will keep it as long as it is useful, unless you decide you no 
longer want to take part or we close the study.  You are allowing access to this information 
indefinitely.   
 
Can you change your mind? 
If you change your mind about being in the study, you may withdraw at any time. If you want us 
to stop collecting your health information, you can send a letter to the researcher at the following 
address: 
Dr. Jon Morgenstern 
1010 Northern Boulevard, Suite 311 
Great Neck, N.Y., 11021 
 
Your letter needs say that you have changed your mind and do not want the researcher to collect 
and share your health information. You may also need to leave the research study if we cannot 
collect any more health information. We may still use the information we have already collected. 
We need to know what happens to everyone who starts a research study, not just those people 
who stay in it. 
 
 We may write about this study and publish it in a scientific journal, however you will not be 
named and all participants’ data will be combined such that no one participant is written about.  
 
Will information about this study be available to the public? 
We may write about this study and publish it in a scientific journal; however, you will not be 
named and all participants’ data will be combined such that no one participant is written about. 
In addition, a description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This website will not include information that can identify you. At 
most, the website will include a summary of the results. You can search this website at any time. 
 
Does the investigator of this study receive money if you take part?   
Funding for this research study is provided by the National Institute of Alcohol Abuse and 
Alcoholism. The investigators on this study receive money to conduct the study but do not 
financially benefit from your participation.  The money they receive is to pay them back for the 
costs of conducting the research study.  If your doctor is an investigator for this study s/he is 


 
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interested in both your healthcare and the conduct of this research. You do not have to take part 
in a research study conducted by your doctor. 
 
Who can answer your questions about this study? 
If you have any questions about the study, you may call Dr. Jon Morgenstern at (516) 837-1694. 
If you have questions about side effects or injury caused by research you should call Dr. Jon 
Morgenstern at (516) 837-1694. If you need emergency care, dial 911 or go to the nearest 
Emergency Room. If you have questions about your rights as a research participant, concerns 
about being in the study, or would like to offer input, you may contact the Office of the 
Institutional Review Board (the committee that oversees research at this institution) at (516) 321-
2100.  
 
A signed copy of this consent form will be given to you. 
 
 
Research Review Questionnaire 
After reviewing the consent form for this study please answer the following questions by circling 
“True” or “False”. The researchers doing this study want to be sure that you know what is 
involved in being in this research study. This questionnaire will help them make that decision. 
You may ask questions of the researcher and review the consent form again at any time. 
 
This study will last for 12 weeks. 
 
 
 
 
 
 
True 
False 
 
I am being asked to participate in a research study.  
 
 
 
True   False 
 
I will be required to take medication as part of this study. 
 
 
 
True   False 
 
This study involves the use of a text messaging. 
 
 
 
 
True   False 
 
I can withdraw from participating in this study at any time.  
 
 
True   False 
 
There are no risks to me from participation in this study.  
 
 
 
True   False 
 
My participation in this study is confidential and a unique code will  
identify me when I complete questionnaires online.     
 
 
 
True 
False 
 
 
 
 
[Signature Page Follows] 
 


 
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Summation/Signature 
 
You have read the above description of the research study. You have been told of the risks and 
benefits involved and all your questions have been answered to your satisfaction. A member of 
the research team will answer any future questions you may have. You voluntarily agree to join 
this study and know that you can withdraw from the study at any time without penalty. By 
signing this form, you have not given up any of your legal rights. 
  
____________________________________________________________ 
Printed Name of Participant   
 
 
___________________________________________________             ______________ 
Signature of Participant 
   Date 
 
_______________________________             ____________________  __________ 
Witness’s Printed Name 
 
 
    Witness’s Signature 
  Date 
(Note: A witness can be a member of the research team, but cannot be the same person signing 
consent as the investigator) 
  
 
Investigator’s Statement  
In addition to advising the above participant of other forms of treatment and therapy which are 
appropriate, I have offered an opportunity for further explanation of the risks and discomforts 
which are, or may be associated with this study and to answer any further questions relating to it. 
 
_________________________________               ____________ 
Investigator’s signature                                                Date  
  
_____________________________________________ 
Investigator’s printed name