A Pilot Study of N-acetylcysteine for Alcohol Use Disorder
Phase: PHASE2
Conditions: Alcohol Use Disorder
Sponsor: Uniformed Services University of the Health Sciences

A pilot study of N-acetylcysteine for alcohol use disorder 
 
NCT number: NCT04964843 
 
Document date: 10/04/2021 

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NAC Informed Consent for Breathalyzer
Title: A pilot study of n-acetylcysteine for alcohol use disorder
Principal Investigator: Joshua C. Gray, PhD
At the beginning of each in-person study appointment, you will be given a breathalyzer test to 
ensure that your blood alcohol content (BAC) is 0, meaning that you have not come to the study 
appointment intoxicated. A member of the study team will instruct you to blow into the 
breathalyzer. If your BAC is 0, you will proceed with the study procedures. If your BAC is 
above 0, the study team member will have you wait a few minutes and blow into the breathalyzer 
again. If your BAC is between .01 and .049, we will ask you to stay at the study location for your 
safety until it is below that threshold. If you refuse to wait, we will reschedule your study 
appointment and you can leave. Furthermore, if your BAC is >.05, you will be transported to 
the WRNMMC Emergency Department to assess potentially dangerous alcohol 
withdrawal. If you refuse, we may need to contact the local police to inform them of the 
situation. For military personnel, there is a risk that your command could be informed by the 
Emergency Department of your intoxication. There is a potential for increased medical cost if 
you are brought to the ER and have lost your DoD healthcare beneficiary status since the start of 
the study.
IF THERE IS ANY PORTION OF THIS DOCUMENT THAT YOU DO NOT 
UNDERSTAND, ASK THE INVESTIGATOR BEFORE SIGNING.  
SIGNATURE OF PARTICIPANT 
By signing below, I agree that I have been provided time to read the information describing the research 
study in the breathalyzer consent form. The content and meaning of this information has been explained 
to me. I have been provided with the opportunity to ask questions. I voluntarily consent to participate in 
this portion of the study.
By signing this form, I have not given up any of my legal rights as a research participant.
________________________________________
Printed Name of Participant
_______________________________________
______________
Signature of Participant
Date
SIGNATURE OF INDIVIDUAL ADMINISTERING CONSENT
(Can only be signed by an investigator or staff approved to administer consent)
_______________________________________
Printed Name of Administering Individual
_____________________________________
______________

		
	
		
					

Signature of Administering Individual
Date

		
	
		
					

(Insert Protocol Reference Number)
Version #____, Date: 2/27/2020
You may be eligible to take part in this research study. This form gives you important information about 
the study.  
Please take time to carefully review this information. You should talk to the researchers about the 
research study and ask them any questions you have. You may also wish to talk to others (for example, 
your friends, family, or your personal physician) about your potential participation in this research 
study. You do not have to take part in this study. Participation is voluntary. You may also leave the 
research study at any time without penalization.  
1. KEY INFORMATION:  
Your consent is being sought for this research study. This proposed study aims to assess the effects of 
N-acetylcysteine (NAC) on alcohol use disorder. Alcohol use disorder affects over 15 million adults, yet 
many of those affected do not significantly benefit from currently approved pharmacotherapies for 
alcohol use disorder. NAC is one promising pharmacotherapy for alcohol use disorder that has minimal 
side effects.
If you choose to participate, you will be randomized to take either placebo or 3000mg of NAC 
daily for 7 weeks. You will be asked to attend 5 in-person study sessions (this includes the session 
today). Today’s session will last approximately 3 hours. The other in-person sessions will last 
approximately 2 hours each. Additionally, you will be asked to complete 3 phone calls every other 
week, lasting 30 minutes each. You will receive a routine physical examination conducted by a 
physician to ensure you are eligible to participate and you will complete psychological and 
cognitive testing. You must have a blood alcohol content of 0 at each visit to participate which 
will be confirmed by a breathalyzer. This is an experiment testing a medication for alcohol use 
disorder, thus we do not know if it is helpful. If you are not active duty or a federal employee, 
you will be paid up to $265. However, please note that you will not receive payment on the day of 
your session and your payments can take up to 10 weeks to process. Risks of participating in this 
study include side effects of NAC; nausea, vomiting, and diarrhea. Alternative treatments include 
psychotherapy, inpatient treatment, outpatient treatment, and FDA-approved medications for 
alcohol use disorder. 
If you decide to take part in this research study, you will be asked to sign this document. Before you sign 
this document, be sure you understand what the research study is about in all sections of the consent 
form, including the risks and possible benefits to you.
Please tell the researchers if you are taking part in another research study.
2. WHAT IS THE PURPOSE AND DURATION OF THIS RESEARCH AND WHO WILL 
TAKE PART?
Uniformed Services University
CONSENT TO PARTICIPATE IN RESEARCH 
Title: A pilot study of N-acetylcysteine for alcohol use disorder
Principal Investigator: Joshua C. Gray, PhD

		
	
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(Insert Protocol Reference Number)
Version #____, Date: 2/27/2020
You are being asked to take part in this research study because you have alcohol use disorder, are 
open to reducing your drinking, and are a current or former patient of Addiction Treatment 
Services (ATS) at Walter Reed National Military Medical Center (WRNMMC). The purpose of 
this research study is to learn about the potential efficacy of an investigational drug, NAC, for 
the treatment of alcohol use disorder. The duration of participation per visit is 3 hours for the 
baseline session, between 2 and 2.5 hours for the remaining in-person sessions, and 30 minutes 
per phone session. 
Study sessions during weeks 0 (i.e., today), 1, 3, 5, and 7 will take place in person at USU 
buildings 17 and 53. Study sessions during weeks 2, 4, and 6 will take place over the phone.
There will be about 50 people taking part in the study at USU, over a period of approximately 2-4 years. 
This research study involves an investigational drug called N-acetylcysteine (NAC). This means that is 
has not yet been approved or cleared by the Food & Drug Administration (FDA) for treating alcohol use 
disorder. However, the FDA has not objected to its use in this research study to learn more about its 
safety and/or effectiveness.
3. SCREENING PROCESS TO QUALIFY FOR PARTICIPATION IN THIS STUDY
Before you can take part in this study, you will need to have some tests and provide some 
information so that the Investigator can confirm that you qualify for the study. This is called the 
“Screening Process.” You will undergo a physical examination completed by a physician, who is 
an associate investigator on the study. You will not be eligible to participate if the physical 
examination reveals a serious medical condition that contraindicates your participation or if you 
are pregnant as verified by a pregnancy test. Further, if you are pregnant, you will be instructed 
to contact your primary care provider to confirm the results and discuss the risks of alcohol use 
during pregnancy. Additionally, you must be between the ages of 18 and 74 to participate. 
4. WHAT WILL HAPPEN IF YOU DECIDE TO BE IN THIS RESEARCH?
You will be randomly assigned to receive NAC or placebo. You will be asked to take the medication 
twice daily for 7 weeks. You will be assessed weekly on your drinking habits, craving, depression and 
anxiety symptoms, adverse events, and cognitive functioning. Study sessions during weeks 0 (i.e., 
today), 1, 3, 5, and 7 will take place in person at USU buildings 17 and 53. During weeks 0, 1, and 3, 
you will be asked to pick up your study medication at the Investigational Pharmacy, located in building 
9. Study sessions during weeks 2, 4, and 6 will take place over the phone. 
During the phone sessions you will be asked questions regarding your alcohol use and any 
potential side effects of the study medication. During the in-person sessions you will first be 
assessed for alcohol intoxication and adverse side effects. Then you will be asked to answer 
several questionnaires related to your consistency of taking the medication and psychological 
health. Finally, you will also be asked to complete several cognitive tasks and participate in an 
alcohol cue-reactivity task, where you are exposed to stimuli associated with alcohol in a virtual 
reality bar lab. During the week 3 in-person session, you will be asked to complete a virtual 
reality-based assessment. The virtual reality-based assessment will involve watching virtual 
scenes while we measure your responses, as described below. 

		
	
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					

(Insert Protocol Reference Number)
Version #____, Date: 2/27/2020
The virtual reality-based assessment will measure your alcohol cue reactivity by exposing you to 
situations with the use of virtual reality. Prior to the assessment, you will be asked several 
screening questions to assess whether it will be safe for you to complete the virtual reality-based 
assessment. For the assessment, you will be asked to wear a head-mounted display, which is like 
a hat with mini-television screens in front of your eyes. A member of the research team will help 
you and will be present at all times. Scenario settings include bar scenes and other scenes related 
to drinking alcohol.  
You will be randomly assigned to one of 2 groups. Randomization is a process like flipping a 
coin and means you will have a chance of being assigned to either of the groups. One of the 
groups will receive NAC and the other group will receive the placebo. 
You will have a one in two chance of being in the placebo group. A placebo is an inactive, harmless 
substance, like a sugar pill, that looks like the research study medication but contains no medication.
This research study is a double-blind study, which means that neither you nor the research team 
will know whether you are receiving the research study medication or a placebo. In the event of 
an emergency, there is a way to find out which one you are receiving. At the end of the study, 
you will not learn whether you received placebo or NAC due to possible issues with unblinding 
the study team.
5. WHAT ARE THE RISKS OR DISCOMFORTS FROM BEING IN THIS RESEARCH?
If you choose to take part in this study, there is a risk of someone getting access to the information 
researchers have stored about you. We have detailed precautionary measures we are taking in Section 
15.
There is a chance that you could face legal consequences for public intoxication if you present 
intoxicated at the security gate before your study visit. Additionally, at the beginning of each 
session you will be administered a breathalyzer to check your blood alcohol content (BAC). If 
your BAC is between .01 and .049, we will ask you to stay at the study location for your safety 
until it is below that threshold. If you refuse to wait, we will reschedule your study appointment 
and you can leave. Furthermore, if your BAC is >.05, you will be transported to the WRNMMC 
Emergency Department to assess potentially dangerous alcohol withdrawal. If you refuse, we 
may need to contact the local police to inform them of the situation. For military personnel, there 
is a risk that your command could be informed by the Emergency Department of your 
intoxication. There is a potential for increased medical cost if you are brought to the ER and have 
lost your DoD healthcare beneficiary status since the start of the study.
There is a chance that your payment could be withheld under certain circumstances. If you owe 
money to the government, your payment for study participation may be applied to that debt and 
not sent to you.
We may also break confidentiality to inform ATS of matters that they were previously unaware 
of that may impact your safety (e.g., previously undisclosed intent to attempt suicide).
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The safety of this drug in humans has been tested in prior research studies and it is FDA 
approved for the treatment of acetaminophen poisoning. However, please note that this drug is 
not approved for alcohol use disorder. This research study will test the preliminary effectiveness 
of this drug taken by mouth as well as the tolerability in a population of adults with alcohol use 
disorder.
Side effects are uncommon and relatively minor. The most frequently reported side effects are 
nausea, vomiting, and diarrhea. Rarely and primarily with intravenous administration, 
anaphylactic reactions may occur and can consist of rash, itchiness, swelling, difficulty 
breathing, rapid heart rate and high or low blood pressure. Finally, given the limited reports on 
NAC in pregnant and lactating women, it should not be used in this population in the context of 
research. The use of birth control is recommended to avoid pregnancy.
Sources: 1) FDA approved acetylcysteine labels 
(https://dailymed.nlm.nih.gov/dailymed/index.cfm)
2) Minarini, A., Ferrari, S., Galletti, M., Giambalvo, N., Perrone, D., Rioli, G., & Galeazzi, G. 
M. (2017). N-acetylcysteine in the treatment of psychiatric disorders: current status and future 
prospects. Expert opinion on drug metabolism & toxicology, 13(3), 279-292.
Although efforts are made to protect your research study records, there is always a risk that someone 
could get access to the medical information contained in your research records or other information 
researchers have stored about you.
It is not known whether NAC can cause birth defects or other problems in an unborn child. If you 
become pregnant or feel you might be pregnant, contact your personal physician and the principal 
investigator of this study listed in the Contact Information section at the end of this document.
There is a chance that you could experience side effects such as nausea, motion sickness, eye strain, or 
seizures while completing the virtual reality-based assessment. Symptoms of virtual reality exposure can 
persist and become more apparent hours after use. These symptoms may put you at an increased risk of 
injury when engaging in normal activities such as driving, operating machinery, or engaging in other 
demanding activities. Because virtual reality is new, there may be other risks that are currently 
unknown. 
DoD-affiliated personnel (military or federal civilian employees) with any concerns about study 
risks and fitness for duty should seek command or Component guidance before participating. 
There may also be other risks of taking part in this study that we do not yet know about.
6. WHAT ARE THE POSSIBLE BENEFITS FROM THIS RESEARCH?:
The possible benefits to you as a research participant in this research study are that NAC may help with 
alcohol use disorder symptoms and co-occurring depression or anxiety. However, there is no guarantee 
that you will benefit from being in this research.
7. WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS RESEARCH?
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There may be other options for treating alcohol use disorder. Alternative treatments and/or procedures 
that may be available to you include: psychotherapy, inpatient treatment, outpatient treatment, and FDA-
approved medications for alcohol use disorder. You should talk with your personal physician (if 
applicable) about these options. 
Choosing not to take part in this research study is also an option. There may be other research studies 
involving experimental treatments that could be helpful to your condition.
8. IS THERE COMPENSATION FOR YOUR PARTICIPATION IN THIS RESEARCH?
Non-active duty/non-federal employees will receive a maximum compensation of $265 for 
completing this study. Payment will be provided in a form of a check or ACH payment after the 
study visit is completed. We will collect your social security number, name, address, and 
banking information on a form in order to complete your payment. You will be given the option 
to either a) complete this form at the end of your appointment; b) complete this form 
electronically and send to us by email; or c) print and fill out this form and send to us by mail. It 
may take up to 10 weeks to clear your payment. We understand this is inconvenient, but this is 
the only way we are able to pay you. Please be aware that this payment is taxable and may be 
withheld if you owe money to the government. The following payment schedule will be used for 
non-active duty/non-federal employees:
Baseline visit (1): $60
In-person visits (4): $40 each.
Phone Calls (3): $15 each.
Even if you are an off-duty federal employee you may not be compensated because this study is 
funded by a federal source (DoD).
9. ARE THERE COSTS FOR PARTICIPATING IN THIS RESEARCH?
Yes, there are costs to you for taking part in this research study. These include the costs to travel to the 
study sessions. 
10. PRINCIPAL INVESTIGATOR (the person(s) responsible for the scientific and technical 
direction of the study): 
Dr. Joshua C. Gray
Assistant Professor
Department of Medical and Clinical Psychology
Uniformed Services University
nacstudy@usuhs.edu
(301) 941-7908
11. STUDY SPONSOR (the organizations or persons who oversee the study and are responsible 
for analyzing the study data): 
USU is the sponsoring organization.
As the sponsor of this research, the Department of Defense may have access to your research data in 
accordance with DoDI 3216.02. 
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12. SOURCE OF FUNDING:
This study is funded by USU start-up funding and also potentially from other grants which are 
currently being reviewed.
13. LOCATION OF THE RESEARCH: 
Uniformed Services University, buildings 17 and 53.
14. DISCLOSURE OF FINANCIAL INTERESTS AND OTHER PERSONAL 
ARRANGEMENTS:
No members of the research team have financial interests to disclose.
15. WHO WILL SEE MY INFORMATION (PRIVACY) AND HOW WILL IT BE PROTECTED 
(CONFIDENTIALITY)? 
Records of your participation in this research study may only be disclosed in accordance with state and 
federal law, including the Federal Privacy Act, 5 U.S.C.552a, and its implementing regulations. DD 
Form 2005, Privacy Act Statement - Military Health Records, contains the Privacy Act Statement for the 
records. A copy of DD Form 2005 can be given to you upon request, or you can read on-line at:  
https://www.esd.whs.mil/Portals/54/Documents/DD/forms/dd/dd2005.pdf
The research team will keep your research records. These records may be looked at by staff from the 
Uniformed Services University, the Institutional Review Board (IRB), and the DoD Higher Level 
Review as part of their duties. These duties include making sure that the research participants are 
protected. Confidentiality of your records will be protected to the extent possible under existing 
regulations and laws but cannot be guaranteed.
Procedures to protect the confidentiality of the data in this study include but are not limited to 
records will be protected with data encryption technology, computer passwords, and locked 
cabinets. Participants will be assigned a subject ID to prevent the release of personally 
identifying information. 
Researchers will make every effort to protect your privacy and confidentiality; however, there are risks 
of breach of information security and information loss.
If applicable, a description of this clinical trial will be available on http://www.ClinicalTrials.gov
as required by U.S. Law. This web site will not include information that can identify you. At most, the 
web site will include a summary of results. You can search this web site at any time. 
We may share your data with outside researchers, collaborators, or as a part of the publication of the 
research findings, but only after all information that can identify you has been removed. This data may 
be used for a variety of research purposes that we may not be able to specify at this time. Complete 
confidentiality cannot be promised for military personnel, because information regarding your health 
may be required to be reported to appropriate medical or command authorities to ensure the proper 
execution of the military mission, including evaluation of fitness for duty.   
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The USU study team will have access to your records and agree to safeguard your protected health 
information by using and disclosing it only as permitted by you in this consent or as directed by state 
and federal law. 
Information gained from your participation in this research study may be published in literature, 
discussed for educational purposes, and used generally to further science. You will not be personally 
identified when your information is shared in these ways; all information will be de-identified.
For this research study, a Department of Health and Human Services (DHHS) Certificate of 
Confidentiality is in place to protect your privacy such as your name or other identifying 
information from being disclosed in any civil, criminal, administrative, legislative or other 
proceedings, whether at the federal, state or local level. The Certificate cannot be used to resist a 
demand for information from personnel of the U.S. Government that is used for auditing or 
evaluation of Federally-funded projects or for information that must be disclosed in order to meet 
the requirements of the Food and Drug Administration (FDA). Further, the researcher is not 
prevented from disclosure for reporting matters such as family abuse, sexual assault, reportable 
communicable diseases, a participant’s threatened violence to self or others, or as military 
regulations may require. You should understand that the Certificate of Confidentiality does not 
prevent you or a member of your family from voluntarily releasing information about yourself or 
your involvement in this research. If an insurer, employer, or other person obtains your written 
consent to receive research information, then the researchers may not use the Certificate to 
withhold that information. 
16. LONG TERM USE OF DATA 
The investigator has requested to save selected data collected from your participation in this research 
study for possible use in future research. Identifiers will be removed, and de-identified information may 
be used or shared for future research. If you do not want your deidentified data to be used long term, you 
should not consent to participate in this study. 
Any future research using your retained data will require a research protocol for the proposed study 
approved by an Institutional Review Board (IRB) (a committee responsible for protecting research 
participants) or other authorized official responsible for protecting human subjects of research. The data 
protections for privacy and confidentiality described in this consent form will apply to any future use of 
your stored data.
17. USE OF INFORMATION AND SPECIMENS
During this research study, you could be asked to provide the following types of samples (biological 
specimens): urine for a pregnancy test. Identifiers will be removed from all biospecimens given in this 
study and they will not be used or shared.
The information that we obtain from you for this study might be used for future studies. We may remove 
anything that might identify you from the information. If we do so, that information may then be used 
for future research studies or given to another investigator without getting additional permission from 
you. 
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Upon publication of research findings, deidentified data may be made publicly available to anyone 
consistent with an increasing number of journal policies. This enhances replicability, data aggregation, 
and potential scientific progress. For examples/further discussion, see:
https://journals.plos.org/plosone/s/data-availibility
https://www.frontiersin.org/articles/10.3389/fpubh.2017.00327/full
18. INCIDENTAL FINDINGS
There is a possibility that during your physical exam we may see an abnormality that we did not expect 
to see in this study. This is what is called an "incidental finding."
We will let you know if we see such an incidental finding. Depending on the type of incidental finding, 
we may contact you by phone. In the case of a potential serious emergency, the researcher will inform 
you right away.
We will also give information about this incidental finding to your primary doctor. We will request your 
primary doctor’s contact information in order to inform them. 
•
An incidental finding may cause you to feel anxious
•
Since an incidental finding will be part of your medical record, you could face greater difficulty 
in getting health or life insurance
The costs for any care that will be needed to diagnose or treat an incidental finding would not be paid for 
by this research study. These costs would be your responsibility. If you are a DoD beneficiary, you will 
have access to care through standard Military Health System and TRICARE procedures.
A qualified person (usually a member of the research team) will talk to you if there is an 
incidental finding.
If we determine that you are in an acute psychological emergency, the principal investigator, Dr. 
Gray, will speak with you to confirm the emergency and have you escorted to the WRNMMC 
Emergency Department.
19. VOLUNTARY PARTICIPATION
The decision to take part in this research study is completely voluntary on your part which means you do 
not have to take part if you do not want to. You may also leave the research study at any time. If you 
choose not to take part in this research study or if you leave the study before it is finished, there will be 
no penalty or loss of benefits to which you are otherwise entitled.  
You will be informed if significant new findings develop during the course of this research study that 
may relate to your decision to continue participation.
20. WHAT HAPPENS IF I WITHDRAW FROM THIS RESEARCH?
Should you choose to withdraw, you must email the research team at nacstudy@usuhs.edu or 
call (301) 941-7908. There are no known risks of withdrawing from the treatment medication, 
however, we ask that you please contact us prior to withdrawing from the study or medication. If 
you decide to no longer participate in this research study, the researcher will keep your 
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deidentified data that was part of this research study. You may withdraw your consent at any 
time and stop participating in this research study without affecting your eligibility for care, status 
in the military, or any other benefits to which you are entitled.
If you are receiving treatment as part of this research study, you will no longer be eligible for such 
research-related treatment. Contact your personal physician to discuss medical treatment for your 
condition.
The principal investigator of this research study may terminate your participation in this research study 
at any time if he determines this to be in your best interest, if you are unable to comply with the 
procedures required, or if you no longer meet eligibility criteria.
21. WHAT HAPPENS IF YOU ARE INJURED AS A RESULT OF THIS RESEARCH? 
If you think that you have a research-related injury, notify your Principal Investigator immediately using 
the contact information in the section below.  
If you are injured because of your participation in this research and you are a DoD healthcare 
beneficiary (e.g., active duty military, dependent of active duty military, retiree), you are authorized 
space-available medical care for your injury within the DoD healthcare system, as long as you remain a 
DoD healthcare beneficiary. This care includes, but is not limited to, free medical care at DoD hospitals 
or DoD clinics.
If you are injured because of your participation in this research and you are not a DoD healthcare 
beneficiary, you are authorized space-available medical care for your injury at a DoD hospital or an 
DoD clinic; medical care charges for care at a DoD hospital or a DoD clinic will be waived for your 
research-related injury. If you obtain care for research-related injuries outside of a DoD or DoD hospital 
or clinic, you will not be reimbursed for those medical expenses.
For DoD healthcare beneficiaries and non-DoD healthcare beneficiaries: Transportation to and from 
hospitals or clinics will not be provided or paid for by DoD. Unless you are covered by TRICARE, no 
DoD reimbursement is available if you incur medical expenses to treat research-related injuries.  No 
compensation is available for research-related injuries. You are not waiving any legal rights. 
22. CONTACT INFORMATION:
Principal Investigator (PI)
The Principal Investigator or a member of the research staff will be available to answer any questions 
throughout this study.
Principal Investigator: Dr. Joshua C. Gray
Phone: (301) 941-7908
Mailing Address: 
Uniformed Services University
Department of Medical and Clinical Psychology 
4301 Jones Bridge Rd
Bethesda, MD 20814
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Uniformed Services University Human Research Protection Program (HRPP) Office
The Human Research Protection Program Office Point of Contact and/or Human Protections 
Administrator (HPA) will be available to answer questions or discuss concerns you may have about this 
research study.  
Human Protections Administrator/HRPP POC:  Petrice Longenecker, PhD, CIP
Phone:  301-295-0819
Institutional Review Board (IRB) Office
If you have any questions about your rights as a research participant or if you have concerns or 
complaints about the research study, please contact the IRB Office at: (301) 319-4730 
Uniformed Services University
Human Research Protections Program Office
4301 Jones Bridge Rd
Bethesda, MD 20814
IF THERE IS ANY PORTION OF THIS DOCUMENT THAT YOU DO NOT UNDERSTAND, ASK 
THE INVESTIGATOR BEFORE SIGNING.  YOU MAY CONSULT WITH YOUR PERSONAL 
PHYSICIAN OR LEGAL ADVISOR, IF YOU WISH.
A signed and dated copy of this document will be given to you.
SIGNATURE OF PARTICIPANT 
By signing below, I agree that I have been provided time to read the information describing the research 
study in the consent form. The content and meaning of this information has been explained to me. I have 
been provided with the opportunity to ask questions. I voluntarily consent to participate in this study.
By signing this form, I have not given up any of my legal rights as a research participant.
________________________________________
Printed Name of Participant
________________________________________
______________
Signature of Participant
Date
SIGNATURE OF INDIVIDUAL ADMINISTERING CONSENT
(Can only be signed by an investigator or staff approved to administer consent)
 
_______________________________________
Printed Name of Administering Individual
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________________________________________
______________
Signature of Administering Individual
Date
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UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES
4301 JONES BRIDGE ROAD 
BETHESDA, MARYLAND 20814-4799
www.usuhs.edu
October 05, 2021
MEMORANDUM FOR JOSHUA GRAY, Ph.D., DEPARTMENT OF MEDICAL AND 
CLINICAL PSYCHOLOGY
SUBJECT: USU Institutional Review Board (IRB) (FWA 00001628; DoD Assurance P60001) 
Approval of Protocol USUHS.2020-040 for Human Subjects Participation
The Initial Review (Reference No. 922575) for your human subjects research protocol 
USUHS.2020-040, entitled "A pilot study of N-acetylcysteine for alcohol use disorder," was 
reviewed by the full Institutional Review Board on September 23, 2021 and Approved as 
minimal risk pending revisions. These revisions have been reviewed and approved by Edmund G 
Howe, MD, JD, Chair IRB. The date of this approval is October 04, 2021. This approval will be 
reported to the USU IRB #1 scheduled to meet on October 14, 2021.
FDA determination: Abbreviated IND. 
Documents reviewed for this study:
1)
EIRB Protocol Template, version 1.7
2)
Informed Consent Document, version 1.10
3)
Breathalyzer Consent, version 1.2
4)
Phone Screen, version 1.5
5)
Email template for upcoming phone calls, version 1.0
6)
Email template for upcoming in-person appts 2-7, version 1.0
7)
Email template for baseline appt, version 1.10
8)
LOS from WRNMMC emergency department, version 1.0
9)
Protocol Script, version 1.8
10)
Assessment Appendix, version 1.7
11)
Flowchart checklist, version 1.2
12)
ATS email stating study team can visit ATS to recruit, version 1.0
13)
COVID screen phone call, version 1.0
14)
COVID screen questions, version 1.0
15)
Business card for participants to give to their provider, version 1.0
16)
CoC approval, version 1.0
17)
Flyer, version 1.5
18)
Physical and Mental Health Resources, version 1.1
19)
Suicide Ideation Protocol, version 1.2
20)
VR images, version 1.0
21)
ATS LOS, version 1.0
22)
IND sample label, version 1.1
23)
FDA email correspondence, version 1.0
24)
Letco capsule information, version 1.0
25)
IND, version 1.0
Learning to Care for Those in Harm’s Way
v.6/27/18

SUBJECT: USU Institutional Review Board (IRB) (FWA 00001628; DoD Assurance P60001) 
Approval of Protocol USUHS.2020-040 for Human Subjects Participation
26)
Research monitor medical license, version 1.0
27)
Pharmacy Impact Statement, version 1.0
28)
Scientific Review Checklist_fillable_2019-02-twbCW_JCG (1), version 1.0
29)
Study team documentation (CV, COI forms, CITI training certificates)
The Principal Investigator is required to provide study participants with a written statement 
regarding the research.
Should your project involve:
Accessing Defense Health Agency (DHA) databases, activities cannot commence until a DHA 
Data Sharing Agreement (DSA) has been executed.
Information Collections (e.g., surveys, focus groups, interviews), OMB clearance and/or RCS 
licensing may be required. Please work with the HRPP Office staff for assistance.
As a reminder, it is your responsibility to ensure all applicable protocol related approvals have 
been obtained prior to initiating study activities.
Authorization to conduct protocol USUHS.2020-040 will automatically terminate on 22 
September 2022. If you plan to continue data collection or analysis beyond this date, IRB 
approval for continuation is required. Please submit an application for continuing approval to the 
IRB Office 60 days prior to your termination date.
You are required to: report to the USU IRB after four (4) patients have completed the 
second in-person study visit, and when you implement the reporting SOP for Blood Alcohol 
Content (BAC) equal to or greater than 0.05; submit amendments to this protocol, changes to 
the informed consent document (if applicable), adverse event reports, and other information 
pertinent to human research for this project. No changes to this protocol may be implemented 
prior to IRB approval. If you have questions regarding this IRB action or questions of a more 
general nature concerning human participation in research, please contact Nikolaos Tountas, 
PhD, at (301) 319-0445 or nikolaos.tountas.ctr@ushus.edu.
Digitally signed by
TOUNTAS.NIK
OL
TOUNTAS.NIKOLAOS.13908
499 70
AOS.1390849970 Date: 2021.10.05 11:05:27
-04'00'
Nikolaos Tountas, PhD 
IRB Analyst
USU HRPP Office