Interactions of Alcohol and Opioids: Pharmacodynamic Effects
Phase: PHASE1
Conditions: Opioid Use, Alcohol Drinking
Sponsor: Sharon Walsh

Document Coversheet 
 
 Study Title: Interactions of Alcohol and Opioids: Pharmacodynamic Effects 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
9/2/2025 
NCT Number: 
NCT04300751 
IRB Number 
55176 
Coversheet created: 
10/13/2025 
 
 

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Opioids & Alcohol – Main Study – Walsh – V8.0 
 
 
Consent and Authorization to Participate in a Research Study 
KEY INFORMATION FOR 
MAIN STUDY CONSENT: 
THE BEHAVIORAL EFFECTS OF OPIOIDS AND ALCOHOL 
 
You are being invited to take part in a research study about the effects of alcohol and opioid (examples: 
oxycodone, tramadol, codeine, hydrocodone) medications when taken alone and in combination. We plan to 
screen approximately 75 participants and plan to have up to 18 complete the study. This page is to give you key 
information to help you decide whether to participate. We have included detailed information after this page. Ask 
the research team questions. If you have questions later, the contact information for the research investigator in 
charge of the study is below. 
 
 
 
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST? 
By doing this study, we hope to learn about the effects of opioids and alcohol, and their effects on mood and 
behavior. Your participation in this research will include an approximately 30-night stay at the UK hospital (you will 
not be allowed to leave or have visitors during this time) and a short (about 3 hours) follow-up appointment 
approximately 2 weeks after leaving the hospital. 
 
 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
There is no direct benefit to you for taking part in this study. Your willingness to participate may help us 
understand how alcohol and opioids affect your body, mood, and behavior. For a complete description of benefits, 
refer to Detailed Consent. 
 
 
 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
 
If you are not between the ages of 21 and 55, if you have any serious medical condition(s) (for example, diabetes) 
or if you experience withdrawal when not using opioid drugs or alcohol, you should not participate in this study. If 
you are pregnant, planning on becoming pregnant, or nursing, you should not participate. If you are seeking 
treatment for substance use, you should not participate, and we will help you find treatment. You may choose not 
to participate if you are not able to live at the UK hospital for about a month. Let us know if that is a concern for 
you. There are also risks related to the use of study medications—a complete description of risks, including a full 
list of study medication side effects, are listed in the detailed portion of the consent form. 
 
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer. 
 
 
 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study 
contact Sharon L. Walsh, Ph.D. of the University of Kentucky, Department of Behavioral Science and Center on 
Drug and Alcohol Research at (859) 257-6485. 
If you have any concerns or questions about your rights as a volunteer in this research, contact staff in the 
University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8am and 5pm EST, 
Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
IRB Approval
10/8/2024
IRB # 55176
IRB2

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Opioids & Alcohol – Main Study – Walsh – V8.0 
 
DETAILED CONSENT: 
 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You will not be allowed to participate in the study if you are: under 21 or over 55 years of age; pregnant, 
breastfeeding, or planning on becoming pregnant; seeking treatment for your substance use; you do not use 
opioids for non-medical purposes (to get high, feel relaxed), or do not drink alcohol. You will not be allowed to 
participate if you are physically dependent on opioids, benzodiazepine/sedative-like drugs, or alcohol; however, 
we will provide treatment referrals to you if you are seeking treatment for your drug/alcohol use. You will not be 
allowed to participate if the medical staff thinks that giving you the study drugs could be dangerous to your health. 
If you have any serious medical problems (e.g., a history of heart problems, breathing problems, head trauma, 
epilepsy, or seizures), you will not be allowed to participate in this study. If you decide that you do not want to 
participate or do not think the study will fit your schedule, you should not take part. 
 
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? 
If you are selected to participate, you will live at the UK hospital Center for Clinical and Translational Science 
(CCTS) Clinical Research Unit (CRU). During your stay you will participate in 10 sessions. Each session will last 
approximately 7 hours and you will typically participate in 2 or 3 sessions per week. You will live on the inpatient 
unit for approximately 1 month and participate in sessions for about 70 hours across the whole month. You will be 
given a calendar that will list the date of each session. On your days off from session, you can read, watch 
movies, and engage in recreational activities, but you will not be permitted to leave the hospital or have visitors. 
 
WHAT WILL YOU BE ASKED TO DO? 
If you agree to participate in the study, we will ask you to do the following things: 
1. Once you are medically cleared for the study, you will be admitted to the CCTS-CRU at the UK hospital. You 
may be asked to share a room with another volunteer of the same gender. 
2. You will need to follow the inpatient unit rules while you are in the study. If you do not follow the rules, you will 
be removed from the study – you will not receive a payment bonus if you are discharged for breaking rules. Some 
examples of these rules are: 
- You will not be allowed to have any visitors, but you will be able to make phone calls 
- You will be allowed to smoke cigarettes, but only under supervision of the CRU nursing staff in the 
outdoor designated smoking area 
- No sexual behavior or sexual intercourse for the duration of the study 
- No drug or alcohol use; you cannot use any drugs that are not given to you as part of the study 
3. After you are admitted to the inpatient unit, we will show you the session room where testing will take place. We 
will teach you how to use the computer and show you the kinds of questions you will be asked and tasks you will 
need to complete. You will have plenty of time to ask questions about how to perform any of the tasks. 
4. There will be a total of 10 sessions. The first session is a qualification session – this session will help us 
determine if you will qualify for the rest of the study. If you continue to qualify, you will complete 9 experimental 
sessions. You will receive a calendar with the actual dates of your sessions, but a sample calendar with session 
dates is provided below. A more detailed calendar can be found in the Appendix section at the end of this packet. 
 
Sample Study Calendar: 
 
Sunday 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
Saturday 
Week 1 
Admission 
Practice/ 
Training 
Session 1 - 
Qualification 
Session 2 
Week 2 
Session 3 
Session 4 
Session 5 
Week 3 
Session 6 
Session 7 
Session 8 
Week 4 
Session 9 
Session 10 
Discharge 
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5. The first session is a qualification session to help us determine if you will qualify for the rest of the study. During 
the qualification session, you will receive a capsule to swallow– this capsule will contain either an opioid drug, (for 
example: hydromorphone, oxycodone, morphine, or hydrocodone) or placebo (an inactive substance). After you 
complete this session, you will be informed whether you qualify to continue with the rest of the study. If you do not 
qualify, you will be discharged. If you qualify, you will complete 9 additional experimental sessions. 
6. During each of the 9 sessions, you will be asked to take capsules that contain a dose of an opioid drug (such 
as oxycodone, tramadol, codeine, hydrocodone). You will also be asked to drink a cocktail with or without an 
active dose of alcohol. Neither you nor the research staff will know what drug or alcohol dose you will receive on 
any particular day. 
7. During sessions, we will measure how you respond to each of the doses by recording things like heart rate, 
blood pressure, oxygen saturation, expired carbon dioxide, respiration rate, and pupil diameter. We will also ask 
you questions about how you are feeling. For example, we may ask you if you like the drug effects or if you are 
feeling sick. We will also ask you to complete tasks that measure your coordination and balance and look at 
blinking lights to test your eyes – this test will not harm your vision. 
You will also participate in a cold-water task during each session. We will ask you to place your arm into a cooler 
of cold water and tell us when you start to feel pain and when you no longer wish to tolerate it. When you can no 
longer tolerate the cold water, you can remove your arm from the cooler. This task will not cause any lasting 
harm, and the pain will subside within a few minutes. We will ask you several questions about the pain you 
experienced during the task. 
During session, you may engage in activities such as reading, as long as these activities do not interfere with the 
study or any of the scheduled tasks or questionnaires. 
8. On days when you are not in session, you will be asked to fill out questionnaires each day. For example, we 
will ask you about how you feel, whether you feel tired or have an upset stomach. The nurses will measure your 
vital signs (heart rate, blood pressure, etc.) several times every day. You will also give breath and urine samples 
every day, which will be tested for drugs and alcohol; women will be tested for pregnancy. 
9. If you are female, you will be tested regularly to see if you are pregnant. If the test is positive, you will be 
notified, discharged from the study, and referred for treatment. If you become pregnant at any time during the 
study (during screening, while you are in the hospital, in the time between study discharge and your follow-up 
appointment, or anytime in the 30 days after you leave the study), you will need to notify the study investigator 
(Sharon Walsh, Ph.D (859) 257-6485) or the study physician (Michelle Lofwall, M.D. (859) 323-9321). 
By signing this consent form you are agreeing to practice an effective method of birth control (e.g., oral 
contraceptives, intrauterine device, diaphragm, condom) for the entire study duration (prior to study admission 
through 30 days after study completion). 
10. After you have completed all sessions, you will be discharged from the study. We will ask you to complete a 
follow-up appointment approximately 2 weeks after discharge. We will ask you about your health and drug use. 
You will be paid $25. The follow-up appointment may be conducted over the phone or in person at the Robert 
Straus Behavioral Research Facility. 
11. At any point, if you decide that you want to seek treatment for your substance use, we will assist you in finding 
treatment. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
The risks and discomforts of this study are related primarily to the drugs given to you and the experimental 
procedures. We have carefully selected the doses to minimize the risk of serious side effects. Furthermore, some 
questions you will be asked throughout the study (about your medical, legal drug use history) may cause some 
discomfort. 
The likely/most common risks of receiving opioid drugs include dizziness, stimulation, restlessness, a feeling of 
well-being, talkativeness, itchiness, nausea, vomiting, headache, constipation, dry mouth, sweating, sleepiness, 
light-headedness, and mild decreased breathing. These occasionally occur after receiving an opioid. These 
effects typically will go away on their own after a few hours and do not require any treatment. You should be 
familiar with these effects as you have used opioids previously. The risks of decreased breathing after 
administration of opioid drugs is related to the dose administered, and we have carefully selected doses to 
minimize the chance of serious decreases in breathing. If a serious decrease in breathing were to occur, this 
would be considered a very rare event that can be treated immediately and effectively with medication. 
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The likely risks of receiving alcohol include nausea, vomiting, headache, flushing, stimulation, sleepiness, 
drowsiness, feeling tired, changes in heart rate and blood pressure, changes in motor coordination, reaction time, 
vision, balance, hearing, and speech. These occasionally occur after receiving alcohol depending on the amount 
you use. These effects typically will go away on their own after a few hours and do not require any treatment. 
We will watch you carefully throughout your participation to minimize the chance of any serious reactions. 
We do not have any plans to draw your blood or conduct an electrocardiogram (ECG) after the screening is 
completed. However, if you were to get sick or hurt during the study, we may need to conduct these tests. There 
are risks related to drawing blood during screening or any time. Soreness, bruising, pain and a small amount of 
bleeding are likely to occur; fainting and infection are more rare. It is possible that we may have to try more than 
once to draw blood (which is not uncommon). An ECG is painless. Approximately 12 sticky pads will be placed on 
your skin and your heart’s electrical activity will be measured. The electrodes may feel cold when first applied. In 
rare cases, some people may develop a rash or irritation where the patches were placed. 
Exposure to drugs and alcohol may have harmful effects on a fetus or a newborn, and you will not be allowed to 
participate in the study if you are pregnant, planning to become pregnant or breastfeeding during the study, or if 
you cannot use an appropriate contraception method. 
We will make every effort to keep private all research records that identify you to the extent allowed by law. 
However, there is a risk that a breach in confidentiality may occur. If this occurs, it may cause problems such as 
embarrassment and emotional stress. 
There is always a chance that any medical treatment can harm you. The research medications and procedures in 
this study are no different. In addition to risks described in this consent, you may experience a previously 
unknown risk or side effect. We will do everything we can to keep you from being harmed. 
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
You will not get any personal benefit from taking part in this study. However, if you take part in this study you may 
help us learn more about the effects of certain prescription opioids and alcohol when taken alone and together. 
 
IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
If you do not want to be in the study, there are no other choices except not to take part in the study. We can 
provide medical or drug treatment referrals to you if need them. 
 
WHAT WILL IT COST YOU TO PARTICIPATE? 
The study procedures and medications will be provided at no cost to you. 
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care and 
treatment that you would normally receive for any medical conditions you may have. These are costs that are 
considered medically necessary and will be part of the care you receive even if you do not take part in this study. 
The University of Kentucky will not be allowed to bill your insurance company, Medicare, or Medicaid for the 
medical procedures done strictly for research. 
 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
We will make every effort to keep confidential all research records that identify you to the extent allowed by law. 
Your information will be combined with information from other people taking part in the study. When we write 
about the study to share it with other researchers, we will write about the combined information we have gathered. 
You will not be personally identified in these written materials. We may publish the results of this study; however, 
we will keep your name and other identifying information private. We will collect your social security number; this 
is required in order for you to participate. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is. Your name will be kept separate from the information that you give, and 
these two things will be stored in different places under lock and key. Information collected electronically will be 
stored on password-protected computers. 
You should know that there are some circumstances in which we may have to show your information to other 
people because we are required to. 
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For example, the law may require us to share your information with: 
• 
a court or agencies, if you have a reportable disease/condition; 
• 
authorities, if you report information about a child being abused; or if you pose a danger to yourself or 
someone else. 
To ensure the study is conducted properly, officials of the Food and Drug Administration, the National 
Institutes of Health, the University of Kentucky, and the National Institute on Drug Abuse may look at or copy 
pertinent portions of records that identify you. 
Certificates of Confidentiality (CoC): 
To help us protection your privacy, this research has a Certificate of Confidentiality. The researchers can use this 
Certificate to refuse to disclose information that may identify you to anyone not connected with this study, or in 
any legal proceedings. The exceptions to this rule are release of information: 
• 
you have requested us to provide, for instance, to your insurance company or doctor; 
• 
to the sponsor (e.g., National Institutes of Health) or agency auditing the research (e.g., Food and 
Drug Administration); 
• 
about child or elder abuse, neglect, or harm to yourself or others; and 
• 
about you if it involves a reportable disease. 
This policy does not prevent you from releasing information about your own participation in this study. 
 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. If you choose to leave the study early, data collected until that point will remain in the study database 
and may not be removed. 
The investigators conducting the study may need to remove you from the study. You may be removed from the 
study if: 
• 
you are not able to follow the directions, 
• 
we find that your participation in the study is more risk than benefit to you, or 
• 
the agency paying for the study chooses to stop the study early for a number of scientific reasons. 
If you stop the study because of side effects from the medication or another health-related reason, we will follow 
up with you by telephone or request that you come visit us so we can see how you are doing. 
 
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is important to let the 
investigator know if you are in another research study. You should discuss this with the investigator before you 
agree to participate in another research study while you are in this study. 
 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should call 
Michelle Lofwall, MD, at (859) 323-9321 immediately. Dr. Lofwall will determine what type of treatment, if any, is 
best for you at that time. 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the 
cost of any care or treatment that might be necessary because you get hurt or sick while taking part in this study. 
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study. 
Medical costs related to your care and treatment because of study-related harm will be your responsibility. 
You do not give up your legal rights by signing this form. 
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Do you give your permission to be contacted in the future by Dr. Walsh and/or the research team regarding 
your willingness to participate in future research studies? 
□  Yes □  No 
Initials 
 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will receive payment for taking part in this study. You will receive $60 per night that you stay in the hospital. If 
you complete the study, you will receive an additional $60 for every night of your stay ($120/night if you 
complete). However, you will not receive this bonus if you are dismissed from the study, do not qualify after the 
qualification session is completed, or if you choose to quit the study before completion. 
 
The total amount of money that you could earn by completing this study is approximately $3,600. This estimate is 
based on the average length of stay of 30 nights ($120 x 30 inpatient nights = $3600); however, the number of 
days that you will stay may vary. This total does not include screening and follow-up payments. 
You will also receive $25 for your follow-up appointment scheduled approximately 2 weeks after your discharge 
from the study. 
 
UK policy only permits us to pay participants in $500 increments (meaning the maximum amount of each check is 
limited to $500 per day). You will be given your first payment at discharge. We will mail you the remainder of the 
checks. We will mail you $500 per check per day until you are fully paid. We will mail the checks to the address 
that you provide us or you can choose to pick them up in person if that is more convenient. 
 
For example, if you complete the study and earn $3,600, you will receive $500 on the day of discharge and then 
will receive seven $500 checks in the mail and a $100 check in the mail (7 x $500 + $100 = $3600); it will take 
approximately 2 weeks for you to receive all 8 checks. Alternatively, you are permitted to visit our office to pick up 
a check in-person during normal business hours Monday-Friday (closed on weekends, holidays). 
 
Study payments are considered taxable income reportable to the Internal Revenue Service (IRS). You will be 
asked to complete a W-9 form which includes your name, address and Social Security number. A form 1099 will 
be sent to you if your total payments for research participation are $600 or more in a calendar year. 
 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We may ask 
you to sign a new consent form if the information is provided to you after you have joined the study. 
 
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Generally, tests done for research purposes are not meant to provide clinical information. We will not provide 
you with individual research results. 
 
WILL WE CONTACT YOU WITH INFORMATION ABOUT PARTICIPATING IN FUTURE STUDIES? 
The research staff would like to contact you in the future with information about participating in additional studies. 
If so, it will be limited to approximately 4 times per year. 
 
 
WHAT ELSE DO YOU NEED TO KNOW? 
This study is funded by the National Institute of Health/National Institute on Drug Abuse. 
 
A description of this clinical trial will be available on 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. 
 
WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH? 
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OPTIONAL FUTURE USE: 
Do you give permission for Dr. Sharon Walsh to store your information for future research? 
□ Yes 
□ No 
Initials  
 
Remember, you can still be in the main study even if you even if you do not wish to allow your information stored 
for this investigator’s future research. 
STORING AND SHARING YOUR INFORMATION FOR FUTURE USE: 
The researchers would like to store, use, and share your identifiable information for future research use. Having 
information from many people helps researchers identify trends and discover better ways to diagnose, prevent, and 
treat many conditions. Researchers can use the stored information to learn more about substance use or research 
additional scientific questions. 
 
WHERE WILL INFORMATION OR SPECIMEN SAMPLES BE STORED AND FOR HOW LONG? 
The information will be stored at the Robert Straus Behavioral Research Facility for a minimum of 7 years. 
 
ARE THERE RISKS FROM ALLOWING YOUR INFORMATION OR SPECIMEN SAMPLES TO BE STORED 
FOR FUTURE RESEARCH? 
There is a risk that someone could get access to the stored information or samples. In spite of the security 
measures and safeguards we will use, we cannot guarantee that your identity will never become known. 
There may be risks that at this time are unknown. As technology advances, there may be new ways of linking 
information back to you that we cannot foresee now. 
 
HOW WILL YOUR PRIVACY AND CONFIDENTIALITY BE PROTECTED? 
Researchers will take careful steps to keep your information confidential. 
Researchers will store your identifiable information, in a password-protected database to protect it from being 
accessed by anyone outside of the approved staff. 
Researchers will remove your name or other direct identifiers from your information or samples. We will label your 
information or samples with a code and will store the key separately from the master code list. Only select staff will 
have access to the list that links the code to you. 
 
WHAT IF YOU CHANGE YOUR MIND AND WANT TO WITHDRAW YOUR INFORMATION OR SPECIMEN 
SAMPLES? 
You may withdraw your permission to allow your information or samples to be used for future research. To do so, 
you must send a written withdraw request to: 
Sharon L Walsh, Ph.D. 
845 Angliana Ave 
Lexington, KY 40508 
We will destroy any remaining information and samples that have been stored. In addition, it may be possible to 
destroy the code that links you with your information and specimen samples. However, we cannot withdraw the 
information and samples that have already been used. 
 
WILL YOU RECEIVE ANY COMMERCIAL PROFIT FROM FUTURE RESEARCH DISCOVERIES? 
The information and samples that you provide will no longer belong to you. The research may lead to new 
medical knowledge, tests, treatments, or products. These products could have some financial value. There are no 
plans to provide financial payment to you or your relatives should this occur. 
 
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE FUTURE RESEARCH TESTS? 
Tests done for research purposes are not meant to provide clinical information or help care for you. The results 
are only important for research. Therefore, the results of tests done with your information and samples will not be 
provided to you. In the rare event that a finding might affect the health of you or your family, we will contact you 
and you can choose whether to receive or refuse the information. 
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AUTHORIZATION TO USE OR DISCLOSE YOUR INDENTIFIABLE HEALTH INFORMATION 
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information. 
 
Your health information that may be accessed, used and/or released includes: 
• 
Name and date of birth 
• 
Demographic information (age, gender, ethnicity) 
• 
Contact Information (street address, city or county of residence, email, phone number) 
• 
Social security number 
• 
Results of physical exams, blood tests, ECGs, other diagnostic and medical procedures related to the 
study 
• 
Personal medical history related to the study 
The Researchers may use and share your health information with: 
• 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity 
• 
Law enforcement agencies when required by law 
• 
University of Kentucky representatives 
• 
UK HealthCare and their representatives 
• 
UK Health system (EPIC, the electronic medical records) and health systems outside of UK for which you 
have a patient relationship 
• 
The U.S. Food and Drug Administration (FDA) 
• 
The National Institute on Drug Abuse (NIDA) 
• 
Investigational Drug Service (IDS) at the University of Kentucky 
• 
Center for Clinical and Translational Science (CCTS) and Clinical Research Unit (CRU) 
If you become pregnant anytime during the study or within 30 days after stopping the study drug, you must inform 
the study doctor. The study doctor must then report the outcome of your pregnancy to the Sponsor (and/or the 
FDA). 
The researchers agree to only share your health information with the people listed in this document. 
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health information would 
still be regulated by applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
• 
Current or future healthcare at the University of Kentucky 
• 
Current or future payments to the University of Kentucky 
• 
Ability to enroll in any health plans (if applicable) 
• 
Eligibility for benefits (if applicable) 
 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization: 
• 
Send a written letter to Dr. Sharon L. Walsh, to inform her of your decision. Her address is 
Sharon L. Walsh, Ph.D. 
845 Angliana Ave 
Lexington, KY 40508 
• 
Researchers may use and release your health information already collected for this research study. 
• 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
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You understand that you will not be allowed to review the information collected for this research study until after 
the study is completed. When the study is over, you will have the right to access the information. The use and 
sharing of your information has no time limit. 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184. 
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APPENDIX – Detailed Study Calendar 
 
STUDY ACTIVITIES 
Informed Consent 
SCREENING 
INPATIENT STUDY 
FOLLOW-UP 
1-2 Weeks 
• 
Inpatient Week 1 
Inpatient Week 2 
Inpatient Week 3 
Inpatient Week 4 
2-4 Weeks After 
Study Completion 
Urine/Breath Sample 
• 
Labs/ECG 
• 
Screening Questionnaires 
• 
Physical Exam 
Questionnaires 
• 
• 
• 
• 
• 
Urine/Breath Samples 
• 
• 
• 
• 
Study Sessions 1-3 times/week 
• 
• 
• 
• 
Study Drug Administration 
• 
• 
• 
• 
Session Questionnaires 
• 
• 
• 
• 
Vitals/Safety monitoring 
• 
• 
• 
• 
Brief Questionnaires 
• 
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Signature of Principal Investigator or Sub/Co-Investigator 
Date 
Printed name of [authorized] person obtaining informed consent and 
HIPAA authorization 
Printed name of research subject 
Date 
Signature of research subject 
INFORMED CONSENT SIGNATURES 
 
This consent includes the following: 
• Key Information Page 
• Detailed Consent 
• Appendix (Calendar) 
 
You are the subject. You have read this information, and you will receive a copy of this form after it is 
signed. 
 
 
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