Clinical trial NCT04315181
Conditions: Opioid Use Sedative Use
Keywords: opioid sedative opiate
Sponsor: Sharon Walsh
Start date: 2019-03-25; Completion date: 2023-05-06
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Detailed description:
Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature of gabapentin's abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or another opioid agonist) and gabapentin in combination. This study's objective is to characterize the subjective effect profile of gabapentin, examine the interaction between gabapentin and oxycodone, and assess the acute analgesic response to gabapentin and oxycodone, alone and in combination, across a range of doses for each drug.

Arms: arm 1: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 2: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 3: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 4: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 5: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 6: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 7: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 8: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses. arm 9: Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.
Interventions: intervention 1: Opioid Agonist intervention 2: Sedatives
Intervention descriptions: intervention 1: Abuse liability evaluation. intervention 2: Abuse liability evaluation.

Protocol documents:
ICF_000.pdf: 
Document Coversheet 
 
 Study Title: Prescription Medications: Pharmacodynamics and Interaction Effects  
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
7/18/2023 
NCT Number: 
NCT04315181 
IRB Number 
46591 
Coversheet created: 
1/17/2024 
 
 


 
Combined Consent and Authorization to Participate in a Research Study 
KEY INFORMATION FOR 
 
MAIN STUDY CONSENT: 
 
PRESCRIPTION MEDICATIONS: PHARMACODYNAMICS AND INTERACTION EFFECTS 
 
You are being invited to take part in a research study about the effects of sedatives (examples: gabapentin, 
alprazolam, zolpidem) 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 
approximately 18 participants complete the study. 
 
 
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THIS STUDY? 
By doing this study, we hope to learn about how certain prescription medications affect your body, 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 visit 
approximately 2 weeks after leaving the hospital. 
 
 
 
WHAT ARE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
You may choose to participate in this study to earn extra money; however, there is no direct benefit to you for 
taking part in this study. Your willingness to participate may help us to understand how certain prescription 
medications affect your body, mood, and behavior. For a complete description of benefits, refer to the Detailed 
Consent. 
 
 
 
WHAT ARE REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
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 use of the 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? 
The person in charge of this study is Sharon L. Walsh, Ph.D. of the University of Kentucky, Department of 
Behavioral Science and Center on Drug and Alcohol Research. If you have questions, suggestions, or 
concerns regarding this study or you want to withdraw from the study, her phone number is: (859) 257-6485. 
If you have any questions, suggestions or concerns 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. 
 
 
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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 18 or over 55 years of age; pregnant, breastfeeding, 
or planning on becoming pregnant; seeking treatment for your substance use; you do not use prescription medications 
for non-medical purposes (to get high, feel relaxed). You will not 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 IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST? 
If you are selected to participate, you will live at the UK Hospital in the CCTS Inpatient Unit. During your stay, you will 
participate in 10 sessions. Each session will last approximately 8 hrs and you will participate in about 2-3 sessions per 
week. You will live on the inpatient unit for approximately 1 month and participate in sessions for about 80 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 unit 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 CCTS nursing staff 
- 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 
5. The first session is a qualification session to help us determine if you will qualify for the rest of the study. 
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During the qualification session, you will receive capsule(s) to swallow at two different times – these capsules 
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 receive oral capsule(s) at two different times. These capsules may 
contain an opioid medication (such as oxycodone, tramadol, codeine, hydrocodone), a sedative medication (such 
as gabapentin, alprazolam, zolpidem), or a placebo (an inactive substance). 
 
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. Each session will last approximately 8 hrs. 
 
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 
your 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. Use of drugs 
or alcohol that are not given to you as part of the study is forbidden and will result in your dismissal from the 
study. 
 
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.) or the study physician (Michelle Lofwall, M.D.) as soon as possible: Sharon Walsh, 
Ph.D. (859) 257-6485; 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 come back 
to the CDAR Building approximately 2 weeks of discharge for a follow-up visit. We will ask you about your 
health, drug use, and collect an observed urine sample. You will be paid $25. 
 
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 
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effects typically will go away on their own after a few hours and do not require any treatment. 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. 
The possible side effects of receiving the sedative medication that are not uncommon and occur occasionally 
(i.e. occurring in greater than 5% of persons during clinical trials) include fatigue, swelling of hands and feet, 
sleepiness, diarrhea, tremor, uncontrolled rapid eye movements, double vision, dizziness, and coordination 
problems. These effects typically will go away on their own after a few hours and do not require any treatment. 
In rare cases, fever, chest pain, confusion, and rash may occur. We carefully select doses to avoid serious risks. 
If these rare effects were to occur, there is a chance that they would require treatment, depending on their 
severity. 
 
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. 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 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/treatments/procedures in 
this study are no different. In addition to risks described in this document, 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 medications 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 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 may not be allowed to bill your insurance company, Medicare, or Medicaid for the 
medical procedures done strictly for research. Therefore, these costs will be your responsibility. Your insurer, 
Medicare, or Medicaid may agree to pay for the costs. However, a co-payment or deductible may be needed 
from you. The amount of this co-payment or deductible may be costly. 
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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. 
 
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of 
Health. With this Certificate, the researchers may not disclose or use information, documents, or biospecimens 
that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, 
or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for 
this use. The researchers will use the Certificate to resist any demands for information that would identify you, 
except as explained below. You should understand that a 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. 
 
You should know that there are some circumstances in which we may have to show your information to other 
people. For example, the law may require us to show your information to a court or to tell authorities if you report 
information about a child being abused or if you pose a danger to yourself or someone else. The Certificate of 
Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information 
that would identify you as a participant in the research project under certain circumstances including: abuse or 
neglect, harm to self or others, or diagnosis of certain communicable diseases (including but not limited to, 
hepatitis C, HIV, or tuberculosis), which will be reported to the State Health Department along with your full 
name as required by law. 
 
Officials of the Food and Drug Administration, National Institutes of Health, and the University of Kentucky may 
look at or copy pertinent portions of records that identify you. 
 
 
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Do you give permission for us to contact you about research results or incidental findings that are determined to 
be important to you/your family’s health? (Incidental findings are unforeseen findings discovered during the 
course of the research that may affect you or your family’s health). 
□ Yes □ No 
 
Initials 
You may also withdraw your consent to be contacted with information about research results or incidental 
findings by sending a written request to 845 Angliana Ave, Lexington, KY 40508 or call 859-257-6485. 
 
 
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, we plan to contact you between approximately 1-4 times per year. 
 
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 
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WILL YOUR INFORMATION BE USED FOR FUTURE RESEARCH? 
Your information or samples collected for this study will NOT be used or shared for future research studies, 
even if we remove the identifiable information like your name, medical record number, or date of birth. 
 
 
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. 
The investigators conducting the study may need to remove you from the study. This may occur for a number of 
reasons. You may be removed from the study if: 
• 
you are not able to follow the directions, 
• 
they 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 done during the study, you should call 
Michelle Lofwall, M.D. (859) 323-9321. 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. 
That cost will be your responsibility. Also, the University of Kentucky will not pay for any wages you may lose if 
you are harmed by this study. The medical costs related to your care and treatment because of research related 
harm will be your responsibility. 
 
You do not give up your legal rights by signing this form. 
 
 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
 
You will receive payment for your participation. 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. Total payment depends 
on your length of stay (for example: you would earn $3,600 for a 30-night stay). 
 
 
You will also receive $25 for your follow-up visit scheduled approximately 2 weeks of your discharge from the 
study. 
 
We will provide your earnings to you via check(s). The maximum amount of each check is $500. You will 
receive your first check 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. 
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For example, if you complete the study and earn $3,600, you will receive $500 on the day of discharge and then 
will receive six $500 checks and one $100 check in the mail (6 x $500 = $3,000 + $100 = $3,100); it will take 1-2 
weeks for you to receive all seven 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? 
You will be informed if the investigators learn new information that could change your mind about staying in the 
study. You may be asked to sign a new informed consent form if the information is provided to you after you 
have joined the study. 
 
 
WHAT ELSE DO YOU NEED TO KNOW? 
The National Institute on Drug Abuse is providing financial support for this study. 
 
A description of this clinical trial will be available on 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. 
 
FUTURE USE OF YOUR PROTECTED HEALTH INFORMATION OR SPECIMEN(S): 
Identifiable information such as your name, medical record number, or date of birth may be removed from 
the information or samples collected in this study. After removal, the information or samples may be used for 
future research or shared with other researchers without your additional informed consent. 
In addition to the main study, you are being asked to allow us to keep and use your information and/or 
specimens for future research that is currently unspecified. 
 
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE 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, address, date of birth, weight, gender, social security number, results of physical exams, blood tests, urine tests 
related to the study, and ECG results. 
 
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 (only when required by law) 
• 
University of Kentucky representatives 
• 
UK Healthcare and their representatives 
• 
UK Hospital 
• 
The National Institutes of Health and/or its divisions 
• 
The Investigational Drug Service (IDS) at the University of Kentucky 
• 
Food and Drug Administration 
• 
Center for Clinical and Translational Science (CCTS) 
 
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If you are a woman and you become pregnant anytime during the study or within 30 days after discharging from 
the study, you must inform Dr. Lofwall or Dr. Walsh – they 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); or 
• 
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: 
• 
You will send a written letter to: Sharon L. Walsh, Ph.D. at 845 Angliana Ave. Lexington, KY 40508 to 
inform her of your decision. 
• 
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). 
 
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. 
46591


Page 9 of 10 
Prescription Medication Interactions - Main Consent - Walsh - V9.0 
 
APPENDIX – Detailed Study Calendar 
 
 
46591


Page 10 of 10 
Prescription Medication Interactions - Main Consent - Walsh - V9.0 
 
INFORMED CONSENT SIGNATURE PAGE 
 
 
You are a participant or are authorized to act on behalf of the participant. This consent includes the 
following: 
• Key Information Page 
• Detailed Consent 
 
You will receive a copy of this consent form after it has been signed. 
 
 
Signature of research participant 
Date 
Printed name of research participant 
Printed name of person obtaining informed consent/ 
HIPAA authorization 
Date 
Signature of Principal Investigator 
or Sub/Co-Investigator 
46591

SAP_002.pdf: 
 
Study Title: Prescription Medication Interactions 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
IRB 7/18/2023 
NCT Number: 
NCT04315181 
IRB Number 
46591 
Coversheet created: 
4/29/24 
 
 
 


 
Protocol Number 46591 
Prescription Medication Interactions 
NCT: 04315181 
 
Statistical Analysis Plan for Primary Study 
1. Introduction 
The purpose of this document is to provide details about the study population, how 
missing data will be handled, and the statistical methodologies that will be used to 
analyze the data for the primary study.  
2. General Conventions 
All analyses will be conducted using SAS Version 9.3 or higher (SAS Institute, Inc; 
Cary, NC, USA), and all hypothesis testing will be two-sided with a significance level of 
0.05. P-values will be presented with 3 decimals and p-values that are less than 0.001 
will be represented as <0.001. 
Continuous data will be summarized using descriptive statistics: number of observations 
(n), arithmetic mean, standard error, minimum, and maximum. Frequencies and 
percentages will be used to summarize categorical (discrete) outcomes. Means and 
standard errors will be presented to two decimal places.  
3. Analysis Populations  
Two study populations will be defined for analysis. 
3.1 Enrolled Population 
All subjects who sign the Informed Consent Form. 
3.2 Completer Population 
Subjects in the who complete the entire Study Phase. 
4. Subjects and Demographics 
4.1 Disposition and Withdrawals 
Subject disposition will be summarized using the number and percent of subjects who 
are in the Enrolled Population and Completer Population. 
4.2 Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics will be summarized for the Completer 
Population. No statistical comparisons will be made on demographic or baseline 


characteristics. The demographic and baseline characteristics will consist of age, sex, 
race, ethnicity, height (cm), weight (kg), and BMI (kg/m2).  
Continuous variables (age, height, weight, BMI) will be summarized by n, mean, 
standard deviation, min, median, and max. Frequencies and percentages will be used to 
describe categorical (discrete) variables including gender, race, and ethnicity. 
5. Pharmacodynamic Analyses 
5.1 Primary Pharmacodynamic Analyses 
The primary analyses will be performed based on the Completer Population. The 
primary Emax VAS item Drug Liking and will be analyzed in a mixed model including the 
nine drug conditions with a compound symmetry covariance structure. Within each 
model, subject will be treated as random effects, and the remaining parameter as fixed 
effects. Mixed models are suited for data with repeated measures, correlations among 
observations within an individual subject, and the presence of missing data. The 
response of individual subjects is first modeled, and then the estimates for each 
individual are combined in a group analysis (Singer, 1998; Ballinger 2004; Diggle et al. 
1996; Gibbons et al. 1993; Kreft and De Leeuw 1998). Tukey post-hoc tests will 
compare active doses to placebo and other relevant active dose comparisons.  
5.2 Secondary Pharmacodynamic Analyses 
Secondary analyses will be performed based on the Completer Population. Secondary 
pharmacodynamic outcomes will include: 
• Raw time course data of VAS items (e.g., High, Good Drug Effects, Bad Drug 
Effects, Any Drug Effects, Desire to Use Opioids), subjective opioid adjectives, 
street value, observer adjectives, DSST, cold pressor test, cold water VAS, 
flicker/fusion, balance task, heart rate, systolic blood pressure, diastolic blood 
pressure, respiration rate, oxygen saturation, end tidal carbon dioxide, and pupil 
diameter from the nine dose conditions. 
• Emax and Emin (where appropriate) on the VAS items, subjective opioid 
adjectives, street value, observer adjectives, DSST, cold pressor test, cold water 
VAS, flicker/fusion, balance task, heart rate, systolic blood pressure, diastolic 
blood pressure, respiration rate, oxygen saturation, end tidal carbon dioxide, and 
pupil diameter from the nine dose conditions. 
Secondary analyses will be completed in mixed models that include drug condition and 
time (when appropriate with an autoregressive covariance structure) with a compound 
symmetry covariance structure. Subject will be treated as random effects and the 
remaining parameters fixed. Tukey post-hoc tests will compare active doses to placebo 
and other relevant active dose comparisons. 
5.2.1 Drug Identification Assessments: Drug identification assessments completed 
during the experimental dose sessions will be summarized by frequencies and 
percentages to describe categorical outcomes. 
 


 
6. Safety and Tolerability Analyses 
Safety analyses will be performed on the Enrolled Population. Adverse events (AEs) 
recorded after signing informed consent but prior to the first dose will be recorded as 
baseline AEs and will be listed by subject but will not be included in the summary safety 
analysis. AEs will be summarized by relationship to study drug and severity. 
The numbers and frequencies of subjects reporting AEs, including abuse-related AEs, 
will be summarized. If the same AE (preferred term) is reported more than once for the 
same subject, it will only appear once in the summary tables and the highest severity 
grade and strongest relationship to treatment will be included in the summary. Any AEs 
leading to a study discontinuation will be summarized. 
All deaths, other SAEs, and AEs will be listed. 
Other safety variables, including clinically significant changes in the participant’s 
physical examination, vital signs, electrocardiograms, and clinical laboratory results, will 
be tabulated and presented by study drug received. 
7. Missing Data 
Within-session missing data are expected to be less than 3% for each outcome. 
Inspection of missing data and correlates of missingness will be examined upon study 
completion. The use of mixed models as an analytic strategy obviates the need for the 
missing values to be imputed. 
8. Identification and Summary of Protocol Deviations 
Major protocol deviations from the participant’s entry criteria through study completion 
will be documented and summarized as far as they can be extracted from the numeric 
and coded study data. 
 
References: 
Ballinger GA (2004) Using generalized estimating equations for longitudinal data 
analysis. Organizational Research Methods 7(2): 127-150. 
Diggle PJ, Liang K, Zeger SL (1996) Analysis of Longitudinal Data. Oxford University 
Press, Inc., Oxford University Press, Inc. 
Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, 
Imber SD, Sotsky SM, Watkins JT (1993) Some conceptual and statistical issues in 


analysis of longitudinal psychiatric data. Application to the NIMH treatment of 
Depression Collaborative Research Program dataset. Arch Gen Psychiatry 50: 739-50. 
Kreft I, De Leeuw J (1998) Introducing Multilevel Modeling. Sage Publications, Ltd., 
Sage Publications, Ltd. 
Singer JD (1998) Using SAS PROC MIXED to fit multilevel models, hierarchical models, 
and individual growth models. J Educ Behav Stat 24: 323-355. 
 
 

Prot_001.pdf: 
PROTOCOL TYPE (VERSION 4)
0 unresolved
comment(s)
 
IMPORTANT NOTE: You will not be able to change your selections for "Which IRB" and "Protocol Process Type" after
saving this section. If you select the wrong IRB or Protocol Process Type, you may need to create a new application. 
For guidance, see:
Which IRB?
Which Protocol Process Type?  
"Getting Started"
Please contact the Office of Research Integrity (ORI) at 859-257-9428, IRBsubmission@uky.edu, or request a consult to resolve any
questions prior to saving your selections.
 
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
 
 
The revised Common Rule expanded exemption certification category 4 for certain secondary research with
identifiable information or biospecimens. The regulations no longer require the information or biospecimens to be
existing.  For more information see the Exemption Categories Tool.
 
Section 1 Page 1 of 1
IRB Approval
2/8/2024
IRB # 46591
IRB2


Modification Request Section
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comment(s)
*** If this modification changes the scope of your activities to include COVID-19 related research, please insert “COVID19” at
the start of your Project and Short Titles.***
Select One:
This modification does not increase risk to study participants.
This modification may or will increase risk to study participants.
Is this modification request due to an Unanticipated Problem/Adverse Event, or Protocol Violation?
Yes
No
In your professional opinion, does this modification involve information that might relate to a subject’s willingness to continue to
take part in the research?
Yes
No
If yes, state how the information will be communicated to subjects (i.e., re-consent, send letter, etc.):
For each proposed modification, include a justification.
Example: Jane Doe, MD, is being added as co-investigator because she has expertise with the subjects on this protocol.
She has completed human subject protections training, and is authorized to obtain consent.
Update Study Personnel: Add Chamblin. She has completed required
trainings and is NOT authorized to consent.
Section 2 Page 1 of 1
46591


PROJECT INFORMATION
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comment(s)
Title of Project: (Use the exact title listed in the grant/contract application, if applicable). 
If your research investigates any aspect of COVID-19, please include "COVID19" at the beginning of your Project Title and Short Title 
Prescription Medications: Pharmacodynamics and
Interaction Effects
Short Title Description 
Please use a few key words to easily identify your study - this text will be displayed in the Dashboard listing for your study.
Prescription Medication Interactions
Anticipated Ending Date of Research Project: 
Maximum number of human subjects (or records/specimens to be reviewed) 
72
After approval, will the study be open to enrollment of new subjects or new data/specimen collection? 
Yes
No
Are you requesting that the UK IRB serve as the lead IRB for a multi-site study, OR that the UK IRB defer review to another IRB? [Click
here for "IRB Reliance" help]
Yes
No
If "Yes," before completing your IRB application, fill out the Reliance Request Form and submit it to irbreliance@uky.edu.
12/31/2024
Section 3 Page 1 of 1
46591


PI CONTACT INFORMATION
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comment(s)
Principal Investigator (PI) role for E-IRB access
The PI is the individual holding primary responsibility on the research project with the following permissions on the E-IRB application:
1. Read; 
2. write/edit;
3. receive communications; and 
4. submit to the IRB (IR, CR, MR, Other Review*).
If research is being submitted to or supported by an extramural funding agency such as NIH, a private foundation or a
pharmaceutical/manufacturing company, the PI listed on the grant application or the drug protocol must be listed as PI here. 
Please fill in any blank fields with the appropriate contact information (gray shaded fields are not editable). Required fields left blank will
be highlighted in pink after you click "Save".
To change home and work addresses, go to myUK and update using the Employee Self Service (ESS) portal. If name has changed,
the individual with the name change will need to submit a 'Name Change Form' to the Human Resources Benefits Office for entering
into SAP. The new name will need to be associated with the individual's Link Blue ID in SAP before the change is reflected in E-IRB.
Contact the HR Benefits Office for additional information.
The Principal Investigator's (PI) contact information is filled in automatically based on who logged in to create the application.
If you are not the Principal Investigator, do NOT add yourself as study personnel.
To change the PI contact information on an application in Researcher edit status:
click "Change Principal Investigator";
search for the PI's name using the search feature;
click "Select" by the name of the Principal Investigator, then "Save Contact Information".
You will automatically be added as study personnel with editing permissions to continue editing the application.
Change  Principal Investigator:
First Name: Sharon
Room# &
Bldg: 845 Angliana Avenue
Last Name: Walsh
Speed
Sort#: 
40508
Middle Name L
Department:
Dept Code: 7H150
 
PI’s
Employee/Student
ID#:
00058631
Rank: 
Professor
 
PI's Telephone #: 8592576485
Degree: PhD
PI's e-mail
address: sharon.walsh@uky.edu
PI's FAX
Number: 8592575232
PI is R.N.
Yes
No
HSP Trained: Yes
HSP Trained
Date: 1/18/2022
RCR Trained: Yes
Do you, the PI, have a significant financial interest related to your responsibilities at the University of Kentucky (that requires
disclosure per the UK administrative regulation 7:2)?
Yes
No
Behavioral Science - 7H150

Section 4 Page 1 of 2
46591


Section 4 Page 2 of 2
46591


RISK LEVEL
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comment(s)
Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects
(Risk Level 3) Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests.
Refer to UK's guidance document on assessing the research risk for additional information.
Section 5 Page 1 of 1
46591


SUBJECT DEMOGRAPHICS
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Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 to 55
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and
exclusion. 
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design;
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to
coercion or undue influence.
Please consider these resources: 
NIH Diversity Policy 
FDA Diversity Guidance 
Volunteers will be approximately 72 persons who are screened for the study, with up to 18 (up to 6 pilot phase participants and 12 main phase, fully
randomized participants) completing the protocol. We anticipate starting recruitment on December 1, 2018, and finishing recruitment by December 1, 2020. 
Inclusion criteria: 
- ages 18-55 years old 
- healthy adult male and female participants as determined by physical exam, 12-lead ECG, blood chemistries and routine urinalysis
- recreational (non-medical) opioid use within the past year
- recreational (non-medical) sedative use within the past year
- must be using an effective form of birth control
- literate and able to provide informed consent
- able and willing to follow the protocol
Exclusion criteria:
- physical dependence on any drug requiring medical management (e.g., opioids, sedatives, alcohol)
- seeking treatment for substance use disorder
- liver function tests exceeding 3x the normal limit
- known hypersensitivity to any of the study drugs
- any psychiatric disorder that would interfere with study participation
- any medical condition that is clinically significant or requires ongoing prescription medication
- acute medical illness unresolved (e.g., infection)
- women who are pregnant or lactating
- current seizure disorder, chronic pain, asthma or other respiratory disorders that may increase risk of respiratory depression, history of head injury,
hypertension, or history of cardiovascular disease or abnormal ECG
- HIV-positive patients if they are not symptomatic with AIDS-defining illness (e.g., opportunistic infections, T-cell less than 200/mm3)
- anyone unable to fulfill the protocol requirements based on investigator judgment
- currently under parole or probation with urine testing requirements
- inability to tolerate the pain stimuli during training, reporting no pain/discomfort from cold water test
Attachments
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic
sources: Census Regional Analyst Edition, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated
Expedited review and Full review applications):
Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native:
Asian:
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
4
2
3
1
40
20
Section 6 Page 1 of 3
46591


People Around
the World:
More than One
Race:
Unknown or Not
Reported:
 
If unknown, please explain why:
The volunteers in the "Other" category represent individuals reporting more than one race
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g.,
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories
if the focus of the study has nothing to do with that status.
Check All That Apply (at least one item must be selected)
Children (individuals under age
18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
ADDITIONAL INFORMATION:
Please visit the IRB Survival Handbook for
more information on:
Children/Emancipated Minors
Students as Subjects
Prisoners
Impaired Consent Capacity Adults
Economically or Educationally
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers
[see requirement of GME]
Non-English Speaking [see also the
E-IRB Research Description section
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
1
1
Section 6 Page 2 of 3
46591


Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in
consent capacity? (see examples below)
Yes
No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Attachments
Section 6 Page 3 of 3
46591


INFORMED CONSENT/ASSENT PROCESS/WAIVER
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comment(s)
For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be
used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and 
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a read-only PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Check All That Apply
Informed Consent Form (and/or Parental Permission Form and/or translated short form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Reliance Consent Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Stamped Consent Doc(s) Not Needed
Attachments
Attach Type
File Name
Informed Consent/HIPAA Combined Form 46591 Screening Consent - Prescription Med Interactions v10.0 Jun 13 2023 (f).pdf
Informed Consent/HIPAA Combined Form 46591 Main Study Consent - Prescription Med Interactions v9.0 Jun 13 2023 (f).pdf
Informed Consent Process:
Section 7 Page 1 of 4
46591


Using active voice, describe how investigators will obtain consent/assent. Include:
the circumstances under which consent will be sought and obtained
the timing of the consent process (including any waiting period between providing information and obtaining consent)
who will seek consent
how you will minimize the possibility of coercion or undue influence
the method used for documenting consent
if applicable, who is authorized to provide permission or consent on behalf of the subject
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of
this application.
Special considerations may include:
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate
document.
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture.
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent
Template.
Prior to obtaining informed consent, each potential subject must have an expired breath alcohol content (BAC) of 0.00 and not
appeared intoxicated (nodding, appearing sedated). Sharon L. Walsh, Ph.D. or her designated staff will obtain consent for this
project. There are two consent forms for this project: a screening consent and the main study consent. Designated staff may conduct
and sign the informed screening consent with the volunteer. However, the volunteer will meet with the investigator, senior staff
member, or co-investigator on an outpatient basis prior to admission to review all experimental procedures and allow the volunteer
ample time to ask questions regarding the protocol before signing the study consent form. There is no time limit on this process. The
investigator will inform the volunteer that this is not a treatment program and signing the consent form does not obligate them to
participate. Each subject will receive a copy of his/her informed consent document.
Participants may also be consented via Zoom. All consenting procedures will be identical to an in-person consent, except the PI will
be present via Zoom (instead of the same room). The participant will be screened by in-person research staff (e.g., participants
provided photo ID, negative breathalyzer samples and protocol-appropriate urine samples; staff confirmed participants were not
intoxicated). Research staff will provide the a copy of the hardcopy (paper) consent form to the participant, which will be verified on
camera by the PI. This process allows for a thorough discussion and exchange of information with the participant, a method to ensure
the participant’s identity, and documentation of the consent itself.
Subjects may ask study personnel questions about the study procedures or make complaints at any time. All staff will be aware to
contact Drs. Walsh and/or Lofwall about any subject concern or complaint as it arises. Phone numbers for the PI and staff, as well as
the Office of Research Integrity, are included in the consent form. It is expected that providing a phone number and contact
information for the PI may offer a safe, confidential and reliable channel for participants to express problems, concerns or questions
and obtain study information.
Request for Waiver of Informed Consent Process
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the
elements of informed consent, complete, Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
SECTION 1.
Check the appropriate item:
I am requesting a waiver of the requirement for the informed consent process.
I am requesting an alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the
alteration.
Section 7 Page 2 of 4
46591


SECTION 2.
Explain how each condition applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information
after they have participated in the study.
Section 7 Page 3 of 4
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Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study. 
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is
an English and a Spanish version.
 
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm.
b) The research presents no more than minimal risk to the subject.
c) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
Section 7 Page 4 of 4
46591


STUDY PERSONNEL
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Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must click the 'Save Study Personnel Information' button. 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is required for a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be listed below. ***Residents and
students who are PI’s are encouraged to designate the faculty advisor or at least one other individual as a contact with an editor role (DP).***
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR/FR, MR) or 'Other Review", and submit Other Reviews on behalf of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature:
Search for personnel;
Click "select" by the listing for the person you want to add;
For each person, specify responsibility in the project, whether authorized to obtain informed consent, AND denote who should receive E-IRB notifications (contact status).
NOTE: Study personnel must complete human subject protection (HSP) and Responsible Conduct of Research (RCR) training before implementing any research
procedures. For information about training requirements for study personnel, visit UK’s HSP FAQ page, the RCR Getting Started page, or contact ORI at 859-257-
9428. If you have documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI (HSPTrainingSupport@uky.edu) for
credit.
Study personnel assisting in research project: 
Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Adams
Christian
Medical Supervisor
SP
N
N
MD
P
Y
12/21/2022
Y
N
09/20/2023
N
Y
Allen
Timothy
Medical Supervisor
SP
N
N
MD
P
Y
12/04/2023
Y
N
09/20/2023
N
Y
Anderson
Danielle
Medical Supervisor
SP
N
N
MD
P
Y
05/31/2023
Y
N
10/18/2022
N
Y
Andrews
Lelia
Data Collection
SP
Y
N
 
P
Y
01/20/2023
Y
N
01/19/2023
N
Y
Atwater
Chelsea
Medical Supervisor
SP
N
N
MD
P
Y
10/25/2023
Y
N
11/10/2022
N
Y
Babalonis
Shanna
Co-Investigator
DP
Y
Y
PhD
P
Y
02/21/2023
Y
N
11/06/2018
N
Y
Bailey
Rebecca
Project
Assistance/Support
SP
N
N
 
P
Y
09/08/2022
Y
N
10/12/2022
N
Y
Batsel-
Thomas
Sandra
Medical Supervisor
SP
N
N
MD
P
Y
05/03/2021
Y
N
09/20/2023
N
Y
Brown
Paul
Project
Assistance/Support
SP
N
N
 
P
Y
09/08/2023
Y
N
10/12/2021
N
Y
Buckler
Regan
Project
Assistance/Support
SP
N
N
RN
P
Y
04/14/2021
Y
N
04/30/2021
N
Y
Cady
Corissa
Project
Assistance/Support
SP
N
N
 
P
Y
06/05/2023
Y
N
07/20/2023
N
Y
Camper
Zenith
Project
Assistance/Support
SP
N
N
RN
P
Y
02/08/2023
Y
N
02/09/2023
N
Y
Chamblin
Lisa
Project
Assistance/Support
SP
N
N
 
P
Y
08/02/2022
Y
N
02/08/2024
N
Y
Chang
Loui
Data Collection
SP
Y
N
 
S
Y
06/05/2023
Y
N
06/06/2023
N
Y
Chilton
Elizabeth
Project
Assistance/Support
SP
N
N
 
P
Y
09/28/2023
Y
N
08/04/2023
N
Y
Cobb
Susan
Project
Assistance/Support
SP
N
N
 
P
Y
04/18/2021
Y
N
07/15/2020
N
Y
Cooley
Andrew
Medical Supervisor
SP
N
N
MD
P
Y
12/29/2023
Y
N
03/29/2021
N
Y
Cooley
Andrew
Medical Supervisor
SP
N
N
MD
P
Y
12/29/2023
Y
N
03/29/2021
N
Y
Davis
Miranda
Data Collection
SP
Y
N
 
P
Y
08/31/2022
Y
N
09/23/2022
N
Y
Dowden-
Kruger
Melinda
Project
Assistance/Support
DP
N
Y
 
P
Y
02/21/2023
Y
N
08/07/2019
N
Y
Fanucchi
Laura
Medical Supervisor
SP
Y
N
 
P
Y
01/24/2022
Y
N
08/02/2021
N
Y
Forenback
Denece
Project
Assistance/Support
SP
N
N
RN
P
Y
12/07/2023
Y
N
03/09/2021
N
Y
Fuller
Grayson
Data Collection
SP
Y
N
 
P
Y
03/15/2023
Y
N
03/16/2023
N
Y
Gamble
Bethanie
Data Collection
SP
N
N
 
P
Y
10/03/2022
Y
N
10/12/2022
N
Y
Gayhart
Sarah
Data Collection
SP
N
N
 
P
Y
09/21/2023
Y
N
11/07/2018
N
Y
Gibson
Pamela
Project
Assistance/Support
SP
N
N
RN
P
Y
07/27/2023
Y
N
02/01/2024
N
Y
Section 8 Page 1 of 4
46591


Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Gonzalez-
Lozano
Evelyn
Data Collection
SP
Y
N
 
P
Y
08/04/2021
Y
N
08/18/2021
N
Y
Hamm
Anna
Data Collection
SP
N
N
 
P
Y
03/29/2023
Y
N
08/28/2018
N
Y
Harris
Shontel
Project
Assistance/Support
SP
N
N
 
P
Y
09/06/2021
Y
N
10/12/2021
N
Y
Hash
Matthew
Project
Assistance/Support
SP
N
N
 
P
Y
01/26/2024
Y
N
03/03/2020
N
Y
Hatton
Kevin
Co-Investigator
SP
Y
N
MD
P
Y
10/14/2021
Y
N
08/27/2018
N
Y
Hawthorne
James
Medical Supervisor
SP
N
N
MD
P
Y
05/09/2023
Y
N
09/20/2023
N
Y
Hays
Lon
Medical Supervisor
SP
N
N
MD
P
Y
11/08/2023
Y
N
09/20/2023
N
Y
Humphries
Timothy
Project
Assistance/Support
SP
N
N
RN
P
Y
02/21/2023
Y
N
03/06/2023
N
Y
Hunt
Cassandra
Project
Assistance/Support
SP
N
N
 
P
Y
03/15/2021
Y
N
08/28/2018
N
Y
Islam
Mohammed
Medical Supervisor
SP
N
N
MD
P
Y
10/12/2023
Y
N
09/20/2023
N
Y
Kroupa
Spencer
Project
Assistance/Support
SP
N
N
 
P
Y
06/07/2023
Y
N
07/20/2023
N
Y
Kunzelman
Wyatt
Data Collection
SP
Y
N
 
P
Y
09/12/2023
Y
N
09/12/2023
N
Y
Lester
Clark
Medical Supervisor
SP
N
N
MD
P
Y
07/05/2022
Y
N
11/10/2022
N
Y
Lester
Clark
Medical Supervisor
SP
N
N
MD
P
Y
07/05/2022
Y
N
11/10/2022
N
Y
Leung
Steve
Medical Supervisor
SP
N
N
MD
P
Y
10/16/2021
Y
N
10/29/2020
N
Y
Lofwall
Michelle
Co-Investigator
SP
Y
N
MD
P
Y
06/29/2023
Y
N
08/27/2018
N
Y
Mandal
Anjana
Project
Assistance/Support
SP
N
N
 
P
Y
12/22/2021
Y
N
08/29/2022
N
Y
Mandal
Prabin
Project
Assistance/Support
DP
N
N
 
P
Y
06/27/2022
Y
N
08/29/2022
N
N
Maynard
Marshall
Project
Assistance/Support
SP
N
N
 
P
Y
06/16/2022
Y
N
08/29/2022
N
Y
Meadows
Amy
Medical Supervisor
SP
N
N
 
P
Y
08/11/2021
Y
N
08/28/2018
N
Y
Min
James
Medical Supervisor
SP
N
N
MD
P
Y
10/23/2023
Y
N
09/20/2023
N
Y
Nieto
Alayne
Project
Assistance/Support
SP
N
N
RN
P
Y
05/16/2022
Y
N
06/14/2022
N
Y
Nuzzo
Paul
Study Coordinator
SP
Y
N
 
P
Y
01/30/2023
Y
N
08/02/2021
N
Y
Oros
Sarah
Medical Supervisor
SP
N
N
MD
P
Y
02/16/2023
Y
N
03/05/2021
N
Y
Perpar
Justin
Data Collection
SP
Y
N
 
P
Y
10/26/2022
Y
N
10/26/2022
N
Y
Quarles
Allison
Project
Assistance/Support
SP
N
N
RN
P
Y
11/16/2021
Y
N
11/30/2021
N
Y
Rakesh
Gopalkumar
Medical Supervisor
SP
N
N
MD
P
Y
09/15/2022
Y
N
10/12/2022
N
Y
Ross
Dorothy
Project
Assistance/Support
SP
N
N
 
P
Y
11/03/2023
Y
N
08/28/2018
N
Y
Shelton
Charles
Medical Supervisor
SP
N
N
MD
P
Y
04/05/2023
Y
N
11/10/2022
N
Y
Shelton
Charles
Medical Supervisor
SP
N
N
MD
P
Y
04/05/2023
Y
N
11/10/2022
N
Y
Stamper
Brady
Project
Assistance/Support
SP
N
N
 
P
Y
06/05/2023
Y
N
07/20/2023
N
Y
Stephens
Tonya
Project
Assistance/Support
SP
N
N
RN
P
Y
09/01/2023
N
N
02/01/2024
N
Y
Swain
Audrie
Project
Assistance/Support
SP
N
N
 
P
Y
01/28/2024
Y
N
08/29/2022
N
Y
Thompson
Tamra
Project
Assistance/Support
SP
Y
N
 
P
Y
09/28/2022
Y
N
10/12/2022
N
N
Tuttle
Teresa
Project
Assistance/Support
SP
N
N
RN
P
Y
02/25/2023
Y
N
03/06/2023
N
Y
VanMeter
Connor
Data Collection
SP
Y
N
 
P
Y
10/10/2022
Y
N
10/12/2021
N
Y
Vessels
Victoria
Data Collection
SP
Y
N
 
P
Y
05/03/2022
Y
N
08/28/2018
N
Y
Vincent
Sylvia
Data Collection
SP
N
N
 
P
Y
01/30/2024
Y
N
11/07/2018
N
Y
White
Jessica
Project
Assistance/Support
SP
N
N
RN
P
Y
02/23/2023
Y
N
02/01/2024
N
Y
Yadon
Rachele
Medical Supervisor
SP
N
N
MD
P
Y
01/21/2022
Y
N
03/05/2021
N
Y
AbouAhmed
Amira
Data Collection
SP
N
N
 
P
N
10/22/2019
 
Y
04/29/2022
N
N
Section 8 Page 2 of 4
46591


Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Adams
Elizabeth
Project
Assistance/Support
SP
N
N
RN
P
N
10/22/2020
 
Y
04/29/2022
N
N
Ali
Nur-Ur-
Sahar
Data Collection
SP
Y
N
 
P
N
08/06/2020
 
Y
07/23/2021
N
N
Allen
Nicola
Project
Assistance/Support
SP
N
N
RN
P
N
10/29/2020
N
Y
02/03/2023
N
Y
Bradley
Robin
Project
Assistance/Support
SP
N
N
 
P
N
05/24/2019
 
Y
07/22/2022
N
N
Britch
Stevie
Data Collection
SP
Y
N
 
P
Y
07/29/2022
Y
Y
07/20/2023
N
N
Broome
Bibi
Data Collection
SP
N
N
 
P
Y
03/21/2023
Y
Y
04/29/2022
N
Y
Brown
Vickie
Project
Assistance/Support
SP
N
N
 
P
N
02/14/2020
N
Y
03/06/2023
N
Y
Browning
Christopher
Project
Assistance/Support
SP
N
N
 
P
Y
09/18/2023
Y
Y
10/26/2022
N
Y
Clark
Katie
Project
Assistance/Support
SP
Y
N
 
P
Y
10/10/2022
Y
Y
07/20/2023
N
Y
Devine
Amber
Project
Assistance/Support
SP
N
N
 
P
Y
11/23/2021
N
Y
06/13/2023
N
N
Dugan
Joseph
Project
Assistance/Support
SP
N
N
 
P
N
05/30/2019
 
Y
10/12/2021
N
N
Elder
Katherine
Project
Assistance/Support
SP
N
N
 
S
N
01/19/2021
Y
Y
10/12/2022
N
Y
Evans
Rachel
Project
Assistance/Support
SP
N
N
RN
P
Y
05/21/2023
N
Y
02/01/2024
N
N
Fancher
Joshua
Data Collection
SP
Y
N
 
P
Y
01/17/2023
N
Y
03/06/2023
N
N
Farrell
Carla
Project
Assistance/Support
SP
N
N
 
P
N
04/07/2019
 
Y
04/04/2022
N
N
Finch
Megan
Project
Assistance/Support
SP
N
N
 
P
Y
08/08/2022
Y
Y
07/20/2023
N
N
Foltz
Denise
Project
Assistance/Support
SP
Y
N
 
P
Y
02/02/2023
Y
Y
05/17/2023
N
Y
Garnett
Kimberly
Project
Assistance/Support
SP
N
N
RN
P
Y
09/07/2021
 
Y
04/29/2022
N
Y
Garton
Jackson
Data Collection
SP
Y
N
 
P
Y
09/24/2021
 
Y
10/12/2021
N
N
Gevedon
Teresa
Medical Supervisor
SP
N
N
 
P
Y
06/01/2022
Y
Y
05/11/2021
N
Y
Gifford
Mariah
Project
Assistance/Support
SP
N
N
RN
P
Y
09/04/2021
 
Y
04/29/2022
N
Y
Hamilton
Rebekah
Project
Assistance/Support
SP
N
N
RN
P
N
10/31/2020
 
Y
06/15/2022
N
N
Holbrook
Kathryn
Project
Assistance/Support
SP
N
N
 
P
N
12/12/2018
 
Y
03/10/2021
N
N
Hurt
Amber
Data Collection
SP
Y
N
 
P
Y
06/14/2021
 
Y
06/15/2022
N
N
Jones
Dowana
Data Collection
SP
N
N
 
P
Y
04/18/2021
 
Y
04/29/2022
N
Y
Knight
Stephanie
Project
Assistance/Support
SP
N
N
RN
P
N
10/20/2020
 
Y
04/29/2022
N
Y
Lewis
Russell
Data Collection
SP
Y
N
 
P
Y
02/16/2021
 
Y
07/12/2022
N
N
Mann
Shannon
Project
Assistance/Support
SP
N
N
 
P
N
01/21/2021
 
Y
11/30/2021
N
N
Minix
Kathleen
Project
Assistance/Support
SP
N
N
RN
P
Y
04/12/2021
 
Y
04/29/2022
N
Y
Nadim
Amina
Project
Assistance/Support
SP
N
N
 
S
Y
02/16/2021
 
Y
06/15/2022
N
Y
Napier
Janice
Project
Assistance/Support
SP
N
N
RN
P
N
10/27/2020
 
Y
06/13/2023
N
Y
Neltner
Matthew
Medical Supervisor
SP
N
N
 
P
Y
03/09/2021
Y
Y
03/05/2021
N
Y
Rayapati
Abner
Medical Supervisor
SP
N
N
 
P
Y
04/19/2021
N
Y
07/20/2023
N
N
Redmon
Nancy
Project
Assistance/Support
SP
N
N
 
P
Y
08/24/2022
N
Y
02/03/2023
N
N
Rice
Linda
Project
Assistance/Support
SP
N
N
 
P
Y
09/10/2021
Y
Y
04/29/2022
N
N
Roads
Andrew
Medical Supervisor
SP
N
N
 
P
Y
05/11/2022
N
Y
10/12/2021
N
Y
Ross
James
Project
Assistance/Support
SP
N
N
 
P
Y
04/27/2022
Y
Y
07/20/2023
N
N
Rudd
Triana
Project
Assistance/Support
SP
N
N
 
P
Y
09/16/2021
N
Y
02/01/2024
N
N
Section 8 Page 3 of 4
46591


Last Name
First Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Active
Rudd
Trinity
Project
Assistance/Support
SP
N
N
 
P
N
09/22/2020
Y
Y
06/13/2023
N
N
Silverstein
Lily
Project
Assistance/Support
SP
N
N
RN
S
Y
01/10/2022
Y
Y
02/01/2024
N
Y
Skaggs
Kylee
Project
Assistance/Support
SP
N
N
RN
P
Y
11/01/2022
Y
Y
10/12/2022
N
Y
Smith
Kayla
Data Collection
SP
N
N
 
P
N
06/04/2019
 
Y
07/22/2022
N
Y
Smoot
Holly
Project
Assistance/Support
SP
N
N
RN
P
Y
08/17/2021
 
Y
04/29/2022
N
N
Stanley
Catherine
Data Collection
SP
Y
N
 
P
Y
05/11/2021
N
Y
02/03/2023
N
N
Stiehler
Julie
Project
Assistance/Support
SP
N
N
 
P
Y
04/15/2021
Y
Y
04/29/2022
N
Y
Tarr
Rebecca
Project
Assistance/Support
SP
N
N
RN
P
N
10/08/2020
 
Y
07/20/2023
N
Y
Tarrence
Jacob
Data Collection
SP
Y
N
 
P
Y
04/20/2021
 
Y
01/11/2022
N
N
Tillery
Melanie
Project
Assistance/Support
SP
N
N
 
P
Y
10/05/2021
Y
Y
06/15/2022
N
Y
True
Laura
Data Collection
SP
N
N
 
P
N
04/13/2020
 
Y
06/15/2022
N
N
Watts
Linda
Project
Assistance/Support
SP
N
N
 
P
Y
11/10/2021
Y
Y
02/01/2024
N
N
Wengert
Brandon
Recruitment
SP
N
N
 
P
Y
04/11/2022
Y
Y
07/07/2021
N
Y
Wilson
Aimee
Project
Assistance/Support
SP
N
N
RN
P
Y
06/22/2022
N
Y
10/12/2022
N
N
Woodson
Andrea
Data Collection
SP
N
N
 
P
Y
05/13/2021
 
Y
07/13/2022
N
N
Section 8 Page 4 of 4
46591


RESEARCH DESCRIPTION
0 unresolved
comment(s)
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph.
Pro Tips:
Save your work often to avoid losing data.
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research,
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s).
Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely
misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature
of gabapentin’s abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive
reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and
illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or
another opioid agonist) and gabapentin in combination. Moreover, few data are available on the pharmacodynamic profile of
gabapentin when administered alone, and, despite its apparent abuse potential, it remains an uncontrolled drug in the U.S. under the
Controlled Substances Act.
Objectives
List your research objectives. Please include a summary of intended research objectives in the box below.
1. Characterize the nature of the subjective effect profile of gabapentin
2. Examine the interaction between gabapentin and oxycodone
3. Assess the acute analgesic response to gabapentin and oxycodone, alone and in combination
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository,
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
This study will first employ a quasi-randomized, double-blind, placebo-controlled, inpatient, within-subject design to ensure that all
doses and combinations are safely tolerated. Gabapentin doses and the combination doses of oxycodone and gabapentin will be
given in ascending order, but imposed on an otherwise randomized design for all other conditions. Up to six volunteers will complete
the pilot phase, and a review of safety will be conducted before enrolling additional volunteers.
After completion of the pilot phase study, a fully randomized, double-blind, placebo-controlled, inpatient, within-subject design will be
used utilized.
Attachments
Subject Recruitment Methods & Advertising
Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants?
Who will first contact the potential subjects, and how?
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Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations.
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising:
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
Volunteers will be recruited through newspaper and radio advertisement, local postings, online advertisements on forums such as
ResearchMatch, Cragislist, BuildClinical, Facebook, by geo-fencing techniques, and word-of-mouth. Volunteers will make initial contact
by phone, Facebook or BuildClinical with one of our staff who have completed the research training and HIPAA compliance web-based
teaching modules. If the volunteer discloses information that would make him/her potentially eligible for the study, they will be invited to
come in for a screening appointment. Screening is completed by one of our trained research assistants/research nurses/investigators
at the Behavioral Science Research Building or the UK CCTS. Study investigators may interact with volunteers in any of these settings
and appropriate cautions are in place to ensure privacy during the intake process. We will not use any biological samples or
information collected for this study for future research studies, even if we remove the identifiable information.
Volunteers will be recruited through newspaper and radio advertisement, local postings, online advertisements on forums such as
ResearchMatch, Facebook, BuildClinical, Craigslist, by geo-fencing techniques and by word-of-mouth. Volunteers will make initial
contact by phone, Facebook, or BuildClinical with one of our staff who have completed the research training and HIPAA compliance
web-based teaching modules. If the volunteer discloses information that would make him/her potentially eligible for the study, they will
be invited to come in for a screening appointment. Screening is completed by one of our trained research assistants/research
nurses/investigators at the Behavioral Science Research Building or the UK CCTS. Study investigators may interact with volunteers in
any of these settings and appropriate cautions are in place to ensure privacy during the intake process. Our Facebook page template
and study flyers have been approved by UK PR.
Attachments
Attach Type
File Name
Advertising
Facebook page - revised Dec 17 APPROVED.pdf
Advertising
Non-Dependent OPI Advertisements APPROVED.pdf
Advertising
Possible Accompanying Text APPROVED.pdf
Advertising
20183 Ad 1.pdf
Advertising
20183 AD 2.pdf
Advertising
20183 AD 5.jpg
Advertising
20183 AD 6.jpg
Advertising
20183 AD 3.jpg
Advertising
20183 AD 4.jpg
Advertising
20183-Ad 7.pdf
Advertising
BuildClinical Secure questionnaire.pdf
Advertising
RX Interactions Cards 6.1 - CLEAN COPY.pdf
Advertising
RX Interactions Flyer 6.1 - CLEAN COPY.pdf
Advertising
RX Interactions Digital Ads 6.1 - CLEAN COPY.pdf
Advertising
General - Card 1 _20183_C-FINAL-STAMPED.pdf
Advertising
General - Cards 2_20183_A-FINAL-STAMPED.pdf
Advertising
General - Cards 3_20183_B-FINAL-STAMPED.pdf
Advertising
General - Digital 1_20183_B-1-FINAL-STAMPED.pdf
Advertising
General - Digital 2_20183_C-FINAL-STAMPED.pdf
Advertising
General - Digital 3_20183_A-1-FINAL-STAMPED.pdf
Advertising
General - Digital 3_20183-1-FINAL-STAMPED.pdf
Advertising
General - Flyer 3 _20183_C-FINAL-STAMPED.pdf
Advertising
General Flyer 1_20183_A_Revised-STAMPED.pdf
Advertising
General Flyer 2_20183_B_Revised-STAMPED.pdf
Advertising
General - Card 1 _20183_C-FINAL.pdf
Advertising
General - Cards 2_20183_A-FINAL.pdf
Advertising
General - Cards 3_20183_B-FINAL.pdf
Advertising
General - Digital 1_20183_B-1-FINAL.jpg
Advertising
General - Digital 2_20183_C-FINAL.jpg
Advertising
General - Digital 3_20183_A-1-FINAL.jpg
Advertising
General - Digital 3_20183-1-FINAL.jpg
Advertising
General - Flyer 3 _20183_C-FINAL.pdf
Advertising
General Flyer 1_20183_A_Revised.pdf
Advertising
General Flyer 2_20183_B_Revised.pdf
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Research Procedures
Describe how the research will be conducted.
What experience will study participants have?
What will study participants be expected to do?
How long will the study last?
Outline the schedule and timing of study procedures.
Provide visit-by-visit listing of all procedures that will take place.
Identify all procedures that will be carried out with each group of participants.
Describe deception and debrief procedures if deception is involved.
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this
research project. List medications that are explicitly forbidden or permitted during study participation.
Screening and Admission: Subjects will answer questionnaires related to their drug use and health during screening. They will also
undergo medical examination that includes a physical exam, electrocardiogram (ECG), and blood and urine chemistries. The number
of screening visits may vary depending on the subjects’ availability and staff scheduling. This study will enroll only non-physically-
dependent, recreational sedative/opioid users who have prior non-medical experience with both opioids and sedatives in the past year;
supervised urine samples must corroborate self-reports. Female participants will be tested at screening, on entry, at weekly intervals,
and prior to each session for pregnancy. During screening, each subject will complete a cold pressor test (CPT), which will be
performed during the main study (see description below). This is done during screening to ensure participants understand the
procedure feels to determine if they want to proceed with the study AND in order to ensure that subjects exhibit an algesic (i.e. painful)
response to this pain procedure. Subjects that are unable to tolerate the CPT or who report no pain during the CPT will be excluded
from the study.
General Methods: After admission to the inpatient unit, a trained research staff person will familiarize the participant with the various
computer tasks to ensure that they are comfortable with the tasks prior to study initiation. All experimental session procedures will be
conducted with methods that have been previously used to study the effects of psychoactive drugs. Some physiological measures
(e.g., heart rate, resting blood pressure, and oxygen saturation) will be collected using a Macintosh computer system that is interfaced
with physiological monitoring equipment (DINAMAP) and will be monitored continuously throughout the sessions. Other physiological
measures (e.g., respiratory rate) will be collected at regular intervals. These measures serve as both safety data and as study
outcomes. An array of subjective and observer-rated measures, including but not limited to visual analog scales and Likert adjective
checklists, are presented on a computer screen and a computer mouse is used to respond to questions. Smoking is allowed at any
time with an escort, though only under supervised conditions, with the exception of 30 minutes prior to the start of the session and until
the session is completed. A trained research staff will be present throughout the entire session. 
Experimental Procedures: Prior to starting the experiment, subjects will participate in an initial active control test session during which
the subjects will receive 30 mg oxycodone (oral). This session will serve as a “qualifying day” or responsiveness challenge which is
intended to confirm that subjects are able to detect the active drug and report “liking” for the test agent (i.e., confirmation that the
subject will provide a sensitive signal). If subjects fail to report any drug liking and identify the drug as placebo, they will not proceed
further with dosing.
Experimental Sessions: During each session, subjects will receive two oral doses. All dosing will be double dummy – subjects will
always receive two capsule preparations and each capsule will be a distinct color (ex: blue capsule for oxycodone; white capsule for
gabapentin). None, one or both of the capsules will contain an active drug dose. A total of ten [including the active control test session
described above] 7.5 hr sessions will be conducted including 30 min of baseline data collection. Dose conditions will include: 1)
placebo, 2) oxycodone 20 mg, 3) oxycodone 40 mg, 4) gabapentin 600 mg, 5) gabapentin 1200 mg, 6) oxycodone 20 mg +
gabapentin 600 mg, 7) oxycodone 20 mg + gabapentin 1200 mg, 8) oxycodone 40 mg + gabapentin 600 mg and 9) oxycodone 40
mg + gabapentin 1200 mg. Sessions will be at least 48 hrs apart to ensure adequate wash-out. Dosing will be staggered in order to
align the peak response to both drugs. In this instance, the reported Tmax for gabapentin is estimated at ~2.5 hr and for oxycodone
~1.5 hr; therefore, gabapentin will be administered 1 hr before oxycodone.
Discharge & Follow-up Visit: Subjects will typically be discharged from the CCTS the day after they complete their final session. They
may be discharged early for safety reasons (see below) or if they fail to comply with the protocol or the inpatient rules (e.g. verbal
abuse of staff). They will be asked before they leave if they are interested in treatment for their substance abuse and offered referrals
for treatment if they indicate interest. A follow-up visit will be scheduled within two weeks of discharge. The volunteers will be asked
about their health status and drug use, any adverse events occurring since discharge; an observed urine sample will also be collected.
Attachments
Data Collection & Research Materials
In this section, please provide the following:
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records,
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study.
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts,
survey tools, data collection forms for existing data, etc.).
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If you will conduct a record or chart review, list the beginning and end dates of the records you will view.
During the screening phase of the study, data collected will include demographics, medical history, NEO, drug use history, results of
laboratory tests (blood and urine chemistries and ECG), and results of urine drug screens. 
Outcome measures collected during the inpatient phase of the study include physiological measures (e.g., pupil diameter, expired
CO2, blood pressure, heart rate, respiration rate), subject-rated questionnaires (e.g., Visual Analog Scales for drug effects,
Pharmacological Class Questionnaire, Street Value Questionnaire, Next-Day Questionnaire), responses to the Cold Pressor Test, and
observer ratings.
Attachments
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research;
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
The study will take place at our laboratory and at the University of Kentucky CCTS Inpatient Unit. Screening procedures will largely be
performed at our laboratory while enrolled patients will perform experimental procedures and reside at the CCTS. Experimental rooms
at the CCTS are equipped with the necessary physiologic and computer equipment necessary for the study. There will be 24-hr
nursing supervision of volunteers while in the hospital. Dr. Michelle Lofwall will be the primary medically responsible investigator and is
an adult psychiatrist with ACLS certification who has worked extensively with individuals with substance use disorders both in clinical
and research settings. The Psychiatry Attending Service will monitor subjects daily while they are inpatients. Dr. Walsh will provide
oversight for the study. Overall, the study team and the resources described above are well equipped to protect the participants and
successfully implement, carry out, and complete this study protocol.
Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study.
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional,
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are
reasonable to potential benefits.
The primary risks for the subjects in this study are associated with drug administration. Typical side effects of oxycodone include
nausea, vomiting, headache, dry mouth, itchiness, drowsiness, sweating, dizziness, stimulation, somnolence, lightheadedness,
restlessness, euphoria, talkativeness, urinary retention, and constipation. More serious side effects may include allergic reaction and
respiratory depression, but these are rare and unlikely to occur in a sample of volunteers who have experience using opioids.
Common side effects of gabapentin include: dizziness, weakness, fatigue, ataxia, and somnolence. More serious side effects may
include allergic reaction and increased risk of seizures (reported only at doses exceeding those proposed here). We have carefully
chosen doses to minimize serious drug effects. The combination of these two drugs may have additive or synergistic effects, but
doses have been carefully selected and safety outcomes are carefully monitored (see below). 
During the screening process, it is possible that subjects may feel uncomfortable answering personal questions about their health,
psychiatric, and drug use histories. Also during screening, participants will have blood drawn via venipuncture, which may cause
soreness, bruising, pain, infection, possible fainting, and/or bleeding. Using sterile procedures and well-trained staff minimizes these
risks. There is the risk that someone other than the research staff may see a subject’s Protected Health Information.
There are no direct benefits to volunteers. There are potential indirect benefits to society including the knowledge regarding safety,
abuse liability, and pharmacodynamics of oxycodone and gabapentin (two often co-prescribed and co-abused medications) alone and
in combination. Volunteers will indirectly benefit from receiving a free medical evaluation and free meals. If subjects decide they would
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like substance abuse treatment during the course of the study, we will assist them in finding treatment programs and getting them on
the appropriate waiting lists. The amount of risk to which individual study volunteers are exposed to is low. Overall, the risk/benefit ratio
appears favorable, and the conduct of this research seems well justified.
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
This is not a treatment study. If volunteers express interest in treatment, they will be given referrals and not allowed to participate in this
study.
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Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both.
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material.
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator.
If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK.
For additional considerations: 
Return of Research Results or Incidental Research Findings 
HIPAA policies 
FERPA policies 
Procedures for Transfer agreements 
Information regarding multi-site studies 
NIH Genomic Data Sharing (GDS) Policy 
Digital Data
Sources of research material obtained from our volunteers during screening and study participation include: blood and urine
specimens, expired breath samples for alcohol, ECG data, self reported information on physical and mental health, family history, drug
and alcohol use history, demographic information, volunteer and study staff observation of drug effects, vital signs (e.g. temperature,
blood pressure, heart rate), and other physiological measures. All this information is required to determine eligibility for the study, to
ensure safety during the experimental sessions and for outcome measures. All research material will be obtained and discarded when
necessary in a HIPAA-complaint manner. All materials will be collected specifically for the proposed study by trained staff. The
principal investigator and medical team will have access to private health information about volunteers so that study eligibility can be
determined. All data with personal health information is kept in a locked file cabinet that is separate from a locked file cabinet with de-
identified volunteer data. Prior medical records may be obtained with volunteer consent if there is any question about the volunteers’
health history. Each participant will sign a form that details the HIPAA-compliant manner in which research material is collected.
If in the course of the research study, the investigators discover something that could affect the health of a subject, the medical
monitor will determine if it is in the best interest of the subject to disclose the finding. If the information is to be disclosed, a trained
member of the research team or the medical monitor will inform the subject of the finding and advise them to follow up with a primary
care doctor or other appropriate entity.
Identifying information will be stored in a separate locked file cabinet from all other data and codes that could link an individuals’
Subject ID to their identity. Incidental materials containing subject identifiers will be shredded or incinerated. Electronic data will be
stored on password-protected computers in password-protected files. Access to identifying information will only be available to key
research personnel. In addition, a Certificate of Confidentiality will be obtained. Biological samples will be destroyed no later than after
study completion but typically soon after discharge. Paper records will be locked and stored for a minimum of 7 years and destroyed
through shredding or a professional destruction company.
Subjects will be carefully screened (history and physical examination, routine labs including CBC and LFTs, urinalysis, ECG, and
psychiatric assessments) to exclude those with a risk of adverse events. Those at increased risk may have histories that include a
personal or family history of seizure or head injury associated with more than a brief loss of consciousness, hypertension, psychosis,
etc. During sessions, subjects remain under careful observation. Vital signs will be collected multiple times daily throughout the dosing
period. Dr. Walsh has substantial experience in testing psychoactive substances in human subjects. Female subjects will be given
pregnancy tests weekly and before each session to ensure that we do not administer any potentially harmful agents to a pregnant
woman. To protect confidentiality, all research subjects are identified by a subject identification code (Subject ID) consisting of their
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initials and sequentially assigned subject numbers on all forms and data files, and not by their names. Actual subject names and
corresponding subject IDs are kept in a locked master file separate from the actual data collected during the study. All personal and
experimental information is kept locked and is accessible only to key personnel involved in the research. Risks of allergic reaction or
serious respiratory depression are mitigated due to the volunteers’ history of opioid use. However, should an allergic reaction occur,
diphenhydramine will be available for oral administration. During test sessions when opioids are administered, if respiratory rate drops
below 10 breaths/min accompanied by sedation, volunteers are verbally prompted to breathe. In our experience, physical (e.g., gentle
shaking) and verbal stimulation is often sufficient to prompt breathing and restore a normal respiratory rate. During test sessions,
nurses are instructed to check and record oxygen saturation and respiratory rate before each drug administration as follows: If
respiratory rate falls below 10 breaths/min or oxygen saturation is less than 95%, REPEAT and count breaths for 60 seconds. If either
oxygen saturation or respiratory rate remains outside parameters, HOLD the study medication and call the study physicians. If the
patient is unresponsive, call code team. Naloxone and supplemental oxygen may be administered based on physician evaluation. If
oxygen saturation falls below 90, any subsequent dosing is terminated and participants remain under continuous monitoring until
resolved. The study takes place within a fully functional hospital with emergency code response available. We do not anticipate
needing to employ these interventions but they are available in the event of an emergency.
Because we are exploring possible synergistic or additive effects of oxycodone and gabapentin, this study includes a quasi-
randomized, double-blind, placebo-controlled pilot phase to ensure that all dose conditions are safely tolerated before moving to a
fully randomized dose order. Up to six volunteers will participate in the pilot phase, and a full safety assessment will be made in order
to determine if dose adjustment is necessary for the full study. 
All participants who are discharged early will have a follow-up appointment within two weeks. The entire study could be halted for a few
reasons: any serious adverse event related to the study drug(s) resulting in death would halt the study and any serious adverse event
related to the study drug that results in hospitalization would result in halting the study and spur a review with the FDA and IRB before
proceeding.
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure. Do
you confirm that you will retain all IRB-related records for a minimum of 6 years after study closure?
Yes
No
Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered,
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to
subjects, including restrictions and expectations.
Participants will be paid for each screening visit at the rate of $50/visit. If only a urinalysis is required, subjects will be paid $15. 
For the main inpatient study phase, participants will receive a base pay of $60/night regardless of whether or not they complete the
study. They will receive a bonus of $60/night if they complete the entire study, but not in the case of early departure or dismissal. If the
volunteer completes the study, depending on their length of stay, they may receive a maximum of approximately $3,600 (for 30 study
nights). The study team and others have successfully employed this compensation structure before. 
There will be one follow up visit after discharge from the inpatient unit, and they will be paid $25 for this visit.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
There will be no cost to volunteers for participation in the current study. Cost of research-related harm will be the subjects’
responsibility.
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA-
regulated clinical investigations.
If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to
include with your IRB application.
Medical Safety Monitoring: Volunteers undergo a rigorous screening process to determine their eligibility and safety of their
participation. In addition, our well-trained and vigilant research and medical staff, and the carefully considered medication dosing and
safety criteria all serve as precautionary measures to ensure the safety of volunteers. The principal investigator, Sharon L. Walsh,
Ph.D., will be the primary person responsible for monitoring the safety of this project, executing the DSMP and complying with all
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reporting requirements. Our medical staff, including Dr. Lofwall and CCTS nursing staff, will conduct careful medical monitoring. We
have an experienced anesthesiologist, Kevin Hatton, M.D. consulting on this project as an additional safety precaution. Volunteers will
have daily contact with a physician and CCTS nurses while they reside as inpatients. The safety monitoring of each volunteer is
discussed on an ongoing basis among medical and scientific staff, including our study statistician, Paul Nuzzo. This process has been
successful in protecting volunteers and the integrity of the scientific outcomes. Any minor adverse events will be discussed among all
study staff, documented in the subjects’ medical charts through progress notes and medical logs along with any intervention required
(e.g. headache requiring Tylenol). Any severe adverse events, whether study related or not, will be reported to the UK IRB and the
FDA within 24 hours or as required.
Data Monitoring: Data are collected using a computerized data collection and management system, which eliminates data entry errors.
Data files for experimental tasks and physiological measures from each experimental session will be manipulated and combined into a
single electronic spreadsheet for each volunteer that can then be used for analysis. Any data manipulation is conducted twice and
compared with the original manipulation to ensure accuracy. Research assistants will minimize missing data and adjust potential data
collection errors based upon paper questionnaires. All data requiring hand entry (e.g., urinalysis results, pupil diameter) will be double
entered by two separate staff members and comparison macros conducted to ensure accuracy. The data are stored on password-
protected computers in password-protected files. Data files do not contain PHI. A computer file linking the unique number with the
subjects’ name will be kept on a stand-alone, password-protected computer available only to the study investigators. All paper copies
of the collected data will be stored in locked file cabinets separate from any identifying information. To ensure data integrity and validity,
all questionnaires will be explained to volunteers and time for questions and clarifications will be given. Trained research assistants will
be present when participants are answering questionnaires to ensure that volunteers are staying on task, paying attention, and to be
able to answer any questions from the volunteers should they have questions about the tasks.
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Future Use and Sharing of Material (e.g., Data/Specimens/Information)
If the material collected for this study will be used by members of the research team or shared with other researchers for future studies,
please address the following:
list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers
describe the process for, and limitations to, withdrawal of specimens/data
Information and samples collected for this study will NOT be used or shared for future research studies, even if identifiable information
is removed.
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not include short
form use for incidentally encountered non-English subjects)
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if necessary,
how new information about the research may be relayed to subjects during the study. 
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving this
section, attach both the English and translated consent documents in the “Informed Consent" section. 
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated documents are
the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant for
your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects from a
Foreign Culture. 
Local Requirements:
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If you will conduct research at an international location, identify and describe:
relevant local regulations
data privacy regulations
applicable laws
ethics review requirements for human subject protection
Please provide links or sources where possible. If the project has been or will be reviewed by a local ethics review board, attach a
copy in the “Additional Information/Materials” section. You may also consult the current edition of the International Compilation of
Human Research Standards
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Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s summary
sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
This study will be covered under IND # 69,214 (Sponsor: Sharon Walsh, Ph.D.). Dr. Walsh, the Principal Investigator, has been
conducting FDA-regulated research for 20+ years. She has held several INDs throughout this period and currently holds three
active INDs. She has also served as Principal Investigator for numerous privately sponsored studies in which the IND was held
and sponsored by a private company. Through this extensive experience, she is familiar with the submission of INDs,
amendments, reporting requirements for adverse events, annual progress reporting requirements and recordkeeping
requirements. She is also familiar with Good Clinical Practice guidelines, has participated in numerous related training over the
years, and has trained and managed a multi-disciplinary staff on regulatory affairs, confidentiality issues, reporting requirements,
data management, data quality assurance, data storage, and human subjects’ protections.
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device)
before final IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the
IRB’s consideration. 
Attachments
Section 9 Page 10 of 11
46591


Section 9 Page 11 of 11
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HIPAA
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Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 
HIPAA De-identification Certification Form
HIPAA Waiver of Authorization
Attachments
Section 10 Page 1 of 1
46591


STUDY DRUG INFORMATION
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The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an
investigational drug?
Yes
No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Oxycodone, Gabapentin
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies (Oncology or
Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient studies not using IDS
services are subject to periodic inspection by the IDS for compliance with drug accountability good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
69,214
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By: Sharon L. Walsh, Ph.D.
Other:
Held By:
Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment IND)
or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and attach the
following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access SOP.
Section 11 Page 1 of 2
46591


Complete and attach the required Study Drug Form picking "Study Drug Form" for the document type. Any
applicable drug documentation (e.g., Investigator Brochure; approved labeling; publication; FDA correspondence,
etc.) should be attached using "Other Drug Documentation" for the document type.
Attachments
Attach Type
File Name
Study Drug Form
Study Drug Form (26 Aug 2019).pdf
Study Drug Form
FDA IND Approval (19 May 2004).pdf
Section 11 Page 2 of 2
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STUDY DEVICE INFORMATION
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A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device;
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
Yes
No
If Yes, complete the following: 
IDE or HDE #(s)
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration (FDA)
Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program Information,
and attach the following:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
Confirmation of agreement from manufacturer or entity authorized to provide access to the product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
Section 12 Page 1 of 2
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Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition of
Significant Risk (SR) device?
Yes. Device(s) being tested in this study presents a potential for serious risk to the health, safety, or welfare of a subject and
(1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in
diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents
a potential for serious risk to the health, safety, or welfare of a subject.
No. All devices being tested in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any
applicable device documentation (e.g., Manufacturer information; patient information packet; approved labeling; FDA
correspondence, etc.) should be attached using "Other Device Documentation" for the document type.
Attachments
Section 12 Page 2 of 2
46591


RESEARCH SITES
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To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's IRB Application Instructions -
Off-site Research web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky (UK) or
at sites that do not fall under the UK IRB’s authority, are subject to special procedures for coordination of research
review. Additional information is required (see IRB Application Instructions - Off-Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and
university requirements which need to be completed for their participation. For instance, the other site(s) may need
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK
sites.
Section 13 Page 1 of 2
46591


Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-
9428.
List all other non-UK owned/operated locations where the research will be conducted:
UK Robert Straus Research Facility
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
Attachments
Attach Type
File Name
-Individual Investigator Agreement Grant Proposal.pdf
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of protocol
modifications and interim results from the non-UK sites:
C) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.
Section 13 Page 2 of 2
46591


RESEARCH ATTRIBUTES
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comment(s)
Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Alcohol/Drug/Substance Abuse Research
Biological Specimen Bank Creation (for sharing)
Cancer Research
CCTS-Center for Clinical & Translational Science
Certificate of Confidentiality
Clinical Research
Clinical Trial - Phase 1
Clinical Trial
Collection of Biological Specimens for internal banking and use
(not sharing)
Community-Based Participatory Research
Deception
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Gene Transfer
Genetic Research
GWAS (Genome-Wide Association Study) or NIH Genomic Data
Sharing (GDS)
Human Cells, Tissues, and Cellular and Tissue Based Products
Individual Expanded Access or Compassionate Use
International Research
Planned Emergency Research Involving Exception from
Informed Consent
Recombinant DNA
Registry or data repository creation
Stem Cell Research
Suicide Ideation or Behavior Research
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation
producing devices
Vaccine Trials
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational
Science)
Clinical Research (look up "What is the definition
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Specimen/Tissue Collection...")
Collection of Biological Specimens (look up
"Specimen/Tissue Collection...")
Community-Based Participatory Research (look
up "Community-Engaged...")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the E-IRB
Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Specimen/Tissue
Collection...")
Gene Transfer
HIV/AIDS Research (look up "Reportable
Diseases/Conditions")
Screening for Reportable Diseases [E2.0000]
(PDF)
International Research (look up "International &
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the E-
IRB Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Use, storage and disposal of radioactive material
and radiation producing devices
Section 14 Page 1 of 2
46591


Section 14 Page 2 of 2
46591


FUNDING/SUPPORT
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comment(s)
If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program,
indicate below all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control &
Prevention
(HRSA) Health Resources and Services
Administration
(SAMHSA) Substance Abuse and Mental
Health Services Administration
(DoJ) Department of Justice or Bureau of
Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed
Here
Industry (Other than Pharmaceutical
Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements and information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services
Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons 
(DoE) Department of Energy Summary and Department of Energy
Identifiable Information Compliance Checklist
(EPA) Environmental Protection Agency
Other:
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly
& Company, South Western Oncology Group, Bureau of Prisons, etc.):
 
National Institute on Drug Abuse
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) #
(notif #) associated with this IRB application using the "Add Related Grants" button. 
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
Add Related Grants
Grant/Contract Attachments
Section 15 Page 1 of 2
46591


The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources.
(See DoD SOP and DoD Summary for details)
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in
the DoD SOP.
DOD SOP Attachments
Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Assurance/Certification Attachments
Section 15 Page 2 of 2
46591


OTHER REVIEW COMMITTEES
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comment(s)
If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC) - Attach required IBC
materials
Radiation Safety Committee (RSC) - For applicability, see
instructions and attach form
Radioactive Drug Research Committee (RDRC)
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)** - Attach MCC PRMC materials, if any, per
instructions.
Office of Medical Education (OME)
Graduate Medical Education Committee (GME)
Attachments 
** If your study involves cancer research, be sure to select "Cancer Research" in the "Research Attributes"
section. ORI will send your research protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC). The MCC PRMC is responsible for determining whether the study meets the National Cancer Institute
(NCI) definition of a clinical trial and for issuing documentation to you (the investigator) which confirms either that PRMC
approval has been obtained or that PRMC review is not required. Your IRB application will be processed and reviewed
independently from the PRMC review.
Section 16 Page 1 of 1
46591


ADDITIONAL INFORMATION/MATERIALS
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comment(s)
Do you want specific information inserted into your approval letter?
Yes
No
Approval Letter Details:
If you wish to have specific language included in your approval letter (e.g., serial #, internal tracking identifier, etc…), type that
language in the box below exactly as it should appear in the letter. The text you enter will automatically appear at the top of all
approval letters, identical to how you typed it, until you update it. Don't include instructions or questions to ORI staff as those will
appear in your approval letter. If these details need to be changed for any reason, you are responsible for updating the
content of this field.
Additional Materials:
If you have other materials you would like to include for the IRB's consideration, check all that apply and attach the corresponding
documents using the Attachments button below.
Detailed protocol
Dept. of Health & Human Services (DHHS) approved protocol (such as NIH sponsored Cooperative Group Clinical Trial)
Other Documents
Protocol/Other Attachments
Attach Type File Name
Other
20183 Adverse Events Log - 06.12.2023.pdf
Other
46591 Progress Report 2023 - 06.12.2023.pdf
Protocol
Example Screening Measures.pdf
Protocol
Example Session Questionnaires.pdf
NOTE: Instructions for Dept. of Health & Human Services (DHHS)-approved protocol]
If you have password protected documents, that feature should be disabled prior to uploading to ensure access for IRB review.
To view the materials currently attached to your application, click “All Attachments” on the left menu bar.
Section 17 Page 1 of 1
46591


SIGNATURES (ASSURANCES)
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comment(s)
Introduction
All IRB applications require additional assurances by a Department Chairperson or equivalent (DA), and when applicable, a Faculty
Advisor or equivalent (FA). This signifies the acceptance of certain responsibilities and that the science is meritorious and deserving of
conduct in humans. The person assigned as DA should not also be listed in the Study Personnel section, and the individual assigned
as FA should be listed in the Study Personnel section.
For a list of responsibilities reflected by signing the Assurance Statement, refer to "What does the Department Chairperson’s
Assurance Statement on the IRB application mean?"
For a detailed illustration of how to complete this section, please review the short online video tutorial "Signatures
(Assurance) Section - How to Complete." Otherwise, follow the steps below.
Required Signatures:
First
Name
Last
Name
Role
Department
Date
Signed
 
Carl
Leukefeld
Department
Authorization
Behavioral
Science
09/07/2018
06:59 AM
View/Sign
Sharon
Walsh
Principal
Investigator
Behavioral
Science
09/06/2018
01:34 PM
View/Sign
Department Authorization
 This is to certify that I have reviewed this research protocol and that I attest to the scientific validity and importance of
this study; to the qualifications of the investigator(s) to conduct the project and their time available for the project; that
facilities, equipment, and personnel are adequate to conduct the research; and that continued guidance will be provided
as appropriate. When the principal investigator assumes a sponsor function, the investigator has been notified of the
additional regulatory requirements of the sponsor and by signing the principal investigator Assurance Statement, confirms
he/she can comply with them.
*If the Principal Investigator is also the Chairperson of the department, the Vice Chairperson or equivalent should complete
the "Department Authorization".
**IF APPLICABLE FOR RELIANCE: I attest that the principal investigator has been notified of the regulatory requirements of
both the Reviewing and Relying IRBs, according to the information provided in the E-IRB application. The attached Reliance
Assurance Statement, signed by the principal investigator, confirms that he/she can comply with both sets of IRB
requirements.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky's policies concerning research involving human subjects and I agree:
1. To comply with all IRB policies, decisions, conditions, and requirements;
2. To accept responsibility for the scientific and ethical conduct of this research study;
3. To obtain prior approval from the Institutional Review Board before amending or altering the research protocol or
implementing changes in the approved consent/assent form;
4. To report to the IRB in accord with IRB/IBC policy, any adverse event(s) and/or unanticipated problem(s) involving risks to
subjects;
5. To complete, on request by the IRB for Full and Expedited studies, the Continuation/Final Review Forms;
6. To notify the Office of Sponsored Projects Administration (OSPA) and/or the IRB (when applicable) of the development of
any financial interest not already disclosed;
7. Each individual listed as study personnel in this application has received the mandatory human research protections
education (e.g., CITI);
8. Each individual listed as study personnel in this application possesses the necessary experience for conducting research
Section 18 Page 1 of 2
46591


activities in the role described for this research study.
9. To recognize and accept additional regulatory responsibilities if serving as both a sponsor and investigator for FDA
regulated research.
Furthermore, by checking this box, I also attest that:
I have appropriate facilities and resources for conducting the study;
I am aware of and take full responsibility for the accuracy of all materials submitted to the IRB for review;
If applying for an exemption, I also certify that the only involvement of human subjects in this research study will be in the
categories specified in the Protocol Type: Exemption Categories section.
If applying for an Abbreviated Application (AA) to rely on an external IRB, I understand that certain items above (1, 3, 4, 7-8)
may not apply, or may be altered due to external institutional/IRB policies. I document my agreement with the Principal
Investigator Reliance Assurance Statement by digitally signing this application.
*You will be able to "sign" your assurance after you have sent your application for signatures (use Submission section). Please notify the
personnel required for signing your IRB application after sending for signatures. Once all signatures have been recorded, you will need
to return to this section to submit your application to ORI. 
Section 18 Page 2 of 2
46591


SUBMISSION INFORMATION
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comment(s)
Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of
Research Integrity/IRB.
If applicable, remember to update the Approval Letter Details text box under the Additional Information section
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and you will receive a message to notify you of the date.
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate
Document Type for the item(s)). Do not delete approved attachments that are still in use.
Your protocol has been submitted.
Section 19 Page 1 of 1
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Document Type
File Loaded
Document Description
File
Size
Modified
By
Mod
Date
ApprovalLetter
ApprovalLetter.pdf
 
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Stamped Consent Form
46591 Screening Consent -
Prescription Med Interactions v10.0
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13 2023 (f).pdf
 
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AddInfoProduct
46591 Progress Report 2023 -
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46591 Progress Report dated
12JUN2023
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46591 Main Study Consent -
Prescription Med Interactions v9.0
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Prescription Med Interactions
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STAMPED.pdf
Flyer 3 - 20183 - C - PR
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General - Digital 3_20183-1-FINAL-
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General - Digital 2_20183_C-FINAL-
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General - Cards 3_20183_B-FINAL-
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Advertising
RX Interactions Digital Ads 6.1 -
CLEAN COPY.pdf
RX Interactions Digital Ads
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RX Interactions Flyer 6.1 - CLEAN
COPY.pdf
RX Interactions Flyers
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RX Interactions Cards 6.1 - CLEAN
COPY.pdf
RX Interactions Cards
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Advertising
BuildClinical Secure questionnaire.pdf
BuildClinical Secure questionnaire
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AdditionInfoConsiderations CDAR Instagram & Google
Examples.docx
CDAR Instagram & Google
Examples
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Advertising
20183-Ad 7.pdf
20183 Ad 7 Clean Version
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Advertising
20183 AD 4.jpg
20183 Ad 4 Clean Version
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20183 AD 3.jpg
20183 Ad 3 Clean Version
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20183 AD 6.jpg
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20183 AD 2.pdf
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Advertising
20183 Ad 1.pdf
20183 Ad 1 Clean Version
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StudyDrug
FDA IND Approval (19 May 2004).pdf
 
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StudyDrug
Study Drug Form (26 Aug 2019).pdf
 
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Possible Accompanying Text
APPROVED.pdf
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accompany attached
advertisements
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Non-Dependent OPI Advertisements
APPROVED.pdf
Facebook and Flyer
Advertisements
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AdditionInfoConsiderations 20190218111529261[1].pdf
 
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Facebook page - revised Dec 17
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-Individual Investigator
Agreement
Grant Proposal.pdf
Grant Proposal
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AddInfoProtocol
Example Session Questionnaires.pdf
Example Session Questionnaires
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AddInfoProtocol
Example Screening Measures.pdf
Screening Measures - Example
Packet
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AdditionInfoConsiderations Gabapentin package insert.pdf
Package Insert Gabapentin
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AdditionInfoConsiderations Oxycodone HCl package insert
(mallinckrodt).pdf
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Section 20 Page 3 of 3
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Protocol Changes
Protocol Number: 46591
Study Personnel Changes:
Status
PPIdentity ProtocolID PersonID RoleInProtocol IsContact LastName FirstName Email
DeptCode RoomBuilding SpeedSort PhoneNum DeptDesc AuthorizedConsent ResponsibilityInProject Degree Rank StatusFlag IsRemoved ModBy
ModDate SFI IsPIRN MiddleName
Updated 816932
94290
00007063 SP
N
Chamblin
Lisa
lmcham2@uky.edu  
 
 
 
 
N
Project
Assistance/Support
 
 
P
N
mmdo225
2/8/2024
9:13:31
AM
N
 
 
No Changes
There are no recorded changes tracked for this protocol.
Section 21 Page 1 of 1
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Section 22 Page 1 of 1
46591