Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Florida

Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study 
NCT04791917 
Last Uploaded: 7/3/2023 
Last Updated and Approved by University of Florida IRB: 2/8/2022 

IRB Project #: 202000058
Page 1 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
INFORMED CONSENT FORM
to Participate in Research, and
AUTHORIZATION 
to Collect, Use, and Disclose Protected Health Information (PHI)
INTRODUCTION
Name of person seeking your consent:
Place of employment & position: 
GENERAL INFORMATION ABOUT THIS STUDY
1. Name of Participant ("Study Subject")
___________________________________________________________________ 
2. What is the Title of this research study (this “Research Study”)?
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study
3. Whom do you call if you have questions about this Research Study (the “Study 
Team”)?
Jeff Boissoneault, PhD, Principal Investigator (352-273-6147)
Erin Ferguson, MS, Co-Investigator (352-273-5220)
Michael Robinson, PhD, Co-Investigator (352-273-6617)
4.  Who is paying for this Research Study?
 
The sponsors of this study are the University of Florida Center for Addiction Research 
and Education, the Research Society on Alcoholism, and the National Institute on 
Alcohol Abuse and Alcoholism (NIAAA).
5. In general, what do you need to know about this Research Study?
Agreeing to become involved in any research is always voluntary.  By signing this 
form, you are not waiving any of your legal rights.  If you decide not to participate in 
this research, you will not be penalized in any way and you will not lose any benefits 
to which you are entitled. If you have questions about your rights as a research 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 2 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
subject, please call the University of Florida Institutional Review Board (IRB) office at 
(352) 273-9600.  
You are being asked to be in the MUSTAC study because you are a healthy person 
older than 21 who regularly uses alcohol and marijuana and identifies as either 
White/Caucasian or Black/African-American. You should not participate in MUSTAC if 
any of the following apply to you:

You have participated in exercises that involve the biceps in the past 6 
months (e.g. bicep curls, pull-ups, Olympic weightlifting)

You have had wrist/hand, elbow, or shoulder pain in the past 3 months

You have a medical history including diabetes, kidney problems, muscle 
damage, major psychiatric disorder, high blood pressure, or chronic pain

You have a medical marijuana prescription, recommendation, or card

You consume marijuana using only non-inhalational methods (e.g. edibles, 
tinctures, or cannabidiol oil)

You have not used alcohol and marijuana at least 2-3 times per week over the 
past 6 months

You do not own a smartphone with a cellular/data plan

You are pregnant, trying to become pregnant, or breastfeeding
a) In general, what is the purpose of the research, how long will you be 
involved?  
The purpose of the MUSTAC study is to study the relationship between vigorous 
exercise and alcohol and marijuana consumption. Your participation will last 
approximately one week and involves two visits to our laboratory (including this 
one), as well as the completion of daily surveys.
b) What is involved with your participation, and what are the procedures to be 
followed in the research? 
If you decide to participate in this study, you will complete a variety of 
questionnaires followed by brief computer-based tasks. You will then perform a 
series of biceps exercises and be scheduled for your second laboratory session. 
Participation in this study lasts approximately one week and involves two visits to 
our laboratory. The first visit will require about 2.5 hours. The second visit will 
require about 1 hour. Daily surveys will require approximately five minutes per 
day for one week.
c) What are the likely risks or discomforts to you? 
This study collects information about your marijuana use, which is considered 
illegal if not done for medical reasons. Despite safeguards described below, there 
is a risk that information about your marijuana use may reach someone, who 
would use this information against you, e.g. by denying you employment. 
Performing the exercises in this study may result in soreness in your biceps 
muscles, and possibly swelling of the area around the biceps. There is a very small 
risk that you may get some other type of muscle damage from doing the exercise. 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 3 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
This risk can be reduced by drinking plenty of water before doing the exercises. 
Other potential risks are described in detail under Item 10.
d) What are the likely benefits to you or to others from the research? 
There is no direct benefit to you for participating in this study. 
e) What are the appropriate alternative procedures or courses of treatment, if 
any, that might be helpful to you? 
Participating in this study is entirely optional. This is not a treatment study. If you 
are a faculty/staff member or student at the University of Florida, your decision 
whether to participate will have no impact on your employment or academic 
status.
Additional and more detailed information is provided within the remainder of this 
Informed Consent form, please read carefully before deciding if you wish to 
participate in this study.
WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY?
6. What will be done as part of your normal clinical care (even if you did not 
participate in this Research Study)? 
Your normal clinical care will not be affected by participation in this study. 
7.  What will be done only because you are in this Research Study? 
The MUSTAC study involves two visits to our laboratory. The first visit includes the 
following procedures: 
a) After arriving at the Center for Pain Research and Behavioral Health (located 
on the ground floor of the UF Dental Tower in room DG-64), the Informed 
Consent form will be reviewed with you to make certain that you understand 
everything that is involved in the study procedures. 
b) You will complete several questionnaires about your demographics (age, 
education, etc.), typical exercise, typical alcohol and marijuana use patterns, 
emotional state, personality, expectations about how alcohol and marijuana 
may affect you, medical history, and attitudes about pain.
c) You will complete brief computer-based tasks. In one task, you will decide how 
many alcoholic beverages you would consume at different prices, if they were 
available. In the other tasks, you will decide how much marijuana you would 
use at different prices if it were available. However, we do not actually provide 
alcoholic beverages or marijuana in this study.
d) We will test the strength of your biceps muscle using an exercise testing 
machine that you sit on. We are going to ask you to pull as hard as you can on 
a handle that is attached to the machine. Next, you will do some exercise with 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 4 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
your biceps muscles. You will be randomly assigned to either resist the 
machine pushing against you by pulling as hard as you can (“eccentric” 
exercise) or to complete several repetitions pulling against a resistance that is 
based on the results of your strength test (“concentric” exercise).
Following completion of the first session, you will receive instructions related to 
completion of daily surveys about your use of alcohol and marijuana and any 
discomfort/pain you may have experienced due to your biceps exercise. Text 
messages with a link to a survey will be sent every night for one week and will begin 
the day of the first session.
The second visit will take place about 48 hours (2 days) after your first visit, and 
includes the following procedures:
a) You will complete several questionnaires about any discomfort or pain you 
may have experienced as a result of your biceps exercise, both at rest and 
with movement.
b) You will complete the same computer-based tasks about how many alcoholic 
beverages or how much marijuana you would consume at different prices, if 
available.
If you experience a physical or mental emergency during your screening or either 
laboratory session, we will request emergency services by dialing 911. 
Once this research study is completed, any information that could identify you might 
be removed from any identifiable private information or identifiable biospecimens 
collected and that, after such removal, the information or biospecimens could be used 
for future research studies or distributed to another investigator for future research 
studies without additional informed consent from you or your legally authorized 
representative.
If you have any questions now or at any time during this Research Study, please 
contact one of the Research Team members listed in question 3 of this form.
8. What identifiable health information will be collected about you and how will it be 
used?
The Research Team will collect the following protected health information (PHI) about 
you:
a) Your name, research record number, contact information, and dates 
associated with tests related to your participation.
b) Demographic and health status information
c) Responses to questionnaires
d) Results of the biceps exercise protocol
e) Social security number for the purposes of payment
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 5 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
This information will be gathered only through your self-report, participation in study 
procedures, or from your study visits or telephone calls.
To help us protect your privacy, we have obtained a Certificate of Confidentiality from 
the National Institutes of Health. With this Certificate, the researchers cannot be forced 
to disclose information that may identify you, even by a court subpoena, in any federal, 
state, or local civil, criminal, administrative, legislative, or other proceedings. The 
researchers will use the Certificate to resist any demands for information that would 
identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of 
the United States Government that is used for auditing or evaluation of federally 
funded projects or for information that must be disclosed in order to meet the 
requirements of the federal Food and Drug Administration (FDA).
You have been informed that a Certificate of Confidentiality does not prevent you 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.  That is, if you give written consent for the release of information, we 
cannot withhold that information and we cannot hold responsibility for how that person 
may use your information. 
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 the following circumstances. If we learn about child 
abuse, elder abuse, or intent to harm yourself or others, we will report that information 
to appropriate authorities.
The Research Team listed in question 3 above will use or share your health 
information as described below to carry out this research study. 
9. With whom will this health information be shared?
This health information may be shared with:

the UF Department of Clinical and Health Psychology;
United States governmental agencies which are responsible for overseeing 
research, such as the Food and Drug Administration, the Department of Health 
and Human Services, and the Office of Human Research Protections;
The IRB that reviewed this Research Study and ensures your rights as a Study 
Subject are protected 
Otherwise, your identifiable health information will not be shared without your 
permission unless required by law or a court order. Once your health information is 
shared with those listed above, it is possible that they could share it without your 
permission because it would no longer be protected by the federal privacy law. 
 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 6 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
10. How long will you be in this Research Study?
Participation in this study lasts approximately one week and involves two visits to our 
laboratory. The first visit will require about 2.5 hours. The second visit will require about 
1 hour. Daily surveys will require approximately five minutes per day for one week.
This Authorization to use and share your health information expires at the end of the 
study, unless you revoke it (take it back) sooner.
11.How many people are expected to take part in this Research Study?
Our goal is for 56 people to complete this study.
WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND 
WHAT ARE YOUR OPTIONS?
12.What are the possible discomforts and risks from taking part in this Research 
Study?

You may feel uncomfortable answering questions about private topics during 
the screening session. However, you may choose not to answer any questions 
that make you feel uncomfortable.

By performing the exercises in this study, you may get muscle soreness in 
your biceps muscles. It is also possible that the area around the biceps 
muscles will swell. There is a chance that this pain will limit how you move 
around for several days. There is a very small risk that you may get some 
other type of muscle damage from doing the exercise. This risk can be 
reduced by drinking plenty of water before doing the exercises. If you 
experience any severe and unusual symptoms, including vomiting or nausea, 
abdominal pain, confusion, dehydration, or fever, call 911 or seek care from a 
physician.

There is a risk of spreading or contracting COVID-19 during participation in 
this study. We are taking the following steps to limit spread of COVID-19:
o
During laboratory visits, research staff will wear a disposable Level 1 
surgical mask during all interactions with you or other staff members. 
Upon arrival for each session, you will be asked to wait outside of the 
Shands Dental Tower West Entrance, inform our staff of your arrival 
(352-273-5220), and wait for a research assistant to come outside and 
provide you with a disposable Level 1 surgical mask. You are required 
to wear the mask for the duration of all sessions.

If you are not willing to wear a mask, we ask that you do not 
participate in this study.
o
At the beginning of each study session, all consent material documents 
will be presented to you. You will be instructed when to flip to the next 
page, to reduce the number of times forms are passed between 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 7 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
people. Electronic devices (e.g. iPads) used to collect information will 
be designated for participants and thoroughly disinfected between 
study sessions. After the participant begins data collection procedures 
using the iPad, the device will not be passed back to research 
personnel until completion.
o
All study equipment will be sanitized before and after each use with 
alcohol wipes. Study equipment includes, but is not limited to: 
tabletops, door knobs, writing utensils, and the Biodex machine used 
for musculoskeletal induction procedure. .
o
The study personnel have acquired HEPA filtered air purifiers that will 
be placed in study rooms.  
This Research Study may also include risks that are unknown at this time.
Please note that participating in more than one research study or project may further 
increase the risks to you.  If you are already enrolled in a research study, please inform 
one of the Research Team members listed in question 3 of this form or the person 
reviewing this consent with you before enrolling in this or any other research study or 
project.
During the study, the Research Team will notify you of new information that may 
become available and might affect your decision to remain in the study. 
The University of Florida is required by law to protect your health information. Your 
health information will be stored in locked filing cabinets or on computer servers with 
secure passwords, or encrypted electronic storage devices, as required by University 
policy. However, there is a slight risk that information about you could be released 
inappropriately or accidentally. Depending on the type of information, a release could 
upset or embarrass you, or possibly affect your ability to get insurance or a job. 
If you wish to discuss the information above or any discomforts you may experience, 
please ask questions now or call one of the Research Team members listed in question 
3 in this form.
13a. What are the potential benefits to you for taking part in this Research Study?
There is no direct benefit to you for participating in this study.
13b. How could others possibly benefit from this Research Study?
Improving understanding of the relationship between the effects of vigorous exercise 
and alcohol and marijuana use may benefit the scientific community.
13c. How could the Research Team members benefit from this Research Study?
In general, presenting research results helps the career of a researcher. Therefore, the 
Research Team listed in question 3 of this form may benefit if the results of this 
Research Study are presented at scientific meetings or in scientific journals.
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 8 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
14.What other choices do you have if you do not want to be in this study? 
Participating in this study is entirely optional. This is not a treatment study. If you are a 
faculty/staff member or student at the University of Florida, your decision whether to 
participate will have no impact on your employment or academic status.
15a. Can you withdraw from this study?
You may withdraw your consent and stop participating in this Research Study at any 
time.  If you do withdraw your consent, there will be no penalty to you, and you will not 
lose any benefits to which you are otherwise entitled. If you decide to withdraw your 
consent to participate in this Research Study for any reason, please contact the 
Research Team listed in question 3 of this form. They will tell you how to safely stop 
your participation.
You can also change your mind and take back this Authorization at any time by sending 
a written notice to the Research Team listed in question 3 of this form to let them know 
your decision. If you take back this Authorization, the Research Team may only use and 
disclose your health information already collected for this research study. No additional 
health information about you will be collected or disclosed to the Research Team. 
However, if you take back this Authorization, you may not be able to continue in this 
study. Please discuss this with a member of the Research Team listed in question #3.
15b.Can the Principal Investigator withdraw you from this Research Study? 
You may be withdrawn from this Research Study without your consent for the following 
reasons:

If the Principal Investigator obtains information that participating in this study 
might cause you harm.

For administrative reasons at the Principal Investigator’s discretion.
WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE?
16. If you choose to take part in this Research Study, will it cost you anything?
No. The Sponsor will provide all services and activities required as part of your 
participation in the study. There will be no cost to you. If you receive a bill related to 
this study, please contact Erin Ferguson, MS, at 352-273-5220. 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 9 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
17.Will you be paid for taking part in this Research Study?
Yes. You will receive $50 for the first session and $15 for the second, for a total 
amount of $65. If you do not qualify for the study after completing the screening 
questionnaires, you will be paid $15. For the daily surveys, compensation will be 
provided as a function of the number of surveys completed, with a maximum of $30 
for participants who complete at least 5 out of 7 surveys. Additionally, if you refer an 
individual to the study that attends the screening session, you will also receive $20 per 
person referred. The people you refer will be responsible for contacting the study team 
in order to schedule the session. You will be eligible to refer participants regardless of 
whether you qualify to proceed with the study after screening procedures.
Your payment for participation in this research study is handled through the University 
of Florida’s Research Participant Payments (RPP) Program.  Your information which 
will include your name, address, date of birth, and SSN (depending on amount of 
money you are paid) is protected.  Access to the (RPP) Program site is limited to 
certain staff with the assigned security role.  You will be randomly assigned a specific 
identification (ID) number to protect your identity. If you have any problems regarding 
your payment contact the study coordinator.
If you are paid more than $199 for taking part in this study, your name and social 
security number will be reported to the appropriate University employees for purposes 
of making and recording the payment as required by law. You are responsible for 
paying income taxes on any payments provided by the study. Payments to 
nonresident aliens must be processed through the University of Florida Payroll and 
Tax Services department. If the payments total $600 or more in a calendar year, the 
University must report the amount you received to the Internal Revenue Service 
(IRS). The IRS is not provided with the study name or its purpose. If you have 
questions about the collection and use of your Social Security Number, please visit: 
http://privacy.ufl.edu/SSNPrivacy.html. 
18.What if you are injured while in this Research Study?  
If you are injured as a direct result of your participation in this study, the professional 
services that you receive from any University of Florida Health Science Center health 
care provider will be provided without charge. These healthcare providers include 
physicians, physician assistants, nurse practitioners, dentists or psychologists. Any 
other expenses, including Shands hospital expenses, will be billed to you or your 
insurance provider. 
You will be responsible for any deductible, co-insurance, or co-payments. Some 
insurance companies may not cover costs associated with research studies. Please 
contact your insurance company for additional information. 
The Principal Investigator will determine whether your injury is related to your 
participation in this study. 
No additional compensation is routinely offered. The Principal Investigator and others 
involved in this study may be University of Florida employees. As employees of the 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 10 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
University, they are protected under state law, which limits financial recovery for 
negligence. 
Please contact one of the research team members listed in question 3 of this form if 
you experience an injury or have questions about any discomforts that you experience 
while participating in this study.
Please contact one of the Research Team members listed in question 3 of this form if 
you experience an injury or have questions about any discomforts that you experience 
while participating in this Research Study.
 
Study ID:IRB202000058   Date Approved: 2/8/2022

IRB Project #: 202000058
Page 11 of 11
IRB Version: 10/01/2018
PI Version: 2/04/2022
SIGNATURES
As an investigator or the investigator’s representative, I have explained to the participant 
the purpose, the procedures, the possible benefits, and the risks of this Research Study; 
the alternative to being in the study; and how the participant’s protected health information 
will be collected, used, and shared with others: 
Signature of Person Obtaining Consent and 
Authorization
Date
You have been informed about this study’s purpose, procedures, possible benefits, and 
risks; the alternatives to being in the study; and how your protected health information will 
be collected, used and shared with others. You have received a copy of this Form. You 
have been given the opportunity to ask questions before you sign, and you have been told 
that you can ask questions at any time.  
You voluntarily agree to participate in this study. You hereby authorize the collection, use 
and sharing of your protected health information as described above. By signing this form, 
you are not waiving any of your legal rights.
Signature of Person Consenting and Authorizing
Date
 
Study ID:IRB202000058   Date Approved: 2/8/2022

Protocol #:  202000058 
Page 1 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Protocol 
1. Project Title:  
Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study 
2. Investigator(s):   
 
Jeff Boissoneault, PhD (PI) 
Erin Ferguson, MS (Co-I) 
Michael Robinson, PhD (Co-I) 
 
3. Abstract:  
 
A substantial body of research indicates that self-medication of pain with alcohol and 
marijuana (i.e. use to cope with and/or manage pain) is common among chronic pain 
patients, and epidemiological and observational studies suggest that pain can act as a 
potent motivator of substance use. Initial experimental evidence suggests that pain can 
increase urge and intention to consume alcohol, yet this relationship has not been 
replicated using clinically-relevant pain induction methods with greater ecological 
validity than typical experimental pain approaches. Further, despite similar pain-
inhibitory effects and co-occurring use patterns of alcohol and marijuana, current 
research has not simultaneously examined the proximal effects of pain on alcohol and 
marijuana use. Thus, the proposed project will attempt to determine whether 
experimentally-induced musculoskeletal pain (i.e., delayed onset muscle soreness; 
DOMS) increases alcohol and marijuana demand among co-users. We will assess 
demand for alcohol and marijuana using well-validated behavioral economic measures 
before and after DOMS induction in the dominant elbow flexor muscle. 
 
4.   Background: 
 
Chronic pain affects approximately 100 million adults and is one of the most common 
reasons for seeking medical treatment.1 However, front-line treatments for chronic pain, 
including opioid medications, are often considered ineffective by patients and are 
associated with risk of harm (e.g. adverse side effects, diversion, abuse of opioids).2-4 
Growing evidence suggests that many individuals may report substance use, including 
alcohol and marijuana use, as an alternative means to manage pain-related symptoms 
and reduce distress.5-8 Therefore, greater understanding of the causal pathway from 
pain to alcohol and marijuana use is warranted to inform prevention and intervention 
substance use approaches and achieve improved health outcomes for chronic pain 
patients.  
 
Race and Sex Differences in Coping with Pain 
 
Compared to White individuals, African Americans are disproportionately burdened by 
chronic pain and associated outcomes, including greater pain severity, functional 
limitations, and disability.9-12 African Americans have been found to report higher levels 

Protocol #:  202000058 
Page 2 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
of pain catastrophizing,13 lower perceived ability to effectively cope with pain,14 and 
overall greater use of maladaptive coping strategies (i.e., passive, emotion-focused),13-
16 all of which have been linked to poorer chronic pain outcomes. Similarly, research 
consistently suggests that women report greater pain prevalence and severity.16-17 
catastrophize more frequently about pain,18-20 and use emotion-focused coping 
strategies relative to men.21-22 Interestingly, epidemiological studies suggest that White 
individuals and men are more likely to use alcohol to cope with pain, which may reflect 
differences in alcohol use patterns among the general population and/or the influence of 
sociocultural factors.6 Nevertheless, identifying demographic correlates of self-
medication behaviors of pain with alcohol and marijuana may provide clarity for a 
relatively discrepant literature on pain-coping and self-medication, as well as inform 
targeted interventions for pain management and substance use.  
 
Alcohol and Marijuana Use to Cope with Pain 
 
Alcohol and marijuana use are highly prevalent among US adults, with 65.7% and 15% 
reporting past year use respectively.23 While there are several overlapping reasons for 
use (e.g. enhancement, relaxation), coping with pain and distress is often cited as a 
motive of use for both substances.5 Previous studies suggest that alcohol drinkers 
report consuming alcohol to self-medicate their physical pain.6, 24-26 Further, 64% of 
medical marijuana users endorse use to cope with pain, and marijuana use rates are 
higher among chronic pain patients than in the general population.7,27 Of most concern 
with such behaviors is the possibility of adverse interactions between alcohol and pain 
medication, as well as increased risk for alcohol and cannabis use disorders. For 
example, young adults with chronic pain were more likely to endorse heavier patterns of 
marijuana consumption (e.g. extensive histories of regular use, higher quantities of 
marijuana per use episode) than users without chronic pain, which have been 
associated with increased risk of cannabis use disorder (CUD).28 Theoretical models for 
reciprocal alcohol-pain interactions suggest that self-medicating patients may escalate 
consumption over time, consequently creating a feed-forward cycle of greater risk of 
AUD in individuals with chronic pain and vice versa.5,29 
 
Co-Use of Alcohol and Marijuana 
 
Co-use (concurrent or simultaneous) of alcohol and marijuana is common among 
individuals with chronic pain. Medical marijuana users with chronic pain have higher 
rates of hazardous drinking than non-users, 30-31 and hazardous drinking has been 
associated with reduced pain severity and disability.30 Findings that hazardous drinking 
is related to lower pain severity underscore the likelihood of alcohol use to manage pain 
among this population.8, 30 Overall, co-use of alcohol and marijuana is associated with a 
range of deleterious consequences beyond those associated with use of a single 
substance, including increased rates of comorbid substance use and mental health 
disorders, poorer treatment outcomes, and greater social and behavioral consequences 
(e.g. driving under the influence). 32-34 Prevalence estimates for alcohol and marijuana 
co-use among those with chronic pain (~60%) are similar to those in the general 
population.30-31, 35  However, co-users with chronic pain may be even more susceptible 
to heavier consumption over time for pain-coping purposes, 5 thereby resulting in 

Protocol #:  202000058 
Page 3 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
greater risk of adverse consequences. Improved understanding of the proximal, causal 
role of pain on alcohol and marijuana co-use is urgently needed to clarify unique risks of 
co-users with pain and the temporality of the pain-substance use relationship.   
 
Pain as an Antecedent of Alcohol and Marijuana Use 
 
Emerging literature suggests that pain can act as a motivator for substance use, such 
that chronic pain may be associated with increased substance use.5 Marijuana users 
use greater amounts of marijuana when they are experiencing increased pain levels, 
and chronic pain remains one of the most common reasons patients seek medical 
marijuana.36-37 To this point, pain relief has been documented as the most important 
motivation for marijuana use for users with chronic pain.28 With regard to alcohol use, 
higher ratings of pain unpleasantness have been associated with greater motivation to 
consume alcohol among chronic pain patients.38 Moreover, individuals with co-occurring 
AUD and chronic pain report that pain significantly contributes to their alcohol use, with 
many also identifying pain as their initial reason for alcohol misuse.24,39 Findings from 
experimental research indicate that both alcohol and marijuana use can produce acute 
pain-inhibitory effects, highlighting the potential for negative reinforcing effects of 
marijuana and alcohol for those using to cope with pain.40-41 To the authors’ knowledge, 
only one empirical study has examined pain as a causal determinant of alcohol use, 
concluding that thermal pain induction in a laboratory setting increased urge and 
intention to consume alcohol.42 Despite similar analgesic properties of alcohol and 
marijuana, existing literature has not concurrently investigated chronic pain as an 
antecedent to alcohol and marijuana co-use. 
 
Delayed Onset Muscle Soreness (DOMS) 
 
Delayed onset muscle soreness (DOMS) is a sensation of muscular pain and soreness 
that often follows engagement in unfamiliar, strenuous exercises, particularly those 
involving eccentric muscle contractions.43-46 Pain from DOMS peaks in intensity 36-48 
hours after exercise and typically resolves within a week.43,,47 Unlike laboratory pain 
induction methods, DOMS provides an analogous paradigm for musculoskeletal pain as 
an antecedent of alcohol and marijuana use because it produces elevated pain intensity 
for several days, functional impairment, initiation of self-care behaviors, and pain-
associated negative affect,48-52 thereby more effectively mimicking clinical pain 
conditions. Use of DOMS induction also allows for experimental control over intensity, 
duration, and localization of pain that cannot be obtained when recruiting patients with 
clinical pain conditions. Given that musculoskeletal pain is the most common form of 
chronic pain, 1, 53 DOMS associated changes in alcohol and marijuana demand will have 
strong ecological validity, particularly compared to other experimental pain induction 
techniques. Thus, we propose inducing DOMS in the dominant elbow flexor muscles to 
model musculoskeletal pain as a determinant of alcohol and marijuana demand. 
 
Alcohol and Marijuana Purchase Tasks 
 
Behavioral economics approaches provide a valuable theoretical framework for 
measuring the relative value of a substance, as they propose that overvaluation of a 
substance relative to other rewards serves as a determinant of substance misuse.54-55 

Protocol #:  202000058 
Page 4 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Prior research suggests that substance use demand, which refers to the quantitative 
relationship between drug consumption and its cost, may provide a meaningful 
complement to other measures of substance use motivation by denoting potential for 
abuse liability.56 In contrast to direct measurement of demand with operant 
procedures,57-59 hypothetical purchase tasks offer a more parsimonious, rapid 
assessment of demand that reflects the relative reinforcing efficacy of a substance.60-62 
Demand for alcohol and marijuana can be efficiently measured using the Alcohol 
Purchase Task (APT) and Marijuana Purchase Task (MPT), which have demonstrated 
good psychometric validity, test-retest reliability, and correspondence with actual 
substance use consumption and other markers of addiction.60-61,63-65 A single study 
measuring alcohol demand with the APT among co-users of alcohol and marijuana 
suggests that co-use is associated with higher demand for alcohol and overvaluation of 
alcohol rewards compared to alcohol only users.66 However, current research has not 
yet attempted to disentangle the economic relationships between alcohol and marijuana 
among this population. By using both the MPT and APT, this study is designed to 
assess DOMS-related changes in alcohol and marijuana demand, thereby allowing for 
characterization of the relationship between the substances. 
 
Conclusions 
 
Current evidence and theoretical models suggest that pain often motivates use of 
alcohol and marijuana, and co-use of these substances is common. Notably, self-
medication of pain with alcohol and marijuana use may increase risk for heavier 
substance use, substance use disorders, and may even worsen pain symptomatology 
over time. Previous studies are limited by laboratory pain induction methods with 
restricted ecology validity and clinical relevance. Use of a DOMS based approach in this 
study overcomes these limitations by producing time-limited, robust musculoskeletal 
pain and associated impairment, which we believe will provide data relevant to those 
with clinical pain conditions, such as chronic pain. 
 
5. Specific Aims: 
 
The overall aim of this project is to provide clinically-relevant data regarding 
musculoskeletal pain as an antecedent to alcohol and marijuana co-use and identify 
potential psychosocial moderators of this association. This study has two specific aims. 
 
Aim 1. Determine impact of DOMS pain on demand for alcohol and marijuana and 
examine race and sex as moderators of this relationship.  
 
We predict that those who undergo the DOMS induction paradigm will show greater 
increases in alcohol and marijuana demand than participants in the sham DOMS control 
group. We also predict an interactive effect of race and sex on DOMS-related changes 
in alcohol and marijuana demand, such that increases may be greater in White men 
than Black women and men, as well as White women.  
 
Aim 2. Identify psychosocial factors associated with change in demand for alcohol and 
marijuana after DOMS induction. 
 

Protocol #:  202000058 
Page 5 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Consistent with current evidence, 42, 67 we predict that pain-related negative affect will 
mediate the association between DOMS-related pain and increased demand for alcohol 
and marijuana. We also predict that greater expectancy of analgesia from marijuana or 
alcohol use, higher negative urgency, and history of self-medication behaviors will 
predict greater change in alcohol and marijuana demand.  
6. Research Plan: 
 
Participants 
 
We will recruit participants aged 21 years and older who are regular co-users of alcohol 
and marijuana (i.e., concurrent or simultaneous use at least 2-3 times per week over the 
past 6 months). Extent of co-use will be determined using the Alcohol Use Disorders 
Identification Test (AUDIT) and Cannabis Use Disorder Identification Test, Revised 
(CUDIT-R).  A research team member will inform participants of inclusion and exclusion 
criteria via email or the phone. If an individual believes they meet all study criteria, they 
will be scheduled for the first study session (see Phone and Email Scripts for details). 
We will review all inclusion and exclusion criteria one additional time with participants 
before initiating the Informed Consent process. 
Inclusion/Exclusion Criteria 
 
Detailed inclusion/exclusion criteria are provided in Table 1. 
 
Table 1. Inclusion and exclusion criteria 
Inclusion Criteria  
• Aged 21-65 years;  
• English-speaking 
• Self-identify as White/Caucasian or Black/African American 
• Own a smartphone with cellular/data plan 
• Regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on 
item 1 of the CUDIT-R and AUDIT. 
• Willing and able to give informed consent 
Exclusion Criteria  
• Participation in exercises that involve the biceps in the past 6 months* 
• Self-reported wrist/hand, elbow, or shoulder pain the past 3 months 
• Chronic medical condition that may affect pain perception (e.g. diabetes, 
fibromyalgia, headaches) 
• Self-reported kidney dysfunction, muscle damage, or major psychiatric disorder 
• Medical marijuana prescription, recommendation, or card 
• Consumption of marijuana using only non-inhalational methods (e.g. edibles, 
tinctures, or cannabidiol oil) 
• Women who are pregnant, trying to become pregnant, or breastfeeding 
*Examples include bicep curls, pull-ups, olympic weightlifting, etc. 

Protocol #:  202000058 
Page 6 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
In addition, participants who indicate they have consumed of any drugs (e.g., alcohol, 
theophylline, tranquilizers, over-the-counter and prescription pain medications, including 
NSAIDs and opioids) that may affect pain perception or hydration status 24 hours 
before participation in a testing session or used caffeine 4 or less hours before testing 
session will be discontinued or rescheduled at the PI’s discretion. Additionally, 
participants who report that they have used any tobacco products less than 1 hour 
before participation in a testing session will be discontinued or rescheduled at the PI’s 
discretion. 
 
Screening Procedure 
 
Screening assessment procedures will take place in a private exam room within the 
Center for Pain Research and Behavioral Health. Participants will be given a choice of 
completing the informed consent process with paper documents or electronically via 
REDCap. The consent process will take place in person, regardless whether it is 
documented on paper or electronically After providing informed consent, participants will 
complete a series of surveys as part of the assessment on a secured laptop computer 
or tablet, using REDCap. These measures are intended to both address study aims and 
characterize the sample. All participants will be provided with a pamphlet containing 
information about local mental health services; if desired, the PI or research assistant 
will facilitate contact with clinical services. The Patient Health Questionnaire-9 is a well-
validated and widely used measure of depressive symptomatology, including suicidal 
ideation/intent. Responses on the Patient Health Questionnaire-9 regarding suicidal 
intent will be reviewed by the study team prior to the participant leaving the sight of the 
study team. Any subjects endorsing suicidal intent during screening will be withdrawn 
from the study. Dr. Robinson, who is a licensed clinical psychologist, will then provide 
appropriate referral (e.g. Crisis Hot Line referral, or direct referral to clinical services if 
deemed appropriate). Women of childbearing potential will also be given a pregnancy 
test. A positive result will be exclusionary and if desired, the investigative team will 
facilitate referral for medical care. 
 
Screening Measures 
 
Participants will provide demographics and medical history information, including racial 
identity and whether they are pregnant, trying to become pregnant, or breastfeeding. 
They will also complete questionnaires related to mood (Patient Health Questionnaire-
9,68 Generalized Anxiety Disorder 7-item scale69), attitudes about pain (Pain Anxiety 
Symptoms Scale,70 Pain Catastrophizing Scale,71 Fear of Pain Questionnaire,72 
Discomfort Intolerance Scale73), somatization (Pennebaker Inventory of Limbic 
Languidness74), and recovery from difficult life events (Brief Resilience Scale75).  
 
Negative Urgency will be assessed using the Urgency, Premeditation, Perseverance, 
Sensation Seeking, Positive Urgency, Impulsive Behavior Scale.76 Participants will 
complete visual analog scale (VAS) questions related to spontaneous pain and pain 
with movement, with each line being anchored with ‘none’ on the left and ‘worst 
imaginable’ on the right.77 Additionally, participants will complete several pain 
experience visual analog scales (PEVAS); the PEVAS includes seven 10-cm lines that 
measure a different component of the pain experience (i.e. depression, anxiety, 

Protocol #:  202000058 
Page 7 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
frustration, fear, anger, pain intensity, pain unpleasantness) with a written description of 
‘none’ on the left and ‘worst imaginable’ on the right. The PEVAS will measure pain-
related negative affect, and participants will provide their rating by placing a mark along 
each line. Expectancies of muscle soreness from the exercises involved in this study 
will be assessed with a VAS-style question anchored by ‘no muscle soreness’ and ‘most 
intense muscle soreness imaginable.’ In addition, expectancies of analgesia from 
alcohol and marijuana, as well as urge to consume alcohol and marijuana, will also be 
measured using VAS-style questions, with lines being anchored by ‘no pain relief at all’ 
and ‘complete pain relief’ for expectancies of analgesia and lines being anchored by ‘no 
urge’ and ‘very strong urge’ for urge-related questions. History of self-medication 
behaviors will be assessed using separate VAS-style questions measuring likelihood of 
using alcohol or marijuana when experiencing pain in the past. Each line will be 
anchored by ‘none of the time’ and ‘all of the time’.  Other measures will assess alcohol 
use patterns (Alcohol Use Disorders Identification Test, 78 Alcohol Use Questionnaire79), 
marijuana use patterns (Cannabis Use Disorder Identification Test, Revised, 80 Daily 
Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory81), and 
use of other substances (NIDA Modified Alcohol, Smoking and Substance Involvement 
Screening Test,82 Fagerstrom Test for Nicotine Dependence83). Finally, a single-item 
question will measure frequency of simultaneous alcohol and marijuana use behaviors 
over the past 12 months.84 
 
Participants who continue to qualify following completion of screening 
procedures and agree to proceed will be assigned to either the DOMS or Sham 
DOMS group. Assignments will be made according to a participant’s unique 
subject identifier using a spreadsheet listing group assignment in pseudo-
random order using the Excel random number function.  
 
Participants will then complete the Alcohol Purchase Task (APT), Marijuana Purchase 
Tasks, (MPT), and DOMS or sham DOMS induction procedures. They will also be will 
be scheduled for a second lab session 48 hours later so that potential changes in 
DOMS-associated alcohol and marijuana demand can be investigated. Participants who 
complete the screening but either do not qualify or decide not to proceed will be paid 
$15 via gift card. Those who do qualify and proceed with the study will be paid $50 at 
the end of the first lab visit and $15 at the end of the second lab visit. For the daily 
surveys, compensation was provided as a function of the number of surveys completed, 
with a maximum of $30 for participants who completed 5/7 or more of their assessments 
(see “Daily Measures” section for additional information). We will also ask whether their 
DOMS (if any) has resolved with the daily measures. Additionally, participants who refer 
an individual to the study that attends the screening session will also receive $20 per 
person referred. The referee(s) will be responsible for contacting the study team via 
phone or email in order to schedule the session. The referrer will receive the $20 bonus 
once the person they refer attends their screening session, whether or not they 
eventually decide to participate. All participants who provide informed consent will be 
eligible to refer participants to the study regardless of whether they qualify to proceed 
after screening procedures. 
 

Protocol #:  202000058 
Page 8 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Alcohol Purchase Task (APT) and Marijuana Purchase Tasks (MPT) 
 
Both the APT and MPT will be administered on REDCap during the first lab session 
prior to DOMS induction and during the second lab session (48 hours post DOMS 
induction). In the APT, participants are provided with a set of instructions, including a 
definition of a standard drink, and asked how many standard drinks they would 
consume at 21 prices, ranging from free to $30/drink (e.g. “How many drinks would you 
consume if they were $1.00 each?”). Procedures for the MPT are virtually identical, 
except a standard definition of the number of hits of marijuana in one joint is provided, 
and participants are asked how many hits of marijuana they would take at a series of 
escalating price points ranging from free to $10/hit. Participants will also complete an 
adapted form of the MPT that allows for differences in preference for various marijuana-
based products and modes of administration. From these data, the following indices of 
alcohol and marijuana demand will be generated: intensity (consumption of hits/drinks 
when free); breakpoint (the first price at which consumption was zero); Omax (maximum 
expenditure on alcohol and marijuana hits); Pmax (price where demand becomes elastic); 
elasticity (rate of change in consumption with changes in price). Studies have 
demonstrated that these indices can be reduced to two latent factors: persistence 
(maintaining consumption despite increasing price) and amplitude (maximum 
consumption and price levels). Persistence is composed of elasticity, Pmax, breakpoint, 
and Omax, while amplitude is composed of intensity and Omax.85-86 
 
Isometric Strength Testing and DOMS Induction 
Maximum voluntary contraction (MVC) of elbow flexion 
strength will be tested using a Biodex System Isokinetic 
Dynamometer (Biodex Medical Systems, Shirley, NY), 
and torque values obtained from this testing will be used 
to inform exercise protocols. The participant will first be 
seated within the testing apparatus with a stabilizing strap 
attached proximal to the elbow joint. The participant will 
then move through their available range of motion in the 
elbow flexion and extension. The device will be locked at 
90 degrees of elbow flexion, and the participant will be 
instructed to build maximal flexion force while holding onto 
the grip handle of the machine. Once peak effort is achieved, the participant will be 
instructed to relax, the device will be released, and the subject will be returned to a 
neutral position.  
 
DOMS-inducing exercise protocol. To perform the dynamic fatiguing exercise bout, the 
participant will be seated in the Biodex machine in order to isolate elbow flexion. The 
participant will perform the isometric strength test (described above). Following 60 
seconds of rest after the isometric test, participants will complete an exercise protocol 
consisting of eccentric (elbow straightening/biceps lengthening) exercises designed to 
induce DOMS at the biceps. Participants in the DOMS group will perform 3 sets of 
15 repetitions at a speed of 60o/s. Participants in the Sham DOMS group will 
complete one set of 15 concentric (elbow flexion/biceps shortening) repetitions at 
Figure 1. Biodex setup for 
isometric strength and DOMS. 

Protocol #:  202000058 
Page 9 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
a resistance set to 30% of their maximum voluntary contraction, which is unlikely 
to induce significant DOMS. 
 
DOMS-related Pain Measures 
Upon arriving in the laboratory for their second study session, participants will complete 
several measures regarding pain associated with the exercise protocol. 
 
1. Pain Experience:  Pain experience visual analog scales (PEVAS) include seven 10-
cm lines that measure a different component of the pain experience (i.e. depression, 
anxiety, frustration, fear, anger, pain intensity, pain unpleasantness) with a written 
description of ‘none’ on the left and ‘worst imaginable’ on the right. The PEVAS will 
measure pain-related negative affect, and participants will provide their rating by placing 
a mark along each line. 
 
2. Pain with Movement: Participants will also rate pain during elbow extension and 
elbow flexion using the same scale. This will give ratings of both spontaneous pain and 
pain with movement.  
 
Daily Measures 
 
Participants will receive instructions related to the daily electronic diary following DOMS 
induction. These measures will primarily be used evaluate the pain associated with 
DOMS and assess alcohol and marijuana use following the exercise protocol. 
Participants will receive a text message with a link to the REDCap survey every night for 
one week, and text messages will begin the day of the first lab visit. The daily 
assessment will be personalized, such that participants will inform study staff of 
preferences for when they receive the survey each night before bed. Prior to leaving lab 
session 1, participants will be sent a practice text message to ensure that they receive 
it. Individuals who fail to complete their daily diary will be prompted via a reminder text 
or telephone call. Participants will provide daily reports of 1) Pain Experience VASs, 2) 
VAS questions related to spontaneous pain and pain with movement, 3) the number of 
standard alcoholic drinks they have consumed, 4) route of administration (ROA) of 
marijuana use and number of hits taken according to route of administration (in checklist 
form to allow for endorsement of multiple ROAs of marijuana use), and 5) number of 
hours “high.” If a participant endorses marijuana use by a non-inhalational ROA (e.g. 
edibles, tinctures, topicals), they will be prompted with a free-response question to 
describe the quantity of their marijuana use in as much detail as possible. A single 
yes/no item will inquire about whether alcohol and marijuana were used simultaneously, 
such that their effects overlapped, and participants will also report the intensity of their 
“high” from marijuana via a VAS-style question with ‘not at all high’ on the left and 
‘extremely high’ on the right.  Additionally, participants will report whether or not other 
substances (e.g. tobacco, cocaine, hallucinogens) or over-the-counter and prescription 
pain medications were used. They will also indicate the extent to which pain interfered 
with several domains (e.g. general activity, walking ability, enjoyment of life, sleep) over 
the past 24 hours. 
 

Protocol #:  202000058 
Page 10 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Study Design 
 
The overall design of the study is detailed in Figure 2. 
 
 
Figure 2. Study design flowchart. 
 
Data Analysis Strategy 
 
Data will be collected in a Research Electronic Data Capture (REDCap) database and 
analyzed using IBM SPSS 25. 
 
Aim 1: Determine impact of DOMS pain on demand for alcohol and marijuana and 
examine race and sex as moderators of this relationship.  
Hypotheses for DOMS-related changes in alcohol and marijuana demand indices 
(persistence and amplitutde) will be assessed using separate 2 (group: DOMS vs. sham 
DOMS) x 2 (sex: men vs. women) x 2 (race: White vs. Black) x 2 (time: visit 1 vs. visit 2) 
repeated measures analysis of variance (ANOVA). Identical ANOVAs will examine 
changes in marijuana demand indices. 
 
Aim 2: Identify psychosocial factors associated with change in demand for alcohol and 
marijuana after DOMS induction. 
 
To test the hypothesis that negative affect mediates the relationship between DOMS 
pain and increased alcohol and marijuana demand, Pearson correlations will be 
conducted to examine continuous relationships between measures of pain, pain-related 
negative affect (e.g. pain experience VASs), and change in alcohol and marijuana 
demand. A series of linear regressions will then be conducted to examine 1) the effect 
of group (DOMS vs. sham DOMS) on change in alcohol and marijuana demand, and 2) 
the effect of group and pain-related negative affect on change in alcohol and marijuana 
demand. We will test the significance of indirect effects of pain-related negative affect 
using PROCESS, a custom macro in SPSS. 
 
To examine the hypothesis that greater expectancy of analgesia from marijuana or 
alcohol use, higher negative urgency, and history of self-medication behaviors will 
predict greater change in demand, a simultaneous multiple linear regression analysis 
will be conducted with these variables as predictors in the model.   
 

Protocol #:  202000058 
Page 11 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
Power Analysis 
 
Effect size estimates for this study were derived from an interim analysis of data from an 
ongoing pilot project that examined the effect of DOMS on alcohol demand (N=40). In 
our pilot work, alcohol demand was assessed using the Alcohol Purchase Task (APT) 
before and after DOMS induction. Amplitude and persistence were derived from APT 
data using principal components analysis,83-84 and these factors explained 
approximately 89% of the variance in alcohol demand metrics. Changes in amplitude 
and persistence were examined using separate 2 (group: sham vs. DOMS) x 2 (time: 
time 1 vs. time 2) x 2 (sex: men vs. women) repeated measures ANOVAs. Results 
indicated sex x group x time interactions for both factors, such that DOMS tended to 
increase amplitude in men and decrease amplitude in women, F (1,36)=3.13, p=.09, 
partial eta squared=.08. A similar pattern of effects was found for persistence where 
DOMS decreased persistence in women and increased persistence in men, F (1, 36) = 
14.55, p=.001, partial eta squared=.29. With power analyses conducted in G*Power 
(ɑ=.05, power=.80, correlation between repeated measures=0.5), we expect that a 
proposed sample size of 56 participants will be sufficient to achieve the objectives of the 
proposed research and have adequate sensitivity to detect medium between-group and 
interactive effects for which we do not have preliminary data.  
 
7.    Possible Discomforts and Risks: 
 
Psychological Discomforts and Risks. Participants may be reminded of unpleasant 
emotions or experience negative thoughts or bodily sensations while reporting aspects 
of their current psychosocial functioning or medical history. To mitigate this risk, all 
participants will be informed they can withdraw from the study at any time or skip 
individual questions that may be upsetting to them. 
 
Induction of Muscle Pain using Exercise: There is a low risk that exertional 
rhabdomyolysis (breakdown of muscle tissue due to damage) and myoglobinuria (a 
large amount of muscle proteins in the urine) may occur following eccentric exercise. 
However, research suggests that this occurs primarily if a person had not consumed 
enough fluids before multiple muscle groups are exercised eccentrically.87-88 We will 
address this risk by instructing participants to remain well-hydrated 24 hours prior to 
DOMS induction.  
 
Participant Confidentiality Risks. The research team places a high priority on protection 
of participant confidentiality and will do so using the following procedures. Unique 
participant identifiers will be generated in order to collect protected health information 
(i.e., from questionnaires) for research purposes. All data will be stored in encrypted, 
password-protected files on a secure server, and access to the data will be restricted to 
research staff. The devices used to collect self-report data will be double-encrypted: the 
devices and REDCap software used to collect and store the information will be both 
password-protected and stored in a locked room. Data that links the participant to their 
unique identifiers will be stored in a separate location. When the study is completed and 
all data is in an electronic database, participant identifiers will be destroyed. Any 

Protocol #:  202000058 
Page 12 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
adverse events will be reported to the University of Florida IRB and study sponsors as 
appropriate. Despite these procedures, it is possible that participant confidentiality may 
be breached. If a breach occurs, it will be reported to the IRB and appropriate measures 
will be taken. These measures include but are not limited to informing affected 
participants of the breach and assisting with protective measures once the breach is 
detected.  
 
8.    Possible Benefits: There are no potential benefits to participants in this study. 
 
9.    Conflict of Interest: There is no conflict of interest involved with this study beyond 
the professional benefit from academic publication or presentation of the results. 
 
10. Data Safety Monitoring Plan: Because the study does not comprise a clinical trial, 
a formal Data and Safety Monitoring Board has not been planned. The investigative 
team will meet quarterly to discuss data and safety monitoring issues. Any issues 
identified during the course of these meetings will be handled in a manner consistent 
with the University of Florida’s policies. 
 
11.   References: 
1. 
Institute of Medicine (US) Committee on Advancing Pain Research, Care, and 
Education. Relieving Pain in America: A Blueprint for Transforming Prevention, 
Care, Education, and Research. Washington (DC): National Academies Press 
(US); 2011. http://www.ncbi.nlm.nih.gov/books/NBK91497/. Accessed November 
27, 2019. 
2. 
Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for 
chronic noncancer pain. Cochrane database of systematic reviews. 2010;(1). 
3. 
Volkow ND, Collins FS. The role of science in addressing the opioid crisis. New 
England Journal of Medicine. 2017;377(4):391–394. 
4. 
Robinson ME, Brown JL, George SZ, et al. Multidimensional success criteria and 
expectations for treatment of chronic pain: the patient perspective. Pain Medicine. 
2005;6(5):336–345. 
5. 
Ditre JW, Zale EL, LaRowe LR. A reciprocal model of pain and substance use: 
Transdiagnostic considerations, clinical implications, and future directions. Annual 
review of clinical psychology. 2019;15:503–528. 
6. 
Riley III JL, King C. Self-report of alcohol use for pain in a multi-ethnic community 
sample. The Journal of Pain. 2009;10(9):944–952. 
7. 
Zvolensky MJ, Cougle JR, Bonn-Miller MO, et al. Chronic pain and marijuana use 
among a nationally representative sample of adults. The American journal on 
addictions. 2011;20(6):538–542. 
8. 
Alford DP, German JS, Samet JH, Cheng DM, Lloyd-Travaglini CA, Saitz R. 
Primary care patients with drug use report chronic pain and self-medicate with 
alcohol and other drugs. Journal of general internal medicine. 2016;31(5):486–491. 
9. 
Campbell CM, Edwards RR. Ethnic differences in pain and pain management. Pain 
management. 2012;2(3):219–230. 
10. Anderson KO, Green CR, Payne R. Racial and ethnic disparities in pain: causes 
and consequences of unequal care. The Journal of Pain. 2009;10(12):1187–1204. 

Protocol #:  202000058 
Page 13 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
11. Cruz-Almeida Y, Sibille KT, Goodin BR, et al. Racial and ethnic differences in older 
adults with knee osteoarthritis. Arthritis & Rheumatology. 2014;66(7):1800–1810. 
12. Bolen J, Schieb L, Hootman JM, et al. Differences in the prevalence and severity of 
arthritis among racial/ethnic groups in the United States, National Health Interview 
Survey, 2002, 2003, and 2006. Preventing chronic disease. 2010;7(3):A64–A64. 
13. Meints SM, Miller MM, Hirsh AT. Differences in pain coping between black and 
white Americans: a meta-analysis. The Journal of pain. 2016;17(6):642–653. 
14. Tan G, Jensen MP, Thornby J, Anderson KO. Ethnicity, control appraisal, coping, 
and adjustment to chronic pain among black and white Americans. Pain Medicine. 
2005;6(1):18–28. 
15. Jones AC, Kwoh CK, Groeneveld PW, Mor M, Geng M, Ibrahim SA. Investigating 
racial differences in coping with chronic osteoarthritis pain. Journal of cross-cultural 
gerontology. 2008;23(4):339–347. 
16. Andrews P, Steultjens M, Riskowski J. Chronic widespread pain prevalence in the 
general population: a systematic review. European Journal of Pain. 2018;22(1):5–
18. 
17. Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and 
experimental findings. British journal of anaesthesia. 2013;111(1):52–58. 
18. Forsythe LP, Thorn B, Day M, Shelby G. Race and sex differences in primary 
appraisals, catastrophizing, and experimental pain outcomes. The journal of pain. 
2011;12(5):563–572. 
19. Keogh E, McCracken LM, Eccleston C. Do men and women differ in their response 
to interdisciplinary chronic pain management? Pain. 2005;114(1-2):37–46. 
20. Edwards RR, Haythornthwaite JA, Sullivan MJ, Fillingim RB. Catastrophizing as a 
mediator of sex differences in pain: differential effects for daily pain versus 
laboratory-induced pain. Pain. 2004;111(3):335–341. 
21. Fillingim RB, King CD, Ribeiro-Dasilva MC, Rahim-Williams B, Riley III JL. Sex, 
gender, and pain: a review of recent clinical and experimental findings. The journal 
of pain. 2009;10(5):447–485. 
22. Keogh E, Eccleston C. Sex differences in adolescent chronic pain and pain-related 
coping. Pain. 2006;123(3):275–284. 
23. Abuse S. Mental Health Services Administration.(2017). Key substance use and 
mental health indicators in the United States: Results from the 2016 National 
Survey on Drug Use and Health (HHS Publication No. SMA 17-5044, NSDUH 
Series H-52). Rockville, MD: Center for Behavioral Health Statistics and Quality. 
Substance Abuse and Mental Health Services Administration Retrieved from 
https://www samhsa gov/data. 2018. 
24. Sheu R, Lussier D, Rosenblum A, et al. Prevalence and characteristics of chronic 
pain in patients admitted to an outpatient drug and alcohol treatment program. Pain 
Medicine. 2008;9(7):911–917. 
25. Brennan PL, Schutte KK, Moos RH. Pain and use of alcohol to manage pain: 
prevalence and 3-year outcomes among older problem and non-problem drinkers. 
Addiction. 2005;100(6):777–786. 
26. Goebel JR, Compton P, Zubkoff L, et al. Prescription sharing, alcohol use, and 
street drug use to manage pain among veterans. Journal of Pain and Symptom 
Management. 2011;41(5):848–858. 

Protocol #:  202000058 
Page 14 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
27. Kosiba JD, Maisto SA, Joseph W. Patient-reported use of medical cannabis for 
pain, anxiety, and depression symptoms: Systematic review and meta-analysis. 
Social Science & Medicine. 2019. 
28. Fales JL, Ladd BO, Magnan RE. Pain Relief as a Motivation for Cannabis Use 
Among Young Adult Users With and Without Chronic Pain. The Journal of Pain. 
2019;20(8):908-916. doi:10.1016/j.jpain.2019.02.001 
29. Egli M, Koob GF, Edwards S. Alcohol dependence as a chronic pain disorder. 
Neuroscience & Biobehavioral Reviews. 2012;36(10):2179–2192. 
30. Davis AK, Walton MA, Bohnert KM, Bourque C, Ilgen MA. Factors associated with 
alcohol consumption among medical cannabis patients with chronic pain. Addictive 
Behaviors. 2018;77:166-171. doi:10.1016/j.addbeh.2017.10.007 
31. Nugent SM, Yarborough BJ, Smith NX, et al. Patterns and correlates of medical 
cannabis use for pain among patients prescribed long-term opioid therapy. General 
Hospital Psychiatry. 2018;50:104-110. doi:10.1016/j.genhosppsych.2017.11.001 
32. Yurasek AM, Aston ER, Metrik J. Co-use of alcohol and cannabis: a review. 
Current Addiction Reports. 2017;4(2):184–193. 
33. Metrik J, Gunn RL, Jackson KM, Sokolovsky AW, Borsari B. Daily patterns of 
marijuana and alcohol co-use among individuals with alcohol and cannabis use 
disorders. Alcoholism: Clinical and Experimental Research. 2018;42(6):1096–
1104. 
34. Roche DJO, Bujarski S, Green R, Hartwell EE, Leventhal AM, Ray LA. Alcohol, 
tobacco, and marijuana consumption is associated with increased odds of same-
day substance co-and tri-use. Drug and alcohol dependence. 2019;200:40–49. 
35. Subbaraman MS, Kerr WC. Simultaneous versus concurrent use of alcohol and 
cannabis in the National Alcohol Survey. Alcoholism: Clinical and Experimental 
Research. 2015;39(5):872–879. 
36. Sznitman S, Baruch YB, Greene T, Gelkopf M. The association between physical 
pain and cannabis use in daily life: An experience sampling method. Drug and 
Alcohol Dependence. 2018;191:294-299. doi:10.1016/j.drugalcdep.2018.07.014 
37. Boehnke KF, Gangopadhyay S, Clauw DJ, Haffajee RL. Qualifying conditions of 
medical cannabis license holders in the United States. Health Affairs. 
2019;38(2):295–302. 
38. Lawton J, Simpson J. Predictors of alcohol use among people experiencing 
chronic pain. Psychology, health & medicine. 2009;14(4):487–501. 
39. Boissoneault J, Lewis B, Nixon SJ. Characterizing chronic pain and alcohol use 
trajectory among treatment-seeking alcoholics. Alcohol. 2019;75:47-54. 
doi:10.1016/j.alcohol.2018.05.009 
40. Thompson T, Oram C, Correll CU, Tsermentseli S, Stubbs B. Analgesic Effects of 
Alcohol: A Systematic Review and Meta-Analysis of Controlled Experimental 
Studies in Healthy Participants. The Journal of Pain. 2017;18(5):499-510. 
doi:10.1016/j.jpain.2016.11.009 
41. De Vita MJ, Moskal D, Maisto SA, Ansell EB. Association of cannabinoid 
administration with experimental pain in healthy adults: A systematic review and 
meta-analysis. JAMA psychiatry. 2018;75(11):1118–1127. 

Protocol #:  202000058 
Page 15 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
42. Moskal D, Maisto SA, De Vita M, Ditre JW. Effects of experimental pain induction 
on alcohol urge, intention to consume alcohol, and alcohol demand. Experimental 
and clinical psychopharmacology. 2018;26(1):65. 
43. Armstrong RB. Mechanisms of exercise-induced delayed onset muscular 
soreness: a brief review. Medicine and science in sports and exercise. 
1984;16(6):529–538. 
44. Ebbeling CB, Clarkson PM. Exercise-induced muscle damage and adaptation. 
Sports medicine. 1989;7(4):207–234. 
45. Miles MP, Clarkson PM. Exercise-induced muscle pain, soreness, and cramps. 
The Journal of sports medicine and physical fitness. 1994;34(3):203–216. 
46. MacIntyre DL, Reid WD, McKenzie DC. Delayed muscle soreness. Sports 
Medicine. 1995;20(1):24–40. 
47. Clarkson PM, Tremblay I. Exercise-induced muscle damage, repair, and 
adaptation in humans. Journal of Applied Physiology. 1988;65(1):1–6. 
48. Borsa PA, Sauers EL. The importance of gender on myokinetic deficits before and 
after microinjury. Medicine and science in sports and exercise. 2000;32(5):891–
896. 
49. Trost Z, France CR, Thomas JS. Pain-related fear and avoidance of physical 
exertion following delayed-onset muscle soreness. PAIN®. 2011;152(7):1540–
1547. 
50. Dannecker EA, Gagnon CM, Jump RL, Brown JL, Robinson ME. Self-care 
behaviors for muscle pain. The Journal of Pain. 2004;5(9):521–527. 
51. Dannecker EA, Koltyn KF, Riley III JL, Robinson ME. Sex differences in delayed 
onset muscle soreness. Journal of sports medicine and physical fitness. 
2003;43(1):78. 
52. Carpenter JE, Blasier RB, Pellizzon GG. The effects of muscle fatigue on shoulder 
joint position sense. The American journal of sports medicine. 1998;26(2):262–
265. 
53. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bulletin of the 
World Health Organization. 2003;81:646–656. 
54. Bickel WK, Johnson MW, Koffarnus MN, MacKillop J, Murphy JG. The behavioral 
economics of substance use disorders: reinforcement pathologies and their repair. 
Annual review of clinical psychology. 2014;10:641–677. 
55. Heather N, Vuchinich RE. Choice, Behavioural Economics and Addiction. Elsevier; 
2003. 
56. Hursh SR, Galuska CM, Winger G, Woods JH. The economics of drug abuse: a 
quantitative assessment of drug demand. Molecular interventions. 2005;5(1):20. 
57. Bickel WK, Madden GJ. A comparison of measures of relative reinforcing efficacy 
and behavioral economics: Cigarettes and money in smokers. Behavioural 
Pharmacology. 1999;10(6-7):627-637. doi:10.1097/00008877-199908001-00023 
58. Higgins ST, Bickel WK, Hughes JR. Influence of an alternative reinforcer on human 
cocaine self-administration. Life Sciences. 1994;55(3):179–187. 
59. Shahan TA, Bickel WK, Madden GJ, Badger GJ. Comparing the reinforcing 
efficacy of nicotine containing and de-nicotinized cigarettes: a behavioral economic 
analysis. Psychopharmacology. 1999;147(2):210–216. 

Protocol #:  202000058 
Page 16 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
60. Kiselica AM, Webber TA, Bornovalova MA. Validity of the alcohol purchase task: a 
meta-analysis. Addiction. 2016;111(5):806–816. 
61. Aston ER, Metrik J, MacKillop J. Further validation of a marijuana purchase task. 
Drug and alcohol dependence. 2015;152:32–38. 
62. MacKillop J, Murphy JG, Ray LA, et al. Further validation of a cigarette purchase 
task for assessing the relative reinforcing efficacy of nicotine in college smokers. 
Experimental and clinical psychopharmacology. 2008;16(1):57. 
63. Amlung MT, Acker J, Stojek MK, Murphy JG, MacKillop J. Is talk “cheap”? An initial 
investigation of the equivalence of alcohol purchase task performance for 
hypothetical and actual rewards. Alcoholism: Clinical and Experimental Research. 
2012;36(4):716–724. 
64. Amlung M, McCarty KN, Morris DH, Tsai C-L, McCarthy DM. Increased behavioral 
economic demand and craving for alcohol following a laboratory alcohol challenge. 
Addiction. 2015;110(9):1421–1428. 
65. Collins RL, Vincent PC, Yu J, Liu L, Epstein LH. A behavioral economic approach 
to assessing demand for marijuana. Experimental and Clinical 
Psychopharmacology. 2014;22(3):211. 
66. Morris V, Patel H, Vedelago L, et al. Elevated Behavioral Economic Demand for 
Alcohol in Co-Users of Alcohol and Cannabis. J Stud Alcohol Drugs. 
2018;79(6):929-934. doi:10.15288/jsad.2018.79.929 
67. Witkiewitz K, McCallion E, Vowles KE, et al. Association between physical pain 
and alcohol treatment outcomes: The mediating role of negative affect. Journal of 
consulting and clinical psychology. 2015;83(6):1044. 
68. Gilbody, S., Richards, D., Brealey, S., & Hewitt, C. (2007). Screening for 
depression in medical settings with the Patient Health Questionnaire (PHQ): a 
diagnostic meta-analysis. Journal of general internal medicine, 22(11), 1596-1602. 
69. Spitzer, R. L., Kroenke, K., Williams, J. B., & Löwe, B. (2006). A brief measure for 
assessing generalized anxiety disorder: the GAD-7. Archives of internal medicine, 
166(10), 1092-1097. 
70. McCracken LM, Dhingra L. A short version of the Pain Anxiety Symptoms Scale 
(PASS-20): preliminary development and validity. Pain Res Manag. 2002;7(1):45-
50. doi:10.1155/2002/517163 
71. Sullivan MJL, Bishop SR, Pivik J. The Pain Catastrophizing Scale: Development 
and validation. Psychological Assessment. 1995;7(4):524-532. doi:10.1037/1040-
3590.7.4.524 
72. McNeil DW, Rainwater AJ. Development of the Fear of Pain Questionnaire-III. J 
Behav Med. 1998;21(4):389-410. doi:10.1023/A:1018782831217 
73. Schmidt NB, Richey JA, Fitzpatrick KK. Discomfort intolerance: Development of a 
construct and measure relevant to panic disorder. J Anxiety Disord. 
2006;20(3):263-280. doi:10.1016/j.janxdis.2005.02.002 
74. Pennebaker J. Psychological Factors Influencing the Reporting of Physical 
Symptoms. In: The Science of Self-Report: Implications for Research and Practice. 
Psychology Press; 1999. 
75. Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief 
resilience scale: Assessing the ability to bounce back. Int J Behav Med. 
2008;15(3):194-200. doi:10.1080/10705500802222972 

Protocol #:  202000058 
Page 17 of 17 
IRB version:  03.09.04 
PI version:  2/03/2022 
76. Lynam D, Smith G, Whiteside S, Cyders M. The UPPS-P: Assessing five 
personality pathways to impulsive behavior. Purdue University; 2006.  
77. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue 
scales as ratio scale measures for chronic and experimental pain: Pain. 
1983;17(1):45-56. doi:10.1016/0304-3959(83)90126-4 
78. Saunders JB, Aasland OG, Babor TF, Fuente JR de la, Grant M. Development of 
the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project 
on Early Detection of Persons with Harmful Alcohol Consumption–II. Addiction. 
1993;88(6):791-804. doi:10.1111/j.1360-0443.1993.tb02093.x 
79. Cahalan D, Cisin IH, Crossley HM. American drinking practices: A national study of 
drinking behavior and attitudes. Monographs of the Rutgers Center of Alcohol 
Studies. 1969;6:260-260. 
80. Adamson SJ, Kay-Lambkin FJ, Baker AL, et al. An improved brief measure of 
cannabis misuse: The Cannabis Use Disorders Identification Test-Revised 
(CUDIT-R). Drug and Alcohol Dependence. 2010;110(1):137-143. 
doi:10.1016/j.drugalcdep.2010.02.017 
81. Cuttler C, Spradlin A. Measuring cannabis consumption: Psychometric properties 
of the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use 
Inventory (DFAQ-CU). PLOS ONE. 2017;12(5):e0178194. 
doi:10.1371/journal.pone.0178194 
82. Humeniuk, R., Ali, R., Babor, T. F., Farrell, M., Formigoni, M. L., Jittiwutikarn, J., ... 
& Nhiwatiwa, S. (2008). Validation of the alcohol, smoking and substance 
involvement screening test (ASSIST). Addiction, 103(6), 1039-1047. 
83. Heatherton, T. F., Kozlowski, L. T., Frecker, R. C., & FAGERSTROM, K. O. (1991). 
The Fagerström test for nicotine dependence: a revision of the Fagerstrom 
Tolerance Questionnaire. British journal of addiction, 86(9), 1119-1127. 
84. Terry-McElrath YM, O’Malley PM, Johnston LD. Simultaneous alcohol and 
marijuana use among US high school seniors from 1976 to 2011: Trends, reasons, 
and situations. Drug and Alcohol Dependence. 2013;133(1):71-79. 
doi:10.1016/j.drugalcdep.2013.05.031 
85. O’Connor RJ, Heckman BW, Adkison SE, et al. Persistence and amplitude of 
cigarette demand in relation to quit intentions and attempts. Psychopharmacology. 
2016;233(12):2365–2371. 
86. MacKillop J, Murphy JG, Tidey JW, Kahler CW, Ray LA, Bickel WK. Latent 
structure of facets of alcohol reinforcement from a behavioral economic demand 
curve. Psychopharmacology. 2009;203(1):33–40. 
87. Huerta-Alardin AL, Varon J, Marik PE. Bench-to-bedside review: Rhabdomyolysis -
- an overview for clinicians. Crit Care. 2005; 9(2): 158-69. 
88. Milne CJ. Rhabdomyolysis, Myoglobinuria and Exercise. Sports Medicine. 
1988;6(2):93-106. doi:10.2165/00007256-198806020-00004