Medical Marijuana Use and Driving Performance: A Test of Psychomotor Function in Adults 50 and Older
Conditions: Chronic Pain
Sponsor: Florida State University

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 1 of 28
PROTOCOL TITLE:
Medical Marijuana Use and Driving Performance: A Test of Psychomotor Function in 
Adults 50 and Older.
INVESTIGATORS:
Florida State University:
Principal Investigator
Nicole Ennis, PhD
Florida State University
Department of Behavioral Science and Social Medicine
850-644-7955
nicole.ennis@med.fsu.edu
Study Coordinator/Participant Data Collection
Caitlyn Kloss, BA
Florida State University
Department of Behavioral Science and Social Medicine
caitlyn.kloss@med.fsu.edu
Research Assistant 
Colleen Beichner
Florida State University
Department of Behavioral Science and Social Medicine
colleen.beichner@med.fsu.edu
Research Assistant 
Marielise Torres
Florida State University
Department of Behavioral Science and Social Medicine
marieliese.torres@med.fsu.edu
University of Florida:
Co-Investigator/Driving Simulator Development
Sherrilene Classen, PhD, MPH, OTR/L, FAOTA, FGSA
University of Florida
Co-Investigator/Pharmacist/Drug-Drug Interaction Expert
John Markowitz, Pharm D, BCPP
University of Florida
Co-Investigator/UF Research Coordinator
Nichole Stetten, PhD, MPH, CPH 
University of Florida 
Driving Simulator Manager
Jason Rogers
University of Florida
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 2 of 28
VERSION NUMBER/DATE:
version 3/6.27.2022
REVISION HISTORY
Revision 
#
Version Date
Summary of Changes
Consent 
Change?
2
2.8.22
Added Colleen Beichner and Mariliese Torres; 
removed Abbey Folsom
No
3
6.27.22
Added i2b2 
No
4
7.20.22
Remove i2b2; added Consent2Share
No
Table of Contents
1.0
Study Summary .......................................................................................................3
2.0 
Objectives* ..............................................................................................................4
3.0 
Background*............................................................................................................5
4.0 
Study Endpoints*.....................................................................................................6
5.0 
Study Intervention ...................................................................................................8
6.0
Procedures Involved* ..............................................................................................8
7.0
Data and Specimen Banking*................................................................................12
8.0
Sharing of Results with Subjects* .........................................................................12
9.0
Study Timelines*...................................................................................................12
10.0
Subject Population*...............................................................................................12
11.0
Vulnerable Populations*........................................................................................13
12.0
Local Number of Subjects .....................................................................................13
13.0
Recruitment Methods.............................................................................................13
14.0
Withdrawal of Subjects*........................................................................................13
15.0
Risks to Subjects*..................................................................................................13
16.0
Potential Benefits to Subjects* ..............................................................................13
17.0
Data Management* and Confidentiality................................................................13
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*........................16
19.0
Provisions to Protect the Privacy Interests of Subjects .........................................16
20.0
Compensation for Research-Related Injury...........................................................18
21.0
Economic Burden to Subjects................................................................................18
22.0
Consent Process.....................................................................................................18
23.0
Process to Document Consent in Writing..............................................................19
24.0
Setting....................................................................................................................19
25.0
Resources Available ..............................................................................................19
26.0
Multi-Site Research* .............................................................................................20
Appendix A: References Cited ……..…………………………………………………....21
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 3 of 28
1.0
Study Summary
Study Title
Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older
Study Design
We will use a naturalistic observational trial design to 
compare psychomotor function at baseline (in the week prior 
to starting medical marijuana) as well as 1 month and 3 
months post-medical marijuana initiation.
Primary Objective
Simulated driving performance (i.e., errors in response time, 
attention, and executive functioning tasks that predict on-
road performance)
Secondary 
Objective(s)
Adverse effects
Research 
Intervention(s) 
Medical marijuana
Study Population
Adults 50 and Older
Sample Size
60
Study Duration for 
individual 
participants
3 months and 1 week
Study Specific 
Abbreviations/ 
Definitions 
MMTC = Medical Marijuana Treatment Clinics of 
Gainesville
1.1 Abstract
1.1.1 Background: Approximately 6.9 million people in the State of Florida 
are aged 50 and older. Further estimates of chronic pain in this population 
ranges from 35-52%. Of the 33 states (including Florida) with laws that 
legalize marijuana for medical use, chronic pain, a condition with greater 
prevalence in mid to late life, is recognized as a common ailment for which 
physicians prescribe medical marijuana. However, little is known about 
marijuana use during late-middle age (ages 50–64) and older adulthood 
(ages 65 and older). While medical marijuana may benefit older adults by 
reducing pain, factors such as how use may affect everyday functioning 
during real world tasks such as driving is underexamined. To date, a study 
that examines older adults’ pre-exposure to medical marijuana and 
systematically 
tracks 
medical 
marijuana 
initiation, 
dosage, 
and 
psychomotor functioning has not been done.
1.1.2 Method/Design: This protocol describes an assessment of Medical 
Marijuana Use and Driving Performance: A Test of Psychomotor Function 
in Adults 50 and Older. Sixty participants will be recruited from Medical 
Marijuana Treatment Clinics (MMTC) of Gainesville. The intervention 
group will be comprised of adults 50 and older who report severe or chronic 
pain, are newly registered for the Medical Marijuana Registry in the State 
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 4 of 28
of Florida, have no prior history of medical marijuana use, can communicate 
in English, and are willing and able to complete study procedures. The 
control group will be age, gender, and race matched. The primary study 
outcome is simulated driving performance (i.e. errors in response time, 
attention, and executive functioning tasks that predict on-road 
performance). Secondary outcomes include adverse effects.
1.1.3 Expected Value: Currently, there is limited scientific data on how 
medical marijuana affects psychomotor functioning in real world situations 
among those 50 and older. Further, extant literature suggests that certain 
factors (i.e. dosage, frequency, CBD/THC content, and route of 
administration) may be associated with greater risk of adverse effects for 
older adults. While some evidence suggests that marijuana is beneficial for 
pain, other evidence suggests that marijuana use may be associated with 
slowed response time, poor attention, and poor executive functioning. 
Physicians, patients, and policy makers need data-driven guidelines for 
medical marijuana use in older adults, a prevalent population in the State of 
Florida. To that end, the National Institute on Drug Abuse has called for 
data on medical marijuana in adults 50 and older specifically. The long 
range goal of this work is to improve our understanding of the consequences 
of medical marijuana use in later life and to facilitate the development of 
best practice guidelines for adults 50 and older.
 2.0 
Objectives*
2.1 The specific aims for the current project are:
Aim1: Test the association between medical marijuana use and driving errors that 
predict on-road performance on a high-fidelity driving simulator in adults 
50 and older with chronic or severe pain.
H1a: We hypothesize that medical marijuana use will be associated with 
slower response time in a driving performance task.
H1b: We hypothesize that medical marijuana use will be associated with 
poorer divided attention in a driving performance task.
H1c: We hypothesize that medical marijuana use will be associated with 
poorer executive functioning in a driving performance task.
Aim2: Examine the association between medical marijuana use factors (dosage, 
frequency, CBD vs. THC products, and route of administration) and adverse effects 
in adults age 50 and older.
H2a: We hypothesize that higher dosage and frequency of administration 
will be associated with greater adverse effects.
H2b: We hypothesize that THC-based products will be associated with 
greater adverse effects.
H2c: We hypothesize that products administered by vaporizer will be 
associated with greater adverse effects.
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 5 of 28
3.0 
Background*
3.1 Prevalence of marijuana use has increased 300% in the last 10 years among 
those 50 and older, and this upward trend is expected to continue22. Marijuana 
initiation at age 50 and older has also increased exponentially due to changing 
cultural norms 23, 24. In addition, prevalence estimates of chronic or severe pain in 
this population ranges from 35-52%, with some estimates as high as 74% 2-4, 25, 26. 
In the United States, chronic pain is the most frequently endorsed reason for 
medical marijuana use 5, 10, 27.
Current research indicates that marijuana users may experience cognitive 
impairment in areas such as attention, executive functioning, and psychomotor 
speed 7, 19, 20, 28, 29. Specifically, research has explored the effect of marijuana use 
on psychomotor skills, which are skills that combine thinking and movement. 
Researchers assessed psychomotor function on measures of critical tracking, 
attention, and reaction time, and findings indicated that cannabis usage created 
deficits in psychomotor function up to 3.5 hours after use, which is congruent with 
prior work 30, 31. Impairments to psychomotor abilities have practical implications, 
as these impair an individual’s ability to drive 30. In a study that evaluated 
psychomotor function using the same critical tracking and divided attention tasks, 
Bosker et al. (2013) examined whether psychomotor functioning would improve, 
following abstinence among chronic, daily cannabis users32. Extending previous 
research33, results of this study indicated that psychomotor function was impaired, 
but sustained abstinence (3 weeks) did improve psychomotor performance, which 
is consistent with other findings19. However, psychomotor performance did not 
completely recover to a normal performance as based on the control group. Solowij 
& Pesa (2010) extended this conclusion by suggesting that long-term marijuana use 
is also associated with impaired attention, inhibition, working memory, and verbal 
memory20. Furthermore, Nestoros & colleagues (2017) found that chronic, heavy 
cannabis use was related to general cognitive dysfunction34. Some researchers 
suggest that the aforementioned cognitive impairments may be due to the extent of 
changes in CB1 stimulation35, while other studies indicate that cannabis 
composition may influence the type/severity of the marijuana-related cognitive 
impairment16, 17. Together, this lack of consensus indicates that further work is 
needed to understand if medical marijuana use creates a long-term impact on 
psychomotor functioning that impact real world tasks such as response time, 
attention, and executive functions—all critical for the task of driving. Further, 
clarity is needed regarding whether specific factors of marijuana use are associated 
with greater adverse effects in this population.
Research on psychomotor functioning in older adults generally uses cognitive 
assessment tools such as the Trails Making test which have limited real world 
application36-41.  However, studies of driving performance using driving simulators 
have been shown to be a valid predictor of on-road driving performance42-44. 
Driving simulators allow for the systematic presentation of events and the 
manipulation of variables, which offers experimental control that is impossible on 
the road43, 44. Driving simulators also offer optimal stimulus presentation which 
STUDY00004649
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PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 6 of 28
allows for analysis of both healthy and impaired drivers under similar conditions42. 
Therefore, using a driving simulator we can examine response time, attention, and 
executive functions using valid real world tasks42. Research shows that crash 
patterns for older adults are different 45, 46. Older adults are more likely to be 
involved in crashes at intersections or during merges, and these crashes are 
inherently more fatal 47, 48. The challenging, fast-paced environment presented by 
intersections and merges puts extra demand on cognitive, sensory, and motor 
domains applicable to driving; therefore, slower response time, inattention, and 
difficulty with executive functions may lead to more fatal crashes 48.  Therefore, 
how marijuana use influences driving performance needs to be examined, and the 
driving simulator is the safest option to do so.
4.0 
Study Endpoints*
4.1 Simulated Driving Performance
Data will be collected via the kinematic functionality of the high-fidelity driving 
simulator (i.e., speed in mph, lateral lane positioning, braking, etc.) and also 
through observing the performance of the driver.
4.1.1 Response Time
Type: Primary
Time Frame: Baseline (T1), 1 Month (T2) and 3 Months (T3)
Brief Description: After the first 5-minute acclimation scenario, the driver 
will drive the main drive for another 15 minutes. The first 7 minutes of the 
drive will include daytime driving, start in a rural area with some ambient 
traffic, rolling hills, curves in the road, and include the occasional lead 
vehicle, oncoming traffic, and some vehicles behind the driver. Data will be 
collected via the kinematic functionality of the high-fidelity driving 
simulator (e.g. speed in mph, braking, swerving, lateral lane positioning, 
etc.) and also through observing the performance of the driver -- for yes/no 
responses – via a trained evaluator who will use the playback function of 
the simulator to scrutinize the errors. To assess response time, a vehicle is 
pulling out in front of the driver and the driver’s behavior is measured via 
braking milliseconds (ms) and swerving (SD of lateral deviation from center 
lane). 
4.1.2 Divided Attention
Type: Primary
Time Frame: Baseline (T1), 1 Month (T2) and 3 Months (T3)
Brief Description: Data will be collected via the kinematic functionality of 
the high-fidelity driving simulator and observation. During the course of the 
main drive consisting of straight residential roadways connecting 8 left 
turns and 2 right turns with minimal ambient traffic using an established 
protocol, during the course of the drive divided attention (being aware of 
the traffic and surrounding while focusing on critical stimulus) is assessed 
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 7 of 28
via a diamond on the screen turning to a triangle and the participant needs 
to honk (i.e. respond) as soon as (s)he sees it (measured in ms and number 
of omissions and commissions).
4.1.3 Executive Functions
Type: Primary
Time Frame: Baseline (T1), 1 Month (T2) and 3 Months (T3)
Brief Description: The last 8 minutes of the drive starts in a residential area 
with low speeds (15-30 mph) and then progresses to city with speeds 30-45 
mph. This part of the drive will occur in a suburban environment, daytime 
driving with minimal lead, following and oncoming traffic, and some 
pedestrians and cyclists. Streets will be surrounded by buildings and strip 
malls. Executive functions are measured by providing the driver with an 
instruction before the drive (e.g. to turn into a McDonald’s, pull into a 
parking bay, park the car (vehicle positioning), and when it is safe to do so, 
back up out of the parking bay (visual scanning) exit the lot and merge into 
the flow of traffic.  Executive functions are measured via visual scanning 
(yes/no), speed regulation (mph over or under the speed limit), adjustment 
to stimuli (notice the McDonald’s (yes/no), slow down (mph), signaling 
(yes/no), vehicle positioning (buffer around the vehicle yes/no), and gap 
acceptance (narrow or tight via ms).  
4.2 Adverse Effects
In this study, adverse effects are defined as undesired effect that occurs 
 
medication is administered. We will use Scripted Prompting, a proactive 
form of adverse effect capture recognized in the field18. This method is 
designed to elicit adverse effects without biasing the patient; it is a 
standardized question that allows participant to report important symptoms 
without being influenced by suggestion. For this study we will ask: “Since 
initiating medical marijuana are you having any problems related to use?”
To describe factors associated with adverse effects we will report the 
number of adverse effects reported by participants at time points 2 and 3. 
Adverse Effects will be defined as both a count variable and a binary 
variable such that absence or presence of adverse effects will be coded as 
0/1 respectively.  We will then use Poisson and Logistic regression methods 
to examine analyze the bivariate association between dosage, frequency of 
use, route of administration (pills, vape, etc.), and type of product (THC v. 
CBD). Limitations may be related to the frequency and distribution of 
events leading to complete or quasi-separation of data points. Possible 
mitigations would be re-categorization of explanatory variables, exact or 
firth regression, or a different functional form of the model. 
STUDY00004649
FSU IRB Approved
30 October 2023

PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
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5.0 
Study Intervention
5.1 Type: Drug
Name: Medical Marijuana
Description: Medical marijuana is defined by Florida state statue 381.986 
as all parts of any plant of the genus Cannabis, whether growing or not; the 
seeds thereof; the resin extracted from any part of the plant; and every 
compound, manufacture, salt, derivative, mixture, or preparation of the 
plant or its seeds or resin, including low-THC cannabis, which are dispensed 
from a medical marijuana treatment center for medical use by a qualified 
patient.
This protocol describes an assessment of Medical Marijuana Use and 
Driving Performance: A Test of Psychomotor Function in Adults 50 and 
Older. Sixty participants will be recruited from Medical Marijuana 
Treatment Clinics (MMTC) of Gainesville. The intervention group will be 
comprised of adults 50 and older who report severe or chronic pain, are 
newly registered for the Medical Marijuana Registry in the State of 
Florida, have no prior history of medical marijuana use, can communicate 
in English, and are willing and able to complete study procedures. The 
control group will be age, gender, and race matched. The primary study 
outcome is simulated driving performance (i.e. errors in response time, 
attention, and executive functioning tasks that predict on-road 
performance). Secondary outcomes include adverse effects.
6.0 
Procedures Involved*
* NOTE: To minimize risk of exposure to COVID-19, we will initially only 
recruit participants age 50 and older. Any portions of the study that can be 
conducted via videoconference, such as the informed consent process, will be 
conducted via videoconference. HIPAA protected Zoom software provided by 
FSU will be used for videoconferences. FSU Qualtrics will be used for virtual 
informed consent. Participants who are consented virtually will be mailed a copy 
of the informed consent. Participants who are consented virtually will also be 
offered a copy of the informed consent when they arrive for baseline assessments. 
Appointments will be scheduled so that no overlapping appointments occur 
among participants in order to minimize exposure. No person who has been 
exposed to Coronavirus or who is at higher risk for severe illness may take part in 
our study. Severe illness means certain health conditions related to your heart, 
liver, or lungs, or if you have diabetes. Also, persons who live in nursing homes, 
have severe obesity, or who have immune disorders may not take part in this 
study. There may be other conditions, and this list may change.
STUDY00004649
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PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
Page 9 of 28
We will ask some questions to see who may be at risk of severe illness. We will 
also ask people to see if they have been exposed to Coronavirus. If you think that 
you may been exposed to Coronavirus or have a severe illness, let us know. Study 
staff may or may not include licensed medical doctors, and may not be able to 
give you any medical advice on your Coronavirus risk. Please talk to your doctor 
if you have questions about your own risk. Information about persons who may be 
at risk can be found at the following website:
https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-
higher-risk.html. 
We will make sure that at all times everyone stays a safe distance from one 
another. This is called “social distancing.” We follow the rules about use of 
equipment to protect you. This includes masks, gloves and other equipment. If 
needed we will supply these to you. You must wear these in order to take part in 
this part of the study. If study staff need to be close to you, we will take all the 
steps needed to protect you. We follow the rules about use of equipment to protect 
you. This includes masks, gloves and other equipment. If needed we will supply 
these to you. You must wear these in order to take part in this part of the study. If 
study staff need to be close to you, we will take all the steps needed to protect 
you. We will limit the number of people in any face-to-face activity. We will also 
limit the amount of time that anyone has a face-to-face activity. Only the least 
amount of people and time will be used in this study.
If at any time you don’t feel safe with the steps that we will take to protect you, 
please let us know and we will stop. We want to be sure to answer your questions 
and to take any other steps that you feel we should take to protect you.
6.1 Recruitment/Sampling. We will recruit patients using from Medical Marijuana 
Treatment Clinics (MMTC) of Gainesville. Patients who complete the process of 
being entered into the medical marijuana registry and meet study inclusion criteria 
will be informed about the study during their initial visit to their prescribing 
physician. Recruitment for this study begins pre-medical marijuana exposure. 
Once a patient has obtained their official card from the state of Florida, the 
baseline assessment will be scheduled and completed prior to the patient’s first 
dispensation of marijuana. After patients have filled their first prescription, we 
will track patients through MMTC and follow patients for 3 months post medical 
marijuana initiation, using both in person visits and EMR abstraction.
We will recruit N=60 participants total. Participants will be eligible for the current study if 
they: a) report severe or chronic pain; b) are age 50 or older; c) are newly registered for the 
Medical Marijuana Registry in the State of Florida; d) have no prior history of medical 
marijuana use; e) can communicate in English; and f) are willing and able to complete 
study procedures or if they meet control group criteria: (n=30) Medical Marijuana Users 
or (n=30) Age, Gender, Race Matched Controls. Persons will be ineligible if they: a) meet 
STUDY00004649
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PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
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criteria for current or past alcohol and/or illicit drug dependence; b) have vertigo or any 
vestibular systems dysfunction (due to the to develop simulator adaptation syndrome)66; c) 
screen high on the simulator sickness prescreen; d) use contraindicated medication 
(benzodiazepines, beta blockers, antihistamines, or sedatives) from which they cannot 
abstain due to medical reasons; and/or e) are planning to move out of the area within 6 
months.
We will recruit patients in the control group within the local community. This will happen 
by placing recruitment flyers in public places (i.e. grocery stores, libraries, senior living 
communities, etc.). Additionally, we will utilize Consent2Share, an initiative of the UF 
Integrated Data Repository (IDR) and supported by UF CTSI (Clinical and Translational 
Science Institute) that allows for a large group of potential research participants who have 
consented to be re-contacted for future research studies. The control group will be matched 
by age, gender and race. Control subjects will be ineligible if they: a) meet criteria for 
current or past alcohol and/or illicit drug dependence; b) have vertigo or any vestibular 
systems dysfunction (due to the to develop simulator adaptation syndrome)66; c) screen 
high on the simulator sickness prescreen; d) use contraindicated medication 
(benzodiazepines, beta blockers, antihistamines, or sedatives) from which they cannot 
abstain due to medical reasons; and/or e) are planning to move out of the area within 6 
months, f.) have a history of marijuana use. Control subjects will be used to ensure results 
are not attributed to a simple change in time. Results will provide evidence for the effects 
of medical marijuana use on the real work task among adults 50 and older.  
6.2 Baseline Assessment Procedures. Once eligibility has been met, participants 
will be scheduled for their baseline assessment in the week prior to starting 
medical marijuana. At the baseline appointment, participants will be greeted by a 
study research assistant who will introduce the study and provide the patient with 
informed consent.  We have standardized the informed consent procedure to 
ensure that participants not only understand the informed consent process but also 
fully understand what is being asked of them during the study period. Following 
informed consent, participants will complete the baseline assessment. The 
baseline assessment will consist of a battery of psychosocial measures, a cognitive 
test, a 5 minute simulator adaptation drive, and a 15 minute main drive. 
Adherence to simulator sickness protocol will be ensured before, during, and after 
the drives66. In an effort to maintain engagement, participants will be contacted 
via telephone 60 days post-baseline to complete a 3-item questionnaire regarding 
significant life changes as well as a pain scale. We will also request permission to 
extract needed data on an ongoing basis from patients’ electronic medical records.
6.3 Training of Research Assistants. All study research assistants will be trained 
in Good Research Practices, Safety Concerns in Dealing with Patients, and Data 
Collection Procedures. The training will also cover 1) familiarization with study 
aims, instruments, and assessment procedures specific to the study; 2) 
confidentiality and informed consent, data integrity, and data security; 3) 
observation of mock assessment conducted by the project director; and 5) a 
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PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
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practice assessment with the project director. Research assistants will also receive 
“red flag” training on how to recognize and respond to danger to self and others, 
child abuse, elder/dependent adult abuse, and domestic violence.
Several procedures will help standardize data collection and encourage accuracy 
and honesty in reporting, as follows: 1) trained research assistants will conduct 
the assessments; 2) a private interview setting will minimize distractions and 
ensure confidentiality; and 3) research assistants will remind participants of the 
confidentiality of the information that they provide.
6.4 Methods and Procedures: We will use a naturalistic observational trial design 
to compare psychomotor function at baseline (in the week prior to starting medical 
marijuana) as well as 1 month and 3 months post-medical marijuana initiation.
Principal Investigator Dr. Nicole Ennis, a licensed clinical psychologist (Florida 
license PY7458), will serve as the clinical supervisor for this study. The clinical 
supervisor will oversee all data collection and intervene clinically if necessary. As 
a licensed clinical psychologist, Dr. Ennis is trained in all procedures of the current 
project’s brief intervention and referral to treatment protocol.
6.5 Screening Measure. Self-report questionnaires will be use to discern eligibility. 
Eligibility will be confirmed using medical records at enrollment. Simulator 
sickness questionnaire will be administered before, during, and after the drive67. 
The Optec 2500 is a comprehensive vision screener designed to quickly and 
accurately test patients in a controlled environment. Screening conditions include 
monocular, binocular, near, far, distance, and intermediate. Tests performed 
include visual acuity, color and depth perception, contrast sensitivity to ensure 
results observed in the simulator are not due to visual limitations.
6.6 Medical Marijuana Exposure. We will track dosage, frequency, type of product 
used (CBD vs THC), and route of administration. We will not be instructing 
participants on the dosage, frequency, type of product used, and route of 
administration, we will be observing these variables through the self-report 
dispensary info provided by the state of Florida’s Medical Marijuana Use Registry 
(MMUR). All medical marijuana participants will be recruited prior to medical 
marijuana exposure with the assistance of a qualified prescribing physician who is 
authorized by the State of Florida to determine eligibility and prescribe medical 
marijuana.
6.7 Driving Simulator. The simulator uses a high-fidelity RTI (Realtime 
Technologies, MI) configuration with a full car cab (4-door sedan) with seven 
visual channels. The three forward channels create a 180 degree field-of-view 
(FOV). This wide FOV is accomplished by connecting three flat screens with 
scenes provided by three high-resolution LCoS projectors. The rear scene is also 
projected on a flat screen and viewed through the in-cab rear-view mirror.  The 
side-view mirrors and a virtual dash are simulated with LCD panels. Altogether the 
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PROTOCOL TITLE: Medical Marijuana Use and Driving Performance: A Test of 
Psychomotor Function in Adults 50 and Older.
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visual channels form an immersive and realistic driving experience. A 5.1 channel 
audio system external to the car cab provides the environmental sounds such as 
traffic, passing vehicles, and road noise. An internal audio system to the car cab 
provides the engine sounds and vibrations, as well as pre-programmed voice 
commands and any other scripted sounds. A 4-door sedan allows the driver to 
operate normal accelerator, brake, steering, transmission selection, and signaling 
controls with the simulator responding accordingly. All driver inputs are controlled 
by software that interfaces with the electronics in the car cab. The adaptation 
scenario is standardized for older adults and has been used in our prior driving 
studies68, 69. The main drive consists of straight residential roadways connecting 8 
left turns and 2 right turns with minimal ambient traffic. Three scripted events will 
be randomly presented to the drivers. To assess response time, a vehicle is pulling 
out in front of the driver and the driver’s behavior is measured via braking (ms) and 
swerving (SD of lateral deviation from center lane). Next, divided attention is 
assessed via a diamond on the screen turning to a triangle and the participant needs 
to honk as soon as (s)he sees it (measured in ms and number of omissions and 
commissions). Lastly, executive functions are measured by providing the driver 
with an instruction before the drive (i.e. to turn into a McDonald’s, pull into a 
parking bay, and when it is safe to do so, exit the lot and merge into the flow of 
traffic (measured via visual scanning (yes/no) speed regulation (mph over or under 
the speed limit), adjustment to stimuli (notice the  McDonald’s (yes/no), and slow 
down (mph), signaling (yes/no), vehicle positioning (buffer around the vehicle 
yes/no), and gap acceptance (narrow or tight via m/sec)59, 60.
6.8 Adverse Effects: In this study, adverse effects are defined as undesired effect 
that occurs when the medical marijuana is administered. We will use Scripted 
Prompting, a proactive form of adverse effect capture recognized in the field70, 71. 
This method is designed to elicit adverse effects without biasing the patient; it is a 
standardized question that allows participant to report important symptoms without 
being influenced by suggestion. For this study we will ask: “Since initiating 
medical marijuana, are you having any problems related to use?”
6.9 Control Procedures: Control participants will be community-dwelling age, race, 
and gender matched.
6.10 Participant Retention: We will develop a strong collaborative relationship 
between participants and members of the research team through empathy, 
encouragement and skill building.
6.11 Three- and Six-Month Follow-Up Assessment: The second assessment (T2) 
will occur one month after the participant has been dispensed medical marijuana 
for the first time. T3 will occur 3 months after the participant has been dispensed 
medical marijuana for the first time. The follow-up assessments will consist of a 
minimally reduced psychosocial assessment battery, and the same simulator 
adaptation and main drive (described above). All participants will be paid $50 per 
assessment visit ($150 total across all visits over the 3 month period). Participants 
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will not be paid for screening assessments or chart abstracted data. Data will be 
collected using both self-directed methods such as ACASI with headphones or self-
administered on paper and Research Assistant administered tasks. The Baseline 
Assessment is expected to take approximately 90 minutes, and follow-ups will take 
approximately 60 minutes. Though it is time-consuming, we do not anticipate 
participant barrier as a burden based on prior work.
7.0
Data and Specimen Banking*
N/A.
8.0 
Sharing of Results with Subjects*
N/A.
9.0 
Study Timelines*
9.1
Each subject will be enrolled for a total of 3 months and 1 week. The 
duration anticipated to enroll all study subjects is 12 months.
10.0
Subject Population*
10.1 We will recruit 60 patients from Medical Marijuana Treatment 
Clinics (MMTC) of Gainesville. The intervention group will be 
comprised of adults 50 and older who report severe or chronic pain, 
are newly registered for the Medical Marijuana Registry in the State 
of Florida, have no prior history of medical marijuana use, can 
communicate in English, and are willing and able to complete study 
procedures. The control group will be age, gender, and race matched.
10.2 Inclusions and Exclusions of Special Populations
10.2.1
Adults unable to consent will be excluded from the study.
10.2.2
Individuals who are not yet adults (infants, children,
teenagers) will be excluded from the study.
10.2.3
Pregnant women will be excluded from the study.
10.2.4
Prisoners will be excluded from the study.
11.0
Vulnerable Populations*
N/A
12.0
Local Number of Subjects
12.1 N = 60
13.0
Recruitment Methods
13.1 We will recruit patients using convenience sampling technique from 
Medical Marijuana Treatment Clinics (MMTC) of Gainesville.
Introduction of 
study to 
MMTC patient
Decline to participate
Interested in study
Informed
Consent
Baseline 
Assessment
1-Month 
Follow-Up
3-Month 
Follow-Up
Treatment 
as Usual
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14.0
Withdrawal of Subjects*
14.1 The Principal Investigator can withdraw participants from this study 
for unanticipated reasons.
15.0
Risks to Subjects*
15.1
Questions may be unpleasant or difficult for participants to answer. 
Additionally, despite taking appropriate steps to safeguard collected 
information, there is a slight risk that participant information could be revealed 
accidentally or inappropriately. This release of information may upset a 
participant or even affect their insurability or employability. A Certificate of 
Confidentiality issued from the National Institute of Drug Abuse will assist us 
in protecting participant information.
16.0
Potential Benefits to Subjects*
16.1 Participants will not directly benefit from this study.
17.0
Data Management* and Confidentiality
17.1 Test of Aim 1 (Driving Simulator): Between group (medical 
marijuana users vs controls) comparisons will first be examined 
using independent samples t-test (controlling for unequal variances 
using Levene’s test) or Mann-Whitney U tests if the data are 
nonparametric. Repeated measures ANOVA will be used to examine 
within participants differences on measures at all 3 time points in 
order to answer the question of whether medical marijuana impacts 
response time, divided attention, and executive functions. 
Limitations may be related to the distribution of the dependent and 
independent variables. Possible mitigation approaches include 
creating a dichotomous variable of high versus low for outcomes and 
using logistic regression or other functional form as dictated by the 
distribution of the dependent and independent variables.
17.2
Test of Aim 2 (Adverse Effects): To describe factors associated 
with adverse effects we will report the number of adverse effects 
reported by participants at time points 2 and 3. Adverse Effects will be 
defined as both a count variable and a binary variable such that 
absence or presence of adverse effects will be coded as 0/1 
respectively.  We will then use Poisson and Logistic regression 
methods to examine analyze the bivariate association between dosage, 
frequency of use, route of administration (pills, vape, etc.), and type of 
product (THC v. CBD). Limitations may be related to the frequency 
and distribution of events leading to complete or quasi-separation of 
data points. Possible mitigations would be re-categorization of 
explanatory variables, exact or firth regression, or a different 
functional form of the model. The goal of aim 2 is to examine the 
strength of the association between factors of medical marijuana use 
and adverse effects.  As there may be insufficient power for statistical 
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significance, effect size estimates (Cohen’s d) will be used to examine 
the strength of the association between variables.
17.3 Power Analysis
17.4 We compute the power to detect a medium effect size of 0.5 standard 
deviations across groups. Assuming a correlation of 0.2 across the 
repeated measures at three time points, the standard deviation of the 
average of three measures is 0.683 times the standard deviation of 
one measure.  Therefore, with 31 per group we can detect a 
difference in this average of 0.5 times the standard deviation of one 
measure, using a two-sided test with 80% power. We calculated 
Cohen’s d using Dr. Classen’s prior work that examined total driving 
errors  and specific errors (Lane maintenance) in healthy controls 
(M= 24.08 SD=12.38) and (M= 5.78 SD=4.26) versus Parkinson 
patients (M=31.99 SD=22.01) and (M=10.23 SD= 9.26) which 
yielded a Cohen’s d of .46-.65 (medium effect size)59; therefore we 
will be powered to detect this medium effect size.
17.5 Missing Data
17.5.1 We will handle missing data values with a 3-step process. First, the 
dropout rates will be compared across the groups with chi-square 
analyses to assess systematic differences due to condition. Second, 
demographic and dependent variables will be examined for their 
relationship to dropout. Those variables related to dropout status 
will be used to impute missing values for use in the analyses 
described (via SPSS Missing Items Analysis). Finally, comparison 
of the completers vs. imputation analyses will yield an additional 
estimate of the effect of dropouts on hypothesis tests.
17.6 Procedures to Safeguard Against Adverse Events
17.6.1 All data collection protocols include a form on which research staff 
members record any problems with the data collection, concerns 
about the participant, or unusual occurrences during the collection. 
These forms allow our research staff an opportunity to quickly 
review and respond to any possible concerns or adverse effects.
17.7 Data and Safety Monitoring Activities
17.7.1 The data collected by the current project presents low to minimal 
risk to participants. Participants will be asked to answer a set of 
questionnaires, provide a urine specimen which will be used to 
detect the presence or absence of THC and other drugs, and 
participate in an approximately 20 minute simulated drive. 
Participants who meet criteria for current or past alcohol and/or 
illicit drug dependence, have vertigo or any vestibular systems 
dysfunction (due to the risk to develop simulator adaptation 
syndrome), screen high on the simulator sickness prescreen (a 
score of 13 or greater), use medications as identified by the 
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referring physicians that would negatively impact mental or 
physical functioning due to side effects, or have a diagnosis of 
severe psychiatric (e.g., psychoses) or physical conditions (e.g., 
missing limbs) that would preclude full participation will be 
excluded from the study. Further, vulnerable populations will not 
be enrolled in the current trial.
17.8 Confidentiality Safeguards
17.8.1 To ensure confidentiality, all information will be coded so that it 
cannot be associated with any individual. A master sheet with 
individual names and their respective code numbers will be kept in 
a locked file that can be accessed only under supervision of the PI. 
All data entered into the computerized database will be identifiable 
by subject code number only. No one outside of the lead research 
team will have access to records identifying participants' names at 
any time. The information gathered will be used only for scientific, 
educational, or instructional purposes.
17.9  Data Safeguards
17.9.1  All data collection protocols include a form on which research 
staff members record any problems with the data collection, 
concerns about the subject, or unusual occurrences during the 
collection. These forms allow our research staff an opportunity to 
quickly review and respond to any possible concerns or adverse 
effects.
17.10 Oversight
17.10.1
The PI is responsible for the general oversight of all grant 
activities and will inform the IRB about any changes to the DSMP. 
The proposed study will have a yearly review of its DSMP by the 
Florida State University IRB during the regular continuing review 
process, outlining the following points:

Reassessment of the risks and benefits to study participants

Participant recruitment, accrual, and retention

Data quality and confidentiality

Consideration of external scientific or therapeutic developments 
with impact on the safety of participants or the ethics of the study

Review any adverse events
18.0
Provisions to Monitor the Data to Ensure the Safety of Subjects*
18.1 Protection to Reduce or Eliminate Simulator Sickness
18.1.1 In the proposed study, we will implement a simulator sickness 
prevention protocol to reduce the occurrence of simulator sickness. 
The protocol for safeguarding against simulator sickness is detailed 
in the Protection of Human Subjects document and is briefly 
outlined here. The protocol includes a seven minute acclimation 
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period during which participants will begin with simple and slow 
straight-line driving without much texture in the road image. Then, 
speed, texture, curves and turns will be progressively added. 
During the acclimation period and simulation, participants will be 
carefully observed and asked for verbal feedback regarding the 
presence of motion sickness. If at any point throughout the 
experiment the participant reports, or is observed to have motion 
sickness, the trial will be terminated. If participants experience 
symptoms after driving, we will measure simulator sickness with 
the SSQ. We will allow a recovery period for the participants and 
monitor them for 10-minute intervals (up to 30 minutes) to 
determine if their symptoms lessen with time. Participants will be 
released once their SSQ scores are at or near baseline.
19.0
Provisions to Protect the Privacy Interests of Subjects
19.1 Discomfort with Procedures or Disclosure Safeguards
19.1.1 During the course of participation in the research, a 
participant may have questions about the assessment 
procedure. A project staff member or interventionist will be 
available to answer questions. To prevent discomfort or 
embarrassment, staff are trained in building rapport and 
skillful interviewing. Participants are informed prior to the 
assessment that they may choose to skip any questions or 
procedures they find uncomfortable. If any individual 
becomes overly distressed or distraught, the assessment 
will be stopped immediately and a staff clinician will talk 
privately with the affected individual(s) and appropriate 
referrals will be made, as needed.
19.2 Mandatory Reporting Safeguards
19.2.1 As a Licensed Clinical Psychologist in the State of 
Florida I am a mandatory reporter and must inform all 
patients I work (research and clinical) with of my duty 
to report. Therefore, participants are informed in the 
consent document that staff must report to authorities any 
report by any respondent of child abuse, or any report of 
suicidal or homicidal behavior or specific ideations. 
Research and clinical staff are trained to identify events 
that would fall under mandatory reporting guidelines. 
These include physical injury to any child caused by 
anything other than accidental means or information from a 
study participant that leads staff to believe a person is in 
imminent danger of physically harming oneself or others.
19.3
Response Procedures for Adverse Events
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19.3.1 Discomfort with disclosure: During the course of 
participation in the research, a participant may have 
questions about the assessment procedure. A project staff 
member or interventionist will be available to answer 
questions. To prevent discomfort or embarrassment, staff 
are trained in building rapport and skillful interviewing. 
Participants are informed prior to the assessment that they 
may choose to skip any questions or procedures they find 
uncomfortable. If any individual becomes overly distressed 
or distraught, the assessment will be stopped immediately 
and a staff clinician will talk privately with the affected 
individual(s) and appropriate referrals will be made, as 
needed.
19.3.2 Mandatory reporting: One serious adversity a subject may 
encounter is the possibility that staff must report to authorities the 
instances of physical abuse, neglect, or threat of physical harm 
among participants to themselves or others. To anticipate these 
concerns, the project has established procedures and guidelines to 
respond to risk disclosures and crisis situations. Staff will be trained 
to recognize risks or crises that require immediate reporting 
response. Certain situations require special procedures (see sections 
19.3.3 – 19.3.5).
19.3.3 Suicide thoughts or attempts: Two types of risks will be addressed 
in the project: (a) ideation or the presentation of thoughts or 
interest in suicide, and (b) action, which includes both thoughts of 
suicide as well as the presence of a plan and means to accomplish a 
suicide act. If the disclosure occurs during an on-site session, the 
staff member will follow through with an in-person interview to 
clarify the presence of suicidal risk or develop a plan of action. In 
the most extreme cases of risk, the PI then assumes follow-up 
responsibility for the plan of action.
19.3.4  Abuse: Child abuse concerns may arise from any or a 
combination of the following sources: (a) a subject indicates that
abuse has occurred or is occurring, and/or (b) a subject answers
one or more assessment questionnaire items suggesting the 
possibility of abuse. At any time, if any of the above indicators of 
abuse lead staff to suspect abuse or neglect of children, the PI will 
be notified to review the information and determine next steps. 
19.3.5 Threat of danger to others: The threat of danger to others includes 
disclosure of potential physical harm by a participant to others, 
including members of the participant's family or other individuals in 
the community. At any time, if any information derived through 
assessment or intervention lead staff to suspect a participant poses a 
threat of harm to others, steps are outlined for staff to obtain 
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additional information and contact the PI. In all situations that are 
referred to the PI, the written report is kept in a participant's 
confidential file for future reference.
19.4 Reporting Procedures for Adverse Events
19.4.1 The anticipated potential adversity inherent in assessment involves 
situations detailed above and is addressed by the timely intervention 
of the PI skilled in risk assessment and mandatory reporting 
requirements. 
20.0
Compensation for Research-Related Injury
20.1
N/A
21.0
Economic Burden to Subjects
21.1  N/A
22.0
Consent Process
22.1
Informed Consent. All participants will be required to read detailed consent 
forms prior to participation. Before signing, participants will be given the 
opportunity to ask any questions they may have about the study. Participants 
are advised of the voluntary nature of participation and of their right to 
withdraw from the project at any time and their right to require that information 
about themselves be removed from data analysis. Each study participant 
receives a verbal and written description of the study.
22.2
Special Considerations
22.2.1 Non-English Speaking Subjects
N/A
22.2.2 Waiver or Alteration of Consent Process (consent will not be 
obtained, required information will not be disclosed, or the 
research involves deception)
N/A
22.2.3 Subjects who are not yet adults (infants, children, teenagers)
N/A
22.2.4 Cognitively Impaired Adults
N/A
22.2.5 Adults Unable to Consent
N/A
23.0
Process to Document Consent in Writing
23.1 All participants will sign an Informed Consent and they will receive 
a signed copy of the form and a signed copy will be kept for the 
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study. These forms will then be digitized and stored in a secure 
password protected file on the FSU server. 
24.0
Setting
24.1 Patients will be recruited using convenience sampling technique 
from Medical Marijuana Treatment Clinics (MMTC) of Gainesville.
24.2 Patients will be assessed at the Smart House which is the current 
location of the Driving Simulator. The Smart House, property of the 
College of Public Health and Health Professions, is a single-family 
home located in Oak Hammock at the University of Florida, a 
vibrant and energetic retirement community in Gainesville, Florida. 
Built in 2005, the 2,350 square foot home was designed to allow 
researchers to explore how novel applications of technology can 
facilitate independent living and elder care. The Smart House, 
located 3.5 miles from the UF campus, provides convenient access 
for UF’s designated employees and researchers, as well as 
participants who enjoy dedicated parking and lessened traffic as 
compared to the university site.
25.0
Resources Available
25.1
It will be feasible to recruit the patients needed due to the 
fact that MMTC issues between 800 and 1000 medical 
marijuana cards per month on average.
25.2
This project will have the resources needed to complete it
in the next two years.
25.3
The Center for Translational Behavioral Science 
(CTBScience) is a university center, affiliated with the FSU 
College of Medicine. This facility provides 6 faculty offices, 4 
research core offices, a program manager office, two shared 
postdoc offices, offices for a research coordinator and research 
assistants, and a shared space for students and staff working 
with faculty. The center also houses 4 multifunctional 
participant spaces, 2 of which have the ability to function as 
working sleep laboratories equipped with state-of-the-art sleep 
diagnostic equipment, video monitoring / recording capability
and 2 of which have the ability to be used as both assessment 
rooms and therapy rooms. Further, the center houses a 
conference room with video conferencing capabilities and a 
community space that functions as a group meeting room 
and/or classroom. Within its three cores (Management Core, 
Methods Core, and Tech Core), the Center has a dedicated 
clinical trials coordinator, administrative coordinator, grants 
contracts administrator, data manager, biostatisticians, and a 
communications expert as well as access to FSU’s IT, library, 
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and other administrative resources. The Center also has a 
dedicated phlebotomy lab space, equipped with the necessary 
sample collection and sample storage equipment for human 
biological specimens. This facility hosts multiple research 
initiatives related to translational behavioral science.
25.4
Investigators will utilize the UF Integrated Data Repository, 
supported by CTSI (Clinical and Translational Science 
Institute), which is a large-scale database that securely collects 
and organizes data from across UF Health's clinical and
research enterprises, particularly Consent2Share, an initiative 
of the UF Integrated Data Repository (IDR) and supported by 
UF CTSI (Clinical and Translational Science Institute) that 
allows for a large group of potential research participants who 
have consented to be re-contacted for future research studies
25.5
Principal Investigator Dr. Nicole Ennis, a licensed clinical 
psychologist (Florida license PY7458), will serve as the 
clinical supervisor for this study. The clinical supervisor 
will oversee all data collection and intervene clinically if 
necessary. As a licensed clinical psychologist, Dr. Ennis is 
trained in the motivational interviewing skills, referral 
strategies, and all procedures of the current project’s brief 
intervention and referral to treatment protocol.
25.6
During the course of participation in the research, a 
participant may have questions about the assessment 
procedure. A project staff member or interventionist will be 
available to answer questions. To prevent discomfort or 
embarrassment, staff are trained in building rapport and 
skillful interviewing. Participants are informed prior to the 
assessment that they may choose to skip any questions or 
procedures they find uncomfortable. If any individual becomes 
overly distressed or distraught, the assessment will be stopped 
immediately and a staff clinician will talk privately with the 
affected individual(s) and appropriate referrals will be made, 
as needed.
26.0
Multi-Site Research*
As defined by the NIH, this study is a single-site clinical trial. 
The PI of the study, Dr. Ennis (FSU) proposed the study 
examining how medical marijuana effects driving in 
individuals 50 years and older. Dr. Ennis and her research team 
are recruiting for the study in Gainesville, FL through the 
Medical Marijuana Treatment Clinics (MMTC) of Florida. 
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Study participants will be assessed at the UF Smarthouse in 
order to use the driving simulator. Although the study is a 
collaboration between FSU and UF, the NIH defines this study 
as a single-site clinical trial because participants are only being 
assessed at one location. If participants were beings assessed at 
both locations, then the study would be considered a multi-site 
trial.  
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