The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial
Phase: PHASE2
Conditions: Driving Performance, Cognitive Impairment, Sedation Complication, Mood
Sponsor: West Virginia University

Clinical Trial Protocol with Statistical Analysis Plan 
 
Study: The Effects of Cannabidiol on the Driving Ability of Healthy Adults: a Clinical Trial 
NCT#: NCT04590495 
Last updated: 9/27/2021 
PI: Toni Marie Rudisill, MS, PhD 

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Protocol Number & Study Protocol Title 
The effects of cannabidiol on the driving ability of healthy adults: a clinical trial 
 
Table of Contents 
Section 
Page 
Study Team Composition  
2 
Research Summary 
3 
Background and Significance 
4 
Objectives 
5 
Study Design and Methodology 
6 
Target Population and Recruitment 
9 
Risk and Benefits 
10 
Statistical Analysis 
10 
Safety Monitoring and Unanticipated Event Reporting 
11 
Study Duration 
12 
Protected Health Information 
12 
Informed Consent 
12 
Confidentiality and Privacy 
12 
Conflicts of Interest 
13 
Publications and Presentations 
13 
References 
13 
 
 
Abbreviations List 
AE=Adverse event 
BRT=Brake reaction time 
CBD=Cannabidiol 
CO-I=Co-investigator 
DSST=Digital Symbol Substitution Test 
IRB=Institutional Review Board 
IT=Information Technology 
PHI=Protected health information 
PI=Principal Investigator 
PVT=Psychomotor Vigilance Test 
SRT=Simple Reaction Time test 
SSS=Stanford Sleepiness Scale 
THC= Delta-9-tetrahydrocannabinol 
TMT=Trail Making Test 
US=United States 
VAMS=Visual Analog Mood Scale 
WVU=West Virginia University 
 
 
 

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Section I: Team and Research Summary 
 
Study Team Composition 
Toni Marie Rudisill, MS, PhD:  Principal Investigator/Project Director.   
Dr. Rudisill is a Research Assistant Professor in the Department of Epidemiology at the West Virginia University (WVU) 
School of Public Health.  She is an injury epidemiologist and experienced traffic safety researcher with numerous 
manuscripts related to drug-impaired driving.  Even though she is an early-stage investigator, Dr. Rudisill has been the 
Co-I on multiple federal and state grants. Dr. Rudisill will oversee all aspects of this study including staff, data 
collection, data management, data analysis, summarization of findings, drafting manuscripts and progress reports, 
dissemination of findings, and fiscal oversight of the project.   
 
Karen (Kim) Innes, PhD, MSPH: Co-Investigator. 
Dr. Innes is a Professor in the Department of Epidemiology at the West Virginia University School of Public Health.  
She is an experienced clinical researcher and epidemiologist and has extensive background and expertise in clinical 
trials, survey research, chronic disease epidemiology, public health, and behavioral medicine, and have been 
continuously grant-funded as a PI/Co-PI in clinical intervention and epidemiologic research since 1998.  She has 
authored over 230 peer-reviewed articles.  Dr. Innes will support Dr. Rudisill in all aspects of the conduct of this study.   
 
Gordon Smith, MD, MPH: Co-Investigator. 
Dr. Smith, a Stewart M. and Joyce N. Robbins Distinguished Professor of Epidemiology, is an internationally renowned 
physician-epidemiologist with expertise in injury epidemiology, traffic safety, and substance use at WVU.  He has 
continuously maintained research funding from the NIH and CDC.  To date, he has published over 200 peer reviewed 
manuscripts.  Dr. Smith will support Dr. Rudisill in all aspects of this study including training staff, data collection, data 
management, data analysis, summarization of findings, drafting manuscripts and progress reports, dissemination of 
findings.   
 
Sijin Wen, MA, MS, PhD: Co-Investigator. 
Dr. Wen is an Associate Professor in the Department of Biostatistics at the West Virginia University School of Public 
Health.  Dr. Wen has extensive expertise in the preclinical and clinical studies.  Dr. Wen will support Dr Rudisill in the 
statistical analysis of this study.   
 
Dr. Treah Haggerty, MD, MS: Physician 
Dr. Haggerty is an Associate Professor and practicing physician in the Department of Family Medicine at West Virginia 
University Medicine.  She is located at the West Virginia University Health Sciences Center and will serve as the 
consulting physician for this study.  She will be available on site for consultation should medical issues arise during 
testing.   
 
OTHER PERSONNEL 
 
Oscar Oviedo-Trespalacios, MSc, PhD: Consultant. 
Dr. Oviedo-Trespalacios is a Strategic Research Fellow at the Centre for Accident Research and Road Safety in 
Queensland, Australia.  He is an expert in using driving simulators and technology in transportation safety research.  
He will serve as a consultant-in-kind to Dr. Rudisill regarding the driving simulation aspect of this study.   
 
Hourly Graduate Research Assistant: To be determined.  

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The PI will hire a graduate student to assist with the completion of this project.  This individual will assist with the PI 
with various tasks such as overseeing the allocation of study groups, administering the study drug and tests, data 
collection, data management, manuscript preparation, and data dissemination.   
 
Cynthia Fisher-Duda: Study Coordinator 
Ms. Fisher-Duda will serve as the Study Coordinator for this project.  She will assist the PI with the completion of this 
project such as recruiting, consenting participants, overseeing the allocation of study groups, administering the study 
drug and tests, data collection, data management. 
 
Michelle L. Chidester: Study Personnel 
Ms. Chidester will serve as additional study personnel for this project.  She will assist the PI with the completion of 
this project such as completing IRB submissions, amendments and regulatory document collections. 
 
Research Summary 
Study Population – Forty overall healthy adults will be recruited and randomized to receive either 300 mg of CBD 
(N=20) or placebo (N=20).  The criteria for eligibility are as follows: 1) the participant must be currently enrolled as a 
WVU student, 2) be 18-30 years of age at time of study, 3) have a current drivers’ license issued from any state in the 
United States, 4) has driven at least once in the past 30 days 5) is able to speak and read English, 6) is willing to be 
randomized and comply with study requirements including a urine drug test on the day they consent to participate in 
the experiment and complete a test drive to ensure the absence of  simulation sickness, 7) not currently taking any 
daily prescription medications other than birth control, 8) have not been diagnosed with any serious chronic disease 
by a licensed healthcare provider (including but not limited to Alzheimer’s and related dementias, Parkinson’s disease 
or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental 
illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and 
fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study 
staff after testing completion.  
 
 Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including 
cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, 
lysergeic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is 
currently pregnant or lactating.  The health conditions and substances noted above have all been associated with 
changes in driving ability or performance.   Also, limiting participants to those who are currently not using illegal 
drugs, tobacco products, and prescription medications may help minimize bias potentially caused by drug interactions 
with CBD or known impediments to driving performance from the medications themselves.  Because the safety of 
CBD on fetuses or neonates is unknown, individuals who are pregnant or lactating are excluded for safety reasons.  
 
Study Design – This is a randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of 
CBD on driving ability along with changes in psychological status (e.g., sedation) and cognitive function.   Forty healthy 
West Virginia University (WVU) students will be recruited for this study.  Email notifications about the study will be 
sent to the student body and flyers will be posted on boards throughout campus; this type of recruitment has been 
successful in our other studies.  Interested students can contact study personnel.  Study personnel will tell them 
about the study and pre-screen participants using a standardized checklist.  If students are eligible and still want to 
participate, they will be asked to meet at the research office.  After eligibility is reassessed and consent is obtained, 
the individual will be allocated and randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched 
in appearance and taste (N=20). After consuming the study drug, each individual will participate in a 25–35-minute 
driving simulation (which includes a practice drive and brake reaction test (BRT)) and have their driving performance 
measured. To assess changes in mental status (i.e., sedation and drowsiness) and drug impairment-related cognitive 

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function, the VAMS, SSS, DSST, PVT, SRT, and TMT will also be administered to participants at baseline (prior to study 
drug consumption) and following completion of the driving simulation test. The primary outcome of this study will be 
driving performance, quantified using measures strongly associated with collision risk including number of lane 
departures, standard deviation of lateral position (i.e., weaving), brake reaction time, and collision occurrence.   
Secondary outcomes will be pre-post changes in well-validated measures of mental sedation (VAMS, SSS) and 
cognitive function (DSST, TMT, PVT, SRT). We will also collect baseline demographic, health, and driving history data 
along with data at the end of the survey to assess participant satisfaction and tests of blinding.  The entire protocol for 
each participant will be completed in one day and should take 4-4.5 hours to complete.  We chose a parallel design as 
opposed to a cross-over design to minimize participant burden (i.e., to avoid 2 testing sessions) and facilitate 
retention.  As CBD is a legal nutraceutical that can be obtained over the counter, and it typically is well-tolerated, this 
study is minimal risk.  All data will be deidentified and stored on a secure server that is compliant with WVU 
Information Technology (IT) Department.  An overview of the protocol is below. 
 
 
Figure 1. Overview of protocol 
 
Study Duration – 24 months 
 

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Section II: Design 
 
Background & Significance  
BACKGROUND.   Drug-impaired driving has outpaced alcohol-impaired driving in the United States (US) partly due to 
the passage of state medical and recreational marijuana use laws and the national opioid epidemic.1-4 Delta-9-
tetrahydrocannabinol (THC), the psychoactive component of marijuana (Cannabis sativa), is consistently the most 
prevalent drug identified among drivers nationally and its detection has increased nearly 50% since 2007.1,5-7  THC is 
known to impair drivers’ psychomotor function, divided attention, lane tracking, and cognitive function, which can 
increase their risk of motor vehicle collision.8-13  While knowledge of the pharmacodynamic and pharmacokinetic 
properties of marijuana are expanding, virtually nothing is known regarding the effects of cannabidiol (CBD), the non-
psychoactive component of marijuana, and its relationship with driver performance,14-16  despite rapidly increasing 
use and health claims. 
 
Although little is known about CBD’s effects, it is a legal substance in the US and is currently being added to a myriad 
of foods, beverages, tobacco products, and dietary supplements in oil or tincture form.17,18 CBD is immensely popular 
and sales are projected to hit $23 billion per year by 2025.19 A survey of US CBD consumers (N=2,409) revealed that 
many individuals purchase the product for general wellness or recreation (38%), but most use CBD to treat a medical 
condition (62%), such as pain, anxiety, depression, or insomnia.20  Whether CBD actually helps these maladies is 
unclear; peer-reviewed placebo-controlled studies of CBD have only been conducted in small, unique clinical 
populations suffering from conditions such as post-traumatic stress, addiction, anxiety, multiple sclerosis, epilepsy, 
psychosis, movement disorders, or insomnia.21-40  While most studies involving clinical populations show that CBD is 
well-tolerated in high doses, it is not without its side effects; patients often claim to experience drowsiness and 
sedation.41-44  In fact, the Food and Drug Administration package insert for Epidiolex, which is prescription CBD oil for 
Lennox-Gastaut and Dravet syndromes in children, contains a warning about sedation and potential driver 
impairment.45  However, the effects of CBD in healthy adult populations is severely lacking, especially with regard to 
effects on driving.   
 
To our knowledge, only 16 placebo-controlled peer-reviewed studies of CBD have been conducted to date in healthy 
volunteers; most of these studies have been conducted using males and virtually all have involved South American or 
European populations.44,46-59  The sample sizes are small with 79% of these studies having fewer than 16 people (range 
5-57 participants); all these studies have suggested that CBD is sedating and anxiolytic but were not statistically 
significantly different from the effects of placebo, which is likely driven by the very small sample sizes.44,46-59  Surveys 
indicate that females appear to use CBD more than males, but the known effects of CBD are virtually unstudied in 
healthy females.20  Thus, it appears that CBD is likely sedating, but it has not been formally assessed in a placebo-
controlled trial in a healthy US population consisting of both sexes.  Additionally, to date, no peer-reviewed studies 
have investigated whether CBD alone affects the driving ability of healthy adults.   
 
Thus, the objectives of this application are to investigate the effects of CBD on driving performance, psychological 
status (i.e., mood, drowsiness, sedation), and cognitive function in healthy adults aged 18-30 years.  Driving 
performance will be assessed using a driving simulator, which directly correlates with actual driving ability, 60-64 while 
cognitive function and psychological status will be assessed using a battery of well-validated instruments widely used 
in the evaluation of drug impairment.65,66  Given that CBD products are growing exponentially in popularity among all 
age groups,20 and their effects in a healthy population are understudied, the positive impact of this study is the 
collection of essential preliminary data regarding the potential adverse effects of CBD, which may unknowingly put 
drivers and other road users at increased risk of motor vehicle collision and subsequent morbidity and mortality. 
 

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Objectives 
The objective/purpose of this study is to investigate the effects of CBD on driving performance, psychological status 
(i.e., mood, sedation, drowsiness), and cognitive function in healthy adults aged 18-30 years.  This is because CBD is 
widely sold and consumed and there is some evidence that it may be sedating; however, this has never been 
evaluated in healthy adults.  The primary outcome of this study will be driving performance, quantified using 
measures strongly associated with collision risk, including number of lane departures, standard deviation of lateral 
position (i.e., weaving), brake reaction time, and collision occurrence. Driving performance will be assessed using a 
driving simulator.  Secondary outcomes will be changes in well-validated measures of mental sedation and cognitive 
function which includes performance on the VAMS, SSS, TMT, DSST, PVT, SRT.   The VAMS and SSS are Likert-type 
scales which assess mental and physical sedation and sleepiness, respectively, at that moment and time.  VAMS 
consists of 16 questions, while SSS only consists of 1.  These measures can be summed with higher scores equating to 
more sedation.  The SSS will be summed with greater perceived sleepiness receiving a larger score, similar to the 
VAMS.  The DSST measures psychomotor speed, attention and working memory by requiring participants to translate 
numbers into symbols; the test is scored by the degree of completion and accuracy over a timed 90 second period.  
The TMT measures executive function and consists of two parts; the first part requires participants to connect 
numbers in ascending order, while the second part requires individuals to connect numbers and letters in sequence.  
The test is scored by the time it takes to accurately complete each test.  Increases in time correlate with greater 
impairment.  PVT and SRT are tests given on a computer tablet.  They both measure participants reactions to stimuli. 
 
Study Design & Methodology 
This is a randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of CBD on driving 
ability along with changes in psychological status (e.g., sedation) and cognitive function.  Thus, the data will be 
collected prospectively.  The methodology of the study is below. 
 
Study Design and Protocol Overview.  We propose a randomized, parallel-group, double-blind, exploratory two-arm 
trial to assess the effects of CBD on driving ability along with changes in psychological status (i.e., mood, drowsiness, 
sedation) and cognitive function. Forty healthy West Virginia University (WVU) students will be allocated and 
randomized to receive: (1) 300 mg of pure CBD oil or (N=20) (2) placebo matched in appearance and taste (N=20). 
After consuming the study drug, each individual will participate in a 25–35-minute driving simulation, which includes a 
practice drive and brake reaction test, and their driving performance measured. To assess changes in psychological 
status (i.e., mood, drowsiness, sedation) and drug impairment-related cognitive function, the VAMS, SSS, DSST, TMT, 
PVT, SRT will also be administered to participants at baseline (prior to study drug consumption) and following 
completion of the driving simulation test. The primary outcome of this study will be driving performance, quantified 
using measures strongly associated with collision risk including number of lane departures, standard deviation of 
lateral position (i.e. weaving), reaction time, and collision occurrence.78-80   Secondary outcomes will be pre-post 
changes in well-validated measures of mood, drowsiness, mental sedation (VAMS, SSS) and cognitive function (DSST, 
TMT, PVT  SRT).69-76  We will also collect baseline demographic, health (including body mass index), and driving history 
data, including driving habits, along with data at the end of the survey to assess participant satisfaction and tests of 
SIGNIFICANCE.   West Virginia has a traffic fatality rate that is 70% greater than the national rate.67 While the exact 
reason for this disparity is unclear, previous studies have suggested that drug impaired driving may be partly 
responsible.68  Not only is the traffic fatality rate elevated in WV, but our preliminary studies indicate that CBD 
consumption is high as well.  Among WVU students, our preliminary study found that 60% of drivers surveyed had 
consumed CBD (see section C.5.4.1).  This demonstrates the high usage in the population and the need to determine 
if CBD is safe for drivers to consume not only nationally, but also in WV, which already suffers from such a disparate 
traffic fatality rate.  These findings could facilitate public health intervention, driver education, and/or legislative 
initiatives to protect this high-risk population of drivers. 

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blinding.  The entire protocol will be completed in one day and should take 4-4.5 hours to complete for each 
participant.  We chose a parallel RCT design as opposed to a cross-over RCT to minimize participant burden, while still 
being able to study both within individual (i.e., test battery results) and between group effects (i.e., simulator and test 
battery performance). 
 
Study Population, Eligibility, Setting, and Recruitment.  Forty healthy adults will be recruited and randomized to 
receive either 300 mg of CBD (N=20) or placebo (N=20).  The criteria for eligibility are as follows: 1) the participant 
must be currently enrolled as a WVU student, 2) be 18-30 years of age at time of study, 3) have a current drivers’ 
license issued from any state in the United States, 4) has driven at least once in the past 30 days 5) is able to speak 
and read English, 6) is willing to be randomized and comply with study requirements including a urine drug test on the 
day they consent to participate in the experiment and complete a test drive to ensure the absence of  simulation 
sickness, 7) not currently taking any daily prescription medications other than birth control, 8) have not been 
diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer’s 
and related dementias, Parkinson’s disease or other neurodegenerative disorder, major depressive or anxiety 
disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive 
pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia), and 9) has an individual able to drive them 
home after testing or is willing to be driven home by study staff after testing completion.  
 
 Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including 
cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, 
lysergeic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is 
currently pregnant or lactating.   The health conditions and substances noted above have all been associated with 
changes in driving ability or performance.86-115 Also, limiting participants to those who are currently not using illegal 
drugs, tobacco products, and prescription medications may help minimize bias potentially caused by drug interactions 
with CBD or known impediments to driving performance from the medications themselves.84 Participants will be 
recruited from WVU.  Email notifications about the study will be sent to the student body and flyers will be posted on 
boards throughout campus; this type of recruitment has been successful in other studies.116 The study will take place 
at the WVU Health Sciences Center.  
 
Consent, Screening, and Baseline Assessments.  Students who are interested in participating in the study will be 
contacted via study personnel.  Participants will be given a brief overview of the study and its purpose and will be 
initially screened for eligibility using a standardized screening checklist.  If the individual meets the inclusion and 
exclusion criteria, they will be invited to participate in the study.  Participants will be given a list of instructions prior 
to their assessment.  While participants should not be taking any routine prescription medications as part of the 
inclusion criteria, they will be told to abstain from taking any other types of medications including nutraceuticals, 
over-the-counter medications, vitamins, supplements 24 hours prior to coming to their appointment.  Caffeine and 
alcohol should also not be consumed within 10 hours of their appointment.  They will be instructed to get at least 6 
hours of sleep the night prior and to only consume water prior to their scheduled visit.  
 
At the research office, study personnel will explain the requirements, re-screen the participant, and review the 
consent form with each individual in a private room and obtain signed consent.  After consenting, the participant will 
be asked to provide a urine sample which will be analyzed immediately onsite for potentially impairing or illicit drugs 
via a rapid urine test.  If the individual tests positive for any potentially impairing substance, they will not be able to 
participate in the study. Anyone who tests positive for a drug will be referred to the Carruth Center on campus.  If a 
participant’s sample tests negative, they will then be allowed to practice on the driving simulator for approximately 
10 minutes prior to engaging in any other study activities.  This is necessary as some individuals who are prone to 
motion sickness may experience brief, mild nausea (e.g., simulator sickness).85 If there is evidence of simulator 
sickness, the individual will not be able to participate in the study, as they will likely not be able to complete the 

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protocol.  Any reasons as to why an individual is not eligible to participate will be documented in a screening log. If no 
simulation sickness is observed, the student will then take the standardized and pilot-tested baseline survey regarding 
their demographics, health (including body mass index), and driving history along with the VAMS, SSS, TMT, DSST, 
PVT, and SRT tests.    
 
These tests have all been deemed valid and reliable instruments and have been described in detail elsewhere. 69-
76,78,117-119 The tests will be administered by trained study personnel via a computer tablet and/or paper and pencil; 
personnel will then transfer the collected data to a secure, electronic database. Participants will also be given a 
standardized breakfast after baseline assessment. 
 
Allocation, Randomization and Blinding.  Participants will be randomized immediately after baseline assessments are 
completed to the CBD (N=20) or placebo group (N=20) using a sex-stratified 1:1 random block design to ensure equal 
distribution among treatment groups and sex.120  The participant and the PI will be unaware of group assignment (i.e. 
double-blind).  Dr. Wen, who will not have contact with participants, will generate a randomized assignment master 
list and provide sequentially numbered envelopes containing group assignment to the team member that helps 
consent participants.  This team member will assign the unique number from the next envelope in sequence as the 
participant’s study identification number and will record the participant’s information in a secure, electronic master 
database.   
 
Intervention.  Protocol A consists of a 300 mg dosage of CBD oil which will be consumed orally.  This dosage was 
chosen as it has been used in other studies consisting of both healthy and clinical populations and is well-tolerated 
with no major adverse events.46,51,52,54,55,59,121-123 CBD will be obtained from Zatural, a CBD manufacturer from Eden, 
Idaho.  The CBD oil will be tested by Botanacor Laboratories (Denver, CO) for microbials, potency, heavy metals, trace 
THC, pesticides, and residual solvents to ensure purity, label accuracy, and safety; copies of laboratory reports will be 
maintained on premise.  Protocol B is a placebo matched on appearance to the treatment (i.e., avocado oil potentially 
colored with food coloring).  Both the CBD oil and placebo will be matched on taste (i.e., peppermint-flavored oil) 
prior to dispensing to each participant.  After consumption of the respective protocol drug, the participant will be 
given a standardized meal and will then wait for 120 minutes to allow for digestion and for CBD to begin taking effect; 
this time frame was chosen based on the pharmacodynamics of CBD along with the consideration of participant 
burden (max absorption 2-5 hours).44,124 Next, 
individuals will undergo a driving simulation and all 
participants will drive the same course. The simulator 
presents the individual with real life driving scenarios 
and is equipped with screens, a steering wheel, signals, 
and pedals (Figure 2).  The participant will be instructed 
to drive the course for 25-35 minutes (this includes a 
practice drive and brake reaction time (BRT)).  They will 
be instructed to follow normal driving rules, follow 
speed limits, and maintain constant speed and position 
within the lane, and brake when necessary.  The 
simulation will include highway, suburban, rural, and 
urban driving scenarios which will incorporate turns, 
changes in speed, and avoidance of cars/pedestrians; 
this course sequence and times were chosen to minimize simulator sickness.125  The simulator can monitor numerous 
aspects of drivers’ performance and collect the data which is then downloaded and analyzed.  Since we are 
investigating sedation and potential impairment, BRT, lateral position in the lane, lane departures, and collisions are 
the most telling performance measures. 79,80 After the simulation, participants will retake the VAMS, SSS, TMT, DSST, 

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PVT, SRT and complete an end of study questionnaire.  The questionnaire will inquire about acceptability and tests of 
blinding. 
 
Participant Compensation and Safety.  All individuals who complete the study will receive a $50 -gift card for their 
time and participation. All participants will be encouraged to report any adverse events (AE) to study staff during and 
after their participation in the study (i.e., up to 24 hours afterwards) and a physician (Dr. Haggerty) is available if 
needed. However, the half-life of consumed CBD is approximately 17 hours.44,124The PI will report AEs to the WVU 
Institutional Review Board (IRB).  All study personnel will have completed Human Subjects Training and the PI will 
obtain WVU IRB approval prior to study inception.  As part of the inclusion criteria of the study, participants will be 
required to have a friend take them home after testing or they must agree to be transported home by study staff.  We 
will also advise all study participants not to drive 24 hours post-testing for safety purposes. 
 
Data Collection, Management and Analysis.  All collected data will be entered by study staff into the secure, de-
identified database and maintained in accordance with WVU IRB and Information Technology.  All analyses will be 
performed in SAS (Cary, NC).  The variables to be collected and their source are summarized in Table 2.  Missing data 
will be multiply imputed to allow inclusion of all participants regardless of compliance.126-128 We will perform both an 
intent-to-treat analysis based on initial assignment and a protocol analysis, excluding those who fail to complete the 
study.129  Both between and within-group analyses will be conducted.  Demographic characteristics and driving habits 
will be compared between groups via descriptive statistics to ensure proper randomization; we will also investigate 
tests of blinding by comparing 
accuracy of group assignment 
(perceived group assignment 
will be asked on end of study 
survey). If differences are 
noted, models can be adjusted. 
For between group effects, the 
data will be compared using 
Student’s T-tests and/or ANOVA 
for continuous variables if the 
data are normally distributed; if 
non-normally distributed a 
Mann-Whitney test may be 
utilized.130  For within group 
effects, the data will be 
compared using paired 
Student’s T-tests (for normally 
distributed continuous paired 
observations ) or Wilcoxon 
signed-rank test (for those 
continuous paired observations 
not normally distributed).  We 
will perform a correlation using 
Pearson’s R test between the 
variables collected for Aims 1 
and 2, both between and within 
groups, to assess whether 
driving performance is 

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correlated with psychological or cognitive testing measures. Data will also be analyzed via sex as well. 
 
 
As one can see, there is minimal risk to participants.  There is no direct benefit to participants. However, there are 
potential benefits to society that offset the potential risks of this study, which are minimal.  The findings of this study 
will be extremely informative to the public, medical providers, policy makers, and public health practitioners.  
Cannabidiol is commonly used drug, yet its effects in healthy populations are virtually unknown.  Thus, the risk vs. 
benefit is reasonable. 
  
 
Target Population & Recruitment Methods  
Our sample size is 40 individuals.  We chose this number based on an a priori power analysis.   
 
Our inclusion and exclusions criteria are as follows: 1) the participant must be currently enrolled as a WVU student, 2) 
be 18-30 years of age at time of study, 3) have a current drivers’ license issued from any state in the United States, 4) 
has driven at least once in the past 30 days 5) is able to speak and read English, 6) is willing to be randomized and 
comply with study requirements including a urine drug test on the day they consent to participate in the experiment 
and complete a test drive to ensure the absence of  simulation sickness, 7) not currently taking any daily prescription 
medications other than birth control, 8) have not been diagnosed with any serious chronic disease by a licensed 
healthcare provider (including but not limited to Alzheimer’s and related dementias, Parkinson’s disease or other 
neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, 
arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and 
fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study 
staff after testing completion.  
 
 Participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including 
cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, 
lysergeic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed CBD in the past 7 days, or 4) is 
currently pregnant or lactating. The health conditions and substances noted above have all been associated with 
changes in driving ability or performance.   Also, limiting participants to those who are currently not using illegal 
drugs, tobacco products, and prescription medications may help minimize bias potentially caused by drug interactions 
with CBD or known impediments to driving performance from the medications themselves. 
  
Thus, we needed to specify the inclusion and exclusion criteria to avoid confounding.  We wanted a healthy 
population of drivers (i.e., not on medications nor without complex health conditions) to minimize confounding.  
Drivers older than 30 will probably be more likely to take medications and/or be diagnosed with a chronic condition.  
As long as a student meets the inclusion and exclusion criteria, they will be able to participate.  Thus, we will not limit 
anyone by gender or race.  As mentioned previously, we will recruit via flyers/posters and via emails to the student 
body.  All study advertisement will state that this is a research project conducted by the Department of Epidemiology, 
the PI’s contact information will be included along with the time commitment, inclusion/exclusion criteria, voluntary 
participation and that the WVU IRB approval is on file. 
 
 
 
Risk & Benefit 

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Risk –There is minimal risk to participants.  The first concern may be the small risk of a data breaches.  However, this 
should be minimal as participants will be assigned an identification/study number.  All other data will be stored on a 
secure virtual environment maintained by WVU’s Information Technology department that only study personnel will 
have access to.  A second minimal concern is momentary motion sickness from the driving simulator (e.g., simulator 
sickness); some individuals may report feeling brief nausea from the simulator.  It typically clears immediately when 
the simulation is stopped.  If participants experience this, the trial will stop immediately.  The third risk involves the 
CBD itself.  CBD comes from the Cannabis Sativa plant that must have <0.3% delta-9-tetrahydrocannabinol (THC) by 
federal law.  THC is the psychoactive component of Cannabis.  Thus, the CBD oil can contain very trace amounts of 
THC; thus, it is theoretically possible that an individual could test positive for THC/marijuana on an administered drug 
test.  The CBD oil obtained for this study will be obtained from Zatural, a CBD manufacturer from Eden, Idaho.  Zatural 
does attempt to remove THC from their product.  The CBD oil will be tested by Botanacor Laboratories (Denver, CO) 
for microbials, potency, heavy metals, trace THC, pesticides, and residual solvents to ensure purity, label accuracy, 
compliance, and safety.  Testing of the product has shown that it is free of microbials, heavy metals, pesticides, and 
residual solvents.  Potency tests have shown that the concentration of CBD is accurate and that THC and THCa (a 
chemical precursor of THC) were not detected by this test’s level of quantitation.  Trace THC tests, which have a very 
low level of quantitation (i.e., 0.001%), detected no THCa, and 0.006% THC, which is well below acceptable limits 
(legal limit is 0.3%).  Copies of laboratory reports will be maintained on premise.  There are additional minimal risks 
with the CBD itself.  Very little research exists on the effects of CBD even though it is a legal product.  The CBD used in 
this study is a nutraceutical and it is not regulated by the United States Food and Drug Administration.  The United 
States Food and Drug Administration does regulate Epidiolex, which is the prescription version of CBD oil prescribed 
to treat seizure disorders.  According to the package insert for Epidiolex (available at: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf) and the United States Food and Drug 
Administration website (available at: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-
what-were-working-find-out-about-products-containing-cannabis-or-cannabis), several side effects of prescription 
CBD oil have been noted and could potentially harm participants.  Prescription CBD oil can cause liver injury/hepatic 
dysfunction by elevating liver enzymes such as alanine aminotransferase [ALT] and/or aspartate aminotransferase 
[AST]).  Prescription CBD oil can interact with other drugs or alcohol the participant may be taking potentially resulting 
in serious side effects.  Mainly, using CBD oil with alcohol or other drugs, especially those used to treat anxiety, panic, 
stress, or sleep disorders, could slow brain activity, and increase the risk of sedation and/or drowsiness, which could 
lead to injury.  Prescription CBD oil has also been shown to impact the gastrointestinal tract with side effects such as 
decreased appetite, diarrhea, weight loss, gastroenteritis, and abdominal pain/discomfort.  Prescription CBD oil has 
also been shown to affect the nervous system and cause somnolence (drowsiness or sleepiness), lethargy, fatigue, 
malaise, insomnia, poor sleep quality, irritability, agitation, aggression, anger, drooling, or gait disturbances.  Anti-
epileptic drugs, such as prescription CBD oil, have been associated with suicidal behavior and/or suicide ideation.   
Prescription CBD oil has also caused hypersensitivity reactions, rashes, hypoxia, respiratory failure, and infection.  
Studies in animals exposed to CBD oil have also shown male reproductive toxicity, or damage to fertility in males or 
male off-spring of women who have been exposed to CBD oil.  For this study, we are using 300 mg of CBD which is a 
relatively small dose. This dosage was chosen as it has been used in other studies consisting of both healthy and 
clinical populations and is generally well-tolerated with no major adverse events; most studies use 150-600 mg, while 
some have used >1,200 mg. 46,51,52,54,55,59,121-123    
 
 
 
Benefit –There is no direct benefit to participants. However, there are potential benefits to society that offset the 
potential risks of this study, which are minimal.  The findings of this study will be extremely informative to the public, 
medical providers, policy makers, and public health practitioners.  Cannabidiol is commonly used nutraceutical, yet its 
effects in healthy populations are virtually unknown.  Thus, the risk vs. benefit is reasonable. 
 

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PI: Toni Marie Rudisill, MS, PhD 
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Statistical Analysis Plan 
All collected data will be 
entered by study staff into the 
secure, de-identified database 
and maintained in accordance 
with WVU IRB.  All analyses will 
be performed in SAS (Cary, NC).  
The primary outcome of this 
study will be driving 
performance, including number 
of lane departures, standard 
deviation of lateral position (i.e., 
weaving), mean brake reaction 
time, and number of collisions 
(Aim 1). Secondary outcomes 
will be pre-post changes in well-
validated measures of mental 
sedation (SSS, VAMS) and 
cognitive function (DSST, TMT, 
PVT, SRT) (Aim 2).  The variables 
that will be collected and their 
source are summarized in Table 
2.  Missing data will be multiply 
imputed to allow inclusion of all 
participants regardless of 
compliance.118-120  We will 
perform both an intent-to-treat 
analysis based on initial 
assignment and a protocol 
analysis, excluding those who fail to complete the study.121Both between and within-group analyses will be 
conducted.  Demographic characteristics will be compared between groups via descriptive statistics to ensure proper 
randomization; we will also investigate tests of blinding by comparing accuracy of group assignment (perceived group 
assignment will be asked on end of study survey).  For between group effects, the data will be compared using 
Student’s T-tests and/or ANOVA for continuous variables if the data are normally distributed; if non-normally 
distributed a Mann-Whitney test may be utilized.122  For within group effects, the data will be compared using paired 
Student’s T-tests (for continuous paired observations which are normally distributed) or Wilcoxon signed-rank test 
(for continuous paired observations which are not normally distributed).  We will perform a correlation using 
Pearson’s R test between the variables collected for Aims 1 and 2, both between and within groups, to assess whether 
driving performance is correlated with psychological or cognitive testing measures. Data will also be analyzed via sex. 
 
Sample Size – We conducted an analysis to ensure adequate sample size and power.  The analysis was based on mean 
reaction time, which is one of the primary outcomes between groups.  A total sample size of 26 students with a large 
effect size of 0.7 and α=0.05 using a two-sided, two-sample equal variance t-test achieves 80% power to reject the 
null hypothesis of equal means.131 Thus, our total sample size (N=40) should be more than adequate for this study. 
 
 
Data Safety Monitoring – A Data Safety Monitoring Board will not be appointed for this study unless required. 
 

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Safety Monitoring & Unanticipated Event Reporting 
Study personnel will ensure that potential study participants fully understand study procedures and requirements 
before signing the consent, stress that they are under no obligation to participate and refusal to enroll in the study 
will in no way affect their care or university standing, and that they are fully aware that they can withdraw from the 
study at any time. In addition, all participants and study team members will be encouraged to report any adverse 
events (AE). The PI will promptly report AEs to the Institutional Review Board according to protocol and Institutional 
Review Board policies; complete an AE form and grade the AE.  If any AE is considered serious and unexpected, the 
event must be reported to the IRB within 7 days from the time the study team receives knowledge of the event. 
Likewise, any unanticipated problems that occur will be reported to the Institutional Review Board within 7 days from 
the time the study team received knowledge of the event. Monitoring of this study will be performed by the PI 
through annual review. In addition, the PI and other key personnel, will review any adverse events as they may occur 
in each subject, both during testing and afterward. No significant AEs are anticipated but should any occur the event 
will be promptly reported to the Institutional Review Board. Any unanticipated or serious AE will require re-evaluation 
of the risk of the study. Study staff will contact all participants 8-12 hours post testing and approximately 24 hours 
post testing to ensure no AEs occurred.  We will advise all study participants not to drive 24 hours post-testing.  As 
part of the inclusion criteria of the study, participants will need to have a friend escort them home after testing or 
they must agree to being brought home by study staff.    Dr. Haggerty will also be available during testing incase issues 
arise during testing. 
 
 
Study Duration & Timeline 
The projected timeline of this study is below.  It should take 24 months to complete.   
 
C5.14. Projected Timeline (task and months to complete) 
TASK 
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 
1. Recruitment 
X X 
2. Conduct testing 
X X X X X X X X X X X X X X X X X 
3. Data management & analysis 
 
 
 
 
 
 
X X X X 
4. Manuscript preparation 
 
 
 
 
 
 
X X X X 
5. Dissemination 
 
 
 
 
 
 
X X 
 
Section III: Informed Consent Process 
 
Protected Health Information (PHI) 
There will be PHI collected from this study.  This will mainly come from the consent process.  We will obviously collect 
the person’s name on the consent form.  After this, they will be assigned a study identification number and everything 
else will be de-identified.  We will ask if they have any chronic medical conditions or take medication or illegal drugs.  
If they do, they can’t participate in the study.   
 
 
Informed Consent Process 
Dr. Rudisill or her designee will perform the written consent process, which will take place in her office which is 
private.  The Informed Consent Form (ICF) will be written in lay terms and at a 6th grade reading level.  All study 
participants will be 18 or over so assent will not be necessary.   

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Confidentiality & Privacy  
Confidentiality – All data collected will be kept for a minimum of 3 years after the conclusion of the research project.  
Physical copies of data collected will be locked in a drawer or file cabinet, within the PI’s locked office.  Digital data 
will be stored on an encrypted, password protected database located on a secure server maintained by WVU IT 
Department.  All participant identifiers will be stored separately from the data collected.  
 
Privacy – Data will be stored securely to protect the privacy of participants.  Only the minimum amount of data will be 
collected to ensure participant privacy.  The driving simulation and neurocognitive tests will occur in a quiet, secured 
office to maintain privacy.   
 
A Federal Certificate of Confidentiality will be obtained if necessary to further protect participants.   
 
 
Section IV: Other Considerations 
 
Conflict of Interest  
The PI and Co-Investigators have no conflicts of interest. 
 
Publications, Presentations, & References 
The PI will likely present the results of this study at one of the following conferences: Transportation Research Board, 
Society for the Advancement of Violence and Injury Prevention, American Public Health Association. 
 
The PI will likely publish the results of this study in one of the following journals: American Journal of Epidemiology, 
Injury Prevention 
 
 
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Key Information for: 
The effects of cannabidiol (CBD) on the driving ability of healthy adults  
 
You are being asked to participate in the research described below.  This page provides key information that 
may help you to make this decision; more detailed information can be found after this section.   
Why is this research being done and what is involved? 
The purpose of this study is to determine whether cannabidiol (CBD) impacts the driving ability, cognition, and 
drowsiness of healthy adults’ aged 18-30 years.  You will be asked to answer several questions about your 
current health and provide a urine sample which will be analyzed immediately on site for any drugs which may 
influence your performance.  If you meet the study criteria and your urine sample is negative, you will then be 
asked to complete a practice drive on a driving simulator for about 10 minutes.  The driving simulator is set up 
to mimic a car—it has breaks, an accelerator, controls, and steering wheel, along with a computer screen.  You 
will be asked to drive a course on the simulator and follow the rules of the road (i.e., follow speed limits, use 
turn signals, obey traffic control devices, etc.).  You will then complete a brief survey inquiring about your 
driving habits and health history including body mass index where you may need to be weighed.  You will then 
complete 5 brief cognitive tests using a computer tablet and pen/paper.  You will then be randomized to receive 
either CBD or placebo and given food and a beverage to drink.  You will then wait 120 minutes where you are 
free to relax, read, play on the internet, etc.  You will then complete a longer driving simulation (~25-35 
minutes).  After the second simulation, you will retake the 5 computer or pen/paper tests and an end of study 
survey. These activities will take approximately 4-4.5 hours of your time. 
Do I have to participate and what are the risks involved?  
Participation in this research study is completely voluntary and you are free to withdraw from the research at 
any time.  If you do not wish to participate, please discuss alternatives with the researcher or refer to the 
“Alternatives” section in the consent form.  You may or may not directly benefit from participating in this 
research. 
Risks from participation in this study include side effects from the CBD which could include liver injury, 
gastrointestinal changes, mood disturbances (i.e. drowsiness, sedation, anger, agitation), sleep disturbances, 
hypersensitivity reactions, and male reproductive toxicity.  You could also potentially experience mild nausea 
or dizziness from the driving simulator.  Also, we will be collecting health and driving information, which some 
may find invasive.   
Who can I talk to if I have questions or concerns? 
If you have any questions or concerns about this research or would want to withdrawal from the study, you can 
contact Dr. Toni Marie Rudisill at 717-817-3028 from the Dept. of Epidemiology at West Virginia University. 
 
For more information, please see the Informed Consent Form 

 
 
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Informed Consent for Research | Minimal Risk  
 
Principal Investigator (PI) | 
Toni Marie Rudisill, MS, PhD 
Department | 
Epidemiology 
Co-Investigator(s) | 
Drs. Gordon Smith, Karen (Kim) Innes, Sijin Wen, Treah Haggerty   
Sponsor or Funding Source | 
West Virginia Clinical and Translational Science Institute 
WVU IRB Protocol # | 
2007073792 
Study Title | 
The effects of cannabidiol (CBD) on the driving ability of healthy adults: a clinical trial 
 
Introduction 
You, _________________________, have been asked to participate in this research study, which has been 
explained to you by _________________________.  This study is being conducted by Dr. Toni Marie Rudisill, MS, 
PhD in the Department of Epidemiology at West Virginia University, along with Drs. Gordon Smith, MB ChB, 
MPH, Karen (Kim) Innes, PhD, MSPH, Sijin Wen MA, MS, PhD, and Treah Haggerty, MD, MS.  Funding for this 
research is provided by the West Virginia Clinical and Translational Science Institute.   
Purpose 
The purpose of this study is to determine whether CBD impacts healthy adults’ aged 18-30 years ability to drive and 
whether CBD impacts their cognition and/or makes them drowsy.  WVU expects to enroll approximately 40 
subjects at the WVU campus.   A total of approximately 40 subjects, at all sites, are expected to participate in this 
study.  
Description of Procedures 
This study involves a urine drug screen, 3 brief surveys, 5 cognitive tests (to be taken twice), and two short drives 
on the driving simulator (~10 and 25-35 minutes) and will take approximately 4-4.5 hours of time in one visit in 
total to complete.   
First, you will be asked to answer several questions about your current health status (i.e., first survey).  This is done 
to ensure you meet the study requirements.   You are able to see these questions prior to signing the consent form. 
You do not need to answer each question. 
Second, you will provide a urine sample which will be analyzed immediately on site for drugs that may impair 
driving performance and/or cognition.  This is done to ensure that any drugs you may have taken will not influence 
your performance on the activities you are asked to perform.   
If you meet the study criteria and your urine sample is negative for potentially impairing drugs, you will then be 
asked to complete a practice drive on the driving simulator for approximately 10 minutes.  People who are prone to 
motion sickness sometimes experience brief mild nausea or dizziness when operating a driving simulator, which is 
known as simulator sickness.  This practice drive helps ensure that you do not experience simulator sickness and 
can complete the study requirements.  The practice drive will also familiarize you with the equipment.  The driving 
simulator is set up to mimic a car—it has breaks, an accelerator, controls, and steering wheel, along with a computer 

 
 
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screen.  You will be asked to drive a course on the simulator and follow the rules of the road (i.e., follow speed 
limits, use turn signals, obey traffic control devices, etc.). 
If you do not experience simulator sickness on the practice drive, you will then complete a brief survey inquiring 
about your driving habits and health history (second survey).  This survey will also ask you about your height and 
weight so you may need to be weighed.  You are able to see these questions prior to signing the consent form. You 
do not need to answer each question. 
You will then complete 5 cognitive tests using a computer tablet and pen/paper: the Sanford Sleepiness Scale (SSS), 
the Visual Analog Mood Scale (VAMS), Digital Symbol Substitution Test (DSST), Trail Making Test (TMT), 
Simple Reaction Time (SRT), and Psychomotor Vigilance Test (PVT).  These are done to gather your baseline 
cognitive function.  The first test is the SSS, which is one multiple choice question regarding your current level of 
sleepiness.  The second test is the VAMS which assesses mood, mental and physical sedation; this test is 16 
multiple choice questions in length.  The DSST and TMT are tests administered by paper and pencil.  The DSST 
measures psychomotor speed, attention and working memory by requiring participants to translate numbers into 
symbols; the test is scored by the degree of completion and accuracy over a timed 90 second period.  The TMT 
measures executive function and consists of two parts; the first part requires participants to connect numbers in 
ascending order, while the second part requires individuals to connect numbers and letters in sequence.  The test is 
scored by the time it takes to accurately complete each test.  Increases in time correlate with greater impairment.  
The SRT will be administered on a computer tablet and it measures reaction time, general alertness, and motor 
speed through delivery of a stimulus. During the test, a specific object will randomly appear on the tablet screen and 
a participant will have to select a button to acknowledge their response. The program will record response time to 
the stimulus, correct responses, as well as errors of omission. The PVT will be administered on a computer tablet 
and it will assess alertness and vigilance. The participants will have to respond to an object on the screen as quickly 
and accurately as possible.  The program will record response time to the stimulus, correct responses, errors of 
omission, and false starts. 
After completing the cognitive testing, you will be randomized to receive CBD oil or placebo.  You will then be 
given food and a beverage to drink. You will then wait 120 minutes where you are free to relax, read, play on the 
internet, etc.  This will allow the CBD to be absorbed in your system and/or take effect. 
You will then complete a longer driving simulation (25-35 minutes).  This time frame includes a practice drive and 
brake reaction time assessment.  The second driving simulation will be similar to the first, but will be longer in 
length.  You will be asked to drive a course on the simulator and follow the rules of the road (i.e., follow speed 
limits, use turn signals, obey traffic control devices, etc.), avoid objects, and pass slower vehicles/objects.  The 
second simulation is scored and will assess your driving performance. 
After the second simulation, you will retake the 5 computer or pen/paper tests (i.e., SSS, VAMS, DSST, PVT, SRT, 
TMT).  This is to assess your cognitive function after you may have received CBD.   
Finally, you will complete a brief end of study survey (third survey). This is to gauge you thoughts on the study and 
see if you can identify what study drug you received (i.e., placebo or CBD).  You are able to see these questions 
prior to signing the consent form. You do not need to answer each question. 
All these activities, in total, will take approximately 4-4.5 hours of your time and will be completed in one day. 
For patient safety purposes, Dr. Treah Haggerty, MD, MS (Co-Investigator) is a licensed family medicine physician 
in WV and will be available during testing and up to 24 hours post testing for study participants to consult with 
should they have any medical questions or health concerns regarding this research study.  You must first call Dr. 
Toni Marie Rudisill at 717-817-3028 who will then connect you with Dr. Haggerty.  While CBD has a half-life of 
17 hours, we ask that you refrain from driving for 24 hours post-testing.  We also require that you have an 

 
 
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individual take you home after the testing is completed.  If you do not have an individual available, you will be 
taken home by study personnel. 
Risks and Discomforts 
There are some potential risks and discomforts that you could experience if you choose to participate in this study.  
The first concern may be the small risk of a data breach.  However, this should be minimal as participants will be 
assigned a study identification number.  All other data will be stored on a secure virtual environment maintained by 
WVU’s Information Technology department that only study personnel will have access to.  A second minimal 
concern is momentary motion sickness from the driving simulator (e.g., simulator sickness); some individuals who 
are prone to motion sickness may report feeling brief nausea or dizziness from the simulator.  It generally clears 
when the simulation is stopped.  If participants experience this, the trial will stop immediately.  The third risk 
involves the CBD itself.  CBD comes from the Cannabis Sativa plant that must have <0.3% delta-9-
tetrahydrocannabinol (THC) by federal law.  THC is the psychoactive component of Cannabis.  Thus, the CBD oil 
can contain very trace amounts of THC; thus, it is theoretically possible that an individual could test positive for 
THC/marijuana on an administered drug test.  The CBD oil obtained for this study was obtained from Zatural, a 
CBD manufacturer from Eden, Idaho.  Zatural does attempt to remove THC from their product.  The CBD oil has 
been tested by Botanacor Laboratories (Denver, CO) for microbials, potency, heavy metals, trace THC, pesticides, 
and residual solvents to ensure purity, label accuracy, compliance, and safety.  Testing of the product has shown 
that it is free of microbials, heavy metals, pesticides, and residual solvents.  Potency tests have shown that the 
concentration of CBD is accurate and that THC and THCa (a chemical precursor of THC) were not detected by this 
test’s level of quantitation.  Trace THC tests, which have a very low level of quantitation (i.e., 0.001%), detected no 
THCa, and 0.006% THC, which is well below acceptable limits (legal limit is 0.3%).  Copies of laboratory reports 
are available for your review.  There are additional minimal risks with the CBD itself.  Very little research exists on 
the effects of CBD even though it is a legal product.  CBD may increase ocular pressure; thus, you will be excluded 
from the study if you have glaucoma.  The CBD used in this study is a nutraceutical and it is not regulated by the 
United States Food and Drug Administration.  The United States Food and Drug Administration does regulate 
Epidiolex, which is the prescription version of CBD oil prescribed to treat seizure disorders.  According to the 
package insert for Epidiolex (available at: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf) and the United States Food and Drug 
Administration website (available at: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-
what-were-working-find-out-about-products-containing-cannabis-or-cannabis), several side effects of prescription 
CBD oil have been noted and could potentially harm participants.  Prescription CBD oil can cause liver 
injury/hepatic dysfunction by elevating liver enzymes such as alanine aminotransferase [ALT] and/or aspartate 
aminotransferase [AST]).  Prescription CBD oil can interact with other drugs or alcohol the participant may be 
taking potentially resulting in serious side effects.  Mainly, using CBD oil with alcohol or other drugs, especially 
those used to treat anxiety, panic, stress, or sleep disorders, could slow brain activity, and increase the risk of 
sedation and/or drowsiness, which could lead to injury.  Prescription CBD oil has also been shown to impact the 
gastrointestinal tract with side effects such as decreased appetite, diarrhea, weight loss, gastroenteritis, and 
abdominal pain/discomfort.  Prescription CBD oil has also been shown to affect the nervous system and cause 
somnolence (drowsiness or sleepiness), lethargy, fatigue, malaise, insomnia, poor sleep quality, irritability, 
agitation, aggression, anger, drooling, or gait disturbances.  Anti-epileptic drugs, such as prescription CBD oil, have 
been associated with suicidal behavior and/or suicide ideation.   Prescription CBD oil has also caused 
hypersensitivity reactions, rashes, hypoxia, respiratory failure, and infection.  Studies in animals exposed to CBD 
oil have also shown male reproductive toxicity, or damage to fertility in males or male off-spring of women who 
have been exposed to CBD oil.  For this study, we are using 300 mg of CBD which is a relatively small dose. This 
dosage was chosen as it has been used in other studies consisting of both healthy and clinical populations and is 
generally well-tolerated with no major adverse events; most studies use 150-600 mg, while some have used >1,200 

 
 
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mg.  We strongly advise that you do not operate a motor vehicle/drive for 24 hours after your participation in this 
study.  Lastly, we will also be asking you about your driving and health history such as whether you have any 
chronic illnesses, number of motor vehicle collisions, number of speeding tickets, whether you use seat belts when 
you drive, etc.  While most participants will find these questions non-invasive, should you need counseling as a 
result, we encourage you to contact the WVU Carruth Center at 304-293-4431.   
In addition, there is always the risk of uncommon or previously unknown side effect(s) or event.   
Alternatives   
You do not have to participate in this study.   
Benefits 
You may or may not directly benefit from participating in this research.  The knowledge gained from this study may 
eventually benefit others. 
Financial Considerations 
You will be paid a $50 gift card for completing this study.  You can earn up to $50.   
Your information may be provided to the appropriate parties for billing and/or payment purposes.  Please be advised 
that any compensation received for participation in a research study, including a gift card, is considered taxable 
income, and must be reported to the Internal Revenue Service (IRS). 
If you are a WVU employee or a WVU student-employee, you are required to report the total amount of 
compensation received for your participation in a research study to the WVU Tax Services Office upon receipt of 
payment. 
Your data, health information, research results, specimens, or any and all other information related to this research 
study used in this research study may contribute to a new discovery or treatment.  In some instances, your data, your 
health information, your research results, your specimens, these discoveries or treatments, or any other information 
related to this research study, even if identifiers are removed, may be of commercial value and may be sold, 
patented, or licensed by the investigators and West Virginia University for use in other research or the development 
of new products.  You will not retain any property rights, nor will you share in any money or commercial profit that 
the investigators, West Virginia University, or their agents may realize.   
Confidentiality 
Any information about you that is obtained as a result of your participation in this research will be kept as 
confidential as legally possible.  Your research records and test results, just like hospital records, may be 
subpoenaed by court order or may be inspected by the study sponsor or federal regulatory authorities, including the 
Food and Drug Administration (FDA), without your additional consent. 
In addition, there are certain instances where the researcher is legally required to give information to the appropriate 
authorities.  These would include mandatory reporting of infectious diseases, mandatory reporting of information 
about behavior that is imminently dangerous to you or to others, such as suicide, child abuse, etc. 
In any publications that result from this research, neither your name nor any information from which you might be 
identified will be published without your consent. 
Participant’s information or biospecimen collected as part of the research, even if identifiers are removed, will not 
be used, or distributed for future research studies. 

 
 
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ClinicalTrials.gov  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This 
Web site will not include information that can identify you.  At most, the Web site will include a summary of the 
results.  You can search this Web site at any time.   
HIPAA Authorization  
We know that information about your health is private. We are dedicated to protecting the privacy of that 
information. Because of this promise, we must get your written authorization (permission) before we may use or 
disclose your protected health information or share it with others. 
You can decide to sign or not to sign this authorization section. However, if you choose not to sign this 
authorization, you will not be able to take part in the research study. Whatever choice you make about this research 
study will not have an effect on your access to medical care. 
Persons/Organizations Providing the Information 
Patient /West Virginia University Hospitals/ WVU Medicine 
Persons/Organizations Receiving the Information 
• 
The research site(s) carrying out this study.  This includes UHA or UHA Affiliates, WVU, WVU Hospitals, 
West Virginia University Health System (WVUHS).  It also includes each site’s research and medical staff. 
• 
Health care providers who provide services to you as part of this research study. 
• 
Laboratories and other people and groups that look into your health information as part of this study in 
agreement with the study protocol.  
• 
The members and staff of any institutional review board that oversees this research study. 
• 
The West Virginia University Office of Human Research Protection and the West Virginia University 
Office of Sponsored Programs. 
 
The Following Information Will Be Used  
Information from your existing medical records, and new information about you that is created or collected during 
this study, such as: laboratory results, demographic data, and study forms.  
The Information is Being Disclosed for the Following Reasons 
• 
Review of your data for quality assurance purposes 
• 
Publication of study results (without identifying you) 
• 
Other research purposes such as reviewing the safety or effectiveness of the study drug and other products 
or therapies; conducting performance reviews of the study drug; evaluating other products or therapies for 
patients; developing a better understanding of disease; improving the design of future clinical trials. 
You may Cancel this Authorization at Any Time by Writing to the Principal Investigator 
Dr. Toni Marie Rudisill 
West Virginia University School of Public Health 
PO BOX 9190 
Morgantown, WV 26506 
 

 
 
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If you cancel this authorization, any information that was collected already for this study cannot be withdrawn. 
Once information is disclosed, according to this authorization, the recipient may re-disclose it and then the 
information may no longer be protected by federal regulations. 
This authorization will expire at the end of the study unless you cancel it before that time. 
Voluntary Participation 
Participation in this study is voluntary.  You are free to withdraw your consent to participate in this study at any 
time.  If you choose to withdraw your participation from the study, the data collected on you up until that time 
remains a part of the study database and may not be removed.  No additional information will be added to the study 
database after your withdrawal.   
Refusal to participate or withdraw will not affect your class standing or grades and will involve no penalty to you. 
Refusal to participate or withdraw will not affect your employee status at West Virginia University.  Refusal to 
participate or withdraw will not affect your future care or status at West Virginia University.  
In the event new information becomes available that may affect your willingness to participate in this study, this 
information will be given to you so that you can make an informed decision about whether or not to continue your 
participation.  Individual research results will not be disclosed to subjects.   
Contact Persons 
If you have any questions, concerns, or complaints about this research, you can contact Dr. Toni Marie Rudisill at 
717-817-3028.   
If you are hurt from being in this research, you should contact Dr. Toni Marie Rudisill at 717-817-3028.  If injury 
occurs outside of business hours and is related to your participation in this research, please contact Dr. Toni Marie 
Rudisill at 717-817-3028.   
For information regarding your rights as a participant in research or to talk about the research, contact the WVU 
Office of Human Research Protection (OHRP) at (304) 293-7073 or by email at IRB@mail.wvu.edu.   
Future Contact  
Future research may be conducted for which you are eligible.  If you are interested in being contacted for future 
research, please indicate so by completing this section. 
☐  Yes, I want to be contacted if future research studies, for which I am qualified, become available. 
☐  No, I do not want to be contacted if future research studies, for which I am qualified. 
Signatures and Authorization  
You have been given the opportunity to ask questions about the research and your authorization of HIPAA, and you 
have received answers concerning areas you did not understand.  Upon signing this form, you will receive a copy. 

 
 
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Participant Signature 
I willingly consent to participate in this research. 
 
Signature of Subject or Subject’s Legal Representative 
 
 
Printed Name 
 
Date 
 
 
Consenting Individual Signature 
The participant has had the opportunity to have questions addressed.  The participant willingly agrees to be in the 
study. 
 
Signature of Person Obtaining Informed Consent 
 
 
Printed Name 
 
Date