Clinical trial NCT03699540
Conditions: Cannabis Cannabis Use Marijuana Marijuana Usage Alcohol Drinking
Keywords: simulated driving, outpatient
Sponsor: Shanna Babalonis, PhD
Start date: 2019-07-01; Completion date: 2023-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Detailed description:

Arms: arm 1: Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions arm 2: Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions arm 3: Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions arm 4: Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
Interventions: intervention 1: Marijuana intervention 2: Alcohol intervention 3: placebo alcohol intervention 4: Inactive marijuana
Intervention descriptions: intervention 1: Experimental, non-therapeutic administration of active marijuana dose(s) intervention 2: Experimental, non-therapeutic administration of active alcohol dose(s) intervention 3: Experimental, non-therapeutic administration of inactive alcohol dose(s) intervention 4: Experimental, non-therapeutic administration of inactive marijuana dose(s)

Protocol documents:
SAP_002.pdf: 
 
Study Title: Marijuana Effects on Simulated Driving Performance    
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
IRB 12/26/23 
NCT Number: 
NCT03699540 
IRB Number 
43636 
Coversheet created: 
4/29/24 
 
 
 
 


Marijuana Effects on Simulated Driving Performance 
Protocol Number: 43636 
 
 
Statistical Analysis Plan  
All analyses will be conducted using SAS Version 9.3 or higher (SAS Institute, Inc; 
Cary, NC, USA), and all hypothesis testing will be two-sided with a significance level of 
0.05. P-values will be presented with 3 decimals and p-values that are less than 0.001 
will be represented as <0.001. 
Continuous data will be summarized using descriptive statistics: number of observations 
(n), arithmetic mean, standard error, minimum, and maximum. Frequencies and 
percentages will be used to summarize categorical (discrete) outcomes. Means and 
standard errors will be presented to two decimal places.  
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics will be summarized; no statistical 
comparisons will be made on demographic or baseline characteristics. The 
demographic and baseline characteristics will consist of age, sex, race, ethnicity, height 
(cm), weight (kg), and BMI (kg/m2).  
Continuous variables (age, height, weight, BMI) will be summarized by n, mean, 
standard deviation, min, median, and max. Frequencies and percentages will be used to 
describe categorical (discrete) variables including gender, race, and ethnicity. 
Analysis of Primary Outcomes 
The primary Emax for Standard Deviation in Lane Position (SDLP: amount of 
weaving/swerving of the car in and out of the lane) and will be analyzed in a mixed 
model including the nine drug conditions with a compound symmetry covariance 
structure. Within each model, subject will be treated as random effects, and the 
remaining parameter as fixed effects. Mixed models are suited for data with repeated 
measures, correlations among observations within an individual subject, and the 
presence of missing data. The response of individual subjects is first modeled, and then 
the estimates for each individual are combined in a group analysis (Singer, 1998; 
Ballinger 2004; Diggle et al. 1996; Gibbons et al. 1993; Kreft and De Leeuw 1998). 
Tukey post-hoc tests will compare active doses to placebo and other relevant active 
dose comparisons.  
Analysis of Secondary Outcomes 
Secondary outcomes will include: 
 Raw time course data on driving performance (e.g., SDLP, number of lane 
changes, speed, number of collisions), driving VAS (e.g., driving difficult, drive 


safely), drug VAS items (e.g., High, Good Drug Effects, Bad Drug Effects), 
subjective alcohol adjectives, mood scale, street value, observer adjectives, 
DSST, circular lights, heart rate, systolic blood pressure, diastolic blood pressure, 
respiration rate, and oxygen saturation from the nine dose conditions. 
 Emax and Emin (where appropriate) on driving performance, drug VAS items, 
subjective alcohol adjectives, mood scale, street value, observer adjectives, 
DSST, circular lights, heart rate, systolic blood pressure, diastolic blood pressure, 
respiration rate, and oxygen saturation from the nine dose conditions. 
 Secondary analyses will be completed in mixed models that include drug condition and 
time (when appropriate with an autoregressive covariance structure) with a compound 
symmetry covariance structure. Subject will be treated as random effects and the 
remaining parameters fixed. Tukey post-hoc tests will compare active doses to placebo 
and other relevant active dose comparisons. 
 
Safety and Tolerability Analyses 
Adverse events (AEs) recorded after signing informed consent but prior to the first dose 
will be recorded as baseline AEs and will be listed by subject but will not be included in 
the summary safety analysis. AEs will be summarized by relationship to study drug and 
severity. 
Missing Data 
Within-session missing data are expected to be less than 3% for each outcome. 
Inspection of missing data and correlates of missingness will be examined upon study 
completion. The use of mixed models as an analytic strategy obviates the need for the 
missing values to be imputed. 
Identification and Summary of Protocol Deviations 
Major protocol deviations from the participant¶s entry criteria through study completion 
will be documented and summarized as far as they can be extracted from the numeric 
and coded study data. 
References: 
Ballinger GA (2004) Using generalized estimating equations for longitudinal data analysis. 
Organizational Research Methods 7(2): 127-150. 
Diggle PJ, Liang K, Zeger SL (1996) Analysis of Longitudinal Data. Oxford University Press, Inc., 
Oxford University Press, Inc. 
Gibbons RD, Hedeker D, Elkin I, Waternaux C, Kraemer HC, Greenhouse JB, Shea MT, Imber 
SD, Sotsky SM, Watkins JT (1993) Some conceptual and statistical issues in analysis of longitudinal 
psychiatric data. Application to the NIMH treatment of Depression Collaborative Research Program 
dataset. Arch Gen Psychiatry 50: 739-50. 
Kreft I, De Leeuw J (1998) Introducing Multilevel Modeling. Sage Publications, Ltd., Sage 
Publications, Ltd. 
Singer JD (1998) Using SAS PROC MIXED to fit multilevel models, hierarchical models, and 
individual growth models. J Educ Behav Stat 24: 323-355. 

Prot_ICF_001.pdf: 
Document Coversheet 
 
Study Title: Marijuana Effects on Simulated Driving Performance    
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
IRB 12/26/23 
NCT Number: 
NCT03699540 
IRB Number 
43636 
Coversheet created: 
4/29/24 
 
 


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Section 8 Page 4 of 4
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Section 10 Page 1 of 12
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Section 10 Page 6 of 12
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Section 12 Page 2 of 2
43636


 
Combined Consent and Authorization to Participate in a Research Study 
KEY INFORMATION FOR 
 
MEDICAL & ELIGIBILITY SCREENING: 
 
MARIJUANA AND ALCOHOL EFFECTS ON SIMULATED DRIVING PERFORMANCE 
 
You are being invited to take part in medical and screening procedures to determine if you are eligible to take part 
in a research study about the effects of marijuana and alcohol on simulated driving performance. 
 
 
 
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THIS STUDY? 
 
The purpose of this screening is to conduct an interview, screening questionnaires and a medical examination that will 
help us find out if you qualify for study participation. There are approximately 3 screening visits that last about 4 hours 
each. 
 
The purpose of the main study is to learn more about the influence of marijuana and alcohol on simulated driving 
performance. If you qualify, you will be invited to participate in a study where you will receive marijuana and 
alcohol under supervision. If you participate and pass the screening, the study will be described further in another 
consent form. 
 
 
 
WHAT ARE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
 
You may choose to volunteer for this study to earn extra money. However, there are no other direct benefits to you 
for taking part in this study. Your willingness to take part may help us understand how alcohol and marijuana affect 
driving performance. 
 
 
 
WHAT ARE REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
You may not have the time necessary to screen for the study or participate (participation requires at least one 
full 9 hr day per week) – please let us know if this is a concern. 
 
 
 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer. 
 
 
 
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
The person in charge of this study is Shanna Babalonis, Ph.D. of the University of Kentucky, Department of 
Behavioral Science and Center on Drug and Alcohol Research. If you have questions, suggestions, or 
concerns regarding this study or you want to withdraw from the study her contact information is: (859) 257- 
1881. 
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact 
staff in the University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8am 
and 5pm EST, Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
 
 
 
 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
Page 1 of 6 
IRB Approval
4/25/2022
IRB # 43636
IRB2


Page 2 of 6 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
DETAILED CONSENT: 
 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
 
If you are under the age of 21 years of age or older than 50 years of age, you will not be allowed to take part in this 
screening. If you are seeking treatment for drug abuse, you should not take part in this study; please tell us now and we 
will help you find treatment. 
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST? 
 
The research procedures will be conducted at the Robert Straus Behavioral Research Facility and/or the Center for 
Clinical and Translational Science (CCTS), a research unit located in the University of Kentucky Hospital. The intake 
interview and physical examination should last about 3 to 4 hours. The entire screening will require more than one visit. 
The number of screening visits will range from approximately 1-4 visits. 
 
WHAT WILL YOU BE ASKED TO DO? 
 
If you agree to be screened, we will ask you to take part in an interview/complete screening materials to see if you qualify 
for this study. You can stop the visit anytime you want. Completion of the interview/screening materials will take 
approximately 3-4 hrs per visit. You will be asked about the following: 
 
x Your past and present personal life and problems 
x Your alcohol and drug use 
x Your mood and behavior 
x Your health and family health (including medical and psychiatric history) 
x Legal history and problems 
x Living conditions 
x Driving status and experience 
x You will be asked to give urine and breath samples when a staff member is watching. These samples will be 
tested for drugs and alcohol. 
x The names, addresses and phone numbers of people (such as a parent, spouse or close friend) that we can 
contact in case of an emergency or if we cannot find you to conduct a future interview. 
x You will also have a medical exam, psychiatric evaluation and complete questionnaires 
x You will have a physical exam, an ECG (electrodes applied to your chest) and a small amount of blood and urine 
taken for testing. 
x Women will also be required to have a pregnancy test. 
x We will also ask your permission to review your prescription medication history (KASPER report) and 
medical records from health care visits. 
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
There is a risk that discussing some of the topics covered in the interview might be upsetting. As noted above, you are 
free to stop the interview at any time. There is a risk that someone other than the study team could see your personal 
information; we will try very hard to make sure that no one gets your personal information. 
 
During the screening process, we will draw your blood and conduct an ECG. There are risks related to drawing blood. 
These include soreness, bruising, pain, infection, possible fainting and bleeding. It is possible that we may have to try 
more than once to draw blood. An ECG is painless; however, the electrodes may feel cold when first applied. In rare 
cases, some people may develop a rash or irritation where the patches were placed. 
 
In addition to the risks listed above, you may experience a previously unknown risk or side effect. 
43636


Page 3 of 6 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
You will not get any personal benefit from taking part in this screening. The only benefit that you may receive is a free 
medical exam. 
 
WHAT WILL IT COST YOU TO PARTICIPATE? 
The screening procedures will be provided at no cost to you. 
 
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
We will make every effort to keep confidential all research records that identify you to the extent allowed by law. 
Your information will be combined with information from other people taking part in the study. When we write 
about the study to share it with other researchers, we will write about the combined information we have gathered. 
You will not be personally identified in these written materials. We may publish the results of this study; however, 
we will keep your name and other identifying information private. We will collect your social security number; this 
is required in order for you to participate. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is. Your name will be kept separate from the information that you give, and 
these two things will be stored in different places under lock and key. Information collected electronically will be 
stored on password-protected computers. 
 
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of 
Health. With this Certificate, the researchers may not disclose or use information, documents, or biospecimens 
that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or 
proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this 
use. The researchers will use the Certificate to resist any demands for information that would identify you, except 
as explained below. You should understand that a Certificate of Confidentiality does not prevent you or a member 
of your family from voluntarily releasing information about yourself or your involvement in this research. If an 
insurer, employer, or other person obtains your written consent to receive research information, then the 
researchers may not use the Certificate to withhold that information. 
 
You should know that there are some circumstances in which we may have to show your information to other 
people. For example, the law may require us to show your information to a court or to tell authorities if you report 
information about a child being abused or if you pose a danger to yourself or someone else. The Certificate of 
Confidentiality does not prevent the researchers from disclosing voluntarily, without your consent, information that 
would identify you as a participant in the research project under certain circumstances including: abuse or 
neglect, harm to self or others, or diagnosis of certain communicable diseases (including but not limited to, 
hepatitis C, HIV, or tuberculosis), which will be reported to the State Health Department along with your full name 
as required by law. 
 
Officials of the Food and Drug Administration, National Institutes of Health, and the University of Kentucky may 
look at or copy pertinent portions of records that identify you. 
 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. 
The investigators conducting the study may need to remove you from the study. This may occur for a number of 
reasons. You may be removed from the study if: 
x 
you are not able to follow the directions, 
x 
they find that your participation in the study is more risk than benefit to you, or 
x 
the agency paying for the study chooses to stop the study early for a number of scientific reasons. 
 
If you stop the study because of side effects from the medication or another health-related reason, we will follow-up with 
you by telephone or request that you come visit us so we can see how you are doing. 
43636


Page 4 of 6 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is important to let the 
investigator know if you are in another research study. You should discuss this with the investigator before you 
agree to participate in another research study while you are in this study. 
 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is done during the study, you should call Michelle 
Lofwall, M.D. (859) 323-9321. Dr. Lofwall will determine what type of treatment, if any, is best for you at that time. 
 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the cost of 
any care or treatment that might be necessary because you get hurt or sick while taking part in this study. That cost will 
be your responsibility. Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this 
study. The medical costs related to your care and treatment because of research related harm will be your responsibility. 
 
You do not give up your legal rights by signing this form. 
 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will receive payment for your participation. You will receive $50 for each screening visit. If your screening is 
completed but you need to come back in only to give a urine sample for additional drug testing or for an ECG, you will 
receive $15 each time. 
 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION TO 
PARTICIPATE? 
You will be informed if the investigators learn new information that could change your mind about staying in the 
study. You may be asked to sign a new informed consent form if the information is provided to you after you have 
joined the study. 
 
 
WHAT ELSE DO YOU NEED TO KNOW? 
There is a possibility that data/tissue/specimens/blood collected from you may be shared with other investigators in the 
future. If that is the case, the data/tissue/specimen/blood will not contain information that can identify you unless you give 
your consent/authorization or the UK Institutional Review Board (IRB) approves the research. The IRB is a committee that 
reviews ethical issues, according to federal, state and local regulations on research with human subjects, to make sure 
the study complies with these before approval of a research study is issued. 
 
This study is funded by the National Institute of Health/National Institute on Drug Abuse. 
 
A description of this clinical trial will be available on www.ClinicalTrials.gov as required by U.S. Law. This website 
will not include information that can identify you. At most, the website will include a summary of the results. You 
can search this website at any time. 
 
POTENTIAL FUTURE CONTACT 
Do you give your permission to be contacted in the future by staff of the UK Center on Drug and Alcohol 
Research regarding your willingness to participate in future research studies? 
 
Ƒ Yes 
 No 
  
Initials 
43636


Page 5 of 6 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION 
 
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information. 
Your health information that may be accessed, used and/or released includes: 
Demographic information, social security number, results of physical exams, blood tests, and urine test results. 
 
 
The Researchers may use and share your health information with: 
x 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity;
x 
Law enforcement agencies (only when required by law)
x 
University of Kentucky representatives;
x 
UK Hospital
x 
The National Institutes of Health and/or its divisions
x 
The Investigational Drug Service (IDS) at the University of Kentucky
x 
Food and Drug Administration
x 
Center for Clinical and Translational Science (CCTS)
If you are a woman and you become pregnant anytime during the study or within 30 days after discharging from 
the study, you must inform Dr. Lofwall or Dr. Babalonis – they must then report the outcome of your pregnancy to 
the Sponsor (and/or the FDA). 
 
The researchers agree to only share your health information with the people listed in this document. 
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health information would 
still be regulated by applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
x 
Current or future healthcare at the University of Kentucky;
x 
Current or future payments to the University of Kentucky;
x 
Ability to enroll in any health plans (if applicable); or
x 
Eligibility for benefits (if applicable).
 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization: 
x 
You will send a written letter to Dr. Babalonis to inform her of your decision. Her address is: 
Shanna Babalonis, Ph.D.
845 Angliana Avenue 
Lexington, KY, 40508 
x 
Researchers may use and release your health information already collected for this research study.
x 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event).
x 
You may not be allowed to participate in the study.
 
The use and sharing of your information has no time limit. 
 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184. 
43636


Page 6 of 6 
Marijuana Driving Study – Screening Consent – Babalonis – V7.0 
 
Signature of research participant 
Date 
Printed name of research participant 
Printed name of person obtaining informed consent/ 
HIPAA authorization 
Date 
Signature of Principal Investigator 
or Sub/Co-Investigator 
INFORMED CONSENT SIGNATURE PAGE 
 
 
You are a participant or are authorized to act on behalf of the participant. This consent includes the 
following: 
x Key Information Page
x Detailed Consent
 
You will receive a copy of this consent form after it has been signed. 
 
 
43636