Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human Subjects
Phase: NA
Conditions: Alcohol Use Disorder
Sponsor: Colorado State University

Cover Page 
 
Protocol document version date Sept 27, 2021 
Document submi<ed Nov 25, 2023 
 
NCT # NCT06105138 
Title: Cannabidiol Eﬀects on Blood Alcohol Level and IntoxicaMon 

Sta$s$cal Analysis Plan 
Prior to hypothesis tes,ng, we will conduct data wrangling and visualiza,ons on the raw data for 
all outcomes using the R programming language and packages included in ,dyverse (Team 2013; 
Wickham et al. 2019) (e.g., ggplot2 (Wickham 2016)). To examine changes over ,me in BrAC, alcohol 
craving, aﬀect, seda,on, and s,mula,on during the descending limb of the BrAC curve (T2 – T8, see 
Figure 1) and to compare these changes by sex and condi,on, we will run a series of Mul,level Structural 
Equa,on Models (MSEM;(Mehta and Neale 2005) using Mplus 8 (Muthén and Muthen 2017). Due to the 
research design, where each par,cipant completed each condi,on (placebo, 30mg CBD and 200mg CBD) 
and within each condi,on there were 7 repeated measures of interest, MSEMs need to be run with a 
latent growth curve on the within-level to capture the change over ,me. Repeated measures of interest 
were taken at ,mepoints T2-T8, which represent the descending limb of the BrAC curve. We will focus 
on the descending limb because evidence suggests that some subjec,ve eﬀects of alcohol may be 
par,cularly prominent during the descending limb (Pihl et al. 2003; Brick 2006). In addi,on, prior 
medica,on studies have demonstrated that notable medica,on eﬀects such as reduc,on in craving and 
s,mula,on are observed in both the descending and ascending limb (Ray and Hutchison 2007), but 
some unique eﬀects such as increased tension may be speciﬁc to the descending limb (Ray et al. 2008). 
Another advantage of focusing on the descending limb is that changes during this ,me are expected to 
be approximately linear (e.g., BrAC decreases linearly (Posey and Mozayani 2007)), which supports a 
more straigh_orward interpreta,on of model results. Note that T2= 90 minutes aaer the start of the 
alcohol administra,on session and T8=4.5 hours aaer the start of the alcohol administra,on session.  
In all models, condi,on will be treated as a within-person variable, and sex will be treated as a 
between-person variable. To examine whether condi,on inﬂuenced changes over ,me, we will regresse 
the latent slope parameter deﬁned by the latent growth curve model on a dummy coded within-person 
condi,on variable. As there are 3 condi,ons, each model must be run twice to assess all pairwise 

comparisons. First with placebo as the referent group (i.e., comparing placebo to 30mg CBD and placebo 
to 200mg of CBD) and then again with 30mg CBD as the referent group (i.e., to get the comparison of 
30mg CBD to 200mg CBD). To determine if sex moderates the condi,onàchange rela,onship we will 
create a random slope of condi,on predic,ng the latent slope variable and then regressed that random 
slope on the between-person binary sex variable. This is referred to as the random coeﬃcient predic,on 
method (Preacher et al. 2010, 2016). We will also use this method to determine if the overall change 
over ,me is moderated by sex by regressing the random latent slope parameter on the between-person 
sex variable. The MSEM approach allows paths that include within-level eﬀects to have random 
intercepts and allows for the crea,on of Bayesian credible intervals for assessing signiﬁcance of eﬀects. 
Bayesian credible intervals provide a robust test of direct and modera,on eﬀects, are computa,onally 
eﬃcient, and are amenable to a variety of variable characteris,cs (e.g., hierarchical–nested and non-
normal data; (Gelman et al. 2004; Muthén and Asparouhov 2012).  
 
 

#1903 - Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level
and Intoxication in Adult Human Subjects
Protocol Information
Approval Comment
Amendment [v7] has been reviewed and granted approval by expedited review (§46.110(b)(2)) of minor changes on September 27, 2021. This 
amendment includes updated recruitment flyer CBD Alcohol Flyer 2. The IRB has determined that the risk level remains unchanged and the 
safeguards for participants is appropriate. The study was assessed as being in accordance with 45 CFR 46.111 of the 2018 Requirements. 
RISK: More than Minimal
SPONSOR: CCTSI
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1. Complete this Amendment overview.
2. Update the sections of your protocol that you are requesting to amend.
3. Upload any amended documentation (consent; assent; attachments)
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Summarize the proposed changes to the protocol in lay terms.
We have resubmitted a new recruitment Yyer for distribution.
Indicate whether you think the level of risk increases, decreases, or does not change the risk determined by the IRB at initial review.
(If level of risk has changed, please update the section 'Risks' in the protocol information.)
No Change
Review Type
Expedited
Status
Superseded
Approval Date
Sep 27, 2021
Continuing Review Date
--
Expiration Date
Aug 18, 2022
Initial Approval Date
Mar 09, 2021
Initial Review Type
Full Board
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Please document how many participants have been enrolled to date who may be impacted by your proposed changes.
no participants will be impacted by the proposed change
Will you re-consent subjects?
No
General Information
Principal Investigator
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Title
Exploring the Effects of Acute Cannabidiol Administration on Blood Alcohol Level and Intoxication in Adult Human
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Psychology (CO-1876)
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Karoly, Hollis Catherine
Psychology (CO-1876)
Karoly, Hollis Catherine
Drennan, Meggan L
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Crain, Sage A
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Legacy eProtocol ID number
If applicable, enter the ID number this study was previously assigned in eProtocol.
20-10303H
General Questionnaire
Application Type
Full Board
Does this study include use of existing data or biospecimens?
No
Does this study include use of student educational records and data?
No
Does this study include the use of human blood, cells, tissues or body fluids?
Yes
Does this study include evaluation of medical equipment or devices?
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No
Does this study include evaluation of drugs, biologics, reagents or chemicals?
Yes
Is this study a clinical trial?
No
Does this study include the use of Protected Health Information (PHI)?
No
Is this study a Graduate Level Thesis or Dissertation Project?
No
Is this study another type of class project?
No
Is the project funded?
Yes
Study Participants
Subjects Checklist (Select All that Apply)
Adults
Collaborators
Will Colorado State serve as the Single IRB for other collaborating institutions on this study?
No, Colorado State University is the only participating institution in this study.
Funding
Funding Sources
Funding Type
Other (i.e. State, Local)
KP Proposal Number or OSP Reference
Number
147332
Title of Grant (if different from protocol title)
CCTSI
Period of Funding
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Is the study occurring at CSU?
Yes
Prime or Subawardee?
Prime
Funding was secured by:
CSU Ojce of Sponsored Programs
Please provide your IRB Approval documentation to Sponsored Programs upon receipt.
Summary and Purpose
Proposed Start Date
February 15, 2021
Proposed End Date
February 15, 2022
Provide a brief summary or abstract of the project, using non-technical terms that would be understood by a non-scientific reader. This
summary should be no more than 200 words.
Cannabidiol, or CBD, is commonly found in the cannabis plant and has shown promise in treating alcohol use
disorders (AUD). Several rodent studies show that CBD decreases alcohol intake. However, only three human
studies have ever been conducted on this topic. These studies showed conYicting results regarding the impact of
CBD on intoxication and blood-alcohol level. Importantly, existing studies have used synthetic CBD, which is
dissimilar from the plant-based CBD products popular in the U.S. Thus, the conclusions that can be drawn from
the existing work are limited, and tightly controlled human studies of the effects of plant-based CBD on blood
alcohol level, psychomotor intoxication and subjective intoxication following acute alcohol consumption are
needed. In this study, we will explore the effects of two doses of plant-based CBD (compared to placebo CBD) on
blood alcohol level, motor and balance impairment as craving/desire for alcohol over the course 4 hours after
subjects consume a standardized dose of alcohol. We hypothesize that in the CBD condition, blood alcohol level
(estimated using a breathalyzer) will be lower, cognitive and motor/balance performance will be better and craving
will be lower for all timepoints. These outcomes have implications for understanding the potential of CBD as an
AUD treatment.
Describe the purpose for the proposed project.
The purpose of the project is to improve our understanding of how plant-based CBD products may impact alcohol
use among individuals who regularly use alcohol. Since alcohol and cannabis co-use is common in the U.S., CBD
is commonly found in recreational and medical cannabis products, and animal research suggests that CBD may
decrease alcohol intake, it is important to determine whether CBD have applications for reducing drinking in
humans. Ultimately, this could have implications regarding the use of CBD as a potential treatment for alcohol use
disorders. Primary objectives are to explore how CBD impacts blood alcohol level, as well as cognitive and motor
performance during an acute alcohol administration session. Specihc Aims are described in detail below: Aim 1.
Assess effects of CBD+alcohol vs. placebo+alcohol on breath alcohol level (BrAC). Hypothesis 1. After consuming
CBD, subjects will have lower BrAC throughout the 4-hour period compared to when they consume placebo CBD.
Aim 2. Assess effects of CBD+alcohol vs. placebo+alcohol on subjective intoxication. Hypothesis 2a. After
consuming CBD, subjects will experience decreased alcohol craving across all timepoints post-alcohol
consumption compared to when they consume placebo CBD. Hypothesis 2b. Differences in self-reported
stimulation and sedation effects will emerge in the CBD condition compared to the placebo condition across all
post-alcohol consumption timepoints. We lack sujcient prior evidence to predict the direction of these effects.
Aim 3. Assess effects of CBD+alcohol vs. placebo+alcohol on psychomotor intoxication. Hypothesis 3a. CBD will
be associated with better performance on an inhibitory control task compared to placebo across all timepoints.
Hypothesis 3b. CBD will also be associated with better balance/motor performance at all timepoints after alcohol
consumption compared to placebo.
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What do the investigators hope to learn from the project?
We hope to gain a better understanding of the impact of CBD on blood alcohol level. We also hope to better
understand whether CBD impacts levels of acute alcohol intoxication (specihcally as regards craving, subjective
effects of alcohol and cognitive and motor impairment). This has implications regarding CBD's potential as a
treatment for alcohol use disorder.
Describe how sharing results of this study could influence behavior, practice, theory, future research designs. Specifically, how will study
results apply to a larger population than the studied participants?
The results from this research will be disseminated as publications (estimated at least 3-4 papers total spanning
all three main study aims) and as symposia/presentations and posters at national and international conferences.
Background
Provide a brief overview of the relevant background. Discuss the present knowledge, appropriate literature and rationale for conducting the
research.
Increases in alcohol consumption, high risk drinking and AUD constitute a public health crisis in the U.S.(Grant et
al., 2017). Although decades of preclinical and clinical research have shed light on risk factors associated with the
etiology and maintenance of AUD, currently available interventions demonstrate only modest ejcacy (Dutra et al.,
2008; Jonas et al., 2014). Thus, there is increasing interest in exploring alternative AUD treatments targeting novel
biological systems. Notably, the endocannabinoid system (ECS) has emerged in recent years as a potential
treatment target for AUD (Sloan et al., 2017). In particular, the non-psychoactive cannabinoid cannabidiol (CBD)
has shown preclinical promise in ameliorating numerous clinical symptoms of AUD. Specihcally, CBD reduces the
reinforcing properties of alcohol and decreases drinking motivation and consumption in mice (Viudez-Martínez,
García-Gutiérrez, et al., 2018; Viudez-Martínez, García-Gutiérrez, et al., 2018) and attenuates cue-induced and
stress-induced alcohol-seeking, reinstatement, anxiety, and impulsivity in a rat model of AUD (Gonzalez-Cuevas et
al., 2018). Although we lack a complete understanding of the mechanism(s) through which CBD may reduce
alcohol consumption and/or ameliorate the clinical symptoms of AUD, CBD is known to modulate several neural
pathways implicated in AUD. For example, in one rodent study, administration of CBD during ethanol self-
administration was associated with decreased expression of the opioid receptor OPRM1 gene, the GPR55 gene,
and the CB1 gene (all of which code for proteins associated with AUD and the reward response to alcohol (Mague
and Blendy, 2010; Musella et al., 2017; Parsons and Hurd, 2015), and increased expression of the CB2 gene in the
nucelus accumbens (NAcc). This study also found that CBD was associated with decreased expression of the
tyrosine hydroxylase gene (TH; an enzyme critical for regulation of dopamine synthesis, and which inYuences
dopamine levels after alcohol administration) in the ventral tegmental area (VTA). Given that the dopaminergic
signaling from the VTA to the NAcc is responsible for mediating the rewarding effects of alcohol (Koob, 1992;
Spanagel and Weiss, 1999), and that increased TH expression is observed in association with acute and chronic
alcohol (Lee et al., 2005; Oliva et al., 2008; Ortiz et al., 1995), it is possible that modulation of reward-related genes
in the VTA and NAcc could contribute to the ejcacy of CBD in decreasing alcohol consumption. In another study,
CBD administered with the opioid receptor antagonist naltrexone decreased ethanol consumption and drinking
motivation in mice to a greater extent than either CBD or naltrexone alone (Viudez-Martínez et al., 2018a). This
study also found that serotonin 1A (5HT1A) receptor expression was reduced in the dorsal raphe nucleus after
CBD+naltrexone treatment. The serotonergic pathway projecting from the dorsal raphe to the NAcc is activated
during reward-associated tasks in mice (Liu et al., 2014). Given that chronic alcohol exposure is associated with
increased 5HT1A receptor sensitivity and increased ethanol drinking in mice (Kelaï et al., 2006), these studies
suggest that reduction of 5HT1A receptor expression in the dorsal raphe may be one mechanism through which
CBD reduces the rewarding properties of alcohol. In sum, CBD modulates several neural pathways implicated in
AUD, and the next logical step is to explore the effects of CBD on alcohol consumption and other AUD phenotypes
in heavy drinking human subjects, as is proposed in this study.
Please describe the expertise you have, or have access to, which prepares you to conduct research in this location and/or with this subject
population, including specific qualifications (e.g., relevant coursework, background, experience, and training).
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P.I. Hollis Karoly is a clinical psychologist and neuroscientist studying alcohol and cannabis use. She has been
working with this population both clinically and in a research capacity for the past 10 years. Dr. Karoly has a dual
PhD in Clinical Psychology and Neuroscience which was awarded in 2018 from CU Boulder. Additionally, she has
published over 34 papers on the topic of substance use, and has presented her work and numerous national and
international conferences. Dr. Karoly has been conducting research on substance users along the Front Range
Urban Corridor since she began her graduate work at CU boulder in 2011. As a post-doc at CU Boulder, she was
involved in numerous studies with CU Boulder PIs Dr. Kent Hutchison and Dr. Cinnamon Bidwell studying cannabis
and alcohol users across the Front Range. She was also involved in a clinical trial of alcohol dependent individuals
in the same geographic region, and independently conducted a dissertation project on alcohol and cannabis co-
users while at CU Boulder.
Explain your knowledge of local community attitudes and cultural norms and cultural sensitivities necessary to carry out the research.
Thus, Dr. Karoly has many years of experience working with the substance using population across the Front
Range.
Procedures
List all research activity procedures in which a participant will be involved, including follow-up procedures. Please provide details.
Procedure Description
Study Overview. Heavy drinkers (N=40) who do not regularly use cannabis but are not cannabis naïve will be
recruited for this pilot study involving 3 half-day visits to our lab at CSU. Interested individuals will be phone
screened, and eligible subjects will be scheduled for their hrst visit. For both visits, subjects will be asked to
arrive in the lab at 11:15am and will be asked to have someone drive them to the lab and pick them up at the end
of the day if possible. If this is not possible we will call a Lyft for them and cover the cost. At the hrst visit, they
will complete informed consent and a demographics form and several questionnaires on psychological
functioning and substance use. Subjects will then consume their their CBD (30 mg or 200 mg) or placebo.
Alcohol administration (up to .8g/kg) will occur about 25 min after CBD ingestion, and testing procedures will
occur every 30 minutes for the next 4 hours. The timeframe of the visit was selected because maximum plasma
concentration of this CBD product occurs in the blood after 45 minutes (Williams et al 2021) Also, peak BrAC
occurs for the alcohol dose we are administering (up to .8g/kg) approx. 1 hour after alcohol ingestion. The order
of study visits (CBD 30 mg vs. CBD 200 mg vs. placebo) will be counterbalanced across participants, such that
participants will be randomly assigned to complete each the three visits in different orders. Also note that the
research assistants running the study will also be blinded to participant condition (and a non-blinded graduate
student will prepare the CBD product for the subjects before the session). The three study visits will occur 1
week apart. There will also be 3 venous blood draws for Blood Cannabinoids at both visits. Blood draws will
occur before CBD/placebo ingestion (to verify no CBD use prior to experiment), before alcohol consumption and
60 min post-alcohol ingestion. Blood will be assayed for CBD, THC and THC metabolites using High
Performance Liquid Chromatography-Mass Spectrometry.
This procedure is:
Other Procedure
Please explain:
Overview of procedures/activities.
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Procedure Description
Laboratory Sessions (CBD 30 mg Session, CBD 200 mg Session and Placebo-CBD Session). At each subject’s
hrst session, they will arrive at the lab at approximately 11:15am, undergo informed consent procedures with a
trained research assistant, undergo urine pregnancy and drug screening and receive a breathalyzer test. We will
use the Intoximeter Alcosensor IV Breathalyzer, which is the gold standard for alcohol research studies. Urine
drug screening will test for the presence of illicit drugs (besides cannabis). If urine drug or pregnancy tests are
positive, participants will be disqualihed from participation. If BrAC is above 0.000, participants will be
rescheduled. If all tests are negative, participants will complete a brief demographics form and psychological
fuctioning/substance use questionnaires. Next, they do the hrst blood draw and will then be given either 30 or
200mg CBD dissolved in water or plain water (as the placebo CBD condition). They will then be asked to wait for
25 minutes in our lab. They will be provided with internet access during this time. Participants are allowed to
consume water ad libitum throughout the entire day of the study. Immediately before the alcohol administration
procedures begin, subjects will again have their blood drawn and will complete measures of balance/motor
performance, inhibitory control, alcohol craving, stimulation and sedation. Specihcally, the following measures
will be administered to measure alcohol craving, stimulation and sedation: The Biphasic Alcohol Effects Scale
(BAES) is a self-report rating scale measuring stimulant and sedative effects of alcohol. It has shown good
reliability and validity in AUD. The Subjective High Assessment Scale (SHAS) is a standard self-report measure
used to assess subjective responses to alcohol. The Alcohol Urge Questionnaire (AUQ) is a well-established
measure of alcohol craving and desire to drink that is commonly used in the context of acute alcohol
administration. To test balance/motor function we will use a psychomotor battery designed to capture
measures of cognitive and motor impairment in divided attention, decision making, reaction time, motor tracking
and balance movements following the intake of drugs or alcohol and designed to be administered repeatedly in
a single session to assess changes in impairment without being susceptible to practice effects. Finally, to test
inhibitory control we will use the The Flanker Inhibitory Control and Attention Task, which requires participants to
focus on a stimulus while inhibiting attention to stimuli Yanking it. These measures will be administered on an
ipad. Next, participants will consume up to .8g/kg of vodka mixed with orange juice, following procedures from
previous alcohol and cannabis co-administration studies. The dose will be reduced 8% for females to adjust for
expected BrAC differences between males and females. An .8g/kg dose should produce a peak BrAC of no more
than.089% approximately 1 hour after alcohol consumption, which should not signihcantly exceed the BrAC
reached by heavy drinkers during a typical heavy drinking period. There will be a third blood draw at this time
(approximately 1 hour after the start of the alcohol administration procedure). As in the three prior human
studies of alcohol and CBD co-administration, participants will be asked to consume their alcohol within a 20-
min. time period. The above procedures (breathalyzer measurement of BrAC, measures of inhibitory control and
balance/motor performance, alcohol craving, stimulation and sedation) will be repeated every 30 min. for 4
hours post-alcohol administration. Participants will be required to reach a BrAC of <.03 before going home,
which is estimated to take no more than 4 hours post-alcohol administration, given the elimination rate of
alcohol from the body. They will also be required to either have someone pick them up from the lab after the
study session is over, or if this is not possible our lab will call them a Lyft, and will cover the cost for them.
Participants will be offered snacks after testing is complete to facilitate BrAC reduction. The visit will end at
approx. 4:00pm. They will also be required to either have someone pick them up from the lab after the study
session is over, or if this is not possible our lab will call them a Lyft. CBD Product. Consistent with the Colorado
Department of Agriculture (CDA) and CSU regulations, the 30 mg and 200 mg CBD products will be sourced by
Caliper Foods (https://www.caliperfoods.life/), which is a CDA compliant product containing <.3%THC (thus
qualifying as hemp rather than cannabis, which means it is allowed on CSU’s campus). Subjects will consume
Caliper's 5% CBD concentrate liquid in water on the day of their CBD study appointment, and they will consume
plain water with no CBD on the day of their placebo-CBD appointment. Caliper's CBD readily solubilizes into
water within seconds and does not impact Yavor, consistency, texture or appearance of the water. Thus,
participants will not be able to tell whether they are consuming water containing CBD or plain water. Note that
Individuals who report very high levels of alcohol consumption on the questionnaires, those that report
symptoms of severe depression or suicidality, or those that determine that they do need to seek alcohol
treatment will be referred to the Psychological Services Center in the CSU Psychology Department
(https://psychology.colostate.edu/psc/), Aspenridge recovery (https://www.aspenridgefortcollins.com/) and
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Mountain Crest, which provides inpatient MH services (https://www.uchealth.org/locations/uchealth-mountain-
crest-behavioral-health-center/). More specihcally, if suicidality is revealed during the study session (i.e., if the
participant selects a 2 ("I would like to kill myself') or a 3 ("I would kill myself if I have the chance") on BDI item
#9), the study procedures will be stopped and the research assistant will call the PI, Dr. Karoly, who has a PhD in
Clinical Psychology. Dr. Karoly will then conduct a risk assessment over the phone. If participants indicate that
they have plans, means and intent to harm themselves, and Dr. Karoly determines that the participant would be a
danger to themselves if allowed to leave the session, procedures for hospitalization will be initiated. At this time,
Dr. Bradley Conner (a licensed clinical psychologist in the psychology department) will be called to assist, as a
licensed psychologist is needed to sign off on hospitalization procedures. Please note that this is extremely
unlikely to happen, given that we will screen individuals out of participating in the study if the report suicidal
ideation on the phone screen. However, because we are administering a self-report measure that asks about
suicidality, the procedures described above are in place to ensure participant safety.
This procedure is:
Research Activity Involving Participants, Participants Data, or Biospecimens
This procedure is:
Experimental
Where and when will this procedure take place?
Please identify the location of procedures.
Who will conduct this procedure?
Personnel
Karoly, Hollis Catherine
Personnel
Drennan, Meggan L
Personnel
Gutierrez,Hector
Personnel
Adams, Tyler Ann
Personnel
Ford,Melanie
Indicate the frequency and duration of visits/sessions as well as the subject's total time commitment for the study.
Visits will take about 4.5 hours.
Describe how the data will be collected (i.e. in person or online).
In person
Will any video, photography, or audio be recorded as part of this procedure?
No
Privacy and ConSdentiality
Explain how the established data management plan along with consent processes and other elements of the research design address the
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Will data be collected anonymously?
No
following.
Privacy is considered from the perspective of the participant and is a right to be protected. Privacy refers to an individual's interest in
controlling others' access to themselves. Based on their privacy interests, participants may want to control:
•             The time and place where they give information
•             The nature of the information they give
•             Who receives and can use the information
For example, persons might not want to be seen entering a place that might stigmatize them, such as a pregnancy-counseling center
identified as such by signs on the front of the building.
Describe how you will protect subject's privacy.
Participants are recruited either using targeted mailer or or online. Initial screening is conducted via phone, and
prospective participants are asked at the beginning of the call if they are in a location where they feel comfortable
answering questions about substance use. The study will be conducted in a secure space in Dr. Karoly's research
lab at CSU.
Confidentiality is about data. Confidentiality pertains to protecting information from disclosure based on an agreement between the
participant and the researcher. When an individual shares information in a relationship of trust and expects it to be kept private or will be
disclosed only with specific permissions, researchers must uphold this agreement and maintain data appropriately.
Describe how you will maintain the confidentiality of subjects' information.
The PI and study staff will have access to identifying information, which will be stored in locked hling cabinets.
Research data will be stored separately, in a password-protected documents on a secure, password-protected
server.
Biospecimens
Identify which type(s) of biospecimens will be used as part of this research project:
Blood
Fecal/Urine Samples
Are the specimens known to be diseased or dangerous
No
Will tissues be stored for future research projects? 
Yes
Will tissues or associated data be sent out of this institution as part of a research agreement under a Data Use Agreement or Material
Transfer Agreement?
No
Do you require approval through the Institutional Biosafety Committee (IBC)?
Yes
IBC Project Approval Request Form (PARF)# or pending
Project 21-012B
IBC Agent Approval Request Form (AARF)# or pending  
not required
For more information or support, contact the CSU IBC at: RICRO_IBC@colostate.edu
Drugs and Devices
Identify which drugs, reagents or chemicals will be used as part of this research:
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Drug/Agent Name
CBD 30 mg and 200 mg CBD products will be sourced by Caliper Foods
Identify Criteria
Cannabis/Hemp/CBD
Participant Population
Are you interacting or intervening with participants? 
Yes
Provide an estimate of the anticipated participant total.
20
Are you analyzing existing data records or biospecimens?
No
Inclusion and Exclusion Criteria (e.g., Participants must have 20/20 vision, Participants must be 30-45 years of age, etc.) This should match
your screening, consent, and recruitment materials.
Please list all inclusion criteria
Participants must be between 21-60 years old, be able to provide consent, be willing to consume CBD during the
study, be a heavy drinker (>5 drinks [>4 for women] per occasion) at least 5 days/month in the past 3 months).
They must not be a regular or recent cannabis user (used cannabis less than monthly over past year and not in
past month), but they must not be cannabis naiive (they must report having using THC or CBD at least once in
past year).
Please list all exclusion criteria
Participants will be ineligible if they report daily tobacco use, state that they are currently seeking treatment for
AUD or other substance use disorder, are pregnant, breastfeeding or trying to become pregnant, meet criteria for
psychotic, bipolar or major depressive disorder with suicidal ideation, report illicit drug use in past 60-days or fail
urine drug screen, or have a major medical condition contradicting alcohol or CBD use (e.g., liver disease, heart
disease). They are also ineligible if they report taking blood thinners, as CBD may increase the level of blood
thinners in a person's body. Regarding the urine drug screen, will be using the 6-panel Germaine™ Laboratories
SafeCup™ III Urine Test Cup from Fisher Scientihc, catalog number 23-111-320. This product tests for the
presence of amphetamines, benzodiazepines, cocain,e THC, methamphetamine and opioids. Individuals that
determine that they do need or want to seek alcohol treatment will be referred to the Psychological Services
Center in the CSU Psychology Department (https://psychology.colostate.edu/psc/), Aspenridge recovery
(https://www.aspenridgefortcollins.com/) and Mountain Crest, which provides inpatient MH services
(https://www.uchealth.org/locations/uchealth-mountain-crest-behavioral-health-center/).
What is the rationale for studying the requested group(s) of participants?
Age criteria minimizes noise and reduces the impact of age-related differences on biological and behavioral
outcomes. Individuals under 21 are not legally allowed to use alcohol or cannabis, and thus cannot be included in
this study. This age criteria is also consistent with my other alcohol and cannabis study protocol which has been
previously approved by the IRB (Protocol # 20=10213H). Because the primary aims of the study involve exploring
the effects of legal-market cannabis on alcohol consumption and involve an alcohol and CBD administration, we
need to recruit heavy alcohol users. Heavy drinking criteria is consistent with The Substance Abuse and Mental
Health Service Administration dehnition. We will recruit individuals who are not regular or recent cannabis users to
ensure that they do not have signihcant CBD or THC in their blood during the visits. However, because subjects are
being given CBD (a hemp-based product), they should not be cannabis naïve. Overall, inclusion criteria are
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deliberately broad, to increase the range of use patterns represented in the sample.
Will you use a screening procedure, instruments, tools, questionnaires etc.?
Yes
Describe any planned screening procedures. Attach your screening document(s) (e.g., health history questionnaire), if applicable at then end
of the form. 
Interested subjects will be screened over the phone by a trained research assistant. Phone screening
documentation is attached in the attachment section.
Recruitment Process
Describe the procedures for identifying and recruiting potential research subjects or requesting pre-existing data or materials. 
Participant Group Descriptor
Adults
Please describe the recruitment process:
Participants will be recruited from the greater Fort Collins/Denver/Boulder metropolitan area in Colorado. We
will use Yyers in the community as well as targeted mailings that make use of a list of names and addresses of
individuals from publicly available records purchased from a marketing hrm who ht target demographics and
geographical area. In addition to posting Yyers, we will print out smaller versions of our Yyers and research staff
will hand them out to adults in public spaces such as downtown Fort Collins They will approach adults walking
in the area and offer a Yyer. We will also post ads on social media (e.g., Facebook, craigslist, reddit, etc.).
Recruitment materials will direct individuals to call a phone number to reach a professional research assistant to
be screened for participation in the study.
Planned Subject Identification Methods
Direct advertising
Will a specific agency or institution provide access to prospective subjects?  
No
Please select the recruitment personnel
Karoly, Hollis Catherine
Drennan, Meggan L
Gutierrez,Hector
Adams, Tyler Ann
Ford,Melanie
Weishaar, Megan Marie Gardner
Zulic, Leila
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Crain, Sage A
Gray, Bethany Ariel
Brefere,Veronica
No
Planned Recruitment Materials/Methods
*(All advertising must be submitted for review in its final printed/recorded form)
Note: Attach copies of ALL recruitment materials in the attachment Section
Flyers/posters
Internet ads/postings
Is there any possibility that potential participants may feel coerced to participate? 
No
Is there any possibility that potential participants may feel undue influence to participate?
No
Participant Compensation/Costs
Will participants be compensated?
Yes
Form of Compensation
Cash or Check
What is the approximate monetary value?
297
Describe the remuneration plan.
Compensation is $99 per session which will be disbursed in cash following the completion of each session.
Maximum compensation for the study is $297. A 1099 will not be issued.
Will a 1099 be issued?
No
Will participants incur any costs to participate in this research?
No
Risks and BeneSts
Minimal risk “means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or
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tests.” [Department of Health and Human Services 45 CFR 46.102(j)]
Please indicate the researchers' evaluation of the overall risk level, and describe all known risks or discomforts associated with the study
procedures, as prompted below. Note that any risks identified here should be consistent with risks you will disclose to participants in the
consent process.
Greater than Minimal Risk
Are there risks associated with physical well-being?
Yes
Please describe.
Risk of Phlebotomy. When having blood drawn, participants may experience some discomfort as a result of the
needle prick in the arm. Some bruising or slight bleeding may occur. Although infection is possible, it is extremely
rare, because the needle is sterile and disposable. Occasionally, people feel lightheaded or faint when blood is
drawn, but the volume taken will be small (no more than 10mL is drawn for each of three blood draws). Protection
Against Risks of Phlebotomy. Individuals trained in phlebotomy will conduct all blood draws. They have completed
IBC training, BBP, BSL1, BSL2 and Hazardous Waste trainings and have demonstrated competence in phlebotomy,
following the Karoly lab's SOP. Individuals who may draw blood during the study are: Meggan Drennan, Hector
Guttierez, Patrick Gonzalez, Leila Zulic and Cody Conner. Risks of Alcohol Administration. Adverse effects of
alcohol such as intoxication, acute mood shifts (e.g., feelings of sadness or depression), and odd perceptual
experiences are possible. However, individuals are recruited because they are heavy drinkers, dehned as
consuming >5 drinks [>4 for women] per occasion) at least 5 days/month in the past 3 months. The dose of
alcohol given in the study is only designed to bring BAC to a maximum of .089, which is not higher than a typical
BAC reached by individuals drinking 4-5 drinks in a single occasion. Thus, individuals in the present study are not
likely to experience alcohol intoxication beyond the level that they normally experience in their daily life as a heavy
drinker. Protection Against Risks of Alcohol Administration. Several steps will be taken to minimize risk to
participants as a result of the acute effects of alcohol including those based on guidelines provided by NIAAA
(NIAAA Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation; NIAAA,
2005). More specihcally, the following protections are in place: First, participants will be excluded from the study if
they have a medical condition, have an alcohol use disorder (AUD) or another substance use disorder (SUD), are
current in treatment for or seeking treatment for AUD or another SUD, or have a medical condition that that may
contraindicate the consumption of alcohol. Urinalysis drug screens will be used at both laboratory sessions to
exclude for any illicit drug use. Participants will only be included in the study if they are current heavy drinkers who
report 5 binge drinking episodes per month over the last three months (note that a binge is dehned by SAMHSA as
consuming 5 drinks per occasion [4 for women]). Study staff will closely monitor participant BAC via breathalyzer
throughout the alcohol administration protocols to ensure that BAC never xceeds .089 (which is roughly the
equivalent of four standard drinks and is at the legal limit for alcohol impairment) following established alcohol-
administration procedures. Thus, the amount of alcohol provided over the sessions will not exceed the dosage
level consistent with participants’ normal drinking practices. At both laboratory visits, a picture ID will be required
to prove age eligibility (> 21 years). Female participants will be required to take a private urine sample pregnancy
test on the day of both laboratory sessions. In case of any positive reading, participants will not be eligible to
participate. The results of all pregnancy tests will be kept conhdential and the tests will be safely discarded.
During the laboratory procedures, an experimenter will be present at all times. Participants will be required to
remain in the laboratory until their BAC <.03 g/dL. Participants will be supervised by the experimenter during this
period. Participants will also have an opportunity to ask questions of the experimenter. In addition, Dr. Karoly (a
trained clinical psychologist) will be on call during all study appointments if any participant experiences negative
psychological effects. Risks of CBD Administration. There may be mild physical side effects of CBD consumption,
including nausea, fatigue and irritability. In addition, CBD can increase the level in your blood of the blood thinner
coumadin. Individuals will be screened out and not allowed to participate in this study if they are taking this
medication.
Are there risks associated with psychological well-being?
Yes
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Please describe.
Psychological Risk Associated with Questionnaires: Participants may experience some discomfort associated
with hlling out questionnaires and answering personal questions during baseline and follow-up study sessions.
They may also experience embarrassment because of items about medical conditions, health- related behaviors,
and stigmatized behaviors, such as alcohol use, cannabis use and use of other legal and illegal psychoactive
substances. Protection Against Risks Association With Questionnaires. Participants will be forewarned of this
possibility and notihed that discomfort with questions may be handled by discussing the resultant discomfort
with a trained clinician (e.g., the study PI, Dr. Karoly, a clinical psychologist) to help resolve the issue or, in some
cases, by declining to answer particularly troubling questions.
Are there risks associated with economic well-being, including employability?
No
Are there risks associated with social well-being, including reputational risks?
Yes
Please describe.
The Risk of Breach of Conhdentiality. A conhdentiality breach is possible, but highly unlikely given the precautions
taken (see below) Protection Against The Risk of Breach of Conhdentiality. The study staff will have access to
identifying information, which will be stored in locked hling cabinets. Research data will be stored separately in
password-protected documents on a secure, password-protected server.
Describe how the benefits of the research justify the likely risks to participants.
Broadly, the hndings of this investigation will increase the body of knowledge about the effects of CBD on alcohol
consumption among heavy drinkers. Existing research on the effects of alcohol and CBD together is very minimal,
and has has largely used either animal models with extracted synthetic CBD (which differs considerably from the
plant-based cannabis used by humans). Data are therefore lacking in terms of the effects of plant-based CBD on
alcohol consumption. Thus, the proposed study will ultimately add critical information to the knowledge base
regarding alcohol and CBD. These results may inform public policy approaches to harm reduction, which is much
needed in states that are legalizing cannabis use. In addition, the proposed study will provide an evidence-base
that will inform personal decisions and could reduce harm in individuals who are currently using alcohol and
cannabis. The results of this study will be disseminated through national and international scientihc conferences,
publication in peer-reviewed scientihc journals, and press releases to mainstream media outlets. Given that this
study could generate highly externally valid data to potentially inform harm reduction efforts at relatively low risk
to participants, the risks/benehts ratio seems reasonable. The risks associated with participating have been
minimized via procedures described above.
Describe direct research benefits to the participants, if any.
None
Describe the indirect research benefits to society.
This study could beneht public health by increasing our understanding of how cannabidiol (CBD) impacts the brain
and body when used in combination with alcoohol. This information may help people who use alcohol and/or
cannabis to make decisions about their use, and may help clinicians advise patients regarding cannabis and
alcohol use.
Data Management
Data management plans, including plans for data sharing, are integral to project development. How you decide to collect, store, share and/or
destroy data impacts your consent process, research procedures, data analysis, and publication. 
Responses in this section constitute your plan. For guidance on how to answer these questions and plan for the data lifecycle,
reference the resources and tools listed here. 
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Data Management Services at CSU Libraries 
General guidance and unfunded projects (DMPTool) 
Funder-specific guidance and templates (DMPTool) 
If you choose to create a standalone data management plan (DMP) for your own purposes or at the direction of a funding agency, please
attach that document to your protocol, also. 
A DMP fillable template is available from CSU Libraries.
How will the data be stored and backed up during the research?
Participant conhdentiality is strictly held in trust by the PI. Signed paper consent forms will be stored in a locked
hling cabinet in Dr. Karoly’s lab. All data, including biological data, from the proposed study will be identihed by a
numerical ID code only. Self-report data for this study will be collected via individual password-protected laptop
computers using Qaltrics. Participant data that is not self-report, such as blood cannabinoid levels, will be
reported to the PI with excel sheets that only contain deidentihed data points coded by participant ID and that are
stored on the lab's password protected server. Adverse events will be documented and reported using the CSU
Adverse Event forms (i.e. mild/moderate adverse event form; and the serious/unanticipated adverse event form).
Who will be responsible for data and access management, and
security?
Data Access Responsibility
Karoly, Hollis Catherine
Who will have access to study records or
specimens?
Personnel
Karoly, Hollis Catherine
Personnel
Drennan, Meggan L
Personnel
Gutierrez,Hector
Personnel
Adams, Tyler Ann
Personnel
Ford,Melanie
Personnel
Weishaar, Megan Marie Gardner
Personnel
Gray, Bethany Ariel
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Personnel
Zulic, Leila
Personnel
Crain, Sage A
Personnel
Brefere,Veronica
Personnel
Clark, MacKenzie
Will any external personnel have access to study records or specimens?
No
How will you share the data?
No identihable data will be released.
Will identifiable data collected as part of the research be released in identifiable form? (e.g., pictures, recordings, responses to research
questions, quotes)  
No
Will the identifying information be destroyed at a specific date? For guidance, please reference any associated contract or grant (if
applicable) and/or the CSU Research Data Policy.
No
What is the long-term preservation plan for the dataset?
Data will be retained in excel spreadsheets indehnitely following project completion. A small amount of blood
specimens from each subject will also be retained in a -80degree freezer for up to 5 years following study
completion, to facilitate further study should the PI obtain additional funds to pay for additional assays (e.g., to
measure inYammatory markers or other markers of health that are commonly collected in heavy drinkers).
Identifying information will be destroyed 2 years after project completion. It will be permanently deleted from all
servers and computers.
Do you intend to deposit your research data/specimens into a repository for future use? 
No
Consent/Assent
Consent
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The informed consent process involves presenting potential research participants with the key elements of a research study and what their
participation will involve before they decide whether to participate. Please visit the IRB website for templates and guidelines on what
information to include.
The default process for gaining consent is to use a signed form. Knowing that this does not always make sense, the IRB can approve
alterations to what information is included, waive the requirement to get a signature or waive the requirement to obtain consent altogether
when the request meets specific criteria. 
Follow the prompts below to describe all consent processes and provide justification for any requested alterations or waivers.
Will informed consent be obtained from all research subjects (and/or their parents or legally authorized representatives)?
Yes
CSU Consent Personnel
Karoly, Hollis Catherine
Drennan, Meggan L
Gutierrez,Hector
Adams, Tyler Ann
Ford,Melanie
Zulic, Leila
Crain, Sage A
Brefere,Veronica
Gray, Bethany Ariel
Weishaar, Megan Marie Gardner
Clark, MacKenzie
No
Are you requesting a waiver of documentation of consent?
No
Consent
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You do not have any procedures that include deception. If you are going to deceive or incompletely inform any subjects about any aspect of
this study describe in the procedures section.
List each consent process
Who will obtain subjects consent?
Personnel
Karoly, Hollis Catherine
Personnel
Drennan, Meggan L
Personnel
Gutierrez,Hector
Personnel
Adams, Tyler Ann
Personnel
Ford,Melanie
Personnel
Zulic, Leila
Personnel
Crain, Sage A
Personnel
Brefere,Veronica
Personnel
Gray, Bethany Ariel
Personnel
Weishaar, Megan Marie Gardner
Personnel
Clark, MacKenzie
Which participant group is this consent process
for?
Adult
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How is consent being obtained?
In person
Will non-English speaking participants be
enrolled?  
No
Bilingual will be included.
Are any subjects unable to legally provide consent?
No
ConXict of Interests
For guidance on how to answer these questions and information please visit the CSU Conflict of Interest page.
Does the research involve a drug, device, or biological invented by you, an immediate family member or other Research Personnel?
No
Is the research sponsored by an entity with which you, an immediate family member, or other Research Personnel have a paid consulting or
advising relationship?
No
Will you, members of your immediate family, or other Research Personnel receive special compensation or increased compensation if the
research generates a favorable outcome?
No
Will you, members of your immediate family, or other Research Personnel receive any money, gift or anything of monetary value above and
beyond the actual costs of enrollment, conduct of the research, and reporting on the results, including, but not limited to, finders fees, referral
fees, recruitment bonuses, and an enrollment bonus for reaching an accrual goal or similar types of payments?
No
Do you, members of your immediate family or other Research Personnel have any other interests or relationships (including volunteer
services) that might constitute a conflict of interest or an appearance of conflict of interest in connection with the research project?
No
Will the payment you receive for services provided during the conduct of the research (e.g., investigator and Research Personnel time and
tests) be inconsistent with fair market value for those services?
No
Significant Financial Interest: Please check Yes or No for each item below.
Will you, your immediate family members or other Research Personnel receive salaries, royalties and/or other payments for services (e.g.,
consulting fees, honoraria, research design, management position, independent contractor, service on advisory or review committees, board
membership seminars, lectures or teaching engagements when totaled together exceeded $5,000 during the previous 12 months or are
expected to exceed $5,000 over the next 12 months)? This excludes reasonable costs of conducting the research, as specified in the research
agreement.
No
Do you, your immediate family members, or other Research Personnel hold any ownership interests including stocks, bonds, or stock options
that exceed $5,000 and/or that constitute more than a five percent (5%) ownership interest in the sponsoring organization? This does not
include any interests held solely by reason of investment in a business by a mutual, pension or other institutional investment fund over which
the investigator and/or his or her immediate family do not exercise day-to-day control of investment decisions.
No
Minimizing Risks and Disclosure to Subjects
Have you disclosed any actual, potential or perceived conflicts of interest in the consent form? Research Personnel are required to disclose
all such conflicts to all research participants in the research consent form.
No
By submitting this form, you are attesting that you have read Colorado State University’s policy on Conflict of Interest and agree to abide by its
terms. You will update this disclosure form when new or changes in conflict of interest arise, and that you will comply with any conflict
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management plan required by the Institutional Review Board (IRB) to manage, reduce, or eliminate any actual or potential conflict of interest
for the duration of the research.
Attachments
Attach all relevant documentation to your research in this section. Please label each item appropriately, so your IRB reviewers understand the
purpose and population each document aims to address. Please delete the existing attachment and upload the Tracked Changes version and
Clean revised document for review to update or revise any existing attachments.
Any documentation that a participant will see must be reviewed and approved by the IRB, including consent, recruitment, communications,
tools, instruments, etc. Additional documents required for review include funding proposals, contracts, letters of agreement, methodology,
related approvals, etc. For more information and guidance on what documentation to attach, please visit the IRB website.
Answers within your application indicate that the following documentation is required:
Attachment Type
Consent
Attachment
Name
Attachment Type
Recruitment Materials
Attachment
Name
Attachment Type
Grant or Contract
Attachment
Name
Attachment Type
Drug Documentation
Attachment
CONSENT_CBD ALCOHOL_FINAL (2).DOCX
EMAIL SCRIPTS_UPDATE.DOCX
CO-X-20-39.PDF
CALIPER TS-002, T-P-S-5_ REV 4.0 .PDF
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Name
Attachment Type
Drug Documentation
Attachment
Name
Attachment Type
Data Safety and Monitoring Plan
Attachment
Name
Attachment Type
Other
Attachment
Name
Attachment Type
Other
Attachment
Name
Attachment Type
Other
Attachment
Name
COMPARISON OF FIVE CBD PREPARATIONS (1).PDF
KAROLY_DATASAFETYMONITORING_CBD (1).DOCX
KAROLY LAB SAFETY PLAN(1).DOCX
DOA INFO.DOCX
CONSROE1979_ARTICLE_INTERACTIONOFCANNABIDIOLANDALC.PDF
Protocols
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Attachment Type
Screening Tool or Procedure
Attachment
Name
Attachment Type
Screening Tool or Procedure
Attachment
Name
Attachment Type
Recruitment Materials
Attachment
Name
Attachment Type
Screening Tool or Procedure
Attachment
Name
Attachment Type
eProtocol History
Attachment
Name
Attachment Type
eProtocol History
QUALTRICS REVISED CBD_ALCOHOL_PILOT_2021.DOCX
QUALTRICS REVISED CBD_ALCOHOL_SESSION_1_DEMOGRAPHICS__INITIAL_QUESTIONNAIRES.DOCX
ONLINE AD_CBD ALCOHOL STUDY.DOC
PHONESCREENSCRIPT_KAROLY_CBD.DOCX
PROTOCOL_INITIAL 20-10303H.ZIP
Protocols
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Attachment
Name
Attachment Type
eProtocol History
Attachment
Name
Attachment Type
Other
Attachment
Name
CITI forms--Melanie Ford
Attachment Type
Other
Attachment
Name
CITI training Hector
Attachment Type
Other
Attachment
Name
Meggan Drennan CITI
Attachment Type
Other
PROTOCOL_AMEND 1 20-10303H.ZIP
PROTOCOL_AMEND 2 20-10303H.ZIP
MF CITI CERTIFICATION.PDF
HG CITI CERTIFICATION.PDF
CITICOMPLETIONREPORT_DRENNAN.PDF
Protocols
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Attachment
Name
CITI_TaylorSullivan
Attachment Type
Other
Attachment
Name
CITI_RCR_ TaylorSullivan
Attachment Type
Other
Attachment
Name
CITI_GCP_Taylor Sullivan
Attachment Type
Attachment
Name
Attachment Type
Attachment
Name
Attachment Type
Attachment
TAYLOR_GROUP1.PDF
TAYLOR_RCR.PDF
TAYLOR_GCP.PDF
MARISSA_CITI.PDF
MARISSA_RCR.PDF
MARISSA_GCP.PDF
Protocols
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Name
Attachment Type
Other
Attachment
Name
CITI_Cody Conner
Attachment Type
Other
Attachment
Name
CITI_TabithaMcMichael
Attachment Type
Other
Attachment
Name
CITI
Attachment Type
Other
Attachment
Name
RCR
Attachment Type
Other
Attachment
CITI CERT_CODY.PDF
TABITHA_CITI CERT.PDF
PATRICK_CITI.PDF
PATRICKRCR.PDF
CITI_HUMANRESEARCH_MC.PNG
Protocols
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Name
MacKenzie Clark human research citi training certihcate
Attachment Type
Other
Attachment
Name
MacKenzie Clark RCR citi training
Attachment Type
Other
Attachment
Name
Attachment Type
Other
Attachment
Name
Attachment Type
Recruitment Materials
Attachment
Name
Obligations
The Principal Investigator is ultimately responsible for the conduct of this project. Obligations of the Principal Investigator include the
following:
·        Receive IRB approval or determination prior to enrolling any subjects or collecting any data intended for research use.
·        Manage and maintain all research records, including consent retention, for at least three (3) years after the close of the study, or longer
per sponsor requirement.
·        Ensure that personnel training status remains current.
·        Provide all subjects a copy of the signed consent form, when applicable.
·        Keep protocol up to date by submitting amendments for review and approval before instituting changes in any aspect of the study.
·        Maintain current protocol approval by submitting renewals, as required.
·        Promptly report any violations, deviations, unanticipated problems or adverse events to the IRB.
·        Notify the IRB when the study is complete and take steps to close the protocol.
I understand that as the Principal Investigator I am fully responsible for the execution and management of this
CITI_RCR_MC.PNG
DANIELLEOLSON_HUMANRESEARCH.PDF
DANIELLEOLSON_RESPONSIBLECONDUCT.PDF
CBD ALCOHOL FLYER 2.DOCX
Protocols
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study and that I am responsible for the performance of any sub-investigators or key personnel including their
adherence to all applicable policies and regulations. I understand and agree to the obligations listed above.
I certify that I have reviewed this application, including attachments and that all information contained herein is
accurate to the best of my knowledge.
Protocols
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Administrative Details Form
Determinations
Review Type
Study Status
Protocols
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