Clinical trial NCT05192239
Conditions: Endurance Exercise
Sponsor: Christopher Bell
Start date: 2021-12-09; Completion date: 2022-07-19
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Lots of people, including athletes and people who like to exercise regularly, enjoy marijuana. Some people believe marijuana might improve their ability to exercise. There are no recent, up-to-date scientific studies to suggest that this belief is right or wrong. The goal of this study is to determine the influence of marijuana on exercise performance.

Detailed description:
The purpose of the proposed project is to provide athletes and the scientific community with data pertaining to the acute influence of edible marijuana on exercise performance, and the physiological responses to standardized exercise. Specifically, the investigators wish to determine: 1. The influence of edible marijuana on cardio-respiratory and metabolic responses to standardized cycle ergometer exercise. 2. The influence of edible marijuana on endurance exercise (time-trial) performance.

The investigators wish to determine if edible marijuana, ingested prior to exercise, is ergogenic (improves performance) or ergolytic (decreases performance).

The investigators hypothesize that edible marijuana will be ergolytic.

Arms: arm 1: Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. arm 2: Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout.
Interventions: intervention 1: THC 5 intervention 2: Placebo
Intervention descriptions: intervention 1: 5 milligrams of THC in gummy form intervention 2: Commercially available non-THC fruit snack

Protocol documents:
ICF_002.pdf: 
Christopher Bell, Ph.D., Dept. of Health & Exercise Science, Colorado State University 
IRB #2827 
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Cover Page for ClinicalTrials.gov 
 
 
Document: 
Informed Consent Form 
 
Official Study Title: 
Influence of Edible Marijuana on Endurance Exercise Performance 
 
NCT Number:  
NCT05192239 
 
Document Date: 
October 27, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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ADULT PARTICIPANT INFORMED CONSENT 
Department of Health and Exercise Science 
 
Study Title:   
Influence of Edible Marijuana on Endurance Exercise Performance 
 
PRINCIPAL INVESTIGATORS:  
Christopher Bell, Ph.D., Associate Professor 
 
GRADUATE AND UNDERGRADUATE STUDENT INVESTIGATOR(S):  
Taylor Ewell, Kieran Abbotts, Matthew Bomar, and Hannah Butterklee 
 
WHAT IF I HAVE QUESTIONS?    
For questions or concerns about the study, you may contact Dr. Bell at 970-491-7522 
(office) and christopher.bell@colostate.edu. For questions regarding the rights of 
research subjects, any complaints, or comments regarding the manner in which the 
study is being conducted, contact the CSU Institutional Review Board at:  
RICRO_IRB@mail.colostate.edu; 970-491-1553.   
 
CONCISE STATEMENT OF STUDY 
Lots of people, including athletes and people who like to exercise regularly, enjoy 
marijuana.  Some people believe marijuana might improve their ability to exercise.  
There are no recent, up-to-date scientific studies to suggest that this belief is right or 
wrong.  The goal of this study is to determine the influence of marijuana on exercise 
performance.  You may be eligible to participate because you: (1) are an adult male or 
female that is aged 21-40 years, (2) weigh more than 110 Lbs, (3) have exercised, on 
average, 5 or more days per week during the previous year, (4) have used cannabis 
products, including marijuana, an average of once or more per month during the 
previous year, and (5) have used a cannabis product containing a minimum of 10 mg of 
Δ9-tetrahydrocannabinol (also known as THC) without an adverse reaction.  THC is the 
ingredient in marijuana that changes the way you feel.  This study will require 5 
sessions, the first 3 sessions will take place in our lab, the final 2 at a venue of your 
choosing.  The total number of hours for participation will be approximately 6 ½ hours, 
and these will be spread over approximately 5 weeks.  Participation in the study will 
require lots of cycling exercise, and one session of cycle exercise after swallowing 
marijuana.  There are some risks to participating in this study, such as using marijuana, 
the discomfort of having blood sampled from a vein, exposure to low strength X-rays, 
and discomfort/risks associated with difficult exercise.  We hope that this research will 
benefit our understanding of how edible marijuana might influence exercise 
performance. You can find more details on this study in the body of this consent form. If 
you are interested in continued discussion about the presentation, we would like to 
discuss more with you through this consent presentation.  
 


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WHAT IS THE PURPOSE OF THIS STUDY?  
• Lots of athletes and exercisers use marijuana. 
• Many athletes appear to believe consuming marijuana prior to exercise will 
improve exercise performance. 
• There is very little scientific evidence describing the influence of marijuana on 
exercise performance. 
• The most relevant studies on this topic were completed 35-45 years ago and do 
not reflect modern marijuana behaviors nor do they utilize modern, sensitive 
physiological instruments 
 
The purpose of this study is to determine the influence of marijuana on exercise 
performance.   
 
WHY AM I BEING INVITED TO TAKE PART IN THIS RESEARCH?  
You are being asked to participate in the study because you fit these criteria: (1) Age 
21-40 years, inclusive. (2) You weigh more than 110 lbs (50 kg).  (3) You are a habitual 
user of cannabis; your average use cannabis is minimum of once per month during the 
previous year.  (4) You have previously used a cannabis product containing at least 10 
mg of THC with no adverse reaction.  (5) You are a habitual exerciser: you have 
exercised a minimum of 5 days per week, for a minimum of 30-minutes/session, during 
the previous year. 
 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?  
The study will take place in two locations.  One location is the Human Performance 
Clinical Research Laboratory (HPCRL) in the Department of Health and Exercise 
Science on the Fort Collins campus of Colorado State University.  The other location is 
a residential location of your choice.  A residential location might be the house where 
you live, or the house of a friend or member of your family.  The reason parts of the 
study will take place in a residential location is it is currently against the rules of 
Colorado State University to use marijuana on campus.      
 
This study will require 3 visits to the HPCRL and 2 study sessions in the residential 
location.  The first visit to the HPCRL will last 90 minutes.  The second visit will last 60 
minutes.  The third visit will last 60 minutes.  Each of the study sessions in the 
residential location will last approximately 60 minutes.  The total number of hours for 
participation will be approximately 6 ½ hours, spread over approximately 5 weeks.   
 
How Does COVID19 Influence Participation In This Study 
Any interaction with people outside of your own home may increase your risk of 
becoming ill with Covid19.  To promote your safety, and the safety of others in our 
research facility, you will be asked to do the following: 
 
1) The day before your visit to the Human Performance Clinical Research Laboratory 
you will receive an email or text reminding you of your appointment.  The reminder will 
also include a short list of questions specific to symptoms and behaviors linked to 
Covid19. 


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2) When you arrive at the Human Performance Clinical Research Laboratory you will be 
asked several questions specific to Covid19. 
 
3) The day before the appointment in the residential location of your choosing, you will 
receive an email or text reminding you of your appointment.  The reminder will also 
include a short list of questions specific to symptoms and behaviors linked to Covid19. 
 
4) During the entire study, the researchers will wear a mask.  You will also be asked to 
wear a mask.  You will be asked to briefly remove your mask during some of the 
research procedures (detailed below).  Whenever you are asked to remove your mask, 
you will not be within the vicinity of research staff; that is, the research staff may not be 
present in the room.     
 
WHAT WILL I BE ASKED TO DO? 
If you volunteer to participate in this study, you will be asked to do the following:  
 
SIMPLE BIG DESCRIPTION 
You will visit the Human Performance Clinical Research Laboratory on 3 different 
days.  During the 1st visit you will complete brief questionnaires about your health, 
medical history, exercise habits and cannabis use, and you will undergo measures 
of body composition, and aerobic capacity.  The next two visits will be identical and 
will involve low-to-moderate intensity cycle exercise, time trial tests (how fast you 
can ride a specific distance) and sprint tests on an exercise bike.   
 
The 4th and 5th sessions taking place in the residential location will be very, very 
similar to the 2nd and 3rd visits to the lab and will involve low-to-moderate intensity 
cycle exercise, time trial tests (how fast you can ride a specific distance) and sprint 
tests on an exercise bike.  On one day you will swallow marijuana.  On the other day 
you will swallow a placebo.  A placebo is something that has no physiological effect.  
 
DETAILED DESCRIPTION 
Visit 1: Initial Visit - Duration: Up to 90 minutes 
Questionnaires 
You will be asked to answer several questions related to your health, any illness you 
may have or have had, and medications you use or have used in the past.  You will also 
be asked about your usual exercise habits and previous use of marijuana. (Duration: 
less than 30 minutes)  
 
Pregnancy Test  
If you are female, you will be required to have a sample of your urine tested for the 
presence of human chronic gonadotropin (HCG), a hormone that indicates whether you 
may be pregnant.  This will require approximately 1 small cup of your urine. If you are 
pregnant or the test indicates that you are pregnant you will not be able to participate in 
this study. (Duration: 5 minutes)  
 


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Body Composition 
We will measure how much fat you have in your body using a test called dual energy x-
ray absorptiometry (DEXA).  The DEXA test requires you to lie quietly on a padded 
table while a small probe gives off low-level x-rays and sends them over your entire 
body.  This test gives very accurate measurements of your body fat and bone mineral 
density.  We will also measure the circumference of your waist and hip using a tape 
measure. (Duration: less than 15 minutes) 
 
Exercise Stress Test 
You will be asked to perform a vigorous exercise test.  This test will tell us if your 
heart is healthy.  You will be asked to ride an exercise cycle (cycle ergometer) for 
approximately 10-15 minutes. The exercise will become a little more difficult every 
few seconds.  While you are riding, we will measure your heart rate with an 
electrocardiogram (ECG) and your blood pressure with a cuff placed around your 
upper arm.  We will also ask you to wear a nose clip (something that stops you 
breathing through your nose) and ask you to breathe through a mouthpiece.  The 
mouthpiece/nose clip and mask will let us measure the gases you breathe and will 
allow us to calculate the highest rate of oxygen you can use while exercising.  This 
value is known as your VO2max.   
 
Visits 2 and 3 – Practice (Habituation) Visits (Each lasting 60 minutes) 
Visits 2, and 3 will be identical.   
You will be asked to ride a stationary cycle ergometer at 3 low-to-moderate workloads 
(50, 100 and 150 W) for 8 minutes each.  During this test we will measure your heart 
rate and blood pressure.  We will also ask you to wear a nose clip (something that stops 
you breathing through your nose) and ask you to breathe through a mouthpiece.  The 
mouthpiece/nose clip and mask will let us measure the gases you breathe and will allow 
us to calculate the rate of oxygen you use while exercising. 
 
After a brief break, you will be asked to ride a distance equivalent to 10-km (6 miles).  
You will be asked to do this as quickly as possible.  During this test you will be given 
lots of encouragement to ride as fast as you can.  We will also ask you how hard you 
think you are working, and we will measure your heart rate.   
 
Shortly after the time-trial, you will complete 30-seconds of very difficult cycle exercise.  
You will exercise as hard and as fast as you can.  The exercise will be like a sprint.  We 
will measure your power outputs during this exercise.    
 
Sessions 4 and 5 (Each lasting 60 minutes) 
These sessions will be very similar to Visits 2 and 3 to the lab and will be almost 
identical to each other.  These visits will take place at the residential location. 
 
Before these sessions you will be asked to buy edible cannabis from a state-
registered dispensary.  A single serving will contain 10 mg of cannabis.  Consistent 
with Colorado law, the THC potency of each product must be clearly labeled.  You 
will not be provided with money to purchase the edible cannabis; the researchers 


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will not touch the edible cannabis.  You will be asked to demonstrate that the 
packaging containing the edible cannabis is unopened.  You will be asked to provide 
the receipt from your purchase for inspection. 
 
The edible cannabis product you will be asked to buy is: 
 
Ripple Blood Orange Gummies (to be chewed) 
Typical price: $18-20 for 20 gummies (i.e. 10 servings) 
Please be aware: this product is sold in units of multiple servings; you will only be 
asked to ingest one serving (2 gummies). 
 
The researchers will buy you one cannabis-free candy snack (i.e. a fruit gummy) 
that looks and tastes similar to the marijuana product.   
 
At the start of Session 4, you will be asked to place 2 marijuana gummies (i.e. the 
equivalent of 10 mg THC) into an envelope provided by the research team.  The 
research team will place 2 cannabis-free candy snacks into an identical envelope.      
You will be provided with two sticky labels, one labeled “A” and the other “B”.  While 
blindfolded, you will be asked to secure the labels to the envelopes.  A member of the 
research team will keep a record of the key (i.e. which letters correspond to marijuana 
and placebo).  A coin toss will determine which envelope will be opened and the 
contents swallowed.  You will be responsible for keeping the remaining envelope for the 
final session (Session 5).  You will not be told during which session you swallowed 
marijuana and during which session you swallowed the fruit snack until the study is 
over.  You will be invited to guess during which session you swallowed marijuana.   
 
In order to prevent accidental overdose and/or unintentional marijuana ingestion, we 
respectfully request that you store your marijuana and study envelopes in a secure 
location away from children.  
 
Prior to Sessions 4 and 5 you will be asked to abstain from use of all products derived 
from cannabis for 96 hours (4 days), abstain from alcohol and caffeine for 24 hours, and 
abstain from vigorous exercise for 18 hours.  To standardize pre-session nutrition, 1 
hour prior to session initiation you will be asked to drink 1x350 mL bottle of a liquid meal 
(Ensure) and eat 1 x sports bar.   We will provide you with these. 
 
Before you swallow the marijuana or fruit snack, a small plastic tube will be inserted into 
a vein in your hand or wrist (i.e. a venous catheter). Your hand and forearm will be 
wrapped in a heated blanket. The tube will remain in your vein for approximately 60-
minutes.  We will sample some blood to measure how much THC and how much lactate 
(an important exercise chemical) is in your circulation. 
 
You will be asked to ride a stationary cycle ergometer at 3 low-to-moderate workloads 
(50, 100 and 150 W) for 8 minutes each.  During this test we will measure your heart 
rate and your blood pressure.  We will also ask you to wear a nose clip (something that 
stops you breathing through your nose) and ask you to breathe through a mouthpiece.  


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The mouthpiece/nose clip and mask will let us measure the gases you breathe and will 
allow us to calculate the rate of oxygen you use while exercising. 
 
After a brief break, you will be asked to ride a distance equivalent to 10-km (6 miles).  
You will be asked to do this as quickly as possible.  During this test you will be given 
lots of encouragement to ride as fast as you can.  We will also ask you how hard you 
think you are working, and we will measure your heart rate.   
 
Shortly after the time-trial, you will complete 30-seconds of very difficult cycle exercise.  
You will exercise as hard and as fast as you can.  The exercise will be like a sprint.  We 
will measure your power outputs during this exercise.    
 
Session 5 will be identical to Session 4.  These sessions will be separated by a 
minimum of 5-days.  Session 5 will be completed at approximately the same time of day 
as Session 4.  
 
Total blood collection for Session 4 will be 34 mL (approximately 7 teaspoons).  Total 
blood collection for Session 5 will be 34 mL (approximately 7 teaspoons). 
    
ARE THERE ANY BENEFITS FROM TAKING PART IN THIS STUDY?  
There may be no direct benefit to you as a participant in this study. However, we hope 
to learn more about the influence of marijuana on exercise performance.   
 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?  
Body Composition (DEXA) Scan 
The risks associated with the DEXA are very low. The maximum radiation dose you will 
receive in this study is less than 1/1000th of the federal and state occupational whole-
body dose limit allowed to radiation workers (5,000 mrem).  Put another way, the 
maximum dose from any scan we utilize with this DEXA ranges from 1.2 mrem (whole-
body scan) to 12.2 mrem (for several of the regional scans, such as lumbar, femur, and 
forearm scans).  The average annual background radiation you already receive is at 
least 620 mrem/year.  The more radiation you receive over the course of your life, the 
more the risk increases of developing a fatal cancer or inducing changes in genes.  The 
radiation in this scan is not expected to significantly increase these risks, but the exact 
increase in such risks is not known.  There are no discomforts associated with this 
procedure. Women who are or could be pregnant should receive no unnecessary 
radiation and should not participate in this study.  
 
Exercise 
There is a very slight chance of an irregular heartbeat during exercise (less than 1% of 
all subjects).  Other rare risks of a stress test are heart attack (less than 5 in 10,000) 
and even death (less than 2 in 10,000). Exercise may make you feel very tired and/or 
sick.  Exercise may also make you sore (e.g. muscle aches).  During cycle exercise the 
bike seat can be uncomfortable.  During the sprint test you might damage a muscle 
and/or tendon.  Should you get an injury during the study, you and/or your health 
insurance will be responsible for the cost of medical care.     


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Venous Catheter 
You may feel some discomfort when the needle is inserted and taped to your hand or 
wrist. In about 1 in 10 cases, a small amount of bleeding will occur under the skin that 
will cause a bruise. The risk of forming a blood clot in the vein is about 1 in 100, and the 
risk of significant blood loss is 1 in 1,000.  There is also a risk of minor and temporary 
physical and psychological distress associated with the collection of blood samples, 
including fainting. In very rare cases an infection can occur at the site of needle 
insertion. 
 
Edible Cannabis 
Cannabis might increase your heart rate and your blood pressure.  
It might also increase the risk of a having a heart attack. 
Certain chemicals in cannabis can weaken your immune system. This might make it 
more difficult for your body to fight infections. 
Cannabis might increase your risk of an allergic reaction if you already have allergies to 
foods like tomatoes, bananas, and citrus fruit.  
It is unclear if cannabis worsens chronic liver disease. While some weak evidence 
suggests that there might be a link, other evidence has not found a link. 
Using cannabis after having a stroke might increase the risk of having another stroke. 
Cannabis affects the central nervous system or the brain and nerves. It might slow the 
central nervous system too much when combined with anesthesia and other 
medications during and after surgery. 
Use of cannabis is likely to lead to an altered state of consciousness. You may feel 
"high", very happy, euphoric, relaxed, sociable, and uninhibited. 
You may experience distorted perceptions of time and space. You may feel more 
sensitive to things around you, and you may also experience a more vivid sense of 
taste, sight, smell, and hearing. 
Using cannabis might make manic symptoms worse in people with bipolar disorder. 
Cannabis use, especially frequent use, might increase the chance of getting depression. 
It can also worsen symptoms of depression and increase thoughts about suicide if you 
already have depression. 
Using cannabis might make symptoms of schizophrenia worse. 
If you currently have a job or intend to apply for a job that requires drug testing, you 
should not participate in this study. 
 
Covid19 
It is not possible to lower the risk of catching Covid19 to 0%.  Our staff have all 
completed training to try to minimize the Covid19 risk of research participation.  This 
training includes cleaning and dis-infecting research equipment and laboratory spaces, 
and wearing appropriate protective equipment (e.g. masks, gloves, and lab coats).  
Research staff will leave the room whenever you are requested to briefly remove your 
mask.   
 
 
 
 


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WILL I RECEIVE ANY COMPENSATION FOR TAKING PART IN THIS STUDY?   
You may receive up to $100 for your participation in this study. Your remuneration will 
be as follows: You will not receive remuneration for completing any of the visits to the 
HPCRL. When you complete Session 4 you will receive $40. When you complete visit 5 
you will receive $60. 
 
WHO WILL SEE THE INFORMATION THAT I GIVE? 
All information gathered in this study will be kept as confidential as possible. Your 
privacy is very important to us and the researchers will take every measure to protect it. 
Your information may be given out if required by law; however, the researchers will do 
their best to make sure that any information that is released will not identify you. No 
reference will be made in written or oral materials that could link you to this study.  For 
this study, we will assign a code to your data so that the only place your name will 
appear in our records is on the consent and in our data spreadsheet which links you to 
your code. Only the research team will have access to the link between you, your code, 
and your data. All records will be stored in a restricted access folder at CSU for three 
years after completion of the study. After the storage time, the information gathered will 
be destroyed.    
 
There are organizations that may inspect research records that may include yours. 
These organizations are required to make sure your information is kept private, unless 
required by law to provide information. Some of these organizations are: 
• 
The CSU financial management team may request an audit of research 
expenditure, in which only your participating in the research may be shared, but not 
your research data. 
• 
The Institutional Review Board, IRB, is a group of people who review the 
research with the goal of protecting the people who take part in the study. 
 
A description of this clinical trial will be available on http://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. 
 
DO I HAVE TO TAKE PART IN THE STUDY?  
Your participation in this study is voluntary. You may refuse to participate in this study or 
in any part of this study. You may withdraw at any time without prejudice to your 
relations with CSU. You are encouraged to ask questions about this study at the 
beginning or any time during the research study. 
 
 
 


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Participant Consent: 
Your signature acknowledges that you have read the information stated and voluntarily 
wish to participate in this research.  Your signature also acknowledges that you have 
received, on the date signed, a copy of this document containing _9_ pages. 
 
 
_________________________________________ 
 
_____________________ 
Signature of person agreeing to take part in the study  
 
 
Date 
 
 
_________________________________________ 
Printed name of person agreeing to take part in the study 
 
 
_______________________________________ 
 
_____________________ 
Name of person providing information to participant 
 
 
 
Date 
 
 
_________________________________________    
Signature of Research Staff providing information to participant 
 
 
 
 
 

Prot_000.pdf: 
Official Title: Influence of Edible Marijuana on Endurance Exercise Performance 
NCT Number: NCT05192239, Unique Protocol ID: 2827  
Document Date: 12/31/2022 


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#2827 - Influence of edible marijuana on endurance exercise
performance
Protocol Information
Close Comment
Thank you for informing the IRB that the work associated with this protocol is complete. To comply 
with federal regulations, please be sure to securely keep all research records, including signed 
informed consent documents, for a period of 3 years from this date.
Let us know if you have any questions. 
csu_irb@colostate.edu
Protocol Close Request Form
Close Request
Submission Type
Close Request
Review Type
--
Status
Closed
Time in Current
Status
Since January 3 – 6
months
Initial Approval Date
Nov 30, 2021
Initial Review Type
Full Board
Feedback
PROTOCOLS


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Completed Date
December 31, 1969
Summary of Findings
A manuscript was accepted for publication in the journal, Frontiers In
Physiology. Here is the title and abstract: Edible marijuana and cycle
ergometer exercise Purpose: There is extensive public and scientific interest
in the influence of cannabis and the psychoactive cannabinoid, delta-9-
tetrahydrocannabinol (THC), on exercise performance. Unfortunately, recent,
up-to-date studies are lacking. The aim of the current study was to address
the hypothesis that ingestion of edible marijuana, prior to exercise, would
have unfavorable effects on the physiological response to exercise and on
exercise performance. Methods: 17 Healthy adult male and female habitual
exercisers, who were regular users of cannabis products, were screened for
study participation. 10 were enrolled, and data from 9 [8 males, 1 female,
aged 25±3 years, with peak oxygen uptake of 56.5±11.7 ml/kg/min (mean ±
SD)] were retained. Participation included two exercise sessions, each
preceded by self-administration and ingestion of either edible marijuana
(containing 10 mg THC) or placebo. Cardio-respiratory responses (via indirect
calorimetry) to stationary cycle ergometer exercise (8 min at 50, 100 and 150
W) were recorded before completion of a 20-min Functional Threshold Power
test (FTP20) and a sprint test involving maximal effort until volitional fatigue.
Results: Edible marijuana increased the concentration of circulating THC and
THC metabolites, and evoked sensations of intoxication and altered
psychoactive state. Cardio-respiratory responses to staged cycle ergometer
exercise were normal and were unaffected by edible marijuana. Compared
with placebo, edible marijuana did not influence FTP20 (Placebo 253±75 vs
THC: 251±72 W (mean±SD); p > 0.45) or peak power output during the sprint
test (Placebo: 710±201 vs. THC: 732±136 W; p = 0.864). Conclusion: 10 mg of
THC, when ingested prior to exercise by regular exercisers and habitual users
of cannabis, had little effect on the physiological response to standardized
cycle ergometer exercise, and was neither ergogenic nor ergolytic. The
manuscript is available here: https://pubmed.ncbi.nlm.nih.gov/36545283/


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In the box below, please attach any relevant publications that resulted from the data collection
for this study, and/or any other relevant documentation that should be kept with this file.
Close Request Questions
Completed As Planned?
Yes
Please state the number of participants enrolled in this study.
17
Please state the number of participants who completed this study.
10
Please state the number of participants who withdrew from this study.
7
Were there any unanticipated problems or adverse events that were not previously reported to
the IRB?
No
General Information
Principal Investigator
Bell, Christopher


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Lead Unit
Title
Influence of edible marijuana on endurance exercise performance
People
People
Person
Home Unit
Health + Exercise Science (CO-1582)
Email Address
christopher.bell@colostate.edu
Phone
CSU Status
Researcher Role
Principal Investigator
Contact Roles
Admin
Health + Exercise Science (CO-1582)
Bell, Christopher


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Permissions
Full Access
People Attachments
Person
Home Unit
Health + Exercise Science (CO-1582)
Email Address
taylor.ewell@colostate.edu
Phone
7197611417
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Ewell, Taylor Russell


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Person
Home Unit
Health + Exercise Science (CO-1582)
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kieran.abbotts@colostate.edu
Phone
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Person
Home Unit
Health + Exercise Science (CO-1582)
Abbotts, Kieran Shay Struebin
Butterklee, Hannah Michelle


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Email Address
hannah.butterklee@rams.colostate.edu
Phone
4258989294
CSU Status
Other
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Person
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Health + Exercise Science (CO-1582)
Email Address
matt.bomar@rams.colostate.edu
Phone
6262962552
Bomar, Matthew Charles


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Contact Roles
Permissions
Full Access
People Attachments
No
Legacy eProtocol ID number
If applicable, enter the ID number this study was previously assigned in eProtocol.
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


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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?
No
Does this study include evaluation of drugs, biologics, reagents or chemicals?
No
Is this study a clinical trial?
Yes
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?
No
Study Participants
Subjects Checklist (Select All that Apply)
Adults
University students
Collaborators


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Will Colorado State serve as the Single IRB for other collaborating institutions on this study?
Yes, Colorado State University is the Single IRB for this study.
Summary and Purpose
Proposed Start Date
December 1, 2021
Proposed End Date
November 30, 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.
Lots of people, including athletes and people who like to exercise regularly,
enjoy marijuana. Some people believe marijuana might improve their ability to
exercise. There are no recent, up-to-date scientific studies to suggest that this
belief is right or wrong. The goal of this study is to determine the influence of
marijuana on exercise performance.
Describe the purpose for the proposed project.
The purpose of the proposed project is to provide athletes and the scientific
community with data pertaining to the acute influence of edible marijuana on
exercise performance, and the physiological responses to standardized
exercise. Specifically, we wish to determine: 1. The influence of edible
marijuana on cardio-respiratory and metabolic responses to standardized
cycle ergometer exercise. 2. The influence of edible marijuana on endurance
exercise (time-trial) performance.
What do the investigators hope to learn from the project?
We wish to determine if edible marijuana, ingested prior to exercise, is
ergogenic (improves performance) or ergolytic (decreases performance). We
hypothesize that edible marijuana will be ergolytic.


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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 use of cannabis derived products, including marijuana, is highly prevalent
among athletes. This use appears to be partially motivated by the belief that
marijuana may improve exercise performance. There are no convincing
scientific data to support this belief. Our study will provide athletes with
information that will allow them to make an informed decision pertaining to
the potential futility of using marijuana to improve exercise performance.
Further, use of marijuana is currently banned by the Word Anti-Doping Agency
(WADA) and there have been several high profile incidents of elite athletes
misusing marijuana and receiving potentially career-ending punishments (e.g.
US sprinter Sha'Carri Richardson). Should our hypothesis be correct, our study
may help to persuade athletes from engaging in prohibited behavior. In
addition to athletes, there is considerable scientific interest in marijuana. For
example, at the time of preparing this submission (Oct 5) our recent study in
which we described the pharmacokinetics of edible marijuana has been
accessed/reviewed over 1,300 times since publication on August 20. In
addition, the potential influence of cannabis derived products on exercise has
been a key invited topic at several recent international scientific meetings,
including the European Congress of Sports Science. In summary, we
anticipate that our study has the potential to influence decisions pertaining to
the use of marijuana made by athletes and habitual exercisers worldwide.
Further, we believe that the study will result in a publication that will be
welcomed by the scientific community and in part help address the current
paucity of up-to-date physiological information addressing a very relevant
topic.
Background


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Provide a brief overview of the relevant background. Discuss the present knowledge, appropriate
literature and rationale for conducting the research.
We have attached several scientific review papers addressing the subject of
the potential influence of marijuana on exercise performance. The main take
home messages are: - the use of marijuana by athletes of varying ages and
abilities is highly prevalent - many athletes appear to believe consuming
marijuana prior to exercise will improve exercise performance - there is very
little in the way of scientific evidence describing the influence of marijuana on
exercise performance - the most relevant studies on this topic were
completed 35-45 years ago and do not reflect modern marijuana behaviors
(e.g. smoking vs. edible marijuana, and potency/dose of marijuana) nor do
they utilize modern, sensitive physiological instruments - recent scientific
reviews conclude with pleas for up-to-date research, and acknowledgement
of the logistical difficulties of cannabis research - using our established
naturalistic (self administration) experimental model, CSU is perfectly
positioned to address the questions raised in the scientific reviews while
remaining compliant with state law and institutional rules.
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).
The Principal Investigator has been studying human physiology, including
exercise physiology, since 1988. All members of the research team
contributed to the experimental procedures and data collection in our recently
published field-based study, Pharmacokinetic Investigation of Commercially
Available Edible Marijuana Products in Humans: Potential Influence of Body
Composition and Influence on Glucose Control (Pharmaceuticals (Basel).
2021 Aug 20;14(8):817). Collectively, the research team has extensive
experience with all of the described procedures, and each of the individual
procedures have been previously approved by the CSU-IRB.
Explain your knowledge of local community attitudes and cultural norms and cultural
sensitivities necessary to carry out the research.
All members of the research team are residents of Colorado, are athletic (or
at least are habitual exercisers), and all have previous experience conducting
human physiology field-based research pertaining to marijuana consumption.


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Procedures
List all research activity procedures in which a participant will be involved, including follow-up
procedures. Please provide details.


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Procedure Description
Establishing Relevant Physiological Characteristics of Study Participants
and Habituation to Exercise Protocols. Session 1 - Overview Participants
will answer questions pertaining to health, medical history and habitual use
of marijuana. They will be assessed for body composition, maximal oxygen
uptake and electrocardiographic responses to exercise. Session 2 -
Overview The purpose of this session is to habituate the participants to the
exercise testing protocol. Habituation/familiarization with protocols
decreases within participant variability. Participants will perform
standardized stationary cycle ergometer exercise, and then complete a
performance test (time-trial). Session 3 - Overview This session will be
identical to session 2. Session 1 - Detailed description. This visit is a one
time visit with duration of ~ 90 minutes. During this visit participants will
complete the Informed Consent, provide a brief medical history, answer
questions pertaining to habitual use of marijuana, and will undergo basic
measures of body composition (height, weight, and waist and hip
circumference, and DEXA), and maximal oxygen uptake (VO2max). An
exercise stress test, with 12-lead ECG and blood pressure measurement will
also be completed. The medical history questionnaire will help identify
contra-indications to study participation. Questions pertaining to habitual
marijuana use will confirm that participants meet the inclusion criteria and
may also serve as a co-variable: it is possible that the interaction between
marijuana and exercise performance may be influenced by degree of
habitual consumption. Previously we have demonstrated that body
composition is a known physiological determinant of the resultant
circulating concentrations of cannabis-derived products following ingestion.
While not a primary outcome, DEXA data will be used as an important
statistical co-variable in our final analysis. The graded exercise stress test
with 12-lead ECG and blood pressure measurement will be used to identify
potential contraindications to study participation. The guidelines provided
by the American College of Sports Medicine pertaining to physician
supervision will be followed. During the graded exercise test, exhaled gases
will be collected in order to calculate maximal oxygen uptake (VO2max).
The VO2max measurement will characterize the endurance capacity of the
participants; this is a standard and indeed expected measurement for all
human studies of endurance exercise physiology. Session 2 - Detailed
description The purpose of this session is to habituate the participants to


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the exercise testing protocol. Habituation/familiarization with protocols
decreases within-participant variability (i.e. the day-to-day differences
between test results). Participants will perform standardized stationary
cycle ergometer exercise, and then complete a performance test (time-trial).
Standardized stationary cycle ergometer exercise will comprise 24-minutes
of cycling: 8 minutes at 50 Watts, 8 minutes at 100 Watts, and 8 minutes at
150 Watts. During this cycling heart rate and blood pressure will be
measured and recorded. Exhaled gases will be collected in order to
calculate oxygen uptake (VO2), carbon dioxide production (VCO2) and
ventilation (VE). The rationale for the chosen work rates is they represent
low-to-moderate intensity exercise, and they will provide three observations
that will be used to determine the relationship between work rate and
cardio/respiratory/metabolic responses to standardized exercise. This
information will provide insight as to the physiological responses to
controlled exercise and may explain and differences we may detect in un-
controlled, exertion driven exercise (i.e. the time-trial). The rationale for the
duration of each stage (8 minutes) is this duration is adequate for the
participants to attain steady-state physiology. Participants will then be
asked to cycle a distance equivalent to 10-km (~6 miles) as quickly as
possible, on the stationary ergometer (i.e. a laboratory based time-trial).
Previous studies have demonstrated that practice visits helps to improve
time-trial performance in subsequent tests. This type of exercise test is a
standard protocol in our lab (See Protocols 09-1363H, 10-2065H, 15-5979H,
11-2626H, 11-3032H, 13-4366H, 16-6570H, 17-7252H, etc.). Following
completion of the time-trial, participants will complete one 30-second bout
of high intensity cycle ergometer exercise (also known as a Wingate Test)
during which we will measure peak power output. This type of exercise is a
standard procedure in our lab (See Protocols 09-1124H, 09-1363H, 10-
2065H, and 15-5979H) and has been safely performed in young and older,
previously sedentary and endurance trained adults. Session 3 - This session
will be identical to session 2.
This procedure is:
Research Activity Involving Participants, Participants Data, or Biospecimens
This procedure is:
Standard of Care or Established Practice


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Where and when will this procedure take place?
These procedures will be completed during the first three study visits.
These procedures will take place in the Human Performance Clinical
Research Lab, in the Department of Health and Exercise Science, on the
main CSU Campus.
Who will conduct this procedure?
Personnel
Bell, Christopher
Personnel
Ewell, Taylor Russell
Personnel
Abbotts, Kieran Shay Struebin
Personnel
Butterklee, Hannah Michelle
Personnel
Bomar, Matthew Charles


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Indicate the frequency and duration of visits/sessions as well as the subject's total time
commitment for the study.
3 Sessions: Session 1 ~ 90 minutes. Session 2 ~ 60 minutes. Session 3 ~
60 minutes Total time commitment for the first 3 sessions = 90+60+60 =
210 minutes (3 hours 30 minutes)
Describe how the data will be collected (i.e. in person or online).
Questionnaires may be completed in advance of Session 1 online (via
email) or in-person. All other activities will be completed in person.
Will any video, photography, or audio be recorded as part of this procedure?
No
Will data be collected anonymously?
No


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Procedure Description
Physiological Responses to Standardized Exercise and Time-Trial
Performance - placebo vs. edible marijuana. Sessions 4 and 5 will comprise
two almost identical sessions that will be very similar to Sessions 2 and 3.
Primary differences will be: (1) the venue for the sessions: these will be
field-based locations. Based on our previous protocol (Protocol # 1909)
these locations will typically be residential locations chosen by the research
participants. (2) these visits will involve ingestion of either a placebo
(something that has no physiological effect) or edible marijuana. (3)
Additional procedures will include blood collection (detailed below), and
pre-session preparation (marijuana abstention, etc. - detailed below). The
need for a field-based, off-campus location is dictated by CSU rules banning
the possession of marijuana on campus. Consistent with our previously
approved protocol, the venue will be chosen by the participant (e.g. a
residential location occupied by the participant and/or friends/relatives of
the participant). To remain in compliance with state law and CSU rules, we
will follow the same procedures described in our previous protocol.
Participants will purchase their own edible marijuana from a licensed
distributor. Participants will be instructed to purchase Ripple Blood Orange
Gummies (Stillwater Brands, Commerce City, CO). Our rationale for this
product is based on our established scientific experience: from our previous
protocol (published manuscript attached) we obtained detailed
pharmacokinetic information on the rates of absorption and elimination of
this product. The dose of edible marijuana will be 10 mg of delta-9-
tetrahydrocannabinol (THC). This is considered an industry standard dose,
and was the dose studied in our previous protocol. We will purchase the
placebo. This will be a THC-free candy (Welch's Fruit Snacks (Park Ridge,
NJ). This is the placebo we used in our previous protocol. Consistent with
good science, our intention is to use a randomized, double-blind, placebo-
controlled, cross-over study design. Participants will place 2 marijuana
gummies (i.e. the equivalent of 10 mg THC) into an envelope provided by
the research team. The research team will place 2 THC-free placebo
gummies into an identical envelope. The envelopes will be sealed. The
participant will be provided with two sticky labels, one labeled “A” and the
other “B”. While blindfolded, the participant will be asked to secure the
labels to the envelopes. A member of the research team will keep a record
of the key (i.e. which letters correspond to marijuana and placebo). At no


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time will a member of the research team handle the marijuana or the
envelope containing the marijuana. A coin toss will determine which
envelope will be opened and the contents consumed. The participant will be
responsible for keeping the remaining envelope for the final session
(Session 5). Prior to Sessions 4 and 5 participants will be instructed to
abstain from use of all products derived from cannabis for 96 hours, from
alcohol and caffeine for 24 hours, and vigorous exercise for 18 hours. To
standardize pre-session nutrition, 1 hour prior to session initiation each
participant will be instructed to ingest 1x350 mL bottle of a liquid meal
(Ensure) and 1 x sports bar. These will be provided by the research team. An
intravenous catheter will be placed in a dorsal hand vein, and the hand, wrist
and forearm will be wrapped in a heated blanket. The participants will also
be instrumented for measurement of heart rate and blood pressure.
Approximately 8 mL of blood will be sampled. This will be analyzed for THC
and THC metabolites and will be used to confirm cannabis abstention.
Participants will open the randomly assigned envelope and self administer
the contents. 10 minutes later the participants will begin the standardized
stationary cycle ergometer exercise described in Session 2 and 3. The only
additional measurement will be blood lactate concentration at the end of
each 8-minute stage (requiring ~2 mL of blood per sample). After a brief (5
minutes) opportunity to stretch, drink water, etc., participants will complete
the time-trial described in Session 2 and 3. The only additional
measurement will be blood lactate concentration at the end of the trial
(requiring ~2 mL of blood) and additional blood samples taken (~8 mL)
immediately prior to and following the time trial to be analyzed for THC and
THC metabolites. This will allow us to estimate the THC exposure during
the exercise time trial. Finally, after a brief (5 minutes) opportunity to
stretch, drink water, etc., participants will complete the 30-second cycle
ergometer sprint described in Session 2 and 3. Blood lactate will be
determined 5-minutes following the completion of the sprint. Session 5 will
be identical to Session 4. These sessions will be separated by a minimum
of 5-days. To minimize the influence of circadian variation, Session 5 will be
completed at approximately the same time of day as Session 4. Total blood
collection for Session 4 will be 34 mL. Total blood collection for Session 5
will be 34 mL.


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This procedure is:
Research Activity Involving Participants, Participants Data, or Biospecimens
This procedure is:
Standard of Care or Established Practice
Where and when will this procedure take place?
Two almost identical sessions (Sessions 4 and 5). These will be field-based
locations. Based on our previous protocol (Protocol # 1909) these locations
will typically be residential locations chosen by the research participants.
Who will conduct this procedure?
Personnel
Bell, Christopher
Personnel
Ewell, Taylor Russell
Personnel
Abbotts, Kieran Shay Struebin
Personnel
Butterklee, Hannah Michelle
Personnel
Bomar, Matthew Charles


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Indicate the frequency and duration of visits/sessions as well as the subject's total time
commitment for the study.
Both sessions will last approximately 90 minutes.
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
Will data be collected anonymously?
No
Privacy and Confidentiality
Explain how the established data management plan along with consent processes and other
elements of the research design address the 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 will be given the opportunity to respond to the screening
questionnaire via email, from a location of their choosing, or in person, in a
private interview room in the Human Performance Clinical Research Lab. The
information provided by the participants will include pertinent medical history.
We believe the risk/benefit of providing this information is appropriate in
order to identify potential contra-indications for study participation (see
exclusion criteria) and minimize the risk of an adverse event. The first three
study visits will take place in a private/secure research space within the
Human Performance Clinical Research Lab; only members of the research
team will have access to this space during the subjects' visits.


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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.
Participants will be identified only on a signed consent form and initial
screening form that will be kept locked and separate from other research
data. Each subject will be assigned a randomly generated 8-locked and
separate from other research data. Each subject will be assigned a randomly
generated 8-character code (e.g. 12698afd) that will be used to identify them
in association with all other research data and blood or tissue samples.
Records identifying individuals will be kept in Dr. Bell’s office/laboratory in a
locked cabinet and will be destroyed (shredded) following
completion/publication of the project.
Biospecimens
Identify which type(s) of biospecimens will be used as part of this research project:
Blood
Are the specimens known to be diseased or dangerous
No
Will tissues be stored for future research projects? 
No
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
Pending


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IBC Agent Approval Request Form (AARF)# or pending  
N/A
For more information or support, contact the CSU IBC at: RICRO_IBC@colostate.edu
Clinical Trial
Will participants will be prospectively assigned to one or more interventions (including placebo
or other control)? 
Yes
Will the study evaluate the effects of the intervention on health-related outcomes (biomedical or
behavioral)?
Yes
Does this study involve an FDA-regulated drug or device? 
No
Will the study be conducted as a 
Single-Site Clinical Trial
Will this study be posted on ClinicalTrials.gov?
Yes
ClinicalTrials.gov Registration# (or pending)
Pending
Additional information and support available through CSU Quality Assurance:
RICRO_QA@colostate.edu
Participant Population


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Are you interacting or intervening with participants? 
Yes
Provide an estimate of the anticipated participant total.
30
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
Age 21-40 years, inclusive Body mass greater than 110 lbs (50 kg) Habitual
user of cannabis; average use cannabis is minimum of once per month during
the previous year Prior use of cannabis product containing at least 10 mg of
THC with no adverse reaction Habitual exerciser: exercised a minimum of 5
days per week, for a minimum of 30-minutes/session, during the previous
year.
Please list all exclusion criteria
Identification of a contra-indication to exercise during a 12-lead exercise
stress test. Pregnant or trying to become pregnant. Breastfeeding. Recipient
of treatment for psychotic or bipolar disorder during the previous 2 years
Recipient of treatment for Schizophrenia during the previous 2 years Planned
surgery scheduled within 2-weeks of study participation
What is the rationale for studying the requested group(s) of participants?
Rationale for the inclusion criteria: Legal age limit for cannabis use in
Colorado is 21 years. Body mass greater than 50 kg to remain compliant with
IRB for repeated blood sampling. Habitual use of cannabis and prior use of
cannabis containing 10 mg of THC: we wish to avoid potential side-effects
and unpredictable reactions associated with first-time cannabis use. Habitual
exerciser: this study will be most relevant to athletes and people regularly
engage in exercise, thus we will recruit people who best fit this description.


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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. 
See Attached Questionnaire. Potential participants will be screened prior to
consent and enrollment. We will ask a series of questions in a phone or in-
person interview at the discretion of the participant. All willing individuals that
meet the enrollment criteria will be eligible to participate.
Recruitment Process
Describe the procedures for identifying and recruiting potential research subjects or requesting pre-
existing data or materials. 
Participant Group Descriptor
Adult males and females who are habitual exercisers and habitual users of
cannabis.
Please describe the recruitment process:
Direct advertising Referrals Organization mailing lists
Planned Subject Identification Methods
Direct advertising
Referrals
Organization mailing lists
Will a specific agency or institution provide access to prospective subjects?  
No
Please select the recruitment personnel
Bell, Christopher
Ewell, Taylor Russell


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Abbotts, Kieran Shay Struebin
Butterklee, Hannah Michelle
Bomar, Matthew Charles
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
Email
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?
$100


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Describe the remuneration plan.
Participants will not receive remuneration for Sessions 1-3. Participants will
be paid $40 on completion of Session 4, and $60 on completion of Session 5.
Typically, the information provided from Session 1 is a motivational factor for
participants who are habitual exercisers. An equivalent "fitness assessment"
might cost $200-300, or more. Sessions 2 and 3 are essentially supervised
workouts.
Will a 1099 be issued?
No
Will participants incur any costs to participate in this research?
Yes
Explain. This should be clearly outlined in the consent form.
To remain compliant with state law and university regulations, study
participants must purchase their own marijuana. The typical price for Ripple
Blood Orange Gummies is $18-20 for 20 gummies. The product is sold in
units of multiple servings. This is clearly outlined in the consent form.
Risks and Benefits
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 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


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Please describe.
Venous Blood Sampling Minor discomfort of having the needle inserted and
taped to an hand/wrist. In about 1 in 10 cases, a small amount of bleeding
will occur under the skin that will cause a bruise. The risk of forming a blood
clot in the vein is about 1 in 100, and the risk of significant blood loss is 1 in
1,000. Body Composition The risks associated with the DEXA are very low.
The maximum radiation dose subjects will receive in this study is less than
1/3000th of the federal and state occupational whole body dose limit allowed
to radiation workers. Put another way, subjects will receive less than 1.3
mrem from this scan and they already receive approximately 450 mrem /year
from normal background radiation dose in Colorado. The more radiation one
receive over the course of one's life, the more the risk increases of developing
a fatal cancer or inducing changes in genes. The radiation dose subjects
receive from this scan is not expected to significantly increase these risks,
but the exact increase in such risks is not known. There are no discomforts
associated with this procedure. Women who are or could be pregnant should
receive no unnecessary radiation and should not participate in this study.
Exercise Stress Test, Time-Trial and Wingate Test There is a very small
chance of an irregular heartbeat during exercise (< 1% of all subjects). Other
rare risks of a stress test are heart attack (< 5 in 10,000) and death (<2 in
10,000). Wearing a mouthpiece and nose-clip can sometimes cause dryness
in the mouth and mild discomfort. Exercise can make people feel very tired.
Very difficult exercise might make people feel dizzy or queasy; people may
faint or vomit. Further, very difficult exercise performed by people who don't
usually exercise is likely to induce considerable muscle soreness and
increase the risk of minor musculoskeletal injuries (sprains and strains).
Ingestion of Edible Cannabis (From WebMD and Drugs.com) (also see
"Psychological Well-Being) Cannabis might cause fast heartbeat and high
blood pressure. It might also increase the risk of a having heart attack.
Certain chemicals in cannabis can weaken the immune system. This might
make it more difficult for the body to fight infections. Cannabis might
increase the risk of an allergic reaction in people with allergies to foods like
tomatoes, bananas, and citrus fruit. It is unclear if cannabis worsens chronic
liver disease. While some weak evidence suggests that there might be a link,
other evidence has not found a link. Using cannabis after having a stroke
might increase the risk of having a second stroke. Cannabis affects the
central nervous system or the brain and nerves. It might slow the central


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nervous system too much when combined with anesthesia and other
medications during and after surgery.
Are there risks associated with psychological well-being?
Yes
Please describe.
Ingestion of Edible Cannabis (From WebMD and Drugs.com) (also see
"Physical Well-Being) Use of cannabis is likely to lead to an altered state of
consciousness. The user may feel "high", very happy, euphoric, relaxed,
sociable and uninhibited. The user may experience distorted perceptions of
time and space. The user may feel more sensitive to things around them, and
may also experience a more vivid sense of taste, sight, smell and hearing.
Using cannabis might make manic symptoms worse in people with bipolar
disorder. Cannabis use, especially frequent use, might increase the chance of
getting depression. It can also worsen symptoms of depression and increase
thoughts about suicide in those that already have depression. Using cannabis
might make symptoms of schizophrenia worse.
Are there risks associated with economic well-being, including employability?
Yes
Please describe.
Participants wishing to seek/maintain employment with institutes that
frequently perform drug testing should not participate. Given that the
participants will all be habitual users of cannabis, this risk is low and the
situation unlikely.
Are there risks associated with social well-being, including reputational risks?
No


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Describe how the benefits of the research justify the likely risks to participants.
The use of cannabis by athletes is widespread. Many athletes believe
cannabis may improve their performance during training and competition.
There are no up-to-date data to support these beliefs. Our study will inform
athletes and others considering cannabis use in conjunction with exercise of
the actual effects and determine whether cannabis/marijuana is ergogenic
(less likely) or ergolytic (more likely).
Describe direct research benefits to the participants, if any.
If the participants fall into the category of athletes/exercisers who use
cannabis prior to and/or during exercise, they will learn if/how if affects their
performance and their physiological response to exercise.
Describe the indirect research benefits to society.
Our study will address a knowledge gap identified by several independent
scientific groups; thus the proposed project is a response to
recommendations for future research. The general public may benefit from
the ability to make informed decisions as to the interaction between exercise
and cannabis.
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. 
 
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.


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How will the data be stored and backed up during the research?
As per advice provided by the IRB during previous protocol reviews, we will
employ the 3-2-1 approach to data management. Specifically, our data are
stored on a password protected PC within the lab, on a secure on-campus
server maintained (and backed up) by our college, and on a secure external
(off-campus) server (OneDrive). The data are typically stored as an Excel file,
but also as a csv file (i.e. in a format not dependent on the availability of a
specific platform (OS) or software edition.
Who will be responsible for data and access management, and
security?
Data Access Responsibility
Bell, Christopher
Data Access Responsibility
Ewell, Taylor Russell
Data Access Responsibility
Abbotts, Kieran Shay Struebin
Data Access Responsibility
Butterklee, Hannah Michelle
Data Access Responsibility
Bomar, Matthew Charles
Who will have access to study records or
specimens?
Personnel
Bell, Christopher


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Personnel
Ewell, Taylor Russell
Personnel
Abbotts, Kieran Shay Struebin
Personnel
Butterklee, Hannah Michelle
Personnel
Bomar, Matthew Charles
Will any external personnel have access to study records or specimens?
No
How will you share the data?
There are no plans/needs to share data at this time.
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.
Yes
Destruction Date
December 31, 2026


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What is the long-term preservation plan for the dataset?
Study data and consent documents will be kept for a minimum of three (3)
years after the completion of the study by the PI. Following which hard
(paper) copies will be shredded, and electronic records containing identifying
information deleted. Study data and consent documents will be kept for a
minimum of three (3) years after the completion of the study by the PI. Data
records will be kept in Dr. Bell’s oece/laboratory in a locked cabinet. Only the
research team will have direct access to the data. If required, data maybe
released to governmental entities authorized to inspect research records.
Specimens will be kept in a secure space within the Human Performance
Clinical Research Lab; only members of the HPCRL will have access to this
space.
Do you intend to deposit your research data/specimens into a repository for future use? 
No
Consent/Assent
Consent
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


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Bell, Christopher
Ewell, Taylor Russell
Abbotts, Kieran Shay Struebin
Butterklee, Hannah Michelle
Bomar, Matthew Charles
No
Are you requesting a waiver of documentation of consent?
No
Consent
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
Bell, Christopher
Personnel
Ewell, Taylor Russell


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Personnel
Abbotts, Kieran Shay Struebin
Personnel
Butterklee, Hannah Michelle
Personnel
Bomar, Matthew Charles
Which participant group is this consent process for?
All participants.
How is consent being obtained?
Whenever possible, participants are provided with a copy of the informed
consent in advance (usually via email) for review at their convenience.
During the actual in-person consent process, research team members
review the form line-by-line, ask the participant questions ascertain correct
comprehension, answer questions posed by the participant, and obtain
written signatures.
Will non-English speaking participants be enrolled?  
No
Non-English speaking participants will be unable to provide informed
consent.
Are any subjects unable to legally provide consent?
No
Conflict of Interests


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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.


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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
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


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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
Other
Attachment
Name
Cannabis and Athletic Performance
Attachment Type
Other
Attachment
Name
Cannabis and Exercise Performance
CANNABIS ATHLETIC PERFORMANCE.PDF
CANNABIS EXERCISE PERFORMANCE GATORADE.PDF


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Attachment Type
Other
Attachment
Name
Marijuana and Maximal Exercise
Attachment Type
Other
Attachment
Name
PK Edible Marijuana - CSU Study
Attachment Type
Recruitment Materials
Attachment
Name
Recruitment Flyer
Attachment Type
Recruitment Materials
ACUTE EFFECTS OF MARIHUANA SMOKING ON MAXIMAL EXERCISE PERFORMANCE.PDF
PHARMACOKINETIC INVESTIGATION OF COMMERCIALLY AVAILABLE EDIBLE
MARIJUANA.PDF
2827 RECRUITMENT FLYER.DOCX


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Attachment
Name
Recruitment email
Attachment Type
Screening Tool or Procedure
Attachment
Name
2827 Screening Form
Attachment Type
Other
Attachment
Name
Cannabis Use and Sport
Attachment Type
Consent
Attachment
2827 RECRUITMENT EMAIL.DOCX
2827 SCREENING FORM 10072021.DOCX
CANNABIS USE AND SPORT.PDF
2827 CONSENT 102721.DOCX


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Name
Consent - Revised and Updated Oct 27
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 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.


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Administrative Details Form
Determinations
Review Type
Study Status

SAP_001.pdf: 
Cover Page for ClinicalTrials.gov 
Document: 
Statistical Analysis Plan 
Official Study Title: 
Influence of Edible Marijuana on Endurance Exercise Performance 
NCT Number:  
NCT05192239 
Document Date:        
December 5, 2022 


Statistical Analysis Plan 
 
All data, unless otherwise stated, are expressed as mean and standard deviation. To compare 
baseline values between placebo and edible marijuana for circulating concentrations of THC, 
and THC metabolites, one-way analysis of variance (placebo vs edible marijuana) was used, 
unless a non-parametric equivalent (i.e. one way analysis of variance on ranks) was required on 
account of unequal variance. The standardized exercise statistical analysis was conducted in R 
(R Core Team; Vienna, Austria) as linear mixed models using the Lmer and LmerTest packages 
(Bates et al., 2015), and Emmeans package was used for post hoc Tukey testing to explore main 
effects and interactions. Time and Condition were considered fixed effects, whereas Subject 
was considered a random effect to account for the repeated measures. Unlike an electrically 
braked ergometer, it is not feasible to externally fix the work rate on an air braked ergometer; 
the actual work rate is determined by the damper setting and the participant’s pedal cadence. 
During the standardized exercise test, participants were instructed to exercise at 50, 100 and 
150 W. Accordingly, for statistical analysis of these data, work rate error, defined as the 
difference between the prescribed work rate and the actual work rate, was considered as a 
covariate in our model. One- and two-way analysis of variance, with repeated measures, were 
employed to detect differences among variables during the performance of the FTP20 and in 
the sprint to fatigue tests using SigmaPlot 14.5 (Systat Software Inc., San Jose, California). 
Specifically, one-way repeated measures ANOVA was used to compare mean work rate 
(placebo vs edible marijuana). Two-way ANOVA with repeated measures (time) was used to 
compare power outputs across consecutive stages (placebo vs edible marijuana). One-way 
repeated measures ANOVA was used to compare mean power, peak power, time to fatigue, 
and total work done (placebo vs edible marijuana) during the sprint to fatigue tests. 
Significance was defined as p < 0.05. Wherever a significant difference was detected, a post-hoc 
Tukey test was utilized to further explore these differences.