Endurance ExerciseEarly Phase 1NCT05192239
Influence of Edible Marijuana on Endurance Exercise Performance
A Early Phase 1 study testing THC 5 in people with Endurance Exercise, run by Christopher Bell at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Endurance Exercise
- What is being tested?
- THC 5
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 19 Jul 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the age of 21 and 40.
- Weigh more than 110 pounds
- Habitual user of cannabis; average use of THC 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this 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.
Read the 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.
- Conditions
- Endurance Exercise
- Being tested
- THC 5, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THC 5Drug
Also called Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).
5 milligrams of THC in gummy form
PlaceboDrug
Also called Welch Fruit Snack
Commercially available non-THC fruit snack
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Delta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. Receives: Drug: Placebo |
| 10 mg THC | Active comparator | Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. Receives: Drug: THC 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula.
Measured: Blood was collected at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts), and 24 minutes (150 watts) for analysis of blood lactate.
Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.Heart rate will be collected during standard graded exercise following ingestion of placebo or active formula (10mg THC in the form of two 5mg gummies).
Measured: Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts)
Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.During standard exercise, participants will be asked to report Rating of Perceived Exertion (RPE) on a scale from 6-20 (6 is no exertion and 20 is maximal exertion) during a graded standard exercise test following ingestion of placebo or active formula.
Measured: RPE was reported and averaged for each intensity stage at timepoints 0 minutes- 4 minutes (0 watts), 8 minutes-12 minutes (50 watts), 16 minutes-20 minutes (100 watts), and 24 minutes (150 watts).
Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsVO2 will be collected during graded standard exercise following ingestion of placebo or active formula. Expired gasses were measured and averaged during three time points, 5-8 minutes, 13-16 minutes, and 21-24 minutes. Gasses were not collected or recorded outside of those timeframes.
Measured: Expired gasses were measured and averaged during three time points, 5-8 minutes (50 Watts), 13-16 minutes (150 Watts), and 21-24 minutes (150 Watts).
Comparison of Maximal Mean Power Output to Placebo
Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula
Measured: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
Comparison of Time to Exhaustion to Placebo
Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise
Measured: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start9 Dec 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endurance ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192239
- Sponsor's protocol ID
- 2827
- Status last verified
- Apr 2024
- First submitted
- 31 Dec 2021
- Last updated
- 22 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Edible Marijuana on Endurance Exercise Performance
- ClinicalTrials.gov ID
- NCT05192239
- Acronym / sponsor ID
- 2827
- Conditions
- Endurance Exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Posted 22 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either placebo or intervention separated by a 4 day wash-out period.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDelta-9-tetrahydrocannabinol (THC) free fruit snack gummy. One time, two gummies will be ingested prior to an exercise bout. |
| 10 mg THC | Active comparator | Drug: THC 5Delta-9-tetrahydrocannabinol (THC) 5 milligrams (mg) in gummy form. One time, two gummies will be ingested prior to an exercise bout. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the age of 21 and 40.
- Weigh more than 110 pounds
- Habitual user of cannabis; average use of THC 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC 5Also: Ripple Blood Orange Gummies (Stillwater Brands, Commerce City, CO).5 milligrams of THC in gummy form | Drug | 10 mg THC |
| PlaceboAlso: Welch Fruit SnackCommercially available non-THC fruit snack | Drug | Placebo |
Primary outcome
Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Time frame: Blood was collected at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts), and 24 minutes (150 watts) for analysis of blood lactate.
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions. Blood will be collected to determine Blood Lactate Levels during standard exercise following ingestion of placebo or active formula.
Comparison of Heart Rate During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Time frame: Heart rate was measured at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts) and 24 minutes (150 watts)
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.Heart rate will be collected during standard graded exercise following ingestion of placebo or active formula (10mg THC in the form of two 5mg gummies).
Comparison of Rating of Perceived Exertion (RPE) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Time frame: RPE was reported and averaged for each intensity stage at timepoints 0 minutes- 4 minutes (0 watts), 8 minutes-12 minutes (50 watts), 16 minutes-20 minutes (100 watts), and 24 minutes (150 watts).
Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.During standard exercise, participants will be asked to report Rating of Perceived Exertion (RPE) on a scale from 6-20 (6 is no exertion and 20 is maximal exertion) during a graded standard exercise test following ingestion of placebo or active formula.
Comparison of Indirect Calorimetry (VO2) During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo.
Time frame: Expired gasses were measured and averaged during three time points, 5-8 minutes (50 Watts), 13-16 minutes (150 Watts), and 21-24 minutes (150 Watts).
Separated by a minimum of a 4 day washout period between randomized crossover coded interventionsVO2 will be collected during graded standard exercise following ingestion of placebo or active formula. Expired gasses were measured and averaged during three time points, 5-8 minutes, 13-16 minutes, and 21-24 minutes. Gasses were not collected or recorded outside of those timeframes.
Comparison of Maximal Mean Power Output to Placebo
Time frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions
Mean maximal power will be measured over 20 minutes following ingestion of placebo or active formula
Comparison of Time to Exhaustion to Placebo
Time frame: Separated by a minimum of a 4 day washout period between randomized crossover coded interventions.
Cycling until Time to Exhaustion in seconds following ingestion of placebo or active formula during high intensity exercise
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to Published ManuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing THC 5 in people with Endurance Exercise, run by Christopher Bell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Blood Lactate Levels During a 24 Minute Graded Standard Exercise Test (50 Watts, 100 Watts, and 150 Watts) to Placebo. (time frame: Blood was collected at timepoints 0 minutes (0 watts), 8 minutes (50 watts), 16 minutes (100 watts), and 24 minutes (150 watts) for analysis of blood lactate.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.