Delayed Onset Muscle Soreness (DOMS)Phase 2NCT05026164
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
A Phase 2 study testing CHI-202 and CHI-101 in people with Delayed Onset Muscle Soreness (DOMS), run by Canopy Growth Corporation at 1 site in United States.
Trial summary
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness (DOMS)
- What is being tested?
- CHI-202 and CHI-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2021to 4 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is a healthy adult aged 18-65 years, inclusive, at the time of screening.
- Is exercise-trained, i.e., self-reports exercising at least 3 times per week for at least 30 minutes per session for the past year.
- Has a body mass index between 18 and 35 kg/m2 (inclusive).
- Is judged by the Investigator to be in generally good health at screening based on participants' self-reported medical history.
- Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
Who cannot join
- Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
- Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.
- Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
- Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the month prior to the Exercise Visit.
- Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
- Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).
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- Has musculoskeletal issues that might impede performing maximal elbow flexion exercises.
- Has taken a medication with likely CBD-interactions, including warfarin, clobazam, valproic acid, phenobarbital, mTOR inhibitors, oral tacrolimus, and St. John's Wort within 30 days of the Exercise Visit or during the study.
- Has taken grapefruit products and/or Seville oranges within the 7 days prior to dosing with study IP.
- Has used cannabis, synthetic cannabinoid or cannabinoid analogues (e.g., dronabinol, nabilone), hemp products, synthetic cannabinoid receptor agonists (e.g., spice, K2), or any CBD- or THC-containing product (e.g., Sativex, Epidiolex) within 4 weeks of the Exercise Visit or during the study.
- Has a history or current diagnosis of a significant psychiatric disorder that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.
- Endorses current suicidal intent.
- Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.
- Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.
- Has a positive result on urine drug screen for cocaine, amphetamine, methamphetamine, THC, and opiates at the first study visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
International Society for Sports Nutrition
Boca Raton, Florida, 33432
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
Read the detailed description
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3 times per week for at least 30 minutes per session for the past year) will be recruited from existing panels of participants from past studies, local advertisements, and social media targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a given exercise, will be used in order to induce DOMS. Following the completion of the Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2, and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP to which they have been randomly assigned (i.e., active or placebo) with instruction to consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.
- Conditions
- Delayed Onset Muscle Soreness (DOMS)
- Being tested
- CHI-202, CHI-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHI-202Dietary supplement
Blend of cannabinoids \& other ingredients
CHI-101Dietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | CHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily. Receives: Dietary Supplement: CHI-202 |
| Placebo | Placebo comparator | CHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily. Receives: Dietary Supplement: CHI-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Blood pressure is measure by the combination of systolic and diastolic measurements
Measured: Day 2
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Blood pressure is measure by the combination of systolic and diastolic measurements
Measured: Day 3
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Blood pressure is measure by the combination of systolic and diastolic measurements
Measured: Day 4
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Respiratory rate will be measured as breaths per minute
Measured: Day 2
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Respiratory rate will be measured as breaths per minute
Measured: Day 3
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Respiratory rate will be measured as breaths per minute
Measured: Day 4
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Heart rate will be measured as heart beats per minute
Measured: Day 2
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Heart rate will be measured as heart beats per minute
Measured: Day 3
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Heart rate will be measured as heart beats per minute
Measured: Day 4
Total number of Adverse Events [Safety and Tolerability]
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Measured: Through study completion (Day 4)
Total number of participants with Adverse Events [Safety and Tolerability]
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Measured: Through study completion (Day 4)
Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
Safety and tolerability will be assessed through Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed)
Measured: Through study completion (Day 4)
Secondary outcomes (61)
Average soreness or discomfort intensity using the 11-point (0-10) NRS
Self-reported average soreness or discomfort intensity using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 1 - post DOMS intervention
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 2
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 3
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average soreness or discomfort intensity over the last 24 hours using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 4
Worst soreness or discomfort intensity using the 11-point (0-10) NRS
Self-reported worst soreness or discomfort intensity using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 1 - post DOMS intervention
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 2
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 3
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity
Measured: Day 4
Average stiffness intensity using the 11-point (0-10) NRS
Self-reported average stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 1 - post DOMS intervention
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 2
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 3
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 4
Worst stiffness intensity using the 11-point (0-10) NRS
Self-reported worst stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 1 - post DOMS intervention
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 2
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 3
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity
Measured: Day 4
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 2
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 3
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 4
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 2
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 3
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Self-reported interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS where 10 is most interference
Measured: Day 4
Self-reported sleep quality using the 11-point (0-10) NRS
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
Measured: Day 2
Self-reported sleep quality using the 11-point (0-10) NRS
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
Measured: Day 3
Self-reported sleep quality using the 11-point (0-10) NRS
Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality
Measured: Day 4
Self-reported sleep duration via a sleep diary
Self-reported sleep duration measured in minutes via a sleep diary
Measured: Day 2
Self-reported latency to sleep onset via a sleep diary
Self-reported latency to sleep onset measured in minutes via a sleep diary
Measured: Day 2
Self-reported sleep continuity via a sleep diary
Self-reported sleep continuity measured in minutes via a sleep diary
Measured: Day 2
Self-reported alertness upon waking via a sleep diary
Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
Measured: Day 2
Self-reported sleep duration via a sleep diary
Self-reported sleep duration measured in minutes via a sleep diary
Measured: Day 3
Self-reported latency to sleep onset via a sleep diary
Self-reported latency to sleep onset measured in minutes via a sleep diary
Measured: Day 3
Self-reported sleep continuity via a sleep diary
Self-reported sleep continuity measured in minutes via a sleep diary
Measured: Day 3
Self-reported alertness upon waking via a sleep diary
Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
Measured: Day 3
Self-reported sleep duration via a sleep diary
Self-reported sleep duration measured in minutes via a sleep diary
Measured: Day 4
Self-reported latency to sleep onset via a sleep diary
Self-reported latency to sleep onset measured in minutes via a sleep diary
Measured: Day 4
Self-reported sleep continuity via a sleep diary
Self-reported sleep continuity measured in minutes via a sleep diary
Measured: Day 4
Self-reported alertness upon waking via a sleep diary
Self-reported alertness upon waking via a sleep diary. Alertness is measure on a scale of 1 to 3 where 1 is Alert, 2 is Alert but a little tired and 3 is Sleepy
Measured: Day 4
Pressure threshold
Pressure threshold measured with a 25-lb algometer
Measured: Day 1 - post DOMS intervention
Pressure threshold
Pressure threshold measured with a 25-lb algometer
Measured: Day 2
Pressure threshold
Pressure threshold measured with a 25-lb algometer
Measured: Day 3
Pressure threshold
Pressure threshold measured with a 25-lb algometer
Measured: Day 4
Relaxed elbow angle
Relaxed elbow angle measured with a goniometer in degrees
Measured: Day 1 - post DOMS intervention
Active range of motion
Active range of motion measured with a goniometer in degrees
Measured: Day 1 - post DOMS intervention
Passive range of motion
Passive range of motion measured with a goniometer in degrees
Measured: Day 1 - post DOMS intervention
Relaxed elbow angle
Relaxed elbow angle measured with a goniometer in degrees
Measured: Day 2
Active range of motion
Active range of motion measured with a goniometer in degrees
Measured: Day 2
Passive range of motion
Passive range of motion measured with a goniometer in degrees
Measured: Day 2
Relaxed elbow angle
Relaxed elbow angle measured with a goniometer in degrees
Measured: Day 3
Active range of motion
Active range of motion measured with a goniometer in degrees
Measured: Day 3
Passive range of motion
Passive range of motion measured with a goniometer in degrees
Measured: Day 3
Relaxed elbow angle
Relaxed elbow angle measured with a goniometer in degrees
Measured: Day 4
Active range of motion
Active range of motion measured with a goniometer in degrees
Measured: Day 4
Passive range of motion
Passive range of motion measured with a goniometer in degrees
Measured: Day 4
Muscle circumference
Muscle circumference
Measured: Day 1 - post DOMS intervention
Muscle circumference
Muscle circumference
Measured: Day 2
Muscle circumference
Muscle circumference
Measured: Day 3
Muscle circumference
Muscle circumference
Measured: Day 4
Mood using the Profile of Mood States
Mood using the Profile of Mood States
Measured: Day 1 - post DOMS intervention
Mood using the Profile of Mood States
Mood using the Profile of Mood States
Measured: Day 2
Mood using the Profile of Mood States
Mood using the Profile of Mood States
Measured: Day 3
Mood using the Profile of Mood States
Mood using the Profile of Mood States
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Dec 2021
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset Muscle Soreness (DOMS)Studies 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
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erica Peters, PhD, Study director, Canopy Growth Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026164
- Sponsor's protocol ID
- 710US-1311
- Status last verified
- Feb 2022
- First submitted
- 26 Jul 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
- ClinicalTrials.gov ID
- NCT05026164
- Acronym / sponsor ID
- 710US-1311
- Conditions
- Delayed Onset Muscle Soreness (DOMS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
Detailed description
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS). Healthy adults ages 18-65 years who are exercise-trained (self-report exercising at least 3 times per week for at least 30 minutes per session for the past year) will be recruited from existing panels of participants from past studies, local advertisements, and social media targeted advertisements. Those who meet the inclusion/exclusion criteria will be enrolled into the study, scheduled for the Exercise Visit (Study Visit 1; Day 0) within 2 weeks of screening, and randomized to active vs. placebo IP condition in a 1:1 ratio. One repetition maximum (1RM) method, the maximum amount of weight one can lift in a single repetition for a given exercise, will be used in order to induce DOMS. Following the completion of the Exercise Visit, participants will be scheduled for 3 follow-up visits that will occur 1, 2, and 3 days post-Exercise Visit. Participants will consume 7 scheduled doses of the study IP to which they have been randomly assigned (i.e., active or placebo) with instruction to consume the study IP prior to the exercise at Study Visit 1, at 8PM (±1 hour) that night, and then at 8AM and 8PM (±1 hour) every day until their final study visit. The last dose will occur at 8AM (±1 hour) on Day 4, i.e., immediately prior to Study Visit 4.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: CHI-202CHI-202. Participants will drink one 7.0g CHI-202 powder sachet mixed into 16oz of water twice daily. |
| Placebo | Placebo comparator | Dietary Supplement: CHI-101CHI-101. Participants will drink one 7.0g CHI-101 powder sachet mixed into 16oz of water twice daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is a healthy adult aged 18-65 years, inclusive, at the time of screening.
- Is exercise-trained, i.e., self-reports exercising at least 3 times per week for at least 30 minutes per session for the past year.
- Has a body mass index between 18 and 35 kg/m2 (inclusive).
- Is judged by the Investigator to be in generally good health at screening based on participants' self-reported medical history.
- Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.
Key exclusion criteria (15 listed)
- Women who are pregnant, lactating, breastfeeding, or planning a pregnancy.
- Women of childbearing potential, or men who are sexually active with a woman of childbearing potential, who are unwilling or unable to use an acceptable method of contraception (abstinence or the use of a highly effective method of contraception, including hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, vasectomy, or intrauterine device) from at least 21 days prior to the first dose of study medication until 28 days after the last dose of study medication.
- Has a history of epilepsy, hepatitis, clinically significant hepatic or renal impairment, or human immunodeficiency virus.
- Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the month prior to the Exercise Visit.
- Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.
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 |
|---|---|---|
| CHI-202Blend of cannabinoids \& other ingredients | Dietary supplement | Active |
| CHI-101Placebo | Dietary supplement | Placebo |
Primary outcome
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time frame: Day 2
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time frame: Day 3
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability]
Time frame: Day 4
Blood pressure is measure by the combination of systolic and diastolic measurements
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time frame: Day 2
Respiratory rate will be measured as breaths per minute
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time frame: Day 3
Respiratory rate will be measured as breaths per minute
Changes from baseline in respiratory rate (breaths per minute) [Safety and Tolerability]
Time frame: Day 4
Respiratory rate will be measured as breaths per minute
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time frame: Day 2
Heart rate will be measured as heart beats per minute
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time frame: Day 3
Heart rate will be measured as heart beats per minute
Changes from baseline in heart rate (beats per minute) [Safety and Tolerability]
Time frame: Day 4
Heart rate will be measured as heart beats per minute
Total number of Adverse Events [Safety and Tolerability]
Time frame: Through study completion (Day 4)
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Total number of participants with Adverse Events [Safety and Tolerability]
Time frame: Through study completion (Day 4)
Safety and tolerability will be assessed through Adverse Events and Serious Adverse Events
Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed) [Safety and Tolerability]
Time frame: Through study completion (Day 4)
Safety and tolerability will be assessed through Compliance with IP consumption (total # of self-reported doses consumed/maximum of 7 total possible doses consumed)
61 secondary outcomes
Average soreness or discomfort intensity using the 11-point (0-10) NRS
Time frame: Day 1 - post DOMS intervention
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Worst soreness or discomfort intensity using the 11-point (0-10) NRS
Time frame: Day 1 - post DOMS intervention
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Average stiffness intensity using the 11-point (0-10) NRS
Time frame: Day 1 - post DOMS intervention
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Worst stiffness intensity using the 11-point (0-10) NRS
Time frame: Day 1 - post DOMS intervention
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Interference of soreness, discomfort, or stiffness after exercise on the ability to perform daily activities at home or at work over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 2
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 3
Interference of soreness, discomfort, or stiffness after exercise on the ability to participate in physical activities over the last 24 hours using the 11-point (0-10) NRS
Time frame: Day 4
Self-reported sleep quality using the 11-point (0-10) NRS
Time frame: Day 2
Self-reported sleep quality using the 11-point (0-10) NRS
Time frame: Day 3
Self-reported sleep quality using the 11-point (0-10) NRS
Time frame: Day 4
Self-reported sleep duration via a sleep diary
Time frame: Day 2
Self-reported latency to sleep onset via a sleep diary
Time frame: Day 2
Self-reported sleep continuity via a sleep diary
Time frame: Day 2
Self-reported alertness upon waking via a sleep diary
Time frame: Day 2
Self-reported sleep duration via a sleep diary
Time frame: Day 3
Self-reported latency to sleep onset via a sleep diary
Time frame: Day 3
Self-reported sleep continuity via a sleep diary
Time frame: Day 3
Self-reported alertness upon waking via a sleep diary
Time frame: Day 3
Self-reported sleep duration via a sleep diary
Time frame: Day 4
Self-reported latency to sleep onset via a sleep diary
Time frame: Day 4
Self-reported sleep continuity via a sleep diary
Time frame: Day 4
Self-reported alertness upon waking via a sleep diary
Time frame: Day 4
Pressure threshold
Time frame: Day 1 - post DOMS intervention
Pressure threshold
Time frame: Day 2
Pressure threshold
Time frame: Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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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.
Erica Peters, PhD study director
Canopy Growth Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHI-202 and CHI-101 in people with Delayed Onset Muscle Soreness (DOMS), run by Canopy Growth Corporation 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 15 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 16 Feb 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline in blood pressure (mmHg) [Safety and Tolerability] (time frame: Day 2). The study lists 12 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 16 Feb 2022.