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Completed

NCT Number: NCT05026164

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).

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Key information

Conditions

Delayed Onset Muscle Soreness (DOMS)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

International Society for Sports Nutrition

Boca Raton, Florida, 33432, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).
  • 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.

Treatment and study plan

CHI-202

Dietary Supplement

Blend of cannabinoids & other ingredients

CHI-101

Dietary Supplement

Placebo

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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)

Secondary outcomes

  1. Average soreness or discomfort intensity using the 11-point (0-10) NRS

    Time frame: Day 1 - post DOMS intervention

    Self-reported average soreness or discomfort intensity using 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

  2. Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 2

    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

  3. Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 3

    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

  4. Average soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 4

    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

  5. Worst soreness or discomfort intensity using the 11-point (0-10) NRS

    Time frame: Day 1 - post DOMS intervention

    Self-reported worst soreness or discomfort intensity using the 11-point (0-10) NRS where 10 is most soreness/discomfort intensity

  6. Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 2

    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

  7. Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 3

    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

  8. Worst soreness or discomfort intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 4

    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

  9. Average stiffness intensity using the 11-point (0-10) NRS

    Time frame: Day 1 - post DOMS intervention

    Self-reported average stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity

  10. Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 2

    Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  11. Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 3

    Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  12. Average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 4

    Self-reported average stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  13. Worst stiffness intensity using the 11-point (0-10) NRS

    Time frame: Day 1 - post DOMS intervention

    Self-reported worst stiffness intensity using the 11-point (0-10) NRS where 10 is most stiffness intensity

  14. Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 2

    Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  15. Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 3

    Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  16. Worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS

    Time frame: Day 4

    Self-reported worst stiffness intensity over the last 24 hours using the 11-point (0-10) NRS where 10 is most stiffness intensity

  17. 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

    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

  18. 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

    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

  19. 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

    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

  20. 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

    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

  21. 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

    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

  22. 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 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

  23. 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 where 10 is best sleep quality

  24. 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 where 10 is best sleep quality

  25. Self-reported sleep quality using the 11-point (0-10) NRS

    Time frame: Day 4

    Self-reported sleep quality using the 11-point (0-10) NRS where 10 is best sleep quality

  26. Self-reported sleep duration via a sleep diary

    Time frame: Day 2

    Self-reported sleep duration measured in minutes via a sleep diary

  27. Self-reported latency to sleep onset via a sleep diary

    Time frame: Day 2

    Self-reported latency to sleep onset measured in minutes via a sleep diary

  28. Self-reported sleep continuity via a sleep diary

    Time frame: Day 2

    Self-reported sleep continuity measured in minutes via a sleep diary

  29. Self-reported alertness upon waking via a sleep diary

    Time frame: Day 2

    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

  30. Self-reported sleep duration via a sleep diary

    Time frame: Day 3

    Self-reported sleep duration measured in minutes via a sleep diary

  31. Self-reported latency to sleep onset via a sleep diary

    Time frame: Day 3

    Self-reported latency to sleep onset measured in minutes via a sleep diary

  32. Self-reported sleep continuity via a sleep diary

    Time frame: Day 3

    Self-reported sleep continuity measured in minutes via a sleep diary

  33. Self-reported alertness upon waking via a sleep diary

    Time frame: Day 3

    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

  34. Self-reported sleep duration via a sleep diary

    Time frame: Day 4

    Self-reported sleep duration measured in minutes via a sleep diary

  35. Self-reported latency to sleep onset via a sleep diary

    Time frame: Day 4

    Self-reported latency to sleep onset measured in minutes via a sleep diary

  36. Self-reported sleep continuity via a sleep diary

    Time frame: Day 4

    Self-reported sleep continuity measured in minutes via a sleep diary

  37. Self-reported alertness upon waking via a sleep diary

    Time frame: Day 4

    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

  38. Pressure threshold

    Time frame: Day 1 - post DOMS intervention

    Pressure threshold measured with a 25-lb algometer

  39. Pressure threshold

    Time frame: Day 2

    Pressure threshold measured with a 25-lb algometer

  40. Pressure threshold

    Time frame: Day 3

    Pressure threshold measured with a 25-lb algometer

  41. Pressure threshold

    Time frame: Day 4

    Pressure threshold measured with a 25-lb algometer

  42. Relaxed elbow angle

    Time frame: Day 1 - post DOMS intervention

    Relaxed elbow angle measured with a goniometer in degrees

  43. Active range of motion

    Time frame: Day 1 - post DOMS intervention

    Active range of motion measured with a goniometer in degrees

  44. Passive range of motion

    Time frame: Day 1 - post DOMS intervention

    Passive range of motion measured with a goniometer in degrees

  45. Relaxed elbow angle

    Time frame: Day 2

    Relaxed elbow angle measured with a goniometer in degrees

  46. Active range of motion

    Time frame: Day 2

    Active range of motion measured with a goniometer in degrees

  47. Passive range of motion

    Time frame: Day 2

    Passive range of motion measured with a goniometer in degrees

  48. Relaxed elbow angle

    Time frame: Day 3

    Relaxed elbow angle measured with a goniometer in degrees

  49. Active range of motion

    Time frame: Day 3

    Active range of motion measured with a goniometer in degrees

  50. Passive range of motion

    Time frame: Day 3

    Passive range of motion measured with a goniometer in degrees

  51. Relaxed elbow angle

    Time frame: Day 4

    Relaxed elbow angle measured with a goniometer in degrees

  52. Active range of motion

    Time frame: Day 4

    Active range of motion measured with a goniometer in degrees

  53. Passive range of motion

    Time frame: Day 4

    Passive range of motion measured with a goniometer in degrees

  54. Muscle circumference

    Time frame: Day 1 - post DOMS intervention

    Muscle circumference

  55. Muscle circumference

    Time frame: Day 2

    Muscle circumference

  56. Muscle circumference

    Time frame: Day 3

    Muscle circumference

  57. Muscle circumference

    Time frame: Day 4

    Muscle circumference

  58. Mood using the Profile of Mood States

    Time frame: Day 1 - post DOMS intervention

    Mood using the Profile of Mood States

  59. Mood using the Profile of Mood States

    Time frame: Day 2

    Mood using the Profile of Mood States

  60. Mood using the Profile of Mood States

    Time frame: Day 3

    Mood using the Profile of Mood States

  61. Mood using the Profile of Mood States

    Time frame: Day 4

    Mood using the Profile of Mood States

Sponsors and collaborators

Lead sponsor

Canopy Growth Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2021
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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