Relative Bioavailability of Two Orally Administered CBD Formulations in Healthy Male Adults

Launched by UNIVERSITY OF SASKATCHEWAN · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a new fast-dissolving cannabidiol (CBD) strip, taken by placing it in the cheek, is absorbed into the body compared to traditional CBD powder. The goal is to find out if this new method works better, which could help in deciding how to use CBD for managing concussions in NFL athletes. The study is currently looking for healthy males between the ages of 18 and 35 who are willing to stay at the clinic for 13 hours on the day they receive the CBD dose and return for follow-up blood tests.

To be eligible for the study, participants should not have any serious health issues, particularly related to the heart, liver, or kidneys, and must not be using any medications that might interfere with the study. They also need to be able to commit to all visits and procedures. If you join the study, you can expect to stay in a clinical setting for a full day, where you’ll receive the CBD strip and have your blood tested afterward to see how well your body absorbs it. This research is important for understanding the best ways to use CBD, especially in the context of sports-related injuries.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 - 35 years old
• • 2. Clinical labs within the stated normal range of the Royal University Hospital Test Centre, or values outside the stated normal range that are not of clinical significance as determined by the qualified investigator.
• • 3. No clinically significant disease on medical history or clinically significant findings on physical examination including vital signs as determined by the qualified investigator.
• • 4. Ability to stay in the clinic trial unit for 13 hours on the day of each single oral dose.
• • 5. Ability to return for blood draws in the subsequent days.
• Exclusion Criteria:
• • 1. History or presence of significant gastrointestinal, liver or kidney disease or any other condition known to interfere with drug pharmacokinetics including bioavailability or increase risk of adverse effects.
• • 2. History or presence of serious cardiovascular disease, such as ischaemic heart disease, arrhythmias, poorly controlled hypertension or severe heart failure
• • 3. Males whose partners are trying to conceive (i.e. male subjects intending to start a family during the study period)
• • 4. Lack of medically acceptable contraception by participants whose female partners have childbearing potential for the duration of the study.
• • 5. Personal or family history of schizophrenia or any other psychotic disorder
• • 6. Current or past drug or alcohol dependence or abuse
• • 7. Use of Cannabis-based therapy within 2 months (Participants who have previously used a Cannabis-based therapy may be included if they have a 2-month period without use of Cannabis-based therapy prior to enrolment in the study)
• • 8. Use of recreational Cannabis within 2 months (Participants who have previously used recreational Cannabis may be included if they have a 2-month period without use of recreational Cannabis prior to enrolment in the study)
• • 9. Use of psychotropic medications with serotonergic activity (e.g. Selective Serotonin Reuptake Inhibitors, Tricyclic Antidepressants, Atypical Neuroleptics) within one week
• • 10. Use of narcotic medications (e.g. Codeine, Morphine, Oxycontin) within one week
• • 11. Use of any other medication known to interact with medicinal Cannabis within one week.
• • 12. Allergy or known intolerance to any of the compounds within the study preparation.
• • 13. Resting heart rate HR \< 50 bpm or \> 100 bpm or seated blood pressure \< 100/60 or higher than 140/90
• • 14. Inability of study participants to attend and complete all study visits
• • 15. Bleeding disorder
• • 16. Known low hematocrit