Comparing two CBD formulations for better absorption in healthy adults

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

This study tests whether a new fast-dissolving CBD strip is absorbed better than regular CBD powder in healthy men to help improve how CBD can be used for athletes, especially after concussions.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Male
• Sponsor: University of Saskatchewan (Academic / other)
• Locations: 1 site (Saskatoon, Saskatchewan)
• Trial ID: NCT06574100 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the relative bioavailability of a new fast-dissolving cheek-administered cannabidiol strip compared to traditional cannabidiol powder in healthy male adults. By assessing how well each formulation is absorbed into the body, the research seeks to inform future dosing regimens for NFL athletes, particularly in the context of concussion management. Participants will be monitored for pharmacokinetics over a 13-hour period following administration. The findings will help optimize CBD formulations for therapeutic use in sports medicine.

Who should consider this trial

Good fit: Ideal candidates are healthy male adults aged 18 to 35 with no significant medical history.

Not a fit: Patients with significant gastrointestinal, liver, or kidney diseases, or serious cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective CBD dosing strategies for athletes, enhancing concussion management.

How similar studies have performed: While studies on CBD formulations exist, this specific approach to comparing bioavailability in a controlled setting is relatively novel.

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

Where this trial is running

Saskatoon, Saskatchewan

• University of Saskatchewan — Saskatoon, Saskatchewan, Canada (Recruiting)

Study contacts

• Principal investigator: Payam Dehghani, MD — Pasqua Hospital
• Study coordinator: Abdul Salama, PharmD

Conditions Pharmacokinetics