Cannabidiol Formulations for Healthy Adults
Trial Summary
Will I have to stop taking my current medications?
The trial requires you to stop using certain medications, such as psychotropic medications, narcotic medications, and any drugs that interact with medicinal Cannabis, at least one week before starting. If you're using Cannabis-based therapies or recreational Cannabis, you need a two-month break before joining.
Is cannabidiol (CBD) generally safe for human use?
CBD is generally well tolerated in humans, but it can cause some side effects like diarrhea, sleepiness, and changes in liver function. It may also interact with other medications, so it's important to monitor for any adverse effects. Some CBD products may be contaminated with THC, which can also cause side effects.12345
How is the drug Cannabidiol (CBD) unique compared to other treatments?
Cannabidiol (CBD) is unique because it offers potential therapeutic benefits with mild or no psychoactive effects, unlike other cannabis-derived products that contain higher levels of THC (the compound that causes a 'high'). It is also being explored for its safety and effectiveness in various health outcomes, including neurological and immune-related conditions, which are less frequently studied with other treatments.26789
What is the purpose of this trial?
This project is aimed at understanding whether a new fast-dissolving cheek-administered cannabidiol strip will be absorbed better into the body than cannabidiol powder. The results of this study will help guide dosage formulation choices as well as dosing regimens in NFL athletes for concussion management.
Research Team
Abdul Salama, PharmD
Principal Investigator
University of Saskatchewan
Payam Dehghani, MD
Principal Investigator
Pasqua Hospital
Jane Alcorn, DVM;PhD
Principal Investigator
University of Saskatchewan
Eligibility Criteria
This trial is for healthy male adults interested in participating in a study to compare the absorption of two CBD formulations. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single oral doses of CBD formulations to assess relative bioavailability
Washout
Participants undergo a washout period to clear the drug from their system before crossover
Crossover Treatment
Participants receive the alternate CBD formulation to compare bioavailability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cannabidiol
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Saskatchewan
Lead Sponsor
University of Regina
Collaborator