Researchers at NICM Health Research Institute are currently recruiting participants for a study to understand the effects of fasting conditions and high-fat diets on the absorption of a low-dose formulation of cannabidiol (CBD).
CBD is a non-intoxicating chemical found in cannabis that has established safety and may help with sleep, anxiety, and inflammation. Absorption of CBD does increase with consumption of fatty foods, but the significance of this effect for low-dose products is unknown.
The Therapeutics Goods Administration (TGA) has eased restrictions allowing over-the-counter (OTC) purchases of CBD medicines in pharmacies, however rigorous scientific evidence is required to register and licence products for sale. This research could contribute to Australia’s first CBD product available OTC, making it accessible without the need for a medical prescription.
Who can join?
People aged 18 to 45, who:
- Are not pregnant, breastfeeding or planning to become pregnant in the next six-months.
- Are not taking prescription drugs and/or non-prescription NSAIDs (such as ibuprofen) frequently (more than twice a week).
- Have no history of smoking, drug, or alcohol abuse.
- Have no current cannabis use (less 3 months).
- Have no history of severe liver, renal or other diseases.
- Have no history of cognitive or mental illness.
- Are not knowingly allergic to cannabidiol or coconut.
- Are able to read and understand English.
- After initial assessment (phone call or in person) and consent, participants will be invited to NICM Health Research Institute, 158-160 Hawkesbury Rd, Westmead, NSW. (opens in a new window)
- Participants will be required to fast for at least 10-hours before each visit.
- On the first visit, participants will be given 100 mg of CBD with no breakfast.
- On the second visit, participants will be given 100 mg of CBD and provided a large, fat-rich, meat (pork) and dairy-containing, fast-food meal.
- At each visit, participants will:
- On day one, remain at NICM HRI for 12-hours and give 16 blood samples at different time-points.
- Return on day two to give one blood sample.
- Have meals (lunch, dinner) provided, with quiet public lounge and desk space available between blood collections.
- There will be a six-week interval between visits.
- Follow-up phone call to assess any adverse events after completion of protocol, meeting at the NICM HRI if necessary.
What are the benefits of participating?
- Help further research on the effects of diet on CBD absorption, which may contribute towards increasing accessibility to OTC low-dose CBD medicine.
Interested in participating in this study?
For more details about the study, please read the following information before deciding whether to participate.
To register your interest, or for more information, please contact:
Dr Mitchell Low
NICM Health Research Institute, Chief Investigator
Human Research Ethics Committee Approval: This trial has been approved by Western Sydney University Human Ethics Committee (Approval Number: H15050).
This study is supported by the Australian Natural Therapeutics Group (ANTG).
Study Chief Investigator: Dr Mitchell Low, NICM Health Research Institute.
Recruitment end date: 24 November 2022