None listed
Conditions
Brief summary
This study aims to determine the efficacy and safety of low-dose cannabidiol for anxiety. Cannabidiol or CBD is a major component originally derived from the Cannabis plant and works on cannabinoid receptors. There are two types of cannabinoid receptors, CB1 mainly in the brain and CB2 mainly in the immune system. These two receptors help regulate things like sleep, mood, pain and more. This study will be investigating if low-dose CBD will improve anxiety when compared to a placebo or inactive drug. CBD has been used for a number of conditions but there are limited clinical studies for individual products and conditions. There is evidence that low-dose CBD is safe to use and the Therapeutic Goods Administration (TGA) has scheduled low-dose CBD (maximum of 150mg per day) as Schedule 3 or pharmacist only due to the acceptable safety and tolerability profile. There is evidence to suggest CBD is effective for anxiety but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for anxiety compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for anxiety then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.
Interventions
Cannabidiol be ONE capsule (30 mg) orally twice daily for two weeks then TWO capsules (2 x 30 mg =60 mg) orally twice daily for four weeks totalling a dosing period of six weeks. Participants will be required to return the packaging and any remaining drug at the conclusion of the study to ensure adherence to the intervention.
Sponsors
PharmaCann Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
• Age greater or equal to 18 years • Self-reported complaint of anxiety • Participants capable of childbearing only if using adequate contraception • Willingness to comply with all study procedures including IP administration protocol and required testing • Signed, written and informed consent • Participants are available for follow up
Exclusion criteria
• Under the age of 18 years • Over the age of 70 years • Diagnosed anxiety condition including obsessive-compulsive disorder and post-traumatic stress disorder • Presence of any medical, psychological or social condition that may hinder compliance • Pregnant or breastfeeding • Abnormal liver function o ALT >2x ULN o Bilirubin >1.5 x ULN or normal conjugated bilirubin • Abnormal renal function o Calculated creatinine clearance <40 mL/min using Cockcroft-Gault formula • Treatment with CBD within the last 6 months • Concurrent treatment with medication with inhibitory or induction or substrate potential with drug metabolising enzymes CYP2C, CYP2D6 and/or CYP3A and/or drug transporter P-glycoprotein • Concurrent treatment with medication for anxiety disorders including benzodiazepines (diazepam, alprazolam, etc) and antidepressants (eg paroxetine, clomipramine) • Allergy to the active or inactive ingredient(s) • Concurrent participation in other clinical trials or use of other investigational products
Outcome results
None listed