Efficacy and Safety of Low-dose Cannabidiol for treatment of sleep disturbances
- Conditions
- Sleep disturbanceMental Health - Other mental health disorders
- Registration Number
- ACTRN12623000802606
- Lead Sponsor
- PharmaCann Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
•Age greater or equal to 18 years
•Self-reported complaint of sleep disturbances that includes difficulty initiating sleep or difficulty maintaining sleep
•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
•Under the age of 18 years
•Over the age of 70 years
•Severe sleep disorder such as chronic insomnia
•Presence of any medical, psychological or social condition that may hinder compliance
•Pregnant or breastfeeding
•Abnormal liver function
oALT >2x ULN
oBilirubin >1.5 x ULN or normal conjugated bilirubin
•Abnormal renal function
oCalculated 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 to assist with sleep, eg benzodiazepines, z-drugs”, melatonin
•Concurrent treatment with medication causing sedation including sedating antihistamines (chlorpheniramine, doxylamine, etc) and opioids (morphine, oxycodone, etc).
•Allergy to the active or inactive ingredient(s)
•Concurrent participation in other clinical trials or use of other investigational products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method