Efficacy and Safety of Low-dose Cannabidiol for anxiety

Phase 1

• Conditions: Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12623000803695
• Lead Sponsor: PharmaCann Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-26
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 80

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
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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified