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Trial registered on ANZCTR
Registration number
ACTRN12623000803695
Ethics application status
Approved
Date submitted
25/05/2023
Date registered
26/07/2023
Date last updated
26/07/2023
Date data sharing statement initially provided
26/07/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and Safety of Low-dose Cannabidiol for anxiety
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Scientific title
Efficacy and Safety of Low-dose Cannabidiol for anxiety in adults: A randomised, double-blind placebo-controlled study
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Secondary ID [1]
309518
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
329815
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Condition category
Condition code
Mental Health
326712
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
325960
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Treatment: Drugs
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Comparator / control treatment
The control treatment will be in the form of a oral placebo. The placebo will not contain any drug, and contain the same excipients as the intervention capsule. The placebo treatment will contain Filler (modified food starch), Magnesium Sulphate, Magnesium Stearate, Silicon Dioxide in a capsule.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Efficacy of low-dose CBD for anxiety as measured using Generalised Anxiety Disorder (GAD-7) assessment
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Assessment method [1]
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Timepoint [1]
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Baseline, after 2, 4 and 6 weeks of treatment (primary timepoint) and 4 weeks post-treatment completion.
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Secondary outcome [1]
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Effect of low-dose CBD on cortisol levels in blood.
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Assessment method [1]
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Timepoint [1]
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Measured at baseline, after 6 weeks of treatment and 4 weeks post-treatment completion
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Secondary outcome [2]
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Effectiveness of low-dose CBD on anxiety-induced insomnia using the Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [2]
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Timepoint [2]
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Baseline, after 2, 4 and 6 weeks of treatment and at 4 weeks post-treatment completion
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Secondary outcome [3]
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Safety of low-dose CBD as measured by medical symptoms. Common adverse effects can include mild drowsiness and tiredness. Other reported side effects of CBD include diarrhoea, changes in appetite or weight, and sleep disturbances. All adverse effects will be assessed using a study-specific questionnaire and clinical examination if required.
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Assessment method [3]
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Timepoint [3]
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Baseline, at 2, 4 and 6 weeks of treatment and at 4 weeks post-treatment completion
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Secondary outcome [4]
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Safety of low-dose CBD as measured by pathology markers. These include liver function tests (alkaline phosphatase, alanine aminotransferase, gamma glutamyl transferase), renal function (eGFR and serum creatinine), thyroid function (TSH and T4), haematology (haemoglobin, white cell count, platelet count, white cell differential), and cortisol, all tested in blood.
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Assessment method [4]
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Timepoint [4]
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baseline, at 6 weeks of treatment, and at 4 weeks follow-up post-treatment completion
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Secondary outcome [5]
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Effect of low-dose CBD on inflammatory marker levels measured in blood including prostaglandin E2, interleukin-6 and tumour necrosis factor alpha
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Assessment method [5]
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Timepoint [5]
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baseline, after 6 weeks of treatment and at 4 weeks post-treatment completion
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation will be randomised and allocation will be via contacting the holder of the allocation schedule who is located at a central administration site.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Analysis will occur individually and cumulatively. An interim and final statistical analysis will be conducted. To be deemed to have successfully completed the treatment schedule participants must not have missed more than 10% of their doses. To be deemed to have successfully completed the assessment schedule participants must have completed >80% of the assessments. No formal statistical analysis will be used for this outcome.
An interim and final statistical analysis will be conducted. Analysis of the primary outcome will be determined by changes to the PSQI. An interim analysis will occur after 25% of participants have been recruited followed by ongoing analysis between groups. For secondary outcomes that will be compared between the groups, formal statistical analyses will be used. Ongoing analysis will then occur until final analysis after all participants have completed the follow-up period. Significance for this trial will be taken as p<0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2023
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Actual
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Date of last participant enrolment
Anticipated
7/08/2023
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Actual
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Date of last data collection
Anticipated
30/11/2023
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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St Andrew's War Memorial Hospital - Brisbane
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Recruitment postcode(s) [1]
40209
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4000 - Brisbane
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Recruitment postcode(s) [2]
40210
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4222 - Griffith University
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Recruitment postcode(s) [3]
40211
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4208 - Ormeau
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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PharmaCann Pty Ltd
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Address [1]
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Level 18/324 Queen St, Brisbane City QLD 4000
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
PharmaCann Pty Ltd
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Address
Level 18/324 Queen St, Brisbane City QLD 4000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Other collaborator category [1]
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University
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Name [1]
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Griffith University
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Address [1]
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Parklands Drive, Southport, QLD 4222
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312885
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Griffith University Human Research Ethics Committee
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Ethics committee address [1]
312885
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Griffith University, Parklands Drive, Southport QLD, 4222
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Ethics committee country [1]
312885
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Australia
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Date submitted for ethics approval [1]
312885
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29/11/2022
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Approval date [1]
312885
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08/05/2023
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Ethics approval number [1]
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GU Reference number: 2023/077
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Susan Hall
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Address
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School of Pharmacy and Medical Sciences, Gold Coast campus, Parklands Drive, Southport, QLD, 4222
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Country
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Australia
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Phone
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+61 07 56780637
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Susan Hall
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Address
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School of Pharmacy and Medical Sciences, Gold Coast campus, Parklands Drive, Southport, QLD, 4222
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Country
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Australia
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Phone
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+61 07 56780637
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Susan Hall
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Address
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School of Pharmacy and Medical Sciences, Gold Coast campus, Parklands Drive, Southport, QLD, 4222
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Country
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Australia
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Phone
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+61 07 56780637
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD sharing will be available due to the commercial in confidence nature of the study
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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