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Trial registered on ANZCTR


Registration number
ACTRN12623000802606
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 treatment of sleep disturbances
Scientific title
Efficacy and Safety of Low-dose Cannabidiol for treatment of sleep disturbances in adults: A randomised, double-blind placebo-controlled study
Secondary ID [1] 309534 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep disturbance 329817 0
Condition category
Condition code
Mental Health 326715 326715 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will commence on either low-dose cannabidiol (15mg per capsule) or placebo. Dosing will be one capsule (15 mg) orally twice daily for two weeks then two capsules (2 x 15 mg) orally twice daily for four weeks. Total dosing is for 6 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.
Intervention code [1] 325961 0
Treatment: Drugs
Comparator / control treatment
The placebo will be a white, odourless capsule with no active ingredient and filler (modified food starch), magnesium sulphate, magnesium stearate, silicon dioxide. as the inactive ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 334582 0
Efficacy of low-dose CBD for sleep using the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Timepoint [1] 334582 0
baseline, at 2, 4 and 6 weeks of treatment (primary timepoint) and at 4 weeks follow-up post-treatment completion
Secondary outcome [1] 421289 0
Effectiveness of low-dose CBD on fatigue using the Brief Fatigue Inventory (BFI) questionnaire
Timepoint [1] 421289 0
baseline, at 2, 4 and 6 weeks of treatment and at 4 weeks follow-up post-treatment completion
Secondary outcome [2] 421290 0
Effectiveness of low-dose CBD on anxiety using the Generalised Anxiety Disorder (GAD-7) assessment
Timepoint [2] 421290 0
baseline, at 2, 4 and 6 weeks of treatment, and at 4 weeks follow-up post-treatment completion
Secondary outcome [3] 421291 0
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.
Timepoint [3] 421291 0
Anytime up to 30 days after the last dose of the study or placebo drug
Secondary outcome [4] 421292 0
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.
Timepoint [4] 421292 0
baseline, at 6 weeks of treatment, and at 4 weeks follow-up post-treatment completion

Eligibility
Key inclusion criteria
• 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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• 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
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 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
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% . 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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
Date of last participant enrolment
Anticipated
22/09/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24612 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 40216 0
4000 - Brisbane
Recruitment postcode(s) [2] 40217 0
4222 - Griffith University
Recruitment postcode(s) [3] 40218 0
4208 - Ormeau

Funding & Sponsors
Funding source category [1] 313726 0
Commercial sector/Industry
Name [1] 313726 0
PharmaCann Pty Ltd
Country [1] 313726 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PharmaCann Pty Ltd
Address
Level 18/324 Queen St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 315540 0
None
Name [1] 315540 0
Address [1] 315540 0
Country [1] 315540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312897 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312897 0
Griffith University, Parkland Drive, Southport, QLD, 4222
Ethics committee country [1] 312897 0
Australia
Date submitted for ethics approval [1] 312897 0
29/11/2022
Approval date [1] 312897 0
08/05/2023
Ethics approval number [1] 312897 0
GU Reference number: 2023/076

Summary
Brief summary
This study aims to determine the efficacy and safety of low-dose cannabidiol for sleep disturbances. 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 sleep disturbances 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 sleep disturbances but more clinical studies are needed, including for this particular formulation. This is a clinical trial into whether CBD is effective for sleep disturbances compared to a placebo or inactive drug. If more studies like this one provide supports the safe and effective use of CBD for sleep disturbances then patients, doctors and other health professionals will feel more confident recommending CBD for this condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126262 0
Dr Susan Hall
Address 126262 0
School of Pharmacy and Medical Sciences, Griffith University Gold Coast campus, Parklands Drive, Southport, QLD, 4222
Country 126262 0
Australia
Phone 126262 0
+61756780637
Fax 126262 0
Email 126262 0
[email protected]
Contact person for public queries
Name 126263 0
Susan Hall
Address 126263 0
School of Pharmacy and Medical Sciences, Griffith University Gold Coast campus, Parklands Drive, Southport, QLD, 4222
Country 126263 0
Australia
Phone 126263 0
+61756780637
Fax 126263 0
Email 126263 0
[email protected]
Contact person for scientific queries
Name 126264 0
Susan Hall
Address 126264 0
School of Pharmacy and Medical Sciences, Griffith University Gold Coast campus, Parklands Drive, Southport, QLD, 4222
Country 126264 0
Australia
Phone 126264 0
+61756780637
Fax 126264 0
Email 126264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Commercial in confidence


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.