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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05253417




Registration number
NCT05253417
Ethics application status
Date submitted
20/12/2021
Date registered
23/02/2022

Titles & IDs
Public title
The CANabidiol Use for RElief of Short Term Insomnia
Scientific title
The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study
Secondary ID [1] 0 0
BOD202101
Universal Trial Number (UTN)
Trial acronym
CANREST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disturbance 0 0
Insomnia 0 0
Insomnia Type; Sleep Disorder 0 0
Insomnia, Transient 0 0
Insomnia Due to Anxiety and Fear 0 0
Insomnia Due to Other Mental Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 50 mg Cannabidiol (CBD)
Treatment: Drugs - Placebo
Treatment: Drugs - 100 mg Cannabidiol (CBD)

Experimental: 50 mg CBD - 50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)

Experimental: 100 mg CBD - 100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.

Placebo comparator: Placebo - Placebo capsules contain no CBD. Four capsules to be taken as a single oral dose.


Treatment: Drugs: 50 mg Cannabidiol (CBD)
For the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules.

Treatment: Drugs: Placebo
Participants take four (4) placebo capsules.

Treatment: Drugs: 100 mg Cannabidiol (CBD)
For the study arm, '100 mg CBD' participants take four (4) CBD capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores
Timepoint [1] 0 0
Baseline (week 0), week 4, week 8
Secondary outcome [1] 0 0
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on wake after sleep onset (WASO) as assessed by actigraphy.
Timepoint [1] 0 0
Baseline (week 0), week 8
Secondary outcome [2] 0 0
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Anxiety as assessed by the DASS-21 questionnaire.
Timepoint [2] 0 0
Baseline (week 0), Week 4, week 8
Secondary outcome [3] 0 0
To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Stress as assessed by the DASS-21 questionnaire.
Timepoint [3] 0 0
Baseline (week 0), Week 4, week 8

Eligibility
Key inclusion criteria
1. Male and females aged 18-65 years old, inclusive.
2. Females must be non-pregnant, non-lactating.
3. Proficient in English and have internet access and a mobile phone.
4. Insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8 - 21 and have experienced these symptoms over the past month at pre-screening.
5. Stated willingness to comply with all study procedures and availability for the duration of the study.
6. Provision of signed and dated informed consent form.
7. All male and females of childbearing potential must agree to use two forms of effective contraception from the time of signing informed consent until 30 days after study completion.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.
2. The use of any drug known to affect sleep during the study one week prior the randomization, including:

1. Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).
2. Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
3. Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).
3. Excessive caffeine use (defined as > 600mg caffeine or approximately 6 cups of caffeinated beverages a day) that, in the opinion of the medical doctor, contributes to the participant's insomnia.
4. Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard drinks per day on average for men, and for women, no more than two).
5. The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.
6. Cannabis dependence or any other drug or alcohol dependence within the past two years.
7. Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines, cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
8. Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
9. Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.
10. Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.
11. Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).
12. Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.
13. Medical conditions that result in frequent sleep disturbance (e.g. nocturia).
14. History of attempted suicide in the past 12 months.
15. Clinically significant hepatic abnormalities determined by the screening blood test.
16. Shift work, jet lag or trans-meridian travel (two time zones) in the past month.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2023
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Woolcock Institute - Glebe
Recruitment hospital [2] 0 0
Fusion Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bod Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Woolcock Institute of Medical Research
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ron Grunstein
Address 0 0
Woolcock Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05253417