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Trial registered on ANZCTR


Registration number
ACTRN12620000220965
Ethics application status
Approved
Date submitted
11/02/2020
Date registered
24/02/2020
Date last updated
18/06/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of medicinal cannabis oil on sleep in adults with insomnia: The Cannabis Sleep Study
Scientific title
The effect of medicinal cannabis oil on sleep in adults with insomnia investigated in a randomised double-blind placebo-controlled cross-over trial of 6 weeks duration
Secondary ID [1] 300513 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 316208 0
Condition category
Condition code
Alternative and Complementary Medicine 314498 314498 0 0
Herbal remedies
Neurological 314499 314499 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised double-blind placebo-controlled cross-over trial of 6 weeks duration investigating the effect of a medicinal cannabis oil on sleep in adults with insomnia.
After a run-in period of 1 week, the active treatment group will be allocated to one dose of 0.2-1.5ml per day of THC:CBD (1:1.5) medicinal cannabis oil for 2 weeks to be taken by eyedropper under the tongue in the evening. Participants will be instructed to titrate up by 0.1 ml increments each day, if needed, starting with 0.2ml on day 1, to a maximum of 1.5ml.

After the first treatment period of 2 weeks, there is 1 week wash-out period of 1 week, before participants are crossed-over to the alternative treatment for 2 weeks.

Participants are to record their dose and any side effects in a daily diary. To help with titration, participants are encouraged to report their daily dose to the research team.
Adherence to the intervention will be monitored by participant diary, and unused product return and weighing.
Intervention code [1] 316822 0
Treatment: Other
Comparator / control treatment
The control group will be allocated to one dose of 0.2-1.5ml per day placebo oil containing Median Chain Triglycerides Carrier Oil without THC:CBD.
Control group
Placebo

Outcomes
Primary outcome [1] 322826 0
Sleep Quality measured by questionnaire
Composite measure using the Insomnia Severity Index, Stanford Sleepiness Scale, Pittsburgh Sleep Quality Index, and Brief Fatigue Inventory
Timepoint [1] 322826 0
at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline)
Primary outcome [2] 322827 0
Melatonin levels at midnight (12am-2am) measured by Saliva test kit
Timepoint [2] 322827 0
at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline)
Secondary outcome [1] 379916 0
Cortisol levels at midnight (12am-2am) measured by Saliva test kit
Timepoint [1] 379916 0
at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline)
Secondary outcome [2] 379917 0
Sleep pattern including heart rate - composite measure measured by wrist activity tracking device
Timepoint [2] 379917 0
The activity wrist tracker will be worn continuously for 6 weeks post enrolment. Data will be downloaded/recorded at each post-enrolment visit, Analysis will use recorded daily data for 6 weeks. The mean of a 7 day-period will provide comparative data (e.g. mean of daily data of week 1 = baseline data)
Secondary outcome [3] 379918 0
mood measured by Bond Lader Mood questionnaire
Timepoint [3] 379918 0
at 3 and 6 weeks' time points after 2 weeks intervention compared to 0 (enrolment), 1 (baseline/after run-in) and 4 weeks (after wash-out/new baseline)
Secondary outcome [4] 379919 0
Tolerability by in-house questionnaire designed for this and our previous studies; and daily diary
Timepoint [4] 379919 0
daily during 2x 2 week treatment periods

Eligibility
Key inclusion criteria
Insomnia - measured by insomnia severity index > 7
- having one or more of the following symptoms:
- Difficulty falling asleep
- Waking up often during the night and/or
- Having trouble going back to sleep
& Willing not to drive a vehicle during 6 weeks of the study
Minimum age
25 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Subjects are not pregnant or diagnosed with cancer, unstable cardiac disease, psychotic disorder, schizophrenia, manic episode, seizure disorder, glaucoma, or urinary retention.
• Subjects are not shiftworkers.
• Subjects are not taking anti-depressants including tricyclic anti-depressant, monoamine oxidase inhibitors, or benzodiazepines.
• Subjects known to have hypersensitivity to cannabinoids.
• During the study, subjects will be required to avoid taking any other sleep remedies both natural and pharmaceuticals.

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)
Active and placebo oil, matched in colour, taste, odour, appearance, will be packaged offsite in visually identical numbered opaque containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization using a computerized random number generator by an independent researcher off-site
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. Continuous variables will be analysed by student t-test and analysis-of-covariance (ANCOVA), and categorical variables will be analysed by Chi-square test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 29294 0
3122 - Hawthorn North
Recruitment postcode(s) [2] 29295 0
3123 - Auburn
Recruitment postcode(s) [3] 29296 0
3124 - Camberwell
Recruitment postcode(s) [4] 29297 0
3121 - Burnley

Funding & Sponsors
Funding source category [1] 304929 0
Commercial sector/Industry
Name [1] 304929 0
Entoura Pty
Address [1] 304929 0
Suite 342, 1 Queens Rd, Melbourne, VIC 3004
Country [1] 304929 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Country
Australia
Secondary sponsor category [1] 305280 0
None
Name [1] 305280 0
Address [1] 305280 0
Country [1] 305280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305336 0
NIIM HREC
Ethics committee address [1] 305336 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn, VIC 3122
Ethics committee country [1] 305336 0
Australia
Date submitted for ethics approval [1] 305336 0
03/12/2019
Approval date [1] 305336 0
11/02/2020
Ethics approval number [1] 305336 0
0060N_2019

Summary
Brief summary
Insomnia or difficulty falling and/or staying asleep is experienced by 30% of the general population. Medicinal cannabis has been shown to improve sleep quality, length, and associated quality of life. This randomised cross-over double-blind placebo-controlled study of 6 weeks duration aims to assess the tolerability and effectiveness of a medicinal cannabis oil on sleep in adults with insomnia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100046 0
A/Prof Karin Ried
Address 100046 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 100046 0
Australia
Phone 100046 0
+61 3 9912 9545
Fax 100046 0
Email 100046 0
karinried@niim.com.au
Contact person for public queries
Name 100047 0
A/Prof Karin Ried
Address 100047 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 100047 0
Australia
Phone 100047 0
+61 3 9912 9545
Fax 100047 0
Email 100047 0
karinried@niim.com.au
Contact person for scientific queries
Name 100048 0
A/Prof Karin Ried
Address 100048 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 100048 0
Australia
Phone 100048 0
+61 3 9912 9545
Fax 100048 0
Email 100048 0
karinried@niim.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summary of data will be made available for publication. No individual data will be divulged.
What supporting documents are/will be available?
No other documents available
Summary results
No Results