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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05344170
Registration number
NCT05344170
Ethics application status
Date submitted
12/04/2022
Date registered
25/04/2022
Date last updated
6/02/2024
Titles & IDs
Public title
Cannabinol Use in Patients With Insomnia Disorder
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Single-dose, Crossover, Pilot Study Investigating the Effects of Cannabinol (CBN) 30 mg and 300 mg on Sleep Architecture and Next-day Function in Insomnia Disorder
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Secondary ID [1]
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112/2021-08-907
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Universal Trial Number (UTN)
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Trial acronym
CUPID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 30 mg Cannabinol (CBN)
Treatment: Drugs - 300 mg Cannabinol (CBN)
Treatment: Drugs - Placebo
Experimental: 30 mg Cannabinol (CBN) - Single fixed dose administered 2 hours prior to habitual sleep onset.
Experimental: 300 mg Cannabinol (CBN) - Single fixed dose administered 2 hours prior to habitual sleep onset.
Placebo Comparator: Placebo - Single fixed dose administered 2 hours prior to habitual sleep onset.
Treatment: Drugs: 30 mg Cannabinol (CBN)
Participants will receive a 2 mL oral dose of 'ECS 310' (1.5%), an oral formulation of CBN (15 mg/mL) suspended in medium chain triglycerides (MCT) oil.
Treatment: Drugs: 300 mg Cannabinol (CBN)
Participants will receive a 2 mL oral dose of 'ECS 310' (15%), an oral formulation of CBN (150 mg/mL) suspended in medium chain triglycerides (MCT) oil.
Treatment: Drugs: Placebo
Participants will receive a 2 mL oral dose of placebo. Placebo contains the same excipient, medium chain triglycerides (MCT) oil, as the investigational products but does not contain cannabinoids.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Wake After Sleep Onset (WASO)
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Assessment method [1]
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WASO measured in minutes using in-laboratory overnight polysomnography, from the first epoch after lights out until the last epoch, scored as any stage of sleep by an experienced polysomnographic technician in accordance with American Academy of Sleep Medicine (AASM) 2020 Sleep Scoring criteria (Version 2.6). Comparisons between each CBN dose versus placebo.
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Timepoint [1]
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Night 1
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Secondary outcome [1]
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Traditional sleep staging
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Assessment method [1]
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Proportion of the sleep opportunity scored at the 5 stages (wake, and N1, N2, N3, and REM sleep) between lights out and lights on, measured using overnight in-laboratory polysomnography, scored by a polysomnography technician in accordance with AASM Sleep Scoring criteria. Comparisons between each CBN dose versus placebo.
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Timepoint [1]
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Night 1
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Secondary outcome [2]
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Sleep Onset Latency (SOL)
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Assessment method [2]
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SOL measured in minutes using in-laboratory polysomnography, calculated from the time of lights out to the first sleep epoch as scored by a polysomnographic technician in accordance with AASM Sleep Scoring criteria. Comparisons between each CBN dose versus placebo.
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Timepoint [2]
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Night 1
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Secondary outcome [3]
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Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep.
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Assessment method [3]
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Spectral power of delta (1-4.5 Hz), theta (4.5-8 Hz), alpha (8-12 Hz), sigma (12-15 Hz), beta (15-25 Hz), and gamma (25-40 Hz) frequency ranges between treatment arms. Power spectral analysis will be applied to EEG signals from polysomnography after artefacts are detected and removed. Comparisons between each CBN dose versus placebo.
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Timepoint [3]
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Night 1
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Eligibility
Key inclusion criteria
1. Between 25 - 65 years of age
2. Insomnia Severity Index (ISI) score = 15 at eligibility screening
3. Insomnia disorder (symptoms occurring at least 3 times per week and present for longer
than 3 months) as determined by the study physician
4. Ability to take oral medication
5. Provision of signed and dated informed consent form
6. Stated willingness to comply with all study procedures and availability for the
duration of the study
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Minimum age
25
Years
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Maximum age
65
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
1. Medical condition or medication that is the cause of the insomnia disorder as
determined by the study physician
2. Known hypersensitivity to cannabis or cannabinoid products (including if this becomes
evident during the trial)
3. Reported use of cannabis or cannabinoid products within the past 3 months as confirmed
by at least one negative urine drug screen (UDS) (or at the study physician's
discretion)
4. Sleep apnoea (defined as Apnoea Hypopnea Index [AHI] > 15 and Oxygen Desaturation
Index [ODI]>10) as confirmed by polysomnography at screening
5. Sleep-related movement disorder as determined by the study physician
6. Delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as
confirmed during screening
7. Any medical condition that produces an abnormal EEG (i.e., epilepsy, brain injury)
8. Clinically relevant cardiovascular abnormalities as determined by the study physician
and a 12-lead electrocardiogram (ECG) at screening
9. Shift work or trans meridian travel (two time zones) within the last month
10. History of major psychiatric disorder in the past 12 months at the study physician's
discretion, except clinically managed mild depression and/or anxiety
11. History of suicide attempt or current suicide ideation (score greater than 1 on Q9 of
the Patient Health Questionnaire [PHQ-9])
12. Pregnancy or lactating. Female participants are required to complete a urine pregnancy
test at screening and treatment sessions and all participants are instructed to use a
reliable form of contraception throughout the study duration
13. History of drug or alcohol dependency or abuse within approximately the past 2 years
14. Use of CNS-active drugs (cannabis, amphetamines, cocaine, antidepressants, opioids,
benzodiazepines) in the past 3 months as confirmed by a positive urine drug test at
screening or at the study physician's discretion
15. Use of medications that may have a clinically significant impact upon the metabolism
and excretion of cannabinoids as determined by the study physician (e.g., CYP450
enzyme inducers/inhibitors
16. Excessive caffeine use that in the opinion of the study physician contributes to the
participant's insomnia disorder, or the inability to abstain from caffeine use 24
hours prior to each overnight sleep study
17. Inability to refrain from alcohol consumption 24 hours prior to each overnight sleep
study
18. Individuals with nicotine dependence (i.e., daily smokers)
19. Medical conditions that result in frequent need to get out of bed (e.g., sleep
walking, nocturia)
20. Psychological or behavioural treatment for insomnia disorder, including cognitive
behavioural therapy for insomnia, within 3 months before screening (excluding sleep
hygiene advice)
21. Occupational or judicially ordered drug screening
22. Has held an unrestricted driving license < 1 year
23. Cannot speak English fluently
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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)
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Methods used to generate the sequence in which subjects will be randomised (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
Crossover
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/09/2023
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Glebe
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Recruitment postcode(s) [1]
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2095 - Glebe
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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University of Sydney
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus
placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with
chronic insomnia disorder.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05344170
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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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Camilla Hoyos, MPH, PhD
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Address
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Woolcock Institute of Medical Research
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05344170
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