AzTrials
AzTrials

Insomnia DisorderPhase 1/2CUPIDNCT05344170

Cannabinol Use in Patients With Insomnia Disorder

A Phase 1/2 study testing 30 mg Cannabinol (CBN) and 300 mg Cannabinol (CBN) in people with Insomnia Disorder, run by Woolcock Institute of Medical Research at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Insomnia Disorder
What is being tested?
30 mg Cannabinol (CBN) and 300 mg Cannabinol (CBN)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteAustralia
Study dates
24 Aug 2022to 5 Sep 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 25 - 65 years of age
  • Insomnia Severity Index (ISI) score ≥ 15 at eligibility screening
  • Insomnia disorder (symptoms occurring at least 3 times per week and present for longer than 3 months) as determined by the study physician
  • Ability to take oral medication
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study

Who cannot join

  • Medical condition or medication that is the cause of the insomnia disorder as determined by the study physician
  • Known hypersensitivity to cannabis or cannabinoid products (including if this becomes evident during the trial)
  • 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)
  • Sleep apnoea (defined as Apnoea Hypopnea Index [AHI] > 15 and Oxygen Desaturation Index [ODI]>10) as confirmed by polysomnography at screening
  • Sleep-related movement disorder as determined by the study physician
  • Delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as confirmed during screening
Show all 23Show fewer
  • Any medical condition that produces an abnormal EEG (i.e., epilepsy, brain injury)
  • Clinically relevant cardiovascular abnormalities as determined by the study physician and a 12-lead electrocardiogram (ECG) at screening
  • Shift work or trans meridian travel (two time zones) within the last month
  • History of major psychiatric disorder in the past 12 months at the study physician's discretion, except clinically managed mild depression and/or anxiety
  • History of suicide attempt or current suicide ideation (score greater than 1 on Q9 of the Patient Health Questionnaire [PHQ-9])
  • 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
  • History of drug or alcohol dependency or abuse within approximately the past 2 years
  • 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
  • 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
  • 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
  • Inability to refrain from alcohol consumption 24 hours prior to each overnight sleep study
  • Individuals with nicotine dependence (i.e., daily smokers)
  • Medical conditions that result in frequent need to get out of bed (e.g., sleep walking, nocturia)
  • Psychological or behavioural treatment for insomnia disorder, including cognitive behavioural therapy for insomnia, within 3 months before screening (excluding sleep hygiene advice)
  • Occupational or judicially ordered drug screening
  • Has held an unrestricted driving license < 1 year
  • Cannot speak English fluently

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Woolcock Institute of Medical Research

    Glebe, New South Wales, 2095

Other trials in Australia

About this study

Official 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

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.

Read the detailed description

This is a randomised, double-blind, placebo-controlled, three-arm, crossover, single-centre, proof-of-concept study in twenty participants with chronic insomnia disorder (as per clinician diagnosis and Insomnia Severity Index [ISI] Score ≥15). Across three overnight treatment sessions, participants will receive single dose oral liquid 30 mg cannabinol (CBN), 300 mg CBN, and matched placebo. Participants will undergo overnight sleep assessment using in-laboratory polysomnography (PSG) to examine CBN-related changes to sleep parameters; and various objective and subjective measures of sleep and next-day neurobehavioral function. Each treatment session will be separated by the two-week washout period.

Being tested
30 mg Cannabinol (CBN), 300 mg Cannabinol (CBN), Placebo
Keywords
cannabinol, CBN, cannabinoid, medicinal cannabis, primary insomnia, chronic insomnia disorder, sleep architecture, wake after sleep onset, polysomnography, next-day function, randomised controlled trial, placebo-controlled, crossover, double-blinded
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 30 mg Cannabinol (CBN)Drug

    Also called ECS 310 (1.5%)

    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.

  • 300 mg Cannabinol (CBN)Drug

    Also called ECS 310 (15%)

    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.

  • PlaceboDrug

    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.

Study groups in NCT05344170
Study groupRoleWhat they receive
30 mg Cannabinol (CBN)ExperimentalSingle fixed dose administered 2 hours prior to habitual sleep onset.
Receives: Drug: 30 mg Cannabinol (CBN)
300 mg Cannabinol (CBN)ExperimentalSingle fixed dose administered 2 hours prior to habitual sleep onset.
Receives: Drug: 300 mg Cannabinol (CBN)
PlaceboPlacebo comparatorSingle fixed dose administered 2 hours prior to habitual sleep onset.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wake After Sleep Onset (WASO)

    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.

    Measured: Night 1

Secondary outcomes (3)

  1. Traditional sleep staging

    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.

    Measured: Night 1

  2. Sleep Onset Latency (SOL)

    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.

    Measured: Night 1

  3. Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep.

    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.

    Measured: Night 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start24 Aug 2022
  3. Primary completion29 Aug 2023
  4. Study completion5 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Single site allocation: Randomised Intervention model: Crossover Masking: Double-blind (participant, investigator) Primary purpose: Pilot
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05344170
Sponsor's protocol ID
112/2021-08-907
Acronym
CUPID
Status last verified
May 2023
First submitted
12 Apr 2022
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Non-identifiable IPD will be shared upon reasonable request to the Chief Investigators.

Publications

  • Lavender IG, Marshall NS, McCartney D, Cho G, Irwin C, Suraev A, Gordon R, Arnold JC, D'Rozario AL, Gordon CJ, Saini B, Sivam S, Zheng Y, Grunstein RR, Yee BJ, McGregor IS, Hoyos CM. Cannabinol for Acute Treatment of Insomnia Disorder in a Randomized Placebo-Controlled Crossover Trial. J Sleep Res. 2026 Aug;35(4):e70284. doi: 10.1111/jsr.70284. Epub 2026 Feb 16.

    PubMed 41698831

  • Lavender I, McCartney D, Marshall N, Suraev A, Irwin C, D'Rozario AL, Gordon CJ, Saini B, Grunstein RR, Yee B, McGregor I, Hoyos CM. Cannabinol (CBN; 30 and 300 mg) effects on sleep and next-day function in insomnia disorder ('CUPID' study): protocol for a randomised, double-blind, placebo-controlled, cross-over, three-arm, proof-of-concept trial. BMJ Open. 2023 Aug 23;13(8):e071148. doi: 10.1136/bmjopen-2022-071148.

    PubMed 37612115

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 30 mg Cannabinol (CBN) and 300 mg Cannabinol (CBN) in people with Insomnia Disorder, run by Woolcock Institute of Medical Research at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wake After Sleep Onset (WASO) (time frame: Night 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05344170, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in