CompletedPhase 1/2

Cannabinol Use in Patients With Insomnia Disorder

Australia20 participantsStarted 2022-08-24

Plain-language 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.

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wake After Sleep Onset (WASO)

Timeframe: Night 1

Trial details

NCT IDNCT05344170

SponsorWoolcock Institute of Medical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-29

View on ClinicalTrials.gov More Insomnia Disorder trials