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 range25 Years – 65 Years

SexALL

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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
✕. 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
✕. 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

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