Cannabinol Use in Patients With Insomnia Disorder (CUPID)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    20
  • sponsor
    Woolcock Institute of Medical Research
Updated on 7 October 2022
chronic insomnia

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.

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.

Details
Condition Insomnia Disorder
Treatment Placebo, 30 mg Cannabinol (CBN), 300 mg Cannabinol (CBN)
Clinical Study IdentifierNCT05344170
SponsorWoolcock Institute of Medical Research
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females aged between 25-65 years
Insomnia Severity Index (ISI) score ≥15
Insomnia symptoms for more than 3-times per week for ≥3-months as determined by the medical officer
Ability to take oral medication
Provision of signed and dated informed consent form; and
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 as determined by the medical officer
Known hypersensitivity to cannabis or cannabinoid products
Reported use of cannabis within the past 3 months as confirmed by at least one negative urine drug screen (UDS) (or at the medical officer's discretion)
Sleep apnea (defined as Apnea Hypopnea Index [AHI] >15 and Oxygen Desaturation Index [ODI]>10) as confirmed at screening
Sleep-related movement disorder as determined by the medical officer
Delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as confirmed screening
Any medical condition that produces an abnormal EEG (i.e. epilepsy, brain injury)
Clinically relevant cardiovascular abnormalities as determined by the medical officer and a 12-lead electrocardiogram (ECG) at screening
Shift-work or transmeridian travel (two time zones) over last month
History of major psychiatric disorder in the past 12 months at the medical officer'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. All female volunteers will be required to complete a urine pregnancy test at screening and instructed to use a reliable form of contraception while participating in the project
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 medical officer's discretion
Use of medications that may have a clinically significant impact upon the metabolism and excretion of cannabinoids as determined by the medical officer (e.g. CYP450 enzyme inducers/inhibitors)
Excessive caffeine use that in the opinion of the medical officer contributes to the participant's insomnia, 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, including cognitive behavioural therapy for insomnia, within 3 months before screening (excluding sleep hygiene advice)
Occupational or judicially ordered drug alcohol screening
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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