Cannabinol Use in Patients With Insomnia Disorder

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Woolcock Institute of Medical Research
• Collaborator: University of Sydney

Criteria

Inclusion Criteria:

1. Males and females aged between 25-65 years;

2. Insomnia Severity Index (ISI) score ≥15;

3. Insomnia symptoms for more than 3-times per week for ≥3-months as determined by the medical officer;

4. Ability to take oral medication;

5. Provision of signed and dated informed consent form; and

6. Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

1. Medical condition or medication that is the cause of the insomnia as determined by the medical officer;

2. Known hypersensitivity to cannabis or cannabinoid products;

3. 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);

4. Sleep apnea (defined as Apnea Hypopnea Index [AHI] >15 and Oxygen Desaturation Index [ODI]>10) as confirmed at screening;

5. Sleep-related movement disorder as determined by the medical officer;

6. Delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as confirmed screening;

7. Any medical condition that produces an abnormal EEG (i.e. epilepsy, brain injury);

8. Clinically relevant cardiovascular abnormalities as determined by the medical officer and a 12-lead electrocardiogram (ECG) at screening;

9. Shift-work or transmeridian travel (two time zones) over last month;

10. History of major psychiatric disorder in the past 12 months at the medical officer'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. 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;

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 medical officer's discretion;

15. 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);

16. 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;

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, including cognitive behavioural therapy for insomnia, within 3 months before screening (excluding sleep hygiene advice);

21. Occupational or judicially ordered drug alcohol screening.