Cannabinol Use in Patients With Insomnia Disorder

NCT ID: NCT05344170

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2023-09-05

Brief 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.

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.

Conditions

Insomnia Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

30 mg Cannabinol (CBN)

Single fixed dose administered 2 hours prior to habitual sleep onset.

Group Type: EXPERIMENTAL

30 mg Cannabinol (CBN)

Intervention Type: DRUG

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)

Single fixed dose administered 2 hours prior to habitual sleep onset.

Group Type: EXPERIMENTAL

300 mg Cannabinol (CBN)

Intervention Type: DRUG

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.

Placebo

Single fixed dose administered 2 hours prior to habitual sleep onset.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

30 mg Cannabinol (CBN)

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.

Intervention Type: DRUG

300 mg Cannabinol (CBN)

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

ECS 310 (1.5%); ECS 310 (15%)

Eligibility Criteria

Inclusion Criteria

1. Between 25 - 65 years of age

2. Insomnia Severity Index (ISI) score ≥ 15 at eligibility screening

3. Insomnia disorder (symptoms occurring at least 3 times per week and present for longer than 3 months) as determined by the study physician

4. Ability to take oral medication

5. Provision of signed and dated informed consent form

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 disorder as determined by the study physician

2. Known hypersensitivity to cannabis or cannabinoid products (including if this becomes evident during the trial)

3. 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)

4. Sleep apnoea (defined as Apnoea Hypopnea Index [AHI] > 15 and Oxygen Desaturation Index [ODI]>10) as confirmed by polysomnography at screening

5. Sleep-related movement disorder as determined by the study physician

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

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

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

9. Shift work or trans meridian travel (two time zones) within the last month

10. History of major psychiatric disorder in the past 12 months at the study physician'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. 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

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 study physician's discretion

15. 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

16. 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

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

21. Occupational or judicially ordered drug screening

22. Has held an unrestricted driving license < 1 year

23. Cannot speak English fluently

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

Woolcock Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camilla Hoyos, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Woolcock Institute of Medical Research

Brendon Yee, MBChB, FRACP, FCCP, PhD

Role: PRINCIPAL_INVESTIGATOR

Woolcock Institute of Medical Research

Locations

Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 37612115 (View on PubMed)

Other Identifiers

112/2021-08-907

Identifier Type: -

Identifier Source: org_study_id