Cannabinol Use in Patients With Insomnia Disorder

NCT05344170 | Completed Phase 1 DMC

• 1 other identifier: 112/2021-08-907
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Disorder

Keywords

cannabinol; CBN; cannabinoid; medicinal cannabis; primary insomnia; chronic insomnia disorder; sleep architecture; wake after sleep onset; polysomnography; next-day function; randomised controlled trial; placebo-controlled; crossover; double-blinded

Outcome Measures

Primary Outcomes (1)

• Wake After Sleep Onset (WASO)

  WASO measured in minutes using in-laboratory overnight polysomnography, from the first epoch after lights out until the last epoch, scored as any stage of sleep by an experienced polysomnographic technician in accordance with American Academy of Sleep Medicine (AASM) 2020 Sleep Scoring criteria (Version 2.6). Comparisons between each CBN dose versus placebo.

  Night 1

Secondary Outcomes (3)

• Traditional sleep staging

  Night 1

• Sleep Onset Latency (SOL)

  Night 1

• Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep.

  Night 1

Other Outcomes (21)

• Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep (Tertiary outcome)

  Night 1

• Electroencephalogram (EEG) Arousal Index (Tertiary outcome)

  Night 1

• Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep (Tertiary outcome)

  Night 1

Study Arms (3)

30 mg Cannabinol (CBN)

EXPERIMENTAL

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

Drug: 30 mg Cannabinol (CBN)

300 mg Cannabinol (CBN)

EXPERIMENTAL

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

Drug: 300 mg Cannabinol (CBN)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

30 mg Cannabinol (CBN) 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.

Also known as: ECS 310 (1.5%)

30 mg Cannabinol (CBN)

300 mg Cannabinol (CBN) 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.

Also known as: ECS 310 (15%)

300 mg Cannabinol (CBN)

Placebo 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.

Placebo

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Shift work or trans meridian travel (two time zones) within the last month
• History of major psychiatric disorder in the past 12 months at the study physician'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. 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
• 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 study physician's discretion
• 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

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead
• University of Sydney: collaborator

Study Sites (1)

Woolcock Institute of Medical Research

Glebe, New South Wales, 2095, Australia

Location

Related Publications (1)

• 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.

  PMID: 37612115 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cannabinol

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Camilla Hoyos, MPH, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Brendon Yee, MBChB, FRACP, FCCP, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind: Eligible participants will be assigned to one of six possible treatment orders using a pre-populated randomisation schedule. Study staff (including the study investigators, the clinical trials coordinator and the study medical officer) and the participants will be blinded. Allocation concealment will be managed by the trial epidemiologist and drug distributor who will not have any contact with participants or involvement in day-to-day trial activities. Traditional polysomnographic (PSG) measures will be scored by a PSG technician who will not be aware of participant treatment, nor will they meet the participant. The study drug and matched placebo are expected to be identical in their visual appearance, taste, or smell. A mint-flavoured lozenge will be administered immediately prior to the study drug to mask any possible differences in taste.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site allocation: Randomised Intervention model: Crossover Masking: Double-blind (participant, investigator) Primary purpose: Pilot

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 25, 2022
• Study Start: August 24, 2022
• Primary Completion: August 29, 2023
• Study Completion: September 5, 2023
• Last Updated: February 6, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Non-identifiable IPD will become available one year after the Actual Study Completion Date and will be available for 10 years.
• Access Criteria: Individual participant level meta-analyses of congruent studies

Locations

AU (1)