Completed

CUPIDA Randomised, Double-blind, Placebo-controlled, Single-dose, Crossover, Pilot Study Investigating the Effects of Cannabinol (CBN) 30 mg and 300 mg on Sleep Architecture and Next-day Function in Insomnia Disorder

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What is being tested

30 mg Cannabinol (CBN)

+ 300 mg Cannabinol (CBN)

+ Placebo

Drug
Who is being recruted

Mental Disorders+3

+ Sleep Initiation and Maintenance Disorders

+ Nervous System Diseases

From 25 to 65 Years
+29 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorWoolcock Institute of Medical Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 24, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomised, Double-blind, Placebo-controlled, Single-dose, Crossover, Pilot Study Investigating the Effects of Cannabinol (CBN) 30 mg and 300 mg on Sleep Architecture and Next-day Function in Insomnia Disorder
NCT05344170
Principal SponsorWoolcock Institute of Medical Research
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSleep Initiation and Maintenance DisordersNervous System DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomnias

Criteria

6 inclusion criteria required to participate
Provision of signed and dated informed consent form
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
Show More Criteria
23 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Woolcock Institute of Medical Research

Glebe, AustraliaOpen Woolcock Institute of Medical Research in Google Maps
CompletedOne Study Center