CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
30 mg Cannabinol (CBN) +2 moredrug
Likely dose
30 mg Cannabinol (CBN)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05344170
NCT05344170Phase 2Completed
CompareCT.gov

A 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

Woolcock Institute of Medical Research·interventional·Posted Apr 25, 2022·Updated Feb 6, 2024

In Brief

A Phase 2 clinical trial evaluating 30 mg Cannabinol (CBN), 300 mg Cannabinol (CBN), and 1 other intervention for Insomnia Disorder. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia Disorder
CountriesAustralia
CollaboratorsUniversity of Sydney

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 25, 2022
Enrollment StartAug 24, 2022
Primary CompletionAug 29, 2023
Study CompletionSep 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.2 years ago

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.

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.

Placebodrug

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.