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Cannabinol Use in Patients With Insomnia Disorder

NCT05344170 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-06

No results posted yet for this study

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

Interventions

DRUG

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.

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.

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.

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Camilla Hoyos, MPH, PhD · Woolcock Institute of Medical Research

  • Brendon Yee, MBChB, FRACP, FCCP, PhD · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-24
Primary Completion
2023-08-29
Completion
2023-09-05

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344170 on ClinicalTrials.gov