NCT05253417

The CANabidiol Use for RElief of Short Term Insomnia

The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Bod Australia · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.

Detailed description

This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8-21. Participants will be recruited voluntarily and are able to withdraw at any time. The study will be conducted online with telehealth consults where required.

Conditions

• Sleep Disturbance
• Insomnia
• Insomnia Type; Sleep Disorder
• Insomnia, Transient
• Insomnia Due to Anxiety and Fear
• Insomnia Due to Other Mental Disorder

Interventions

Type	Name	Description
DRUG	50 mg Cannabidiol (CBD)	For the study arm, '50 mg CBD' participants take two (2) CBD capsules and two (2) placebo capsules.
DRUG	Placebo	Participants take four (4) placebo capsules.
DRUG	100 mg Cannabidiol (CBD)	For the study arm, '100 mg CBD' participants take four (4) CBD capsules.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2022-02-23
• Last updated: 2023-08-16

Locations

2 sites across 1 country: Australia