NCT05840822

Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of CBD TPM Capsules in Adults for Use in the Reduction of Insomnia Severity

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 519 (estimated)
• Sponsor: Avecho Biotechnology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associated with insomnia, there is little clinical data available to support the efficacy or utility of CBD in the management of sleep disorders. The proposed study will assess whether nightly doses of 75mg or 150mg of an 8 week period are able to improve patient reported sleep quality when compared to a placebo.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Cannabidiol (CBD) Capsule 75mg	Cannabidiol (CBD) capsule containing 75mg CBD
DRUG	Placebo	Placebo capsule without cannabidiol

Timeline

• Start date: 2024-05-16
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2023-05-03
• Last updated: 2025-06-06

Locations

5 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study