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

Insomnia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT05840822
Study type Interventional
Source Avecho Biotechnology
Contact Paul Gavin
Phone +61390025000
Email pgavin@avecho.com.au
Status Not yet recruiting
Phase Phase 3
Start date June 2023
Completion date May 2024
View Details
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