drugset / Trial / NCT05840822

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

NCT05840822

Phase 3 Active not recruiting 519 enrolled Avecho Biotechnology
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-05-16
Primary completion
2027-09-30
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 75 mg
Subject Cannabidiol Other / unclassified 150 mg

Indications