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

NCT05840822 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 519

Last updated 2025-06-06

No results posted yet for this study

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

Interventions

DRUG

Cannabidiol (CBD) Capsule 75mg

Cannabidiol (CBD) capsule containing 75mg CBD

DRUG

Placebo

Placebo capsule without cannabidiol

Sponsors & Collaborators

  • Avecho Biotechnology

    lead INDUSTRY

Principal Investigators

  • Darren Mansfield · Monash Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT05840822 on ClinicalTrials.gov