CBD Insomnia Study

A Randomized, Double-Blind, Placebo-controlled Phase III clinical study evaluating the efficacy and safety of CBD TPM (Cannabidiol, Tocopheryl Phosphate Mixture) capsules in adults for use in the reduction of insomnia severity

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Quick Reference:

What is the purpose of this study?

Where is my nearest study site?

Who can participate?

Who cannot participate?

What is involved? 




What is the purpose of this study?

Avecho has recognised that existing over-the-counter medications for insomnia either have poor efficacy or are associated with a high degree of next day impairment. There is currently an unmet treatment need for an over-the-counter, effective, fast-acting treatment for insomnia that provides natural, restorative sleep. 

They have developed a potential new treatment for insomnia called CBD TPM (the study drug), with the goal of filling this therapeutic gap. This study aims to investigate the effects the study drug has on you and your condition.



Where is my nearest study site?

Here is a list of all of the sites who are currently recruiting for this study:


  • Blacktown - Paratus Clinical Research Western Sydney
  • Kanwal - Paratus Clinical Research Central Coast


  • Albion - Paratus Clinical Research Brisbane Clinic


  • Clayton - Monash Medical Centre


  • Nedlands - Captain Sterling Medical Centre

Who can participate?
To take part in this study, you will need to meet all the following:

  • You are 18 years of age or older
  • You’ve had difficulty getting to sleep, staying asleep and/or waking up earlier in the morning than desired, for at least the past 3 months (or are diagnosed with insomnia)
  • You have a regular time period spent in bed, either sleeping or trying to sleep (e.g. you go to bed around 9pm and get up at 6am)
  • You have access to a smartphone

Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:

  • You consume more than 300mg or about 3 cups of caffeinated drinks per day (and are not willing to reduce your intake for the duration of the trial)
  • Your insomnia results from another sleep-wake disorder (e.g. narcolepsy, a breathing-related sleep condition, restless leg syndrome, or any other related condition)
  • You nap more than 3 times a week
  • You are currently on/taking any treatments for insomnia

What is involved?

If you agree to take part, and the study is suitable for you, your participation in the
study is expected to last up to 16 weeks. You will be required to return to the study site approximately 4 times and have approximately 4 telephone calls with the study

This study has 3 periods:
● Screening Period (6 weeks)
● Treatment Period (8 weeks)
● Follow-up Period (2 weeks)

As part of the study you will be asked to:
● Complete a daily study diary
● Complete questionnaires

Participation in this research is voluntary, and you may withdraw from the study at any time.


If you take part in the research study, there will be:

  • Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
  • Free study-related medical care: You may gain access to new research treatments, before they are widely available.
  • No overnight stays: All study visits are day clinic visits and telephone calls only.


What is Insomnia?

Insomnia is a common sleep disorder in which people have difficulty falling or staying asleep. It is often defined as inadequate or poor-quality sleep despite having adequate opportunity to sleep. In Australia 12% of the population is clinically diagnosed with chronic insomnia, and as many as 60% of the population have at least one symptom of insomnia (Sleep Health Foundation Report). Some of these symptoms may include:

  • Difficulty getting to sleep
  • Interrupted sleep during the night and trouble going back to sleep
  • Waking up too early
  • Not feeling well-rested after a night's sleep
  • Daytime tiredness or sleepiness
  • Irritability, depression or anxiety
  • Difficulty paying attention, focusing on tasks or remembering

 Insomnia has been associated with increased risk of various serious chronic medical and psychiatric conditions. With the prevalence of insomnia growing, there is an urgent need for more effective treatments to manage its symptoms and to help Australians have better sleep!


Why is this study important?
● The incidence of insomnia is growing in both prevalence and severity in
● In Australia, 12% of the population is clinically diagnosed with chronic insomnia,
and as many as 60% of the population have at least one symptom of insomnia
(Sleep Health Foundation Report).


Who is involved? 
Avecho is an innovation-led biotechnology company based in Melbourne, Australia.
They develop and commercialise innovative Human Health and Animal Health
products, using their proprietary drug delivery system called Tocopheryl Phosphate
Mixture (TPM®).
Currently, Avecho is developing a low dose, over-the-counter product, CBD TPM
(cannabidiol, tocopheryl phosphate mixture) capsules for the management of
symptoms associated with insomnia.


This trial has been approved by an independent ethics committee


Ready to register? Click here to sign up/login to Evrilink and start your clinical trial journey. 


Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!