Sleep Insomnia Medical Study
Do you have Sleep Insomnia? We are recruiting for a medical study investigating the safety and tolerability of an oral capsule for insomnia disorder. The oral tablet contains cannabidiol + tocopheryl phosphate mixture (CBD TPM).
Participation in this medical study is voluntary and will not affect your regular care at Key Health.
What is Sleep Insomnia?
Insomnia is a common sleep disorder that can make it hard to fall asleep or stay asleep.
What are the Symptoms of Sleep Insomnia
Difficulty in falling asleep at night
Awakening during the night
Waking up too early
Feeling tired during the day
Feelings of depression or anxiety
Hard time focusing on tasks
Hard time remembering
What is the purpose of the study?
The study will assess the safety and efficacy of the CBD TPM oral capsule when administered daily for 8 weeks.
The study will do this by assessing the CBD TPM oral capsule against a placebo capsule.
A placebo looks like the study medicine but does not contain any study medicine (active ingredient).
Researchers use a placebo to see if a study medicine is safer than not taking anything at all.This is a double-blinded study, which means neither you or the study team will know if you receive the investigational product or a placebo.
What is involved?
If you are deemed eligible for the study, your study participation will last approximately four months.
This will include 5 clinic visits and 3 phone visits.
Some of the clinic visits could last up to 3 hours. The study includes the following procedures:
Physical Exam: your study doctor will evaluate the basic function of your organs
Vital Signs: your study doctor or nurse will check your height, weight, blood pressure, heart rate, oxygen levels, respiratory rate and temperature.
Blood Tests
Urine Samples
Questionnaires
e-Diary to be filled in on a smart phone
Am I eligible for this study?
To take part in this study, you will need to meet all the following:
✅ You are aged 18 or over
✅ You have been diagnosed or suspect sleep insomnia disorder
✅ You have and can use a smart phone
If you meet any of the following criteria, you are ineligible to participate in the study:
❌ You are pregnant or plan to be in the next four months.
❌ You currently use cannabis or any cannabis treatment such as cannabis oil.
❌ You have excessive caffeine use
❌ You use sedatives (eg. Zopiclone)
❌ You use opioids (eg. Morphine, codeine, oxycodone, fentanyl, tramadol, tapentadol)
❌ You have severe asthma
❌ You are a shift worker
For more details on study eligibility, please see Study Eligibility Information.
*Please note: additional eligibility criteria apply and will be discussed during the screening visit.
How can I take part in this study?
If you meet all the study eligibility criteria, please call or email
Alice Hawkes - Clinical Trials Coordinator for Key Health
Email: alice.hawkes@keyhealth.com.au
Phone: 0473 404 917
