Medicinal cannabis for menopause symptoms study
Are you peri or postmenopausal and experiencing sleep difficulties? If you are aged 45-65 and are of perimenopausal or postmenopausal status and are experiencing sleep difficulties (you may also be experiencing other symptoms too) then you may be eligible to participate in a study on medicinal cannabis for menopausal symptoms.
NICM Health Research Institute's Dr Guoyan Yang is leading an observational study on the effectiveness and safety of medicinal cannabis to treat sleep difficulties associated with menopause, as well as other symptoms associated with menopause. The treatment period is six months, and you would need to attend a local pathology centre for three blood tests to make sure your liver and kidney function is normal. A medical doctor at Natura Clinic will assess your suitability for medicinal cannabis and if you are eligible will prescribe one or more medicinal cannabis products for you. This may include products containing cannabidiol (CBD) and/or tetrahydrocannabinol (THC). The doctor will discuss your treatment goals and preferences with you before making recommendations. All consultations during the study are free of charge, however you will need to purchase the medicinal cannabis products (these will be at a reduced price for the duration you are in the study). You will remain under the care of this doctor during the study, and they can advise on any dosage or product changes where necessary.
Who can join?
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People aged 45-65 years, of perimenopausal or postmenopausal status, who:
- Are currently living in Australia.
- Experiencing difficulties with sleep including either falling asleep or staying asleep.
- Have not used any form of cannabis (including CBD products) in the previous three-months.
- Agree to not drive or operate heavy machinery if you are prescribed THC containing products.
- Possess a smartphone with internet connectivity (to be able to complete the questionnaires).
What's involved?
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After an initial assessment and consent, you will:
- Have blood taken to assess your liver and kidney function.
- Complete a series of questionnaires on a mobile phone, tablet or computer prior to starting the medicinal cannabis.
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Once you have been taking the medicinal cannabis products the doctor has prescribed you, we will ask you:
- Once a month log what products you have used and the average doses you've used,
- We will also ask you to complete some questionnaires about your menopause symptoms once a month, if you needed to use other medication like melatonin, and if you've had any side effects from the treatment.
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At three months and again at the end of the study we will ask you to
- Have blood test taken to monitor liver and kidney function.
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At the end of six months, we will ask you to complete questionnaires similar to those before you started as well as asking you some questions about satisfaction with the treatment.
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In total, we expect that it will take about 30 minutes each month to complete the questionnaires.
What are the benefits for participating?
Participation in this study may help you to manage symptoms associated with peri- and post-menopause including sleep difficulties. However, as there is little research in this area, it is also possible that you may not receive any benefits from medicinal cannabis. By participating in this study you will receive free consultations and discounted products, for the duration of the study. In addition, if medicinal cannabis looks like it might be effective then this study will provide the information needed to design and conduct a randomised controlled trial in the future.
Interested in participating?
For more details about this study please read the following information before deciding on whether to participate.
In order to confirm your eligibility and register your interest, please complete the online form below.
If you have further questions, please contact the research team on menocann@westernsydney.edu.au
Human Research Ethics Committee Approval: This clinical trial has been approved by Western Sydney University Human Research Ethics Committee (Approval Number: H16317 ).
This study is supported by Cannim Group Pty Ltd.
NICM Health Research Institute Chief Investigator: Dr Guoyan Yang, Tel: (02) 9685 4732, Email: e.yang@westernsydney.edu.au.