The Global QUEST Initiative is looking into quality of life in patients accessing medicinal cannabis so only medicinal cannabis prescription medicines will be used in this clinical study.
To ensure consistency across study participants, all products will be supplied by the same Australian manufacturer, Little Green Pharma. The products are either oral or dried flower medications. The oral medications are manufactured from full spectrum extracts into a medical grade cannabis oil. These medicinal cannabis oils come in a range of THC and CBD ratios, including a CBD only option. Your prescribing doctor will consider the appropriate product and ratio based on your medical condition and personal circumstances.
The Australian manufacturer has arranged a distribution agreement with a partner pharmacy to ensure participating patients can get their medicinal cannabis products safely delivered to their home at no extra cost.
You will be prompted to pay for the product before it is distributed. Payment can be made by credit or debit card over the phone with the partner pharmacy, Oxford Compounding.
You will complete questionnaires at the following intervals:
- upon joining the study (before starting treatment)
- two weeks after first starting medicinal cannabis therapy
- three-monthly for the rest of the year
- at six-month intervals until the end of the study
On each occasion, the questionnaires will take approximately 25-30 minutes to complete.
Please note: You will need internet access to complete the questionnaires via a website on your smartphone, tablet or computer. You will then receive notifications by email to complete follow-up questionnaires.
There is no set list of eligible chronic conditions that can be considered for this study. A doctor and the relevant health authorities need to approve its use for the patient considering individual circumstances and if there is evidence or research showing therapeutic benefit from the use of medical cannabis in patients with a similar medical condition.
A doctor can prescribe medicinal cannabis only after established treatments have been trialled and or have been unsuccessful, with the exception of palliative care.
Participating in this study is completely voluntary and you do not have to take part if you do not wish to do so. Your decision whether to participate will not affect your current or future relationship with the researchers or anyone else at the Curtin University, and will not affect your current or future treatment at the clinic you are having treatment or relationships with your doctor or treating team.
If you decide to take part in the study and then change your mind later, you can withdraw at any time. You can do this by contacting the doctor who prescribed medicinal cannabis. If you withdraw from the study, you can still access the medication but will no longer receive your medicinal cannabis prescription at the participant study cost.
Submitting your completed questionnaire is an indication of your consent to participate in the study. If you change your mind about having your responses included in the study, you can withdraw them up to the point that the data has been analysed. After that point your data cannot be removed and will be included in the study.
All patients taking part in this study will be charged a subsidised rate for their medicinal cannabis products. This cost of medical cannabis products for participants will be $130 per 10g sachet or from $135 for 50mL (excluding the high CBD medication which is $195). This pricing includes home delivery.
The results from this study will also help future patients and their doctors to make better-informed decisions about this new treatment and understand the potential impact of medicinal cannabis on overall quality of life.
A doctor who has been registered with the Curtin University team and have received training to screen, register, and support patients on The Global QUEST Initiative.
Yes, doctor consultation fees are the responsibility of the participant. Participants will need to book a telehealth or in-person doctor consultation initially in order to be enrolled and receive a script. Then, additional consultations and any subsequent visits the doctor recommends based on the patient’s individual medical circumstances and for repeat scripts.
Doctor fees vary so please refer to the directory (after you check your eligibility) or call our team on 1300 664 369 for more information about participating QUEST doctor fees.
You can tell us that you wish to receive feedback by ticking the relevant box on the consent form. After the study is finished, you will be emailed a one page summary of the overall results.
All clinical studies are conducted in accordance with the Victorian Health Records Act Privacy Principles. Therefore, your information will be kept confidential and you will not be identifiable in any publication of the results. Your consent to share your information with any other organisation will be obtained before information is released.
All study information will be collected via the Curtin University research data capture system, REDCap, a secure web application that runs on the Curtin University’s servers, ensuring data stays within the Curtin University data centre.
We intend to give the information from this project to other researchers so that they can use it in their projects. Before we do so, we will take out all the identifying information so that the people we give it to won’t know whose information it is. They won’t know that you participated in the project and they won’t be able to link you to any of the information you provided.
The QUEST team can support you with access to free education including courses which can be completed online. You will also gain access to a medical portal which has application support, case studies, dosing chart information and more to assist you on your journey.
- Complete a five-minute online patient screening and registration questionnaire during the primary consult
- Prescribe medicinal cannabis following the ‘normal pathway’ – SAS B or Authorised Prescriber
- Email SAS B or MAP paperwork and patient e-Scripts to partner pharmacy at firstname.lastname@example.org
As this study involves patients completing online questionnaires during the study, there are minimal obligations on the prescribing doctor.
If a patient would like to opt-out of the study, the prescribing doctor will be required to inform the Curtin University researchers. Withdrawn patients can still access medicinal cannabis but may no longer receive the study discount.
If any patient would like to stop taking medicinal cannabis, the prescribing doctor is required to plan an exit strategy to titrate the patient off the medicinal cannabis and monitor them as per the initial standard patient monitoring plan submitted in the Special Access Scheme (SAS) application with the TGA.
Participants in this study will be required to purchase their own medications. An Australian manufacturer of medicinal cannabis, Little Green Pharma, will be supplying their medicines to ensure product standardisation. Each patient taking part in this study will be charged a standardised cost of medicinal cannabis products set at $130 for 10g sachet or $135 for 50mL bottle which includes delivery.
Please note: If a patient withdraws from the study, they can still access medicinal cannabis but will no longer receive the study participant rate as noted above.
Standard doctor consult fees also apply, and it is recommended patients discuss these fees with their doctor of choice.
It is not possible to advise patients exactly how much product they will require daily and the total costs of their medication. This is because dosing of medicinal cannabis remains highly individualised and relies on each patient working with their doctor to find the dose that works best for them where the benefits are maximised and any unwanted side effects are minimised.
A helpful guide to the average costs of medicinal cannabis products can be found in an independent report conducted by Freshleaf Analytics ‘Australian Medicinal Cannabis Market Patient, Product and Pricing Analysis – Q1 2020’. The report advised that the average patient paying full cost for medicinal cannabis is spending less than $10 per day.
As medicinal cannabis is still an unregistered product in Australia, these medications are not covered under the Pharmaceutical Benefits Scheme (PBS). As a result, patients are required to pay the entire cost of the medicine. There are some health insurers such as HIF that will offer a rebate for prescription medicines, but patients should contact their own insurer to discuss if this is indeed an option.
The Global QUEST Initiative is seeking eligible patients who are:
- 18+ years of age and living in Australia
- able to complete the questionnaires in English
- able to provide informed consent
- have access to the internet or a smart phone
- have not taken any type of prescribed cannabis therapy for four weeks before enrolling in the study
- suffering from a chronic condition with symptoms that have lasted for three months or more, and
- eligible for medicinal cannabis as a form of treatment
Only QUEST recruitment doctors can properly assess your eligibility to participate.
Once available the de-identified results will be published in medical journals and other relevant publications. On completion of the study, participants receive a one-page lay summary of the results from the study researchers.
The Consumer Medicine Information (CMI) sheet provided with your medicinal cannabis provides you with full details on possible side effects and actions to take should you experience any side effects. It is always recommended that you advise your prescribing doctor about any side effects and discuss how best to manage.