CANARY FAQs - participants
FAQs FOR PARTICIPANTS | THE CANARY STUDY
What does ultra-high risk for psychosis mean?
Ultra-high risk (UHR) for psychosis refers to symptoms and/or family history that put people at a higher risk than the general population for developing a psychotic disorder.
Symptoms vary for different individuals, but can include feeling low in mood, feeling paranoid or seeing things, or people hearing voices that they know aren’t there. Some people might worry that their thoughts are being heard, may not feel right in themselves, or might be having more difficulty than usual coping with work, school or relationships.
Other people within the UHR group may not experience any of these early symptoms, but have a family member with a psychotic disorder.
For some people, these early symptoms will get worse without help. For others, the symptoms may lessen or go away. It is for this reason that providing a range of effective treatments for young people is so important.
What treatments are there for symptoms experienced by young people who are at risk for psychosis?
There are two main categories of evidence-based treatments available – pharmacological treatments (medicine) and psychological therapies such as cognitive behavioural therapy (CBT).
Why is Orygen running this trial?
Current treatments available don’t work for everyone so Orygen is investigating a potential new treatment known as cannabidiol. Orygen’s hope is that by testing potential new treatments we will be able to find effective treatments with limitedside effects.
CANNABIDIOL
Is cannabidiol the same as cannabis or medical marijuana?
No. Cannabidiol is only one out of many compounds that are found in the cannabis plant. Unlike other substances found in the cannabis plant (for example, tetrahydrocannabinol (THC), cannabidiol does not make people ‘high’.Cannabidiol is extracted from the cannabis plant, purified and does not contain relevant quantities of other substances such as THC.
Aren’t there other drugs you can try? Why does it have to be cannabidiol?
Cannabidiol has been tested as a treatment for adult patients with psychotic disorders as well as in people with other illnesses such as epilepsy or anxiety. Because cannabidiol was found to reduce the severity of psychotic symptoms in adults with psychosis, it is important to test whether it is safe and effective in young people at UHR for psychosis.
Will the young people on the study get addicted to cannabidiol?
No. Unlike THC, cannabidiol is not addictive. In fact, it has been used to treat cannabis addiction in other research trials as it opposes some of the effects of THC.
How do you know for sure?
None of the previous studies have indicated that cannabidiol may be addictive in young people or adults.
What amount of cannabidiol will you be giving people?
Research participants will be randomly allocated to one of three groups:
- group one will take 1000mg cannabidiol daily;
- group two will take 600mg cannabidiol daily; and
- group three will take a placebo (no cannabidiol) each day for 12 weeks..
Orygen researchers decided on these doses based on previous studies testing cannabidiol in adult patients with psychosis, and studies testing cannabidiol in young people with anxiety and epilepsy.
How are you going to make sure participants don’t take more than that?
Trial participants will receive only a certain number of cannabidiol capsules at each study visit, or as appropriate to prescribe for that individual. In addition, Orygen researchers will monitor the number of capsules taken, as well asblood levels of cannabidiol.
Will participants know which group they’re in?
No. Participants and researchers will not know which group each participant has been allocated to. Only the pharmacy will know this so they can provide the right medication. The reason for this is so that researchers can compare improvements within each group without jumping to conclusions based on how much CBD participants were taking.
How will you know if the cannabidiol is working?
Researchers and clinicians will use a range of psychiatric measures, including a questionnaire, to evaluate the effectiveness of cannabidiol. These are well- established approaches that are used in clinical research to measure improvements in symptoms.
Will people on the study be smoking the cannabidiol?
No. The cannabidiol will be administered as a capsule and cannot be smoked or inhaled.
Where is Orygen getting the cannabidiol from?
The cannabidiol used in our study is a natural product extracted from cannabis plants and is distributed by a European pharmaceutical company that specialises in cannabidiol.
Can someone continue using cannabidiol after the trial has concluded? If so, who will pay for it?
Cannabidiol can only be prescribed in Australia via a special access scheme and its cost is currently not subsidised by the Pharmaceutical Benefits Scheme. Trial participants who wish to access cannabidiol following the trial will need to cover the cost themselves. The research team encourages participants who are interested in continuing to take cannabidiol after the trial to speak to their general practitioner.
You can find more information about this here.
CLINICAL TRIAL
What’s a clinical trial?
Clinical trials are systematic research investigations where new treatments or other interventions are tested in patients under the strict surveillance of one or more ethics committees. This trial will be run under the guidance of a human ethics committeeoperated by Melbourne Health.
How many people are going to be participating in the trial?
The research team is planning to enrol up to 450 participants in this trial.
How long willthe trial go for?
Participants will take the study medicine for 12 weeks; however, follow-up assessments will continue over a period of up to two years. In total, Orygen researchers expect the trial to run for about four years.
Trial preparations began in July 2019, with recruitment of participants from June 2022. The trial will finish around January 2026.
Where is the trial being run?
The trial is being conducted at the following centres:
In metropolitan Melbourne: Orygen Clinical Trials Unit in Parkville.
In Western Australia:
- headspace Midland (Perth, Western Australia);
- headspace Osborne Park (Perth, Western Australia);
- headspace Joondalup (Perth, Western Australia); and
- Youth Axis (Perth, Western Australia).
TRIAL PARTICIPATION
How do I get on this trial?
To participate in this trial, eligible participants based in Melbourne can self-refer or be referred by their clinicians. A referral from participants’ regular GP will be required before starting the study treatment. In W.A., only clients of the centres above can take part in the trial. If a young person at one of those centres appears to be eligible, a research assistant will approach them to ask if they would like to take part in the project.
However, the team encourages young people seeking support to contact their local headspace centre.
What age does someone have to be to take part in the trial?
Young people aged between 12 and 25, inclusive, can participate in the study.
Aren’t 12-year-olds too young to be taking cannabidiol?
The age range of participants in this trial is similar to the age range of participants in other trials of cannabidiol (e.g. for epilepsy). It is important to know if this potential new treatment is effective for participants under the age of 18, as they represent a large proportion of headspace clients. Any participants aged under 18 will require the consent of a parent or guardian.
I’ll be turning 26 soon, can I still be part of the trial?
Yes, if you are enrolled in the trial while still aged 25.
What psychosocial support will participants receive during the trial?
Participants will continue to receive treatment as usual with their current mental health provider. Participants in Melbourne who are not currently receiving psychosocial treatment will be engaged with a mental health clinician at Orygen’s Parkville Hub for the duration of the study treatment period.
Who do I contact about a young person I care for taking part in the trial?
To find out more about the study or to contact the research team please email [email protected]
SEP v4.0 041122. HREC/60933/MH-2020