Overview
What is the Medicinal Cannabis Research Program?
Children and adolescents with developmental disorders such as autism, intellectual disability, and ADHD are often prescribed psychiatric medications, which can cause serious side effects.
Medicinal cannabis is a new therapy with great hope and may be a safer alternative. However, there is currently no definitive evidence to support the use of medicinal cannabis to help children with neurodevelopmental or mental health conditions.
This nationally leading program of research is investigating the safety and efficacy of different forms of medicinal cannabis to treat symptoms in children and adolescents with neurodevelopmental, mental health and other conditions.
What is the research program investigating?
This Medicinal Cannabis Research Program will:
- Contribute to the emerging body of evidence regarding the safety of medicinal cannabis for children and adolescents.
- Produce results that support or refute the use of pure CBD in children and adolescents with intellectual disability to treat severe behavioural problems.
- Inform the feasibility and acceptability of conducting medicinal cannabis research in children and adolescents more generally, and specifically in those with Tourette syndrome or undergoing palliative care for non-oncological conditions.
- Generate high quality data to support clinical guidance and education for practitioners considering prescribing medicinal cannabis for children.
Why is this research program needed?
Several uncontrolled observational studies have been published. The studies provide preliminary support of medicinal cannabis as a treatment for children and/or adolescents with various disorders including autism, Tourette syndrome, and anxiety, as well as those undergoing palliative care.
However, high quality studies are required to produce definitive, unbiased results. This research program focuses on developing rigorous double-blind controlled trials that can deliver conclusive findings, which may then be translated into clinical guidance for prescribers.
We hope to learn whether medicinal cannabis improves symptoms associated with developmental and mental health disorders in children and adolescents. We also hope to learn whether improvements extend to quality of life or participation in important activities such as education, leisure or employment.
We expect that improved behaviour or mental health symptoms would result in improvements in family functioning and parental mental health. We also hope to learn whether the side effects of medicinal cannabis are more tolerable than existing medications.
If current trials support the use of medicinal cannabis in children, future research may investigate the best dose and product choice to guide clinical prescribing. For example, the most effective ratio of CBD and THC, or the potential role of other minor cannabinoids.
Current projects
1. A randomised placebo-controlled trial of cannabidiol (CBD) to treat severe behavioural problems in children and adolescents with intellectual disability (ID)
Children with Intellectual Disability (ID) can also have severe behavioural problems. Severe behavioural problems can affect their families and carers, and can also compromise their health care, education and the management of their disability.
At the moment, dealing with behaviour problems can be challenging. There are drugs that can be used to treat behaviour, but these are not always effective. These drugs can also cause side-effects.
In this study, we are testing a treatment called cannabidiol (CBD). CBD is a legal cannabis extract, now available as a medicine. Unlike the other main compound in cannabis, THC (tetrahydrocannabinol), CBD does not cause a 'high' and it is not addictive.
It may be helpful in improving behaviour, and may also have fewer side effects than existing medications. We hope to find out if CBD works and if it is safe.
We aim to recruit 140 children with ID and severe behavioural problems to take part in this study.
2. A pilot study of medicinal cannabis in paediatric patients undergoing palliative care for non-oncological conditions
Many children undergoing palliative care experience a range of debilitating symptoms, such as:
- pain
- nausea/vomiting
- discomfort eating
- dystonia (excessive and involuntary movements).
Parents and doctors are increasingly interested in the possibility of medicinal cannabis as a treatment to relieve symptom burden. However, there is not enough evidence to know if cannabis works for these patients.
This pilot study aims to investigate the feasibility and acceptability of a clinical trial of medicinal cannabis in reducing symptom burden in children and adolescents undergoing palliative care for non-oncological conditions.
Recently completed projects
A pilot randomised controlled crossover trial of medicinal cannabis in adolescents with Tourette syndrome
For some adolescents with Tourette syndrome, tics can have a major impact on daily functioning, quality of life, mental health, relationships, education and employment.
While some people with Tourette syndrome may not need treatment, for others with severe tics medication may be necessary. The medications that are currently used to treat tics are not always helpful.
Case studies of adolescents, and small trials in adults, suggest that medicinal cannabis may be helpful for improving tics. In this study, we tested a type of medicinal cannabis product that contains CBD and THC.
In low doses, this type of medicinal cannabis does not appear to have the same intoxication, addiction, or withdrawal effects that can be associated with recreational cannabis.
This research project was a pilot study. A pilot study helps us to prepare for a bigger study. In a pilot study, we look at how the study works, as well as how the treatment affects people.
In this project, we recruited ten adolescents who were aged between 12 and 18 years and have severe Tourette syndrome. Data from this project is currently being analysed.
Contact us
Contact us today if you would like further information about our trials.
Our team
- Associate Professor Daryl Efron, Principal Investigator
- Kaitlyn Taylor, Clinical Trial Coordinator
Partners and funders
The randomised controlled trial of CBD in children with intellectual disability is being conducted in partnership with researchers at the Murdoch Children’s Research Institute, The Royal Children’s Hospital, Monash University, Monash Children’s Hospital, The University of Sydney and The Children’s Hospital at Westmead.
The Medicinal Cannabis Research Program team would like to acknowledge the support received from:
- Medical Research Future Fund
- Department of Jobs, Skills, Industry and Regions, Victoria
- THC Pharma Pty Ltd
- Cann Group Limited
- Cannatrek Medical Pty Ltd
Resources
- Watch Associate Professor Efron discuss the trial of CBD in intellectual disability
- Efron, D. (2021). Potential therapeutic uses of cannabinoids to treat behavioural problems in children and adolescents with developmental disorders. Australian Journal of General Practice, 50(6), pp.352-355.
- Efron, D., Freeman, J.L., Cranswick, N., Payne, J.M., Mulraney, M., Prakash, C., Lee, K.J., Taylor, K. and Williams, K. (2020). A pilot randomised placebo‐controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability. British Journal of Clinical Pharmacology, 87(2), 436-446.
- Efron, D., Taylor, K., Payne, J.M., Freeman, J.L., Cranswick, N., Mulraney, M., Prakash, C., Lee, K.J. and Williams, K. (2020). Does cannabidiol reduce severe behavioural problems in children with intellectual disability? Study protocol for a pilot single-site phase I/II randomised placebo controlled trial. BMJ open, 10(3), p.e034362.
- Martin, J.H., Hill, C., Walsh, A., Efron, D., Taylor, K., et al., (2020). Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience. Trials 21, 932.
- Efron, D., & Freeman, J. (2018). Medical cannabis for paediatric developmental–behavioural and psychiatric disorders. Journal of paediatrics and child health, 54(7), 715-717.
- Efron, D., & Taylor, K. (2023). Medicinal cannabis for paediatric developmental, behavioural and mental health disorders. International Journal of Environmental Research and Public Health, 20(8), 5430.
Contact us
Contact us today if you would like further information about our trials.