Medical cannabis may reduce behaviour in children with additional needs: pilot study

The severity of behavioural problems experienced by children and adolescents with an intellectual disability may be reduced by introducing cannabidiol, a type of medicinal cannabis, a pilot study led by the Murdoch Children’s Research Institute (MCRI) has found. 

The study findings will be of interest to those working in both the early childhood education and care (ECEC) and disabilities sectors, and for those educators, parents and carers of children with additional intellectual needs, particularly in outside school hours care (OSHC) settings,  with the research sufficiently of merit to attract a substantial grant to support broader investigation of the study findings. 

Recently published in the British Journal of Clinical Pharmacology, the study found a “clinically significant change” in participants’ irritability, aggression, self-injury, and yelling. The intervention was also found to be safe and well-tolerated by most study participants.

A randomised controlled trial, involving eight participants aged between 8 and 16 years of age recruited from paediatric clinics from both hospital and private paediatric practices involved those in the trial taking either cannabidiol or a placebo over eight weeks. 

Although the pilot study was not large enough to make definitive statements, the early findings strongly support a larger follow-up trial, researchers said, sharing their findings in the wake of an announcement from Federal Health Minister Greg Hunt that MCRI would receive an $883,484 Medical Research Future Fund (MRFF) grant to conduct a large scale randomised placebo-controlled trial study to definitively test the findings as well as the cost-effectiveness of the treatment. 

The funding will add weight to the findings, with researchers noting that only a large scale randomised controlled trial can produce “the definitive results necessary to drive changes in prescribing and clinical care guidelines”.

Associate Professor Daryl Efron, a clinician-scientist at MCRI who led the study, said this was the first investigation of cannabidiol to manage severe behavioural problems in children and adolescents with an intellectual disability, with the majority of those participating in the study also having autism.

Participants generally tolerated the medication, with researchers noting that no serious side effects were reported. All parents involved said they would recommend the study to families with children with similar problems.

Severe behavioural problems such as irritability, aggression and self-injury in children and adolescents with an intellectual disability were a major contributor to functional impairments, missed learning opportunities and reduced quality of life, Associate Professor Efron said.

Conventional psychotropic medications typically used to manage these issues, such as anti-psychotics and anti-depressants, are prescribed to almost half of young people with an intellectual disability, despite limited evidence of their effectiveness, he added. 

Given how extremely difficult behavioural problems were to treat in these patients, new, safer interventions were needed to treat this highly vulnerable patient group, Associate Professor Efron believes.

“Current medications carry a high risk of side-effects, with vulnerable people with intellectual disability being less able to report side-effects,” he said. “Common side-effects of antipsychotics, such as weight gain and metabolic syndrome, have huge health effects for a patient group already at increased risk of chronic illness.”

As an alternative form of medication, cannabidiol is already being used to manage a range of medical and psychiatric conditions in adults and epilepsy in children.  

Parents and physicians, Associate Professor Efron said, showed “intense interest” in medicinal cannabis as a treatment for severe behavioural problems in youth with an intellectual disability, and are increasingly seeking further information.  

“Parents of children with an intellectual disability and severe behavioural problems are increasingly asking paediatricians whether they can access medicinal cannabis for their child and some parents have reported giving unregulated cannabis products to their children,” he added. 

Researchers from The Royal Children’s Hospital, the University of Melbourne and Monash University also contributed to the study, which may be accessed here.