The first investigation of its kind, a new pilot randomised placebo-controlled trial published in the British Journal of Clinical Pharmacology has found that cannabidiol (CBD), a cannabis-derived medicine, may reduce severe behavioural problems in children and adolescents with an intellectual disability.
The pilot study, led by the Murdoch Children’s Research Institute (MCRI) involved eight participants, aged 8-16 years who took either CBD or a placebo over eight weeks.
The researchers found that the intervention (CBD) was safe and well-tolerated by most study participants (no serious side effects were reported), and recorded a clinically significant change in participants’ irritability, aggression, self-injury and yelling.
According to Associate Professor Daryl Efron, a clinician-scientists at MCRI who led the study, while psychotropic medications (including anti-psychotics and anti-depressants) are often prescribed to young people with an intellectual disability, given the evidence suggesting their limited effectiveness and given how extremely difficult behavioural problems are to treat, new and safer interventions are needed to treat this highly vulnerable patient group.
“Current medications carry a high risk of side-effects, with vulnerable people with intellectual disability being less able to report side-effects,” says Associate Professor Efron.
“Common side-effects of antipsychotics, such a weight gain and metabolic syndrome, have huge health effects for a patient group already at increased risk of chronic illness.”
While CBD is increasingly being used to manage a range of medical and psychiatric conditions in adults, and epilepsy in children, Associate Professor Efron says that there is significant interest from parents and physicians in CBD as a treatment option for severe behavioural problems in children and adolescence with an intellectual disability.
“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 says.
Although the pilot study was not large enough to make definitive statements, the early findings strongly support a larger follow-up trial.
Only a large scale randomised controlled trial can produce the definitive results necessary to drive changes in prescribing and clinical care guidelines.
The researchers are planning a large study to definitively test the findings.
The researchers are also seeking funding for further research into the effectiveness of medicinal cannabis in children with developmental disorders such as autism and Tourette syndrome.
To read the study, visit: bpspubs.onlinelibrary.wiley.com/doi/abs/10.1111/bcp.14399