In the first controlled clinical trial of CBD in boys with autism, two-thirds of participants showed behavioural improvements with treatment, but there was also a significant placebo effect.
Researchers at the Center for Medicinal Cannabis Research at University of California San Diego School of Medicine have found that cannabidiol (CBD), could help reduce problematic behaviours in autistic boys.
The results provide valuable insights into the potential benefits and limitations of CBD as a therapeutic intervention for autism, the authors say.
Autism spectrum disorder is a complex neurodevelopmental condition characterised by social communication difficulties, repetitive behaviours and restricted interests. In more severe cases, these behaviours can also include self-injury or aggression.
While existing treatments can help manage these symptoms, there is a pressing need for effective and safe interventions to address the diverse needs of autistic individuals.
Some prior studies have suggested that CBD could help reduce problematic behaviours in children with autism. However, no controlled clinical trials have addressed safety, tolerability and efficacy of this treatment approach until now.
In the trial, autistic boys with severe behaviour problems aged 7–14 years were split into two groups. One received eight weeks of daily CBD then eight weeks of placebo, separated by a four-week “washout” period in which no treatment was given.
The other group received placebo first, then CBD. Behavioural assessments were completed before and after each treatment phase. A total of 30 participants completed the trial.
The researchers found that CBD was safe and well-tolerated in boys with severe autism and behavioural problems. Participants were able to take the drug without difficulty and there were no serious adverse events.
While no significant differences were found between CBD and placebo on broad measures of behaviour, clinician impressions suggested that approximately two-thirds of participants showed evidence of clinical improvement with CBD.
Reductions in aggressive behaviours and hyperactivity were observed most frequently by clinicians, with improvements in communication seen in almost 30% of participants.
While both groups showed improvements during the study, demonstrating a strong placebo effect, the CBD group generally showed greater improvement than the placebo group.
The study’s findings suggest that while CBD may have some benefits in reducing problematic behaviours in autistic children, its effectiveness is not universally established, and more research is needed to fully understand its therapeutic potential, the authors say.
The results also underscore the importance of rigorous, controlled trials in evaluating the efficacy of novel treatments for autism.
They state: “Despite the limitations, this study provides valuable new information about a potential role of CBD in improving behaviour in a subset of children with autism, as well as the strong role the placebo effect plays in this condition. Importantly, CBD at a dose of 20 mg/kg/day appears to have an acceptable safety profile and is well tolerated in boys with autism.
“A study utilising the same placebo-controlled and blinded approach with a highly purified and stable dose of CBD but with a larger number of children, more targeted objective measures of treatment response, and controlling for other medications used, powered sufficiently to examine efficacy in boys and girls, may be able to more definitively answer the question of whether CBD reduces problem behaviours in children with autism.”
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