Summary: A new clinical study has found that cannabidiol (CBD) is safe and potentially helpful in reducing challenging behavior in boys with severe autism. While no significant differences were shown compared to a placebo in common behavioral measures, clinicians saw significant improvements in aggression, hyperactivity, and communication in many of the children who took CBD.
Despite a strong placebo effect in both groups, clinical improvement was seen in two-thirds of participants. The results suggest that CBD may have therapeutic potential, although more research is needed to confirm its effectiveness.
Important facts:
- Safe and compatible: CBD did not cause any serious side effects and was well tolerated by autistic boys.
- Targeted benefits: Therapists saw a reduction in aggression and hyperactivity in about 30 percent of participants and saw improvements in communication.
- More research is needed: The results are promising but inconclusive. Controlled studies are important to confirm efficacy.
Source: UCSD
Researchers at the Medicinal Cannabis Research Center at the University of California, San Diego, School of Medicine have found that cannabidiol (CBD), a non-intoxicating compound found in cannabis, may help reduce disruptive behavior in boys with autism.
The results provide valuable insight into the potential benefits and limitations of CBD as a therapeutic intervention in autism.
Autism spectrum disorder (ASD) is a multifaceted neurodevelopmental condition marked by challenges in social interaction, communication, and behavioral flexibility. Individuals with ASD often exhibit repetitive actions and intense focus on specific interests. In more severe presentations, these behaviors can escalate to include self-injury or aggressive outbursts, underscoring the need for tailored support and therapeutic interventions that address both cognitive and emotional needs.
While current treatments can help reduce these symptoms, there is an urgent need for effective and safe interventions to meet the diverse needs of people with autism.
Previous studies have shown that CBD may help reduce challenging behavior in children with autism. However, there are currently no controlled clinical trials investigating the safety, tolerability, and efficacy of this treatment modality.
In the study, researchers divided autistic boys aged 7 to 14, each experiencing severe behavioral challenges into two distinct groups. One group received a treatment involving cannabidiol (CBD), while the other served as a control. This design allowed scientists to closely monitor the effects of CBD on aggression, anxiety, and emotional regulation, offering valuable insights into its potential as a therapeutic aid for autism-related behavioral issues.
One group received CBD daily for eight weeks, followed by eight weeks of a placebo, separated by a four-week washout period without treatment.
The second group first received a placebo and then CBD. Behavioral assessments were conducted before and after each treatment phase. A total of 30 participants successfully completed the study, providing a solid foundation for analyzing the effects of CBD on behavioral challenges in children with autism. This sample size allowed researchers to observe meaningful trends while maintaining the rigor of a controlled clinical trial.
Researchers discovered:
- The study found that CBD was both safe and well-tolerated in boys with severe autism and behavioral challenges. Participants took the medication with ease, and no serious side effects were reported, highlighting its potential as a promising therapeutic option for managing difficult behaviors in autism.
- Although no significant differences were found on general behavioral measures between CBD and placebo, clinician feedback suggests that approximately two-thirds of participants with CBD showed signs of clinical improvement.
- In general, therapists observed a decrease in aggressive behavior and hyperactivity, with improvements in communication seen in about 30% of participants.
- Although both groups showed improvement during the study, suggesting a strong placebo effect, the CBD group generally showed greater improvement than the placebo group.
The study indicates that CBD may offer some relief from behavioral challenges in children with autism, but its overall effectiveness remains uncertain. While initial findings are promising, the treatment is not yet widely accepted in clinical practice, and further research is essential to fully explore its therapeutic potential, safety profile, and long-term impact.
The study results also highlight the importance of rigorous, controlled trials to assess the effectiveness of new autism treatments.
The study, featured in the Journal of Autism and Developmental Disorders, was led by distinguished researchers Doris Traner, MD, who holds appointments in neuroscience and pediatrics and Igor Grant, MD, a leading figure in psychiatry at UC San Diego School of Medicine.
Their leadership brought together deep clinical insight and cutting-edge research to explore the therapeutic potential of CBD in managing behavioral challenges in autism.
Abstract
Cannabidiol (CBD) treatment of severe conduct disorder in autistic boys: a randomized clinical trial
While open-label and observational studies have suggested that cannabidiol (CBD) may help reduce challenging behaviors in children with autism, rigorous clinical evidence has been lacking. To address this gap, researchers conducted a double-blind, placebo-controlled crossover trial using herbal CBD (Epidiolex®).
This study aimed to systematically evaluate the compound’s safety, tolerability, and impact on behavior in boys diagnosed with autism spectrum disorder, offering a more reliable foundation for understanding CBD’s therapeutic potential in this population.Autistic boys aged 7 to 14 years with severe behavioral problems were randomly assigned to receive up to 20 mg/kg/day of CBD for eight weeks. Behavioral assessments were conducted before and after each treatment period.
Plasma CBD concentrations were quantified. The study’s primary endpoints focused on measurable changes in behavior using three standardized tools: the Repetitive Behavior Scale-Revised (RBS-R), the Child Behavior Checklist (CBCL), and the Autism Diagnostic Observation Schedule-2 (ADOS-2). These assessments provided a comprehensive view of how CBD treatment impacted repetitive behaviors, emotional regulation, and core autism symptoms across the participant group.
The study found that while both groups showed improvements in RBS-R and CBCL scores—indicating reduced repetitive behaviors and general behavioral issues—there were no statistically significant differences between the CBD and placebo groups. Interestingly, only the placebo group demonstrated improvement in ADOS-2 scores, suggesting that CBD may not have had a measurable impact on core autism symptoms in this trial. These results highlight the complexity of evaluating therapeutic effects and underscore the need for further research. However, these improvements disappeared when other medications the children were taking were included in the analyses.
Blinded clinical feedback showed that about two-thirds of participants improved their behavior with CBD. One-third showed no change or improvement with the placebo.
A strong placebo effect was observed. CBD exhibited an acceptable safety profile. We could not establish clear efficacy of CBD in reducing the broad spectrum of behaviors characterized by the primary endpoints.
Two-thirds of participants treated with CBD showed clinically meaningful improvements in behavior, highlighting its potential therapeutic value. However, the study also revealed a strong placebo effect, underscoring the critical need for placebo-controlled designs in evaluating treatment efficacy.
Additionally, researchers noted that concurrent use of behavior-modifying medications may lower CBD blood concentrations, potentially influencing the accuracy of outcome assessments and masking true effects.
