Evaluation of the efficacy and safety of cannabidiol-rich cannabis extract in children with autism spectrum disorder: randomized, double-blind, and placebo-controlled clinical trial

Abstract

Objective: Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction and by restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa improve the quality of life of children with ASD without causing serious adverse effects, thus providing an alternative therapeutic option. The objective of this study was to evaluate the efficacy and safety of a cannabis extract rich in cannabidiol (CBD) in children with ASD. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 60 children, aged from 5 to 11 years, were selected and divided into two groups: the treatment group, which received the CBD-rich cannabis extract, and the control group, which received the placebo. They both used their respective products for a period of 12 weeks. Statistical analysis was done by two-factor mixed analysis of variance (two-way ANOVA). Results: Significant results were found for social interaction (F 1,116 = 14.13, p = 0.0002), anxiety (F 1,116 = 5.99, p = 0.016), psychomotor agitation (F 1,116 = 9.22, p = 0.003), number of meals a day (F 1,116 = 4.11, p = 0.04), and concentration (F 1,48 = 6.75, p = 0.01), the last of which was only significant in mild ASD cases. Regarding safety, it was found that only three children in the treatment group (9.7%) had adverse effects, namely dizziness, insomnia, colic, and weight gain. Conclusion: CBD-rich cannabis extract was found to improve one of the diagnostic criteria for ASD (social interaction), as well as features that often co-exist with ASD, and to have few serious adverse effects.

Safety and efficacy of orally administered full-spectrum medicinal cannabis plant extract 0.08% THC (NTI-164) in children with autism spectrum disorder: An open-label study

“…Similarly, several cohort studies in children using full-spectrum products have demonstrated significant overall improvement in ASD symptoms reported by parents [52–54, 56] and clinicians [55, 57]. Specifically, we found that almost half of treated children with ASD showed reduced disruptive behaviour consistent with other studies that have demonstrated improvement in behavioural problems ranging from 32% to 90%, including adaptive behaviours, self-injury and hyperactivity [53, 57, 59]. Social interaction and communication have also significantly improved following treatment with full-spectrum cannabis extract in children with ASD-related symptoms [52, 55–57].…”

“…The most frequent side-effect in our cohort was related to gastrointestinal symptoms, which were transient and improved with rest by the end of the treatment phase. However, the majority of clinical studies using full-spectrum cannabis extract for the treatment of children with ASD reported mild or transient adverse events frequently related to sleep disturbances [52–55, 58, 59], anxiety or irritability symptoms [52, 55, 57, 58] which were absent in our cohort. This might be due to different strains with variable composition of phytocannabinoids and higher doses of THC than our full-spectrum medical cannabis extract with negligible THC (0.08%).…”

“…Social interaction and communication have also significantly improved following treatment with full-spectrum cannabis extract in children with ASD-related symptoms [52, 55–57]. In addition, two randomised controlled trials have shown that cannabinoid treatment, compared to placebo in children, was safe with acceptable tolerability and effective at reducing ASD-associated disruptive behaviours [58, 59]. However, compared to pure cannabinoids, there was no apparent difference with improvements observed for treatment with whole-plant extract after 12 weeks.…”

“…However, there is limited evidence from clinical trials to support the potential therapeutic benefits of this non-psychoactive phytocannabinoid for pediatric neurodevelopmental disorders [51]. Only three randomised controlled studies have been published on medicinal cannabis use in children with ASD; two were short-term [58, 59], and the other only reported sleep outcomes [60]. Additionally, most studies on this topic are open-label observational or retrospective design [52–57].…”

Cannabinoids in the Treatment of Selected Mental Illnesses: Practical Approach and Overview of the Literature

“…Overall, cannabinoids were well tolerated, with only mild adverse effects. These promising effects were corroborated in another recent RCT, including N = 60 children with ASD demonstrating significant improvements in social interaction, anxiety, psychomotor agitation, number of meals a day, and concentration after treatment with a CBD-rich cannabis extract at a concentration of 0.5 % (5 mg/mL) in a 9:1 ratio of CBD:THC (daily dose ranged from 6 to 70 drops) [63].…”