Trends in Psychiatry and Psychotherapy
Trends in Psychiatry and Psychotherapy
Original Article

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

Estácio Amaro da Silva Junior, Wandersonia Moreira Brito Medeiros, João Paulo Mendes dos Santos, João Marçal Medeiros de Sousa, Filipe Barbosa da Costa, Katiúscia Moreira Pontes, Thaís Cavalcanti Borges, Carlos Espínola Neto Segundo, Ana Hermínia Andrade e Silva, Eliane Lima Guerra Nunes, Nelson Torro, Marine Diniz da Rosa, Katy Lísias Gondim Dias de Albuquerque

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Autism Spectrum Disorder is characterized by persistent deficits in social communication, social interaction, and restricted and repetitive patterns of behavior. Some studies have shown that substances derived from Cannabis sativa improve the quality of life of autistic children without causing serious adverse effects, thus providing a therapeutic alternative.

This was a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of a cannabis extract rich in cannabidiol (CBD) in autistic children. Sixty children, aged between 5 and 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, both used the product for a period of 12 weeks. Statistical analysis was done by two-factor mixed analysis of variance (ANOVA two way).

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 latter being significant only in mild autism spectrum disorder. 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.

CBD-rich cannabis extract was found to improve one of the diagnostic criteria for ASD (social interaction), as well as often co-existing features, and to have few serious adverse effects.


Autistic Spectrum Disorder, child behavior, clinical trial, cannabis, cannabidiol

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