Trends in Psychiatry and Psychotherapy
https://trends.org.br/article/doi/10.47626/2237-6089-2021-0396
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

Downloads: 109
Views: 4582

Abstract

Introduction
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.

Method
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).

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 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.

Conclusion
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.

Keywords

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

Submitted date:
09/14/2021

Accepted date:
05/19/2022

628f998aa953955a24119ba3 trends Articles
Links & Downloads

Trends Psychiatry Psychother

Share this page
Page Sections