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Evaluation of the efficacy and safety of medicinal cannabis in children with autism

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-5wr2cqq
Enrollment
Unknown
Registered
2020-12-17
Start date
2019-12-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

Experimental group: 30 children with autism spectrum disorder will receive cannabidiol-rich cannabis extract. Control group: 30 children with autism spectrum disorder will receive a placebo. The sampl
56096

Sponsors

Universidade Federal da Paraíba
Lead Sponsor

Eligibility

Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 5 to 12 years old; live in Paraíba, Pernambuco or Rio Grande do Norte, Brazil; diagnosed with Autism Spectrum Disorder; registered on the site.

Exclusion criteria

Exclusion criteria: Diabetes mellitus; systemic arterial hypertension; autoimmune diseases; refractory epilepsy; who have used any cannabis-based product in the past two months; are under five or over 12 years old.

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of cannabidiol-rich cannabis extract in the symptoms of autism spectrum disorder: social interaction, language and stereotyped movements;CBD-rich cannabis extract was effective for social interaction (p<0.001)

Secondary

MeasureTime frame
To evaluate the efficacy of cannabidiol-rich cannabis extract in the coexisting syntoms of autism spectrum disorder (aggressiveness, psychomotor agitation, concentration, eating habits, sleep and anxiety);CBD-rich cannabis extract was effective for psychomotor agitation (p<0.01), eating habits (p<0.05), anxiety (p<0.01), and concentration only in mild-grade children (p<0.01).

Countries

Brazil

Contacts

Public ContactEstácio Silva Junior

Universidade Federal da Paraíba

estacioamaro@yahoo.com.br+55-83986104726

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 27, 2026