Autism Spectrum Disorder
Study register · detail RCT · Autism Spectrum Disorder · 2026

Cannabidiol blood metabolite levels after cannabidiol treatment are associated with broadband EEG changes and improvements in visuomotor and non-verbal cognitive abilities in boys with autism requiring higher levels of support.

Mixed GRADE Low 1 citations
Samplen = 24 Pat.
Duration8 weeks of CBD treatment
ControlPlacebo
EndpointAperiodic EEG measure
Blindingdoppelblind
DesignRCT
Cannabinoidcbd
Routeoral
Key finding

CBD metabolite levels were associated with improved aperiodic EEG measures and positive associations with receptive vocabulary ability, nonverbal intelligence and visuomotor coordination; overall mixed effects with some children showing improvements while others demonstrated limited changes.

Summary

n=24 boys with autism spectrum disorder and higher support needs (7-14 years), double-blind placebo-controlled, crossover; up to 20 mg/kg/day CBD over 8 weeks. CBD metabolite levels positively associated with receptive vocabulary, nonverbal intelligence and visuomotor coordination. Aperiodic EEG offset increased, aperiodic exponent (occipital) reduced. Mixed effects: some children showed improvements in cognitive/behavioral abilities, others limited changes.

P
PopulationBoys with autism spectrum disorder (ASD) and higher support needs, n=24, age 7–14 years
I
InterventionOral, purified cannabidiol (CBD), up to 20 mg/kg/day daily, 8 weeks
C
ControlPlacebo (double-blind, crossover design)
O
OutcomeCBD blood metabolite levels associated with greater aperiodic EEG offset (global) and reduced aperiodic exponent (occipital); positive association with receptive vocabulary, nonverbal intelligence and visuomotor coordination
Confidence in the evidence
Low

The second of four GRADE levels, the effect estimate is of limited reliability.

Downgraded for
IndirectnessImprecision
Quality profile
Sample size
Blinding Double-blind
Effect size Mixed
Citations / year
Authors
Cazares C, Hutton A, Paez G, Trauner D, Voytek B
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Abstract
Oral cannabidiol (CBD) treatment has been suggested to alleviate severe symptoms of autism spectrum disorder (ASD). While many CBD preparations have been studied in clinical trials involving ASD, none has used purified CBD preparations or preparations approved by the U.S. Food and Drug Administration, nor have they focused on children with ASD with higher support needs. Previous studies have identified several candidate electrophysiological biomarkers of cognitive and behavioral disabilities in ASD, with emerging biomarkers including periodic (oscillatory) and aperiodic measures of neural activity. We analyzed electroencephalography (EEG) recordings from 24 boys with ASD and higher support needs (aged 7-14 years) from a prior double-blind, placebo-controlled, crossover Phase II Clinical Trial (NCT04517799) that investigated whether 8 weeks of daily CBD treatment (up to 20 mg/kg/day) improved severe behavioral problems, measured at baseline, post-CBD, post-placebo, and post-washout. Using linear mixed effect models, we found that aperiodic EEG measures varied with CBD metabolite levels in blood, as evidenced by a larger aperiodic offset across the scalp and a decreased aperiodic exponent across occipital electrodes. Furthermore, CBD metabolite levels in blood had a positive association with receptive vocabulary, nonverbal intelligence and visuomotor coordination. Our data suggest that this daily CBD preparation and administration schedule produced mixed effects, with some children showing improvements in cognitive and behavioral abilities while others demonstrated limited changes. Our findings support the inclusion of aperiodic EEG measures alongside traditional oscillatory EEG measures as candidate biomarkers for tracking the variable clinical impact of purified CBD treatment in children with ASD.

The impediment to action advances action. — Marcus Aurelius