Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism

Phase 2 Active not recruiting 42 enrolled University of California, San Diego Center for Medicinal Cannabis Research · collab Wholistic Research and Education Foundation · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.

Timeline

Start: 2020-06-01
Primary completion: 2025-08-30
Completion: 2025-12-31

Outcome

Missed primary endpoint

paper Both groups improved on the RBS-R and CBCL, with no significant difference between groups. PMID 40410546 ↗

paper We did not find CBD to be clearly effective at reducing the broad range of behaviors characterized by the primary outcome measures. PMID 40410546 ↗

Publications

Trauner D, Umlauf A, Grelotti DJ, Fitzgerald R, Hannawi A, Marcotte TD, Knight C, Smith L, Paez G, Crowhurst J, Brown A, Suhandynata RT, Lund K, Menlyadiev M, Grant I. Cannabidiol (CBD) Treatment for Severe Problem Behaviors in Autistic Boys: A Randomized Clinical Trial. J Autism Dev Disord. 2025 May 24:10.1007/s10803-025-06884-y. doi: 10.1007/s10803-025-06884-y. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	20 mg/kg	Oral