Cannabidiol (CBD) Treatment for Severe Problem Behaviors in Autistic Boys: A Randomized Clinical Trial.
Doris Trauner, Anya Umlauf, David J Grelotti et al.
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In 30 seconds
This double-blind, placebo-controlled crossover trial assessed plant-derived cannabidiol (CBD) in autistic boys aged 7–14 years with severe behavior problems. Participants received eight weeks of CBD, up to 20 mg/kg/day, and eight weeks of placebo, separated by a four-week washout. Both treatment phases were associated with improvement on the Repetitive Behavior Scale-Revised and Child Behavior Checklist, with no significant between-group difference. Blinded clinical impressions indicated behavioral improvement with CBD in almost 2/3 of participants, but the primary measures did not establish clear efficacy across a broad range of behaviors. CBD had an acceptable safety profile.
Key findings
- Repetitive Behavior Scale-Revised and Child Behavior Checklist scores improved in both groups, with no significant difference between CBD and placebo.
- Blinded clinical impressions indicated behavioral improvement with CBD in almost 2/3 of participants; 1/3 showed no change or improvement on placebo.
- ADOS-2 scores improved only in the placebo group, but this finding disappeared after accounting for other medications.
- CBD had an acceptable safety profile, and the study observed a strong placebo effect.
Why it matters
The trial highlights the importance of placebo control when evaluating behavioral treatments in autism, where improvement may occur in both active-treatment and placebo phases. Although some participants appeared to improve clinically with CBD, the primary outcome measures did not show clear benefit over placebo. The findings also raise the possibility that concomitant behavioral medications may affect CBD blood levels or outcome assessments.
What to keep in mind
The crossover trial assessed outcomes over two eight-week treatment phases; the abstract does not report longer-term effects. Primary outcome measures did not demonstrate clear efficacy, and the observed clinical impressions do not establish benefit over placebo.