Cannabidiol for treatment of irritability and aggressive behavior in children and adolescents with autism spectrum disorder: background and methods of the cannabidiol study in children with autism spectrum disorder study

Authors

  • Elise M. Sannar Pediatric Mental Health Institute, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Joan Winter Pediatric Mental Health Institute, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Ronda K. Franke Department of Pediatrics, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Emily Werner Department of Pediatrics, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Rebecca Rochowiak Neuroscience Institute, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Patrick W. Romani Pediatric Mental Health Institute, Children’s Hospital Colorado, Aurora, Colorado, USA
  • Owen S. Miller Department of Clinical Pharmacy, Skaggs School of Pharmacy, Aurora, Colorado, USA
  • Nicole Semmler Department of Clinical Pharmacy, Skaggs School of Pharmacy, Aurora, Colorado, USA
  • Jacquelyn L. Bainbridge Department of Clinical Pharmacy, Skaggs School of Pharmacy, Aurora, Colorado, USA
  • Crystal Natvig Department of Psychiatry, University of Colorado School of Medicine, Aurora, Colorado, USA
  • Susan K. Mikluich-Gilbertson Department of Psychiatry, University of Colorado School of Medicine, Aurora, Colorado, USA
  • Nicole R. Tartaglia Department of Pediatrics, Children’s Hospital Colorado, Aurora, Colorado, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20250131

Keywords:

Autism spectrum disorder, Cannabidiol, Medication, Clinical trial

Abstract

Background: Autism spectrum disorder (ASD) is a neurodevelopmental disorder commonly associated with behavioral challenges. There are few evidence based pharmacological interventions available for the treatment of behavioral symptoms associated with ASD. Cannabidiol (CBD), the non-intoxicating component of cannabis, has known neuroprotective, antiepileptic, anxiolytic, and antipsychotic effects and may be useful in treating the behavioral symptoms of ASD.

Methods: We describe the research methods of a 27-week randomized placebo-controlled crossover trial to evaluate the safety and efficacy of oral CBD for the treatment of irritability and aggression associated with ASD, as measured by the irritability subscale of the aberrant behavior checklist-2nd edition (ABC-2) in children and adolescents.

Conclusions: There is significant need for clinical research exploring alternative medications for the treatment of behavioral symptoms of ASD. Upcoming results from this trial will help answer the question of whether CBD may be a useful intervention in the management of ASD.

Clinical trial registry: NCT04520685.

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Published

2025-01-28

How to Cite

Sannar, E. M., Winter, J., Franke, R. K., Werner, E., Rochowiak, R., Romani, P. W., Miller, O. S., Semmler, N., Bainbridge, J. L., Natvig, C., Mikluich-Gilbertson, S. K., & Tartaglia, N. R. (2025). Cannabidiol for treatment of irritability and aggressive behavior in children and adolescents with autism spectrum disorder: background and methods of the cannabidiol study in children with autism spectrum disorder study. International Journal of Clinical Trials, 12(1), 29–37. https://doi.org/10.18203/2349-3259.ijct20250131