Study: CBD Well Tolerated in Children With Autism, Linked to Improvements in Social Symptoms
- The study found that cannabidiol (CBD) was well tolerated in children and teenagers with autism spectrum disorder, showing significant improvements in social and overall target symptoms during a six-week trial.
- Conducted by NYU Grossman School of Medicine, the Phase 2 open-label trial involved 23 pediatric patients aged 7.8 to 17.8 with fluent verbal language and an IQ of 80 or higher, who received varying doses of pharmaceutical-grade CBD (Epidiolex).
- Response rates varied by symptom area, with the highest improvement in irritability or tantrums (60%), social symptoms (50%), and anxiety (40%), while no improvement was noted for sleep problems; 44% of participants were considered responders overall.
- Adverse events related to CBD were mostly mild and included increased sleep duration and salivation; no severe side effects or changes in vital signs or liver function were observed, and CBD plasma levels did not correlate with treatment response.
A new study published in the Journal of Child and Adolescent Psychopharmacology found that cannabidiol (CBD) was well tolerated in children and teenagers with autism spectrum disorder, with researchers reporting significant improvements in social symptoms and overall target symptoms during a six-week trial.
The study was conducted by researchers from NYU Grossman School of Medicine and involved 23 pediatric patients with autism spectrum disorder who had fluent verbal language and an estimated full-scale IQ of 80 or higher.
Participants, ages 7.8 to 17.8, were enrolled in a Phase 2 open-label trial of cannabidiol (CBD) using Epidiolex, a pharmaceutical-grade CBD product that is at least 98% CBD. Patients received 3, 6 or 9 milligrams per kilogram per day over six weeks.
All 23 participants completed the trial. Researchers found that the highest response rate, 62%, was observed among those receiving 9 mg/kg/day. Overall, 10 of the 23 patients, or 44%, were considered responders based on improvement in an individualized target symptom domain.
Response varied by symptom area. Improvements were seen in 60% of those targeting irritability or tantrums, 50% of those targeting social symptoms, 40% of those targeting anxiety, 25% of those targeting restricted or repetitive behaviors, and none of those targeting sleep problems.
Researchers also reported significant improvements in individualized symptom severity scores, while the Social Responsiveness Scale-2 total score showed the largest effect size. The average score shifted from the severe range to the moderate range.
Of 222 adverse events reported during the study, 27 unique events were considered treatment-related. Most were mild, and none were severe. The most common related adverse events included increased sleep duration, increased dream activity, increased salivation, sleepiness or sedation, and polyuria.
Vital signs, physical exams, weight, liver function tests and complete blood counts were not affected. CBD plasma levels did not correlate with response.
“In this preliminary study, CBD was well tolerated; AEs were mild-moderate,” the study’s authors concluded, adding “Mean SRS2-T and subscores decreased significantly with large effect sizes, shifting from the severe to the moderate range.”