Cannabidivarin (CBDV) Versus Placebo in Children with Autism Spectrum Disorder (ASD)

The CDC currently estimates 1 in 54 children have Autism Spectrum Disorder (ASD). Children with ASD have problems with social communication, irritability, repetitive behaviors, impulsivity, temper tantrums, and a high caregiver burden. The only medications approved by the FDA for symptoms of ASD are aripiprazole and risperidone. Both of these are used to reduce irritability but have short-term and long-term side effects. This double-blind randomized placebo-controlled study will test the efficacy and safety of a new medication, cannabidivarin (CBDV), to treat autism in children ages 5-18. CBDV is non-psychoactive, is derived from the cannabis plant, but has effects opposite to THC. Approximately 100 patients will be enrolled at Montefiore and NYU sites during the duration of the study. The study lasts up to 16 weeks, and during this time, patients will undergo 9 study visits. Mood, social and cognitive functions will be assessed by the means of research questionnaires. All adverse effects will be reported. We will assess the effects of CBDV versus placebo on irritability and social functions in patients with ASD.