ABSTRACT
The CDC currently estimates 1 in 54 children have Autism Spectrum Disorder (ASD). Children with ASD have problemswith 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 areused to reduce irritability but have short-term and long-term side effects. During year 3 of this project, we continued ourefforts in screening and enrolling patients both at AECOM-MMC site and NYU site. We have also adapted study protocolto the COVID-19 pandemic situation making 5 out of 9 visits of study participants remote, and received acknowledgementfrom ORP HRPO that these changes do not require HRPO approval prior to implementation.Study is ongoing. Prior to COVID-19 pandemic onset, we have projected a total of 50 subjects enrolled by end of August2020 end of year 3 at the two sites, including AECOM/MMC and NYU. Total number of subjects enrolled at AECOM/MMCsite is 18. Therefore 18 subjects were screened, 12 subjects randomized, 3 subjects are waiting to be randomized, 2subjects are currently active, and 10 subjects have completed the study. Total number of subjects enrolled at NYU siteis 4 to date. Therefore 4 subjects were screened and 4 are waiting to be randomized.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 cannabisplant, but has effects opposite to THC. Approximately 100 patients will be enrolled at Montefiore and NYU sites duringthe 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 bereported.