Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial

The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC and the effects of NAC on altering restricted and repetitive behavior symptom severity in children with autism spectrum disorder. This is a 12-week double-blind, randomized, placebo-controlled trial of NAC.

Inclusion Criteria:children between 3 years and 12 years 11 monthsdiagnosis of autism spectrum disorder confirmed with the Autism Diagnostic Interview- Revised and the Autism Diagnostic Observation Schedule-2, Brief Observation of Symptoms of Autism, or Childhood Autism Rating Scaleat least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11physical development indicative of prepubescence as defined by criteria for Tanner Stage 1medically stablehave stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trialpasses MR safety screening (e.g., no metal in the body)successfully completes baseline neuroimaging (MRI or EEG)Exclusion Criteria:presence of known genetic abnormalities associated with ASD (e.g. Fragile X)current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia)presence of significant medical problemsthe inability of at least one caregiver to speak and read English to a sufficient levelparticipants taking glutathione agents/prodrugsthe inability to drink a sample study compound dissolved in liquid