RecruitingPhase 2NCT04278898

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

Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study

Sponsor

Stanford University

Enrollment

24 participants

Start Date

Feb 12, 2021

Study Type

INTERVENTIONAL

Conditions

Autism Spectrum Disorder

Summary

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.

Eligibility

Min Age: 3 YearsMax Age: 12 Years

Inclusion Criteria6

children between 3 years and 12 years 11 months at the time of consent
diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,
physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,
medically stable,
passes MR safety screening (e.g., no metal in the body).

Exclusion Criteria6

presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),
current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),
presence of significant medical problems that would interfere with participation,
the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,
individuals taking antioxidant agents and glutathione prodrugs, or
the inability/unwillingness to swallow an agent during the screening visit.