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Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: A Randomized, Controlled Trial
Who can join
Ages 3 to 12 · All sexes
Full eligibility criteria
Inclusion Criteria: * children between 3 years and 12 years 11 months * diagnosis 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 Scale * at least moderate severity of restricted and repetitive behaviors defined by a Children's Yale-Brown Obsessive Compulsive Scale for Autism Spectrum Disorder score ≥ 11 * physical development indicative of prepubescence as defined by criteria for Tanner Stage 1 * if home address is within 300 miles of the primary study site, participants must pass MR safety screening (e.g., no metal in the body) and attempt baseline neuroimaging (MRI or EEG), otherwise baseline neuroimaging is not required for participation * have stable medication regimens (≥ 30 days) and psychosocial treatments (≥ 60 days) prior to randomization with no anticipated changes during the trial 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 problems * the inability of at least one caregiver to speak and read English to a sufficient level * participants taking glutathione agents/prodrugs * history of any adverse effects to glutathione agents/prodrugs * the inability to drink a sample study compound dissolved in liquid
About the study
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.
What is being tested
- N acetyl cysteine (drug)
- Placebo (drug)
Sponsor: Stanford University · Participants: 144 · Started: Apr 26, 2023
Contact the study team
- Ramy Chebbo · Phone: (650)723-7845
- John Hegarty, PhD · Phone: (650)723-7845
Official record on ClinicalTrials.gov — NCT05664789
Locations in the U.S.
| California | Department of Psychiatry and Behavioral Sciences, Palo Alto |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.