Actively Recruiting
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
Led by Stanford University · Updated on 2026-01-20
144
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children between 3 years and 12 years 11 months
- Diagnosis of autism spectrum disorder confirmed by standardized assessments (Autism Diagnostic Interview-Revised, 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 with a CYBOCS-ASD score of 11 or higher
- Physical development indicating prepubescence as defined by Tanner Stage 1
- If living within 300 miles of the study site, must pass MRI safety screening and attempt baseline neuroimaging; otherwise, baseline neuroimaging is not required
- Stable medication regimen for at least 30 days and psychosocial treatments for at least 60 days prior to randomization with no expected changes during the trial
You will not qualify if you...
- Presence of known genetic abnormalities associated with autism spectrum disorder (e.g., Fragile X)
- Current or lifetime diagnosis of severe psychiatric disorders such as schizophrenia
- Significant medical problems
- Inability of at least one caregiver to speak and read English sufficiently
- Taking glutathione agents or prodrugs
- History of adverse effects to glutathione agents or prodrugs
- Inability to drink a sample study compound dissolved in liquid
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Psychiatry and Behavioral Sciences
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
B
Brianna Alconcher
CONTACT
J
John Hegarty, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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