Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial
NCT ID: NCT05664789
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
144 participants
INTERVENTIONAL
2023-04-26
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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N-acetylcysteine
12 week administration of active study compound
N acetyl cysteine
N-acetylcysteine (NAC) is an over-the-counter dietary supplement that is relatively well tolerated and exhibits minimal side effects, even at high dosages. N
Placebo
12 week administration of matched placebo
Placebo
matched placebo
Interventions
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N acetyl cysteine
N-acetylcysteine (NAC) is an over-the-counter dietary supplement that is relatively well tolerated and exhibits minimal side effects, even at high dosages. N
Placebo
matched placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
12 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Stanford University
OTHER
Responsible Party
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John Patrick Hegarty
Clinical Assistant Professor
Principal Investigators
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John Hegarty, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Department of Psychiatry and Behavioral Sciences
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Brianna Alconcher
Role: primary
Other Identifiers
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IRB-68353
Identifier Type: -
Identifier Source: org_study_id