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AWARE: Management of ADHD in Autism Spectrum Disorder

NCT05916339

This study is recruiting at 10 US sites in 7 states, according to its ClinicalTrials.gov record last updated .

Summary

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • ADHD
  • Autism Spectrum Disorder

Eligibility basics and study details

Study type
Interventional
Phase
Phase 4
Ages
4 to 17 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Daniel Coury
Last updated on ClinicalTrials.gov
October 29, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

California · 2

  • University of California, Irvine · Irvine, CA
  • Children's Hospital Los Angeles · Los Angeles, CA

Maine · 1

  • Maine Medical Center · Portland, ME

Massachusetts · 1

  • Massachusetts General Hospital Lurie Center for Autism · Boston, MA

New York · 1

  • University of Rochester · Rochester, NY

Ohio · 2

  • Cincinnati Children's Hospital Medical Center · Cincinnati, OH
  • Nationwide Children's Hospital · Columbus, OH

Pennsylvania · 2

  • Children's Hospital of Philadelphia · Philadelphia, PA
  • University of Pittsburgh · Pittsburgh, PA

Virginia · 1

  • University of Virginia · Charlottesville, VA

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.