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RECRUITING
NCT05916339
PHASE4

AWARE: Management of ADHD in Autism Spectrum Disorder

Sponsor: Daniel Coury

View on ClinicalTrials.gov

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. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.

Official title: Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder

Key Details

Gender

All

Age Range

4 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-10-01

Completion Date

2027-12-30

Last Updated

2025-10-29

Healthy Volunteers

No

Interventions

DRUG

Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication

Amphetamine (AMP) medication names: Adderall, Adderall XR, Adzenys ER, Adzenys XR-ODT, Dayanavel XR, Dexedrine (spansule), Dexedrine (tablet), Mydayis, Procentra liquid Methylphenidate (MPH) medication names: Adhansia XR, Aptensio XR, Azstarys, Concerta, Cotempla XR-ODT, Daytrana, Focalin, Focalin XR, Jornay PM. Metadate CD, Methylin (liquid), Ritalin, Ritalin LA, Quillichew ER, Quillivant XR (liquid)

DRUG

Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.

If first line stimulant therapy (Amphetamine/Methylphenidate) is deemed not effective or tolerable, re-randomization to the alternate stimulant or alpha-2 agonist will occur. If participant is satisfied with first line stimulant treatment, first-line stimulant therapy will continue. Catapres, Clonidine, Guanfacine, Intuniv, Kapvay, Tenex

Locations (12)

University of California, Irvine

Irvine, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Maine Medical Center

Portland, Maine, United States

Massachusetts General Hospital Lurie Center for Autism

Boston, Massachusetts, United States

University of Rochester

Rochester, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Virginia

Charlottesville, Virginia, United States

University of Alberta, Glenrose Rehabilitation Hospital

Edmonton, Canada

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Canada