Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder

Study Overview
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Brief Summary
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Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk. However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.

Official Title
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Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder

Conditions
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Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse

Intervention / Treatment
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* Drug: Adderall


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General: pre-pubertal (e.g. Tanner stage 1 or 2) age 7-12 inclusive signed consent/assent parent communicates sufficiently in English Has ADHD as determined by parent interview ADHD-Rating Scale-5 total score (interview with parent) of 1.5 SD > age/sex norms Youth with CD or severe ODD: CD or ODD + 2 symptoms of CD Exclusion Criteria: major neurological/medical illness history of head injury fetal exposure to alcohol/drugs; diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder) current suicidal ideation or past history of suicide attempt Wechsler Abbreviated Scale of Intelligence (WASI) score <75; 7) current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .) current or past alcohol/drug use (interview; urine toxicology) psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity) metal in the body that cannot be removed visual disturbances that may impair task performance precocious puberty (e.g. Tanner stage >2).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adderall<br>dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth | Drug: Adderall<br>* 3 weeks of Adderall<br>* Other names: Dextroamphetamine-Amphetamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fMRI Measure | Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex) | baseline and 3 weeks post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication