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

ID#: NCT04170738

Age: 7 - 12 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: November 05, 2019

End Date: December 01, 2021

Contact Information:
Jeffrey Newcorn, MD
Beth Krone, PhD
Summary: 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.

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).