Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

ID#: NCT03781765

Age: 7 - 12 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 4

Recruitment Status: Recruiting

Start Date: June 04, 2019

End Date: July 31, 2023

Contact Information:
Beth Krone, PhD
Jeffrey Newcorn, MD
Summary: The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI.

Inclusion Criteria:

- Pre-pubertal (e.g. Tanner stage 1 or 2)

- Age 7-12 inclusive

- Signed consent/assent

- Parent communicates sufficiently in English to provide informed consent and complete assessment instruments;

- ADHD as determined by computerized DISC (C-DISC) parent interview

- ADHD-Rating Scale-5 total score (interview with parent )

- SNAP ADHD total score (teacher) of 1.5 SD > age/sex norms

- CD or severe ODD: CD or ODD + 2 symptoms of CD on C-DISC

- SNAP ODD/CD subscale (parent and teacher) 1.5 SD > age/sex norms

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)75 score <75

- Prior or current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline)

- Current or past alcohol/drug use (DISC 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 (e.g., braces, metal plate)

- Visual disturbances that may impair task performance

- Precocious puberty (e.g. Tanner stage >2) or pregnancy Notes:

- History of SUD in a 1st degree relative is permitted, and is expected in ~1/2 of the subjects

- Ongoing psychosocial treatment is allowed but should not be initiated during the study