RecruitingPhase 4NCT03781765

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

44 participants

Start Date

Jun 4, 2019

Study Type

INTERVENTIONAL

Conditions

Attention Deficit Hyperactivity Disorder ADHD

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.

Eligibility

Min Age: 7 YearsMax Age: 12 Years

Inclusion Criteria9

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 Criteria15

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