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

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Atomoxetine Hydrochloride; Central Nervous System Stimulants; Methylphenidate

Criteria

Inclusion Criteria:

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

• Age 8-12 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