Comparing stimulant and non-stimulant treatments for ADHD in youth at risk for substance use disorders
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
This study tests how two different ADHD medications, one that stimulates and one that doesn't, affect the brain's reward system in young kids at risk for substance use problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03781765 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of FDA-approved stimulant (methylphenidate) and non-stimulant (atomoxetine) medications on the brain's reward systems in drug-naive youth diagnosed with ADHD, some of whom may also have Oppositional Defiant Disorder or Conduct Disorder. Using fMRI, the research aims to understand how these treatments influence reward processing, which is crucial for understanding the risk of developing substance use disorders later in life. The study focuses on pre-pubertal children aged 7-12 and employs a targeted biomarker approach to assess the neurobiological impacts of these medications.
Who should consider this trial
Good fit: Ideal candidates are pre-pubertal children aged 7-12 with a diagnosis of ADHD and possibly Oppositional Defiant Disorder or Conduct Disorder.
Not a fit: Patients with major psychiatric disorders, significant medical illnesses, or those who have previously received treatment for ADHD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for ADHD that minimize the risk of developing substance use disorders.
How similar studies have performed: While there is existing animal research suggesting different effects of stimulant and non-stimulant treatments, this specific approach using fMRI in drug-naive youth is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Newcorn, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Beth Krone, PhD
- Email: beth.krone@mssm.edu
- Phone: 212-241-8012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.