Actively Recruiting
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-08-09
44
Participants Needed
1
Research Sites
329 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pre-pubertal (Tanner stage 1 or 2)
- Age between 7 and 12 years inclusive
- Signed consent and assent obtained
- Parent able to communicate in English to provide consent and complete assessments
- ADHD diagnosis confirmed by computerized DISC (C-DISC) parent interview
- ADHD-Rating Scale-5 total score from parent interview
- Teacher SNAP ADHD total score at least 1.5 standard deviations above age and sex norms
- For CD or severe ODD: diagnosis of CD or ODD plus 2 symptoms of CD on C-DISC
- SNAP ODD/CD subscale scores from parent and teacher at least 1.5 standard deviations above age and sex norms
You will not qualify if you...
- Major neurological or medical illness
- History of head injury
- Fetal exposure to alcohol or drugs
- Diagnosis of major psychiatric disorders such as schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, or autism spectrum disorder
- Current suicidal ideation or past suicide attempt
- Wechsler Abbreviated Scale of Intelligence (WASI) score below 75
- Prior or current treatment with stimulant medications (non-stimulant treatment allowed if off medication for 2 weeks before baseline)
- Current or past alcohol or drug use as determined by DISC interview or urine toxicology
- Psychological or medical conditions preventing MRI scanning (e.g., claustrophobia, morbid obesity)
- Presence of metal in the body that cannot be removed (e.g., braces, metal plates)
- Visual disturbances that might affect task performance
- Precocious puberty (Tanner stage above 2) or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
B
Beth Krone, PhD
CONTACT
J
Jeffrey Newcorn, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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