Status:
RECRUITING
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
ADHD
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
7-12 years
Phase:
PHASE4
Brief 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 Diso...
Detailed Description
Longitudinal studies have shown that childhood Attention Deficit/Hyperactivity Disorder (ADHD) and child disruptive behavior disorders play an important role in the development of later Substance Use ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03781765
Start Date
June 4 2019
End Date
September 25 2025
Last Update
August 9 2024
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029