Phase 4 N=33 Basic Science

Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder

Attention Deficit Disorder With Hyperactivity · Conduct Disorder · Substance Abuse

Bottom Line

View on ClinicalTrials.gov: NCT04170738 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

Primary outcome: Primary: Change in fMRI Measure — -0.957100; 0.572517; -0.139000; 1.876717 BOLD signal

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Adderall (Drug)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Jeffrey Newcorn
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in fMRI Measure	-0.957100; 0.572517; -0.139000; 1.876717; 0.853514; -0.321983	—
SECONDARY ADHD Rating Score (ADHD RS)	43.18; 39.86; 20.36; 12.71; 20.55; 19.71	—
SECONDARY Total Dose of MAS-XR	1487.09; 745.00	—
SECONDARY Change in Clinical Global Impression - Improvement (CGI-I)	2.0; 2.00	—

Summary

Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk. However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.

Eligibility Criteria

Inclusion Criteria

General: pre-pubertal (e.g. Tanner stage 1 or 2)
age 7-12 inclusive
signed consent/assent
parent communicates sufficiently in English
Has ADHD as determined by parent interview
ADHD-Rating Scale-5 total score (interview with parent) of 1.5 SD > age/sex norms
Youth with CD or severe ODD: CD or ODD + 2 symptoms of CD

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) score 2).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04170738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.