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

Jeffrey Newcorn

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Disorder With Hyperactivity

Conduct Disorder

Substance Abuse

Treatments

Drug: Adderall

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04170738

GCO 17-1321

1R21DA046029-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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 <75; 7)
current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .)
current or past alcohol/drug use (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
visual disturbances that may impair task performance
precocious puberty (e.g. Tanner stage >2).