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

Recruitment & Eligibility

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).

Study & Design

Arm && Interventions

Group	Intervention	Description
Adderall	Adderall	dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth

Primary Outcome Measures

Name	Time	Method
Change in fMRI Measure	baseline and 3 weeks post intervention	Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression - Improvement (CGI-I)	baseline and post treatment, average 2 weeks	The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Change in CGi post treatment as compared to baseline.
ADHD Rating Score (ADHD RS)	Pretreatment, baseline and Post-Treatment, average 2 weeks	Subscale for Inattention scores range from 0-27, Subscale scores for Hyper (H/I) range from 0-27. The total ADHD score sums to a score of 0-54. Higher indicates more severe ADHD symptomology, and there are norm ranges, with clinical thresholds set at 1.5 SD above the mean for sex and age.
Total Dose of MAS-XR	average 2 weeks	Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg

Recruitment & Eligibility