Clinical trial NCT04170738: Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Official title: Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Conduct Disorder
Substance Abuse
Keywords: ADHD
substance abuse risk
Adderall
fMRI
ADHD Treatment
Medication
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-11-20
Enrollment: 33
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures
Primary purpose: BASIC_SCIENCE

Brief 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 \<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).

Primary outcomes:
measure: Change in fMRI Measure
timeFrame: baseline and 3 weeks post intervention
Secondary outcomes:
measure: ADHD Rating Score (ADHD RS)
timeFrame: Pretreatment, baseline and Post-Treatment, average 2 weeks
measure: Total Dose of MAS-XR
timeFrame: average 2 weeks
measure: Change in Clinical Global Impression - Improvement (CGI-I)
timeFrame: baseline and post treatment, average 2 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jeffrey Newcorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Iliyan Ivanov, MD
role: PRINCIPAL_INVESTIGATOR
References: