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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-05

Study Completion Date

2023-08-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity Conduct Disorder Substance Abuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Adderall

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

Group Type EXPERIMENTAL

Adderall

Intervention Type DRUG

3 weeks of Adderall

Interventions

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Adderall

3 weeks of Adderall

Intervention Type DRUG

Other Intervention Names

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Dextroamphetamine-Amphetamine

Eligibility Criteria

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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).

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No