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

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

Patrocinadores

Patrocinador principal: Jeffrey Newcorn

Colaborador: National Institute on Drug Abuse (NIDA)

Fuente Icahn School of Medicine at Mount Sinai
Resumen breve

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.

Estado general Active, not recruiting
Fecha de inicio November 5, 2019
Fecha de Terminación December 2020
Fecha de finalización primaria December 2020
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in fMRI Measure baseline and 3 weeks post intervention
Inscripción 44
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Adderall

Descripción: 3 weeks of Adderall

Etiqueta de grupo de brazo: Adderall

Otro nombre: Dextroamphetamine-Amphetamine

Elegibilidad

Criterios:

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)

- prior or current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline)

- 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).

Género: All

Edad mínima: 7 Years

Edad máxima: 12 Years

Voluntarios Saludables: No

Oficial general
Ubicación
Instalaciones:
Boys Town National Children's Hospital | Omaha, Nebraska, 68131, United States
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States
Ubicacion Paises

United States

Fecha de verificación

June 2020

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: Icahn School of Medicine at Mount Sinai

Nombre completo del investigador: Jeffrey Newcorn

Título del investigador: Professor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Adderall

Tipo: Experimental

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

Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures

Propósito primario: Basic Science

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov