Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

NCT03781765 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: GCO 17-04231R21DA045218-01A1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI.

Conditions

ADHD; Attention Deficit Hyperactivity Disorder

Keywords

fMRI Study; MPH; Methylphenidate; ATX; Atomoxetine; Reward System; Substance Abuse Risk

Outcome Measures

Primary Outcomes (1)

• fMRI Measure

  Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)

  3 Weeks

Study Arms (2)

Methylphenidate

ACTIVE COMPARATOR

0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks

Drug: Methylphenidate

Atomoxetine

ACTIVE COMPARATOR

0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks

Drug: Atomoxetine

Interventions

Methylphenidate DRUG

stimulant medication

Also known as: MPH

Methylphenidate

Atomoxetine DRUG

non-stimulant medication

Also known as: ATX

Atomoxetine

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pre-pubertal (e.g. Tanner stage 1 or 2)
• Age 7-12 inclusive
• Signed consent/assent
• Parent communicates sufficiently in English to provide informed consent and complete assessment instruments;
• ADHD as determined by computerized DISC (C-DISC) parent interview
• ADHD-Rating Scale-5 total score (interview with parent )
• SNAP ADHD total score (teacher) of 1.5 SD \> age/sex norms
• CD or severe ODD: CD or ODD + 2 symptoms of CD on C-DISC
• SNAP ODD/CD subscale (parent and teacher) 1.5 SD \> age/sex norms

You may not qualify if:

• 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)75 score \<75
• 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 (DISC 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 (e.g., braces, metal plate)
• Visual disturbances that may impair task performance
• Precocious puberty (e.g. Tanner stage \>2) or pregnancy
• Notes:
• History of SUD in a 1st degree relative is permitted, and is expected in \~1/2 of the subjects
• Ongoing psychosocial treatment is allowed but should not be initiated during the study

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; 5,10-dihydro-5-methylphenazine; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines

Study Officials

• Jeffrey Newcorn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Iliyan Ivanov, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Krone, PhD

CONTACT

212-241-8012; beth.krone@mssm.edu

Jeffrey Newcorn, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a pilot study with no control group. All youth will be treated with MPH or ATX and receive pre and post fMRI.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: June 4, 2019
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)