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

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Adderall

About this trial

This is an interventional basic science trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Boys Town National Children's Hospital
Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adderall

Arm Description

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

Outcomes

Primary Outcome Measures

Change in fMRI Measure

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04170738

First Posted

November 18, 2019

Last Updated

April 14, 2023

Sponsor

Jeffrey Newcorn

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT04170738

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 5, 2019 (Actual)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jeffrey Newcorn

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse

Keywords

ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adderall

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Adderall

Other Intervention Name(s)

Dextroamphetamine-Amphetamine

Intervention Description

3 weeks of Adderall

Primary Outcome Measure Information:

Title

Change in fMRI Measure

Description

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

Time Frame

baseline and 3 weeks post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeffrey Newcorn, MD

Phone

212-659-8775

jeffrey.newcorn@mssm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Krone, PhD

Phone

212-241-8012

beth.krone@mssm.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Newcorn, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Iliyan Ivanov, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boys Town National Children's Hospital

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Individual Site Status

Withdrawn

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Krone, PhD

Phone

212-241-8012

beth.krone@mssm.edu

First Name & Middle Initial & Last Name & Degree

Raquel Rosenberg, BA

Phone

212-241-5423

Raquel.Rosenberg@mssm.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Learn more about this trial

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

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