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Central Nervous System Stimulant

Adderall for ADHD with Risk of Substance Abuse

Phase 4
Recruiting
Led By Iliyan Ivanov, MD
Research Sponsored by Jeffrey Newcorn
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
General: pre-pubertal (e.g. Tanner stage 1 or 2)
parent communicates sufficiently in English
Must not have
major neurological/medical illness
history of head injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 weeks post intervention
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study the effects of a medication used to treat ADHD on the brain reward system in order to better understand the potential impact of the medication on people who are at risk for substance abuse.

Who is the study for?
This trial is for drug-naive youth aged 7-12 with ADHD, and possibly ODD/CD, who are at risk for substance abuse. Participants must speak English and be pre-pubertal. They cannot have major psychiatric disorders, suicidal ideation, visual impairments that affect tasks, head injury history, fetal exposure to substances, metal implants that can't be removed or serious medical conditions.
What is being tested?
The study tests the effects of Adderall (MAS-XR) on the brain's reward system in young participants with ADHD alone or combined with ODD/CD using fMRI scans. It aims to understand how this stimulant medication might influence their future risk of substance abuse.
What are the potential side effects?
Adderall may cause side effects like trouble sleeping (insomnia), decreased appetite leading to weight loss, stomach pain or headaches. In some cases it could also increase heart rate and blood pressure or lead to mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in the early stages of puberty.
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I can communicate well in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major neurological or medical illnesses.
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I have had a head injury in the past.
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I have a major psychiatric disorder or have had suicidal thoughts or attempts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 weeks post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in fMRI Measure

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AdderallExperimental Treatment1 Intervention
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adderall
2018
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

Jeffrey NewcornLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
30 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,881 Total Patients Enrolled
17 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,411 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
JEFFREY NEWCORNLead Sponsor

Media Library

Adderall (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04170738 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Adderall
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Adderall Highlights & Side Effects. Trial Name: NCT04170738 — Phase 4
Adderall (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04170738 — Phase 4
~7 spots leftby Nov 2025
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