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Central Nervous System Stimulant

Adderall for ADHD with Risk of Substance Abuse

Phase 4
Recruiting
Led By Jeffrey Newcorn, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 3 weeks post intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am a young person with Conduct Disorder or severe Oppositional Defiant Disorder plus two symptoms of CD.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in fMRI Measure

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
2,454 Previous Clinical Trials
2,596,827 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks exist when utilizing Adderall?

"According to our team's assessment, Adderall has a safety rating of 3 due its Phase 4 trial status which is considered the final step prior to FDA approval."

Answered by AI

Who is eligible to join in this medical experiment?

"This research study is seeking 44 pre-pubertal children, age 7 to 12, who have been diagnosed with conduct disorder. The eligibility requirements for participants include: signed consent/assent of parent or guardian; evidence of ADHD as determined by parent interview and scores on the Attention Deficit Hyperactivity Disorder Rating Scale-5 that are 1.5 standard deviations higher than average age/sex norms; diagnosis of either Conduct Disorder (CD) or Oppositional Defiant Disorder (ODD) plus two additional symptoms commonly associated with CD."

Answered by AI

How many participants have been accepted for this medical experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial is still accepting patients and has been since November 5th, 2019. The most recent edition was made on May 16th 2022 with the goal of recruiting 44 people from a single site."

Answered by AI

Does this clinical trial accept those aged 55 and older?

"This medical trial is only open to those between the age of 7 and 12. There are 415 trials available for minors, while 824 studies focus on patients over 65 years old."

Answered by AI

To what maladies is Adderall commonly employed as a remedy?

"ADHD, affliction and discomfort can all be managed through the use of Adderall."

Answered by AI

What other empirical research has been conducted on Adderall?

"Currently, 9 trials surrounding Adderall are taking place with 2 of these in their final Phase 3. 13 medical sites across the globe are investigating this medication with a concentration being located in Lexington, Kentucky."

Answered by AI

Is this trial actively seeking participants?

"As per the clinicaltrials.gov records, this research is calling for participants as of now. The study was initially launched on November 5th 2019 and was recently updated on May 16th 2022."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Icahn School of Medicine at Mount Sinai

Why did patients apply to this trial?

I tried Ritalin and metaphenidate also wellbutin. I am 59 years old and I'm going to college to get my bachelor's degree. I have ADD and I need something to Aid me in my learning process. I pray I'm not too old for your study.
PatientReceived 2+ prior treatments
~0 spots leftby Apr 2024