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Stimulant

Stimulants for ADHD

Phase 4
Recruiting
Led By Matthew J O'Brien, PhD
Research Sponsored by Matthew J O'Brien, PhD, BCBA-D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be a child or adolescent between the ages of 4 years, 0 months, and 13 years, 0 months (participants must not be older than 12 years, 11 months).
Participant must have a valid diagnosis of attention deficit/hyperactivity disorder (AD/HD). No specification of type will be necessary.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)
Awards & highlights

Study Summary

This trial will help researchers to understand how well stimulant medication works for children and adolescents with AD/HD who exhibit disruptive behavior, as well as how much they may prefer or choose to participate in activities under medication and non-medication conditions.

Who is the study for?
Children and adolescents aged 4 to under 14 with disruptive behavior and diagnosed ADHD, already on a prescribed stimulant medication. Excluded are those with autism, conduct disorder, or moderate to profound intellectual disability, or on non-therapeutic stimulant dosages.Check my eligibility
What is being tested?
The trial tests how stimulant medication affects disruptive behaviors in kids with ADHD through preference assessments (choice of activities), functional analyses (behavior triggers), and choice assessments (impulse control). Participants alternate between medicated and non-medicated states across eight visits.See study design
What are the potential side effects?
While not explicitly listed for this study, common side effects of stimulants may include decreased appetite, stomach pain, sleep problems, increased heart rate/blood pressure; individual experiences can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 4 and 13 years old.
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I have been diagnosed with ADHD.
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I am already taking prescribed stimulant medication for AD/HD at the correct dose for my age.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly (at each visit): week 1, week 2, week 3, week 4, week 5, week 6, week, 7, week 8; we will compare data from weeks 1, 3, 5, and 7 (on medication) versus weeks 2, 4, 6, and 8 (off medication) 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 Behavioral Function
Change in Item Preference
Change in Preference for Social and Non-Social Activities
+1 more
Secondary outcome measures
Compliance
Item Engagement
Rate of Problem Behavior

Side effects data

From 2014 Phase 4 trial • 41 Patients • NCT02058693
25%
Headache
13%
Dry mouth
13%
Agitation
6%
Decreased appetite
6%
Body ache
6%
Insomnia
6%
Nausea
6%
Mild heart tremor
6%
Racy feelings
6%
Acid reflux
6%
Sinusitis
6%
Injury: slip and fall, bruising
6%
Tachycardia
6%
Weight loss
6%
Word finding
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2(B): MSA/MSA
Group 1(A): Placebo/MSA

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects on stimulant medicationExperimental Treatment1 Intervention
All participants: Children and adolescents diagnosed with AD/HD, displaying disruptive behavior, and taking stimulant medication.

Find a Location

Who is running the clinical trial?

Matthew J O'Brien, PhD, BCBA-DLead Sponsor
1 Previous Clinical Trials
152 Total Patients Enrolled
Matthew J O'Brien, PhD5.01 ReviewsPrincipal Investigator - University of Iowa
University of Iowa
1 Previous Clinical Trials
152 Total Patients Enrolled
5Patient Review
Dr. O'Brien is extremely knowledgeable, gentle, kind, and patient.

Media Library

Stimulant (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT03420339 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Subjects on stimulant medication
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Stimulant Highlights & Side Effects. Trial Name: NCT03420339 — Phase 4
Stimulant (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03420339 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT03420339 — Phase 4

Frequently Asked Questions

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

Does the FDA sanction the use of stimulant drugs by experimental participants?

"The safety profile of stimulant medication was rated 3 out of 3 due to this being a Phase 4 trial, indicating that the drug has already been approved."

Answered by AI

What is the approximate size of the participant pool in this experiment?

"Indeed, clinicaltrials.gov lists this study as actively recruiting participants. This medical trial has been in progress since October 1st 2018 and was most recently updated on the 30th October 2022; it intends to recruit 10 patients from a single site."

Answered by AI

Am I eligible to take part in this medical experiment?

"This trial is recruiting 10 minors aged between 48 months and 153 months who are exhibiting problem behaviors such as physical or verbal aggression, tantrums, diagnoses of disruptive behavior disorder or oppositional defiant disorder, self-injury, destruction and noncompliance. Participants must also have a valid diagnosis of Attention Deficit/Hyperactivity Disorder (AD/HD)."

Answered by AI

Is the enrollment process open to elderly individuals aged 85 and higher?

"This clinical trial has limited enrolment to individuals between the ages of 4 and 13 years old. Additionally, another 174 medical studies are available for minors while elderly patients can choose from 107 different options."

Answered by AI

To what maladies are individuals prescribed stimulant medications typically treated?

"Stimulant medication is commonly prescribed to treat diseases, but also for alleviating symptoms of depression, binge eating disorder (BED), and chronic pain."

Answered by AI

Has research previously been conducted on individuals taking stimulant drugs for therapeutic purposes?

"Currently, 42 clinical trials are assessing the efficacy of stimulant medication. Of these studies, 7 have entered Phase 3. Most experiments occur in Seattle, Washington; however 59 different sites are involved with this research endeavour."

Answered by AI

Are any participants being sought for this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this medical trial, which has been actively recruiting since October 1st 2018, is still searching for 10 participants from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
University of Iowa Hospitals and Clinics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I want to try other treatment options.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Stimulant Effects on Disruptive Behavior
Matthew J O'Brien, PhD, BCBA-D 2018. "Stimulant Effects on Disruptive Behavior". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03420339.
~1 spots leftby Jan 2025
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