Stimulants for ADHD

Overseen By Matthew J O'Brien, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Matthew J O'Brien, PhD, BCBA-D

Must be taking: Stimulants

Disqualifiers: Autism, Conduct disorder, Intellectual disability

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how stimulant medication affects behaviors in children and adolescents with ADHD who often exhibit disruptive behavior. Researchers will assess changes in preferences, reasons for disruptive actions, and impulse control. Participants will attend eight sessions, alternating between taking their medication and not taking it. Children or teens diagnosed with ADHD, who display disruptive behaviors such as aggression or tantrums, and are already on stimulant medication might be suitable for this study. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it benefits more patients.

Do I have to stop taking my current medications for the trial?

For this trial, you will need to stop taking your stimulant medication on certain visits. Specifically, you will refrain from taking it on visits 2, 4, 6, and 8, but continue as usual on visits 1, 3, 5, and 7.

What is the safety track record for these stimulant treatments?

Research has shown that medications used to treat ADHD, known as stimulants, have been studied for safety. A thorough review found no increased risk of serious heart problems in children and young people taking these medications. However, common side effects occur more frequently compared to a placebo. These side effects can include trouble sleeping or loss of appetite.

Using certain stimulants, like methylphenidate, for a long time does not appear to increase the risk of serious mental health issues such as psychosis or tics. Evidence also indicates that ADHD medication can lead to fewer hospital visits for both mental and physical health issues and may lower the risk of suicidal behavior.

While stimulants are generally considered safe, awareness of possible side effects is important. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stimulants for ADHD are unique because they work by increasing the levels of certain neurotransmitters in the brain, specifically dopamine and norepinephrine, which help improve attention and focus. Unlike other treatments that might take longer to show effects, stimulants can often show improvements quickly, sometimes within just a few hours. Researchers are excited about these treatments because they have the potential to significantly improve the quality of life for children and adolescents with ADHD by reducing disruptive behaviors and enhancing their ability to concentrate and learn.

What is the effectiveness track record for stimulant medication in treating ADHD?

Studies have shown that stimulant medications like amphetamines and methylphenidate effectively reduce the main symptoms of ADHD. These medications improve quality of life more than a placebo, providing noticeable benefits. Research consistently shows that they help manage ADHD by enhancing attention and reducing impulsive behavior. In children and teenagers, these medications are well-known for aiding behavior and focus. Overall, stimulant medications offer a reliable option for managing ADHD symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Matthew J O'Brien, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 4 and 13 years old.

I have been diagnosed with ADHD.

I am already taking prescribed stimulant medication for AD/HD at the correct dose for my age.

Exclusion Criteria

I am taking a stimulant medication at a dose not recommended by my doctor.

Diagnosis of autism, conduct disorder, or intellectual disability in the moderate, severe or profound range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Consent and Pre-Visit Interview

Consent is obtained and a pre-visit interview is conducted to gather demographic and medication history

1 week

1 visit (in-person or virtual)

Phase I: Assessment

Preference assessments and functional analysis conducted with and without medication

4 weeks

4 visits (in-person)

Phase II: Assessment

Continuation of preference assessments and introduction of work-play choice tasks with and without medication

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in behavior and preference post-assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stimulant

Trial Overview 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.

How Is the Trial Designed?

Group I: Subjects on stimulant medication Experimental Treatment 1 Intervention

All participants: Children and adolescents diagnosed with AD/HD, displaying disruptive behavior, and taking stimulant medication.

Stimulant is already approved in United States, European Union for the following indications:

Approved in United States as Ritalin for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in European Union as Ritalin for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in United States as Adderall for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Narcolepsy

Approved in United States as Concerta for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Approved in United States as Vyvanse for:

• Attention Deficit Hyperactivity Disorder (ADHD)
• Binge Eating Disorder

Approved in United States as Strattera for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

Matthew J O'Brien, PhD, BCBA-D

Lead Sponsor

Trials

2

Recruited

160+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6109107/

Comparative efficacy and tolerability of medications for ... Atomoxetine had the lowest mean effect size in children and adolescents based on clinicians' ratings, but in adults, its efficacy on ADHD core symptoms was ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0890856724003046

Systematic Review and Meta-Analysis: Effects of ... The analysis showed that medications such as amphetamines, methylphenidate, and atomoxetine improved QoL compared to placebo, with moderate effect sizes.

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2835661

Increased Prescribing of Attention-Deficit/Hyperactivity ... Randomized clinical trials have demonstrated that ADHD medications are effective in reducing core ADHD symptoms and large observational studies ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3489818/

Prescription stimulants in individuals with and without ... A recent controlled, cross-sectional study evaluated the effects of stimulants on cognition in adults with ADHD and found that treated ADHD subjects had ...

5. nature.com nature.com/articles/s41380-021-01391-9

The effects of stimulant dose and dosing strategy on ... More specifically, we found increased reductions in ADHD symptoms and increased likelihood of discontinuation due to AEs with increasing doses ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40343695/

Safety of Stimulants Across Patient Populations: A Meta-Analysis Conclusions and relevance: This meta-analysis found an increased risk of overall AEs associated with stimulants compared with placebo. Future ...

7. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-medications-used-treat-attention

Safety Review Update of Medications used to treat ADHD Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833773

Safety of Stimulants Across Patient Populations: A Meta- ... Stimulants such as methylphenidate, lisdexamfetamine, and other amphetamines were associated with an increased risk of overall AEs compared with placebo.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10601982/

Adverse Effects of Stimulant Interventions for Attention Deficit ... Overall, multiple studies support the safety of long-term MPH use regarding psychosis and tics. However, caution is advised when prescribing MPH ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2816499

Attention-Deficit/Hyperactivity Disorder Medications and ... The use of ADHD medication was associated with fewer hospitalizations for both psychiatric and nonpsychiatric morbidity and lower suicidal behavior.