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

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

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine the effects of stimulant medication on disruptive behavior, function, preference and choice; however, it is primarily methodological and will add to current research by establishing an effective evaluation of the impact of stimulant medication on these behaviors. Three behavior assessments for children and adolescents diagnosed with AD/HD who exhibit disruptive behavior will be conducted: 1. Preference assessments will be conducted to determine whether preference for social and nonsocial items and activities differs under medication and non-medication conditions. 2. Functional analyses will be conducted to determine whether stimulant medication has an effect on the frequency and function or purpose of disruptive behavior. 3. Choice assessments will be conducted to evaluate the impact of stimulant medication on impulse control/delay discounting. This study will be conducted in three phases. For each of the 5 to 10 participants there will be 8 total visits. The first 4 visits will entail a preference assessment, followed by a functional analysis. On visits 1 and 3, the participant will be asked to take his/her stimulant medication as is typically done; however, on visits 2 and 4, the participant will be asked to refrain from taking the medication. For visits 5-8, participants will continue to participate in preference assessments, but will also be presented with a choice arrangement with work and play. In the choice arrangement, participants will be given four work cards and four play cards that they can organize in any order. Work cards will be associated with a brief academic task and play cards will be associated with a brief play period using high-preferred toys/activities. On visits 5 and 7 the participant will be asked to take his or her stimulant medication as usual, while on visits 6 and 8 the participant will be asked to refrain from taking his or her medication.

Research Team

Matthew J O'Brien, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+