Attention Deficit Disorder With HyperactivityPhase 4NCT04170738

Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder

A Phase 4 study testing Adderall in people with Attention Deficit Disorder With Hyperactivity and Conduct Disorder, run by Jeffrey Newcorn at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk. Read more about this study

Who is it for?: Ages 7 to 12 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse
What is being tested?: Adderall
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 5 Nov 2019to 8 Aug 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

General: pre-pubertal (e.g. Tanner stage 1 or 2)
age 7-12 inclusive
signed consent/assent
parent communicates sufficiently in English
Has ADHD as determined by parent interview
ADHD-Rating Scale-5 total score (interview with parent) of 1.5 SD > age/sex norms
Youth with CD or severe ODD: CD or ODD + 2 symptoms of CD

Who cannot join

major neurological/medical illness
history of head injury
fetal exposure to alcohol/drugs;
diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder) current suicidal ideation or past history of suicide attempt
Wechsler Abbreviated Scale of Intelligence (WASI) score <75; 7)
current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline; youth who had a past, brief stimulant medication exposure of no more than about a month, and not within the past 6 months may be included .)

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current or past alcohol/drug use (interview; urine toxicology)
psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
metal in the body that cannot be removed
visual disturbances that may impair task performance
precocious puberty (e.g. Tanner stage >2).

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.

Conditions: Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse
Being tested: Adderall
Keywords: ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Conduct Disorder, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AdderallDrug
Also called Dextroamphetamine-Amphetamine
3 weeks of Adderall

Study groups in NCT04170738
Study group	Role	What they receive
Adderall	Experimental	dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth Receives: Drug: Adderall

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in fMRI Measure
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
Measured: baseline and 3 weeks post intervention

Secondary outcomes (3)

ADHD Rating Score (ADHD RS)
Subscale for Inattention scores range from 0-27, Subscale scores for Hyper (H/I) range from 0-27. The total ADHD score sums to a score of 0-54. Higher indicates more severe ADHD symptomology, and there are norm ranges, with clinical thresholds set at 1.5 SD above the mean for sex and age.
Measured: Pretreatment, baseline and Post-Treatment, average 2 weeks
Total Dose of MAS-XR
Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg
Measured: average 2 weeks
Change in Clinical Global Impression - Improvement (CGI-I)
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Change in CGi post treatment as compared to baseline.
Measured: baseline and post treatment, average 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20198 Aug 2023

First posted20 Nov 2019
Study start5 Nov 2019
Primary completion8 Aug 2023
Study completion8 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04170738
Sponsor's protocol ID: GCO 17-1321
Other IDs: 1R21DA046029-01A1
Status last verified: Aug 2024
First submitted: 18 Nov 2019
Last updated: 29 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
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A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
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All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
ClinicalTrials.gov ID: NCT04170738
Acronym / sponsor ID: GCO 17-1321
Conditions: Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse
Keywords: ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Jeffrey NewcornUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 5 Nov 2019 (actual)
Primary completion: 8 Aug 2023 (actual)
Study completion: 8 Aug 2023 (actual)
First posted: 20 Nov 2019 (actual)
Results: Posted 29 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures

Arm	Type	Receives
Adderall	Experimental	Drug: Adderalldosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth

Who may qualify

Ages: 7 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

General: pre-pubertal (e.g. Tanner stage 1 or 2)
age 7-12 inclusive
signed consent/assent
parent communicates sufficiently in English
Has ADHD as determined by parent interview

Key exclusion criteria (11 listed)

major neurological/medical illness
history of head injury
fetal exposure to alcohol/drugs;
diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder) current suicidal ideation or past history of suicide attempt
Wechsler Abbreviated Scale of Intelligence (WASI) score <75; 7)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AdderallAlso: Dextroamphetamine-Amphetamine3 weeks of Adderall	Drug	Adderall

Primary outcome

Change in fMRI Measure
Time frame: baseline and 3 weeks post intervention
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).

3 secondary outcomes

ADHD Rating Score (ADHD RS)
Time frame: Pretreatment, baseline and Post-Treatment, average 2 weeks
Total Dose of MAS-XR
Time frame: average 2 weeks
Change in Clinical Global Impression - Improvement (CGI-I)
Time frame: baseline and post treatment, average 2 weeks

Results and safety

Results posted to the registry on 29 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Risk	26	11
Low Risk	7	7

Primary outcome: Change in fMRI Measure

Time frame: baseline and 3 weeks post intervention. Mean (Standard Deviation). Unit: BOLD signal

Measure	High Risk n = 7	Low Risk n = 6
Reward Outcome Post-Pre Low>High, Left Amygdala	-0.957100 (1.365781)	0.572517 (0.712410)
Reward Outcome Post-Pre Low>High, ACC	-0.139000 (1.288470)	1.876717 (1.615755)
Reward Outcome Post-Pre Low>High, Ventral Striatum	0.853514 (0.475767)	-0.321983 (1.075986504)
Reward Outcome Post-Pre Low>High, Ventrolateral Pre-Frontal Cortex (VLPFC)	0.712514 (0.944126)	0.460432 (0.744686)

Population analysed: Participants who provided imaging data

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Risk	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Low Risk	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffrey Newcorn, MD principal investigator

Icahn School of Medicine at Mount Sinai

Iliyan Ivanov, MD principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adderall in people with Attention Deficit Disorder With Hyperactivity and Conduct Disorder, run by Jeffrey Newcorn at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fMRI Measure (time frame: baseline and 3 weeks post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04170738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.