- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04170738
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Beth Krone, PhD
- Phone Number: 212-241-8012
- Email: beth.krone@mssm.edu
Study Contact Backup
- Name: Jeffrey Newcorn, MD
- Phone Number: 212-659-8775
- Email: jeffrey.newcorn@mssm.edu
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68131
- Withdrawn
- Boys Town National Children's Hospital
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Beth Krone, PhD
- Phone Number: 212-241-8012
- Email: beth.krone@mssm.edu
-
Contact:
- Raquel Rosenberg, BA
- Phone Number: 212-241-5423
- Email: Raquel.Rosenberg@mssm.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 .)
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adderall
dosage = start at 0.25-0.50mg/kg,
adjusted as necessary pills by mouth
|
3 weeks of Adderall
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in fMRI Measure
Time Frame: baseline and 3 weeks post intervention
|
Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)
|
baseline and 3 weeks post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Iliyan Ivanov, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Substance-Related Disorders
- Disease
- Attention Deficit Disorder with Hyperactivity
- Conduct Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Amphetamine
- Dextroamphetamine
- Adderall
Other Study ID Numbers
- GCO 17-1321
- 1R21DA046029-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Conduct Disorder
-
Istanbul Bilgi UniversityCenter for Regulation Focused PsychotherapyRecruitingChildhood Externalizing Disorder | Childhood Oppositional Defiant Disorder | Childhood Conduct DisorderTurkey
-
Virginia Commonwealth UniversityNational Institute of Mental Health (NIMH)RecruitingConduct Disorder | Conduct Disorders in Adolescence | Conduct Disorders in Children | Callous-Unemotional TraitsUnited States
-
Finnish Institute for Health and WelfareUniversity of HelsinkiCompletedConduct Disorders in Children
-
National Taiwan University HospitalCompletedAttention Deficit Disorder With Hyperactivity | Conduct Disorders in Adolescence | Autistic Spectrum DisorderTaiwan
-
Oregon Research Behavioral Intervention Strategies...RecruitingConduct Disorder | Oppositional Defiant DisorderUnited States
-
Region SkaneRecruitingGambling Disorder | Gaming DisorderSweden
-
Indonesia UniversityRadboud University Medical CenterNot yet recruiting
-
Karolinska InstitutetDeakin UniversityRecruiting
-
Taipei City HospitalRecruiting
-
University Hospital, LilleMinistry of Health, FranceNot yet recruiting
Clinical Trials on Adderall
-
NYU Langone HealthCompletedAttention Deficit Hyperactivity DisorderUnited States
-
London Health Sciences CentreCompletedMultiple Sclerosis | Cognitive Impairment | Impaired Processing SpeedCanada
-
Mayo ClinicCompletedCardiovascular System | HemodynamicsUnited States
-
University of Alabama at BirminghamNot yet recruitingExpectations | Prescription Stimulants | Deception
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedCocaine DependenceUnited States
-
University of WyomingRecruitingAttention Deficit Hyperactivity Disorder | Mood | Working Memory | Stimulant Use | Change in Sustained AttentionUnited States
-
University of California, Los AngelesEnrolling by invitationMajor Depressive DisorderUnited States
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA)CompletedCocaine DependenceUnited States
-
Baystate Medical CenterNational Institute of Mental Health (NIMH)CompletedAttention Deficit Disorder With Hyperactivity