Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Primary Purpose
Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Adderall
Sponsored by
About this trial
This is an interventional basic science trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication
Eligibility Criteria
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).
Sites / Locations
- Boys Town National Children's Hospital
- Icahn School of Medicine at Mount SinaiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adderall
Arm Description
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
Outcomes
Primary Outcome Measures
Change in fMRI Measure
Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)
Secondary Outcome Measures
Full Information
NCT ID
NCT04170738
First Posted
November 18, 2019
Last Updated
April 14, 2023
Sponsor
Jeffrey Newcorn
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04170738
Brief Title
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Official Title
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2019 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey Newcorn
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Conduct Disorder, Substance Abuse
Keywords
ADHD, substance abuse risk, Adderall, fMRI, ADHD Treatment, Medication
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adderall
Arm Type
Experimental
Arm Description
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
Intervention Type
Drug
Intervention Name(s)
Adderall
Other Intervention Name(s)
Dextroamphetamine-Amphetamine
Intervention Description
3 weeks of Adderall
Primary Outcome Measure Information:
Title
Change in fMRI Measure
Description
Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)
Time Frame
baseline and 3 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Newcorn, MD
Phone
212-659-8775
Email
jeffrey.newcorn@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Krone, PhD
Phone
212-241-8012
Email
beth.krone@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Newcorn, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iliyan Ivanov, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boys Town National Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Individual Site Status
Withdrawn
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Krone, PhD
Phone
212-241-8012
Email
beth.krone@mssm.edu
First Name & Middle Initial & Last Name & Degree
Raquel Rosenberg, BA
Phone
212-241-5423
Email
Raquel.Rosenberg@mssm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Learn more about this trial
Brain Indices of Stimulant Treatment in Drug-Naive Youth at Risk for Substance Use Disorder
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