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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04170738
Other study ID # GCO 17-1321
Secondary ID 1R21DA046029-01A
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 5, 2019
Est. completion date April 2024

Study information

Verified date April 2023
Source Icahn School of Medicine at Mount Sinai
Contact Jeffrey Newcorn, MD
Phone 212-659-8775
Email jeffrey.newcorn@mssm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Adderall
3 weeks of Adderall

Locations

Country Name City State
United States Icahn School of Medicine at Mount Sinai New York New York
United States Boys Town National Children's Hospital Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Jeffrey Newcorn National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fMRI Measure Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex) baseline and 3 weeks post intervention
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