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

Substance Abuse Clinical Trial

Official title:

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

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
• 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
• 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).

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Conduct Disorder
• Disease
• Substance Abuse
• Substance-Related Disorders

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