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

NCT04170738 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: GCO 17-13211R21DA046029-01A1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity; Conduct Disorder; Substance Abuse

Keywords

ADHD; substance abuse risk; Adderall; fMRI; ADHD Treatment; Medication

Outcome Measures

Primary Outcomes (1)

• Change in fMRI Measure

  Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).

  baseline and 3 weeks post intervention

Secondary Outcomes (3)

• ADHD Rating Score (ADHD RS)

  Pretreatment, baseline and Post-Treatment, average 2 weeks

• Total Dose of MAS-XR

  average 2 weeks

• Change in Clinical Global Impression - Improvement (CGI-I)

  baseline and post treatment, average 2 weeks

Study Arms (1)

Adderall

EXPERIMENTAL

dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth

Drug: Adderall

Interventions

Adderall DRUG

3 weeks of Adderall

Also known as: Dextroamphetamine-Amphetamine

Adderall

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jeffrey Newcorn: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Conduct Disorder; Substance-Related Disorders

Interventions

Adderall; SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Iliyan Ivanov
• Organization: Icahn School of Medicine at Mount Sinai

iliyan.ivanov@mssm.edu

(212) 523-1924

Study Officials

• Jeffrey Newcorn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Iliyan Ivanov, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 3-week intervention with Adderall as treatment for ADHD among youth with ADHD + Conduct problems. Pre and post fMRI performed as the outcome measures

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: November 5, 2019
• Primary Completion: August 8, 2023
• Study Completion: August 8, 2023
• Last Updated: August 29, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)