CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33 enrolled
Drug / intervention
Adderalldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04170738
NCT04170738Phase 4Completed

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

Jeffrey Newcorn·interventional·Posted Nov 20, 2019·Updated Aug 29, 2024

In Brief

A Phase 4 clinical trial evaluating Adderall for Attention Deficit Disorder With Hyperactivity and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 20, 2019
Enrollment StartNov 5, 2019
Primary CompletionAug 8, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.6 years ago

Interventions

Adderalldrug

3 weeks of Adderall