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Completed

NCT Number: NCT04170738

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Adderall

Drug

3 weeks of Adderall

Other names: Dextroamphetamine-Amphetamine

Primary outcomes

  1. Change in fMRI Measure

    Time frame: baseline and 3 weeks post intervention

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

Secondary outcomes

  1. ADHD Rating Score (ADHD RS)

    Time frame: Pretreatment, baseline and Post-Treatment, average 2 weeks

    Subscale for Inattention scores range from 0-27, Subscale scores for Hyper (H/I) range from 0-27. The total ADHD score sums to a score of 0-54. Higher indicates more severe ADHD symptomology, and there are norm ranges, with clinical thresholds set at 1.5 SD above the mean for sex and age.

  2. Total Dose of MAS-XR

    Time frame: average 2 weeks

    Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg

  3. Change in Clinical Global Impression - Improvement (CGI-I)

    Time frame: baseline and post treatment, average 2 weeks

    The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

    Change in CGi post treatment as compared to baseline.

Sponsors and collaborators

Lead sponsor

Jeffrey Newcorn

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 20, 2019
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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