RECRUITING

Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

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Conditions

ADHDAttention Deficit Hyperactivity DisorderfMRI StudyMPHMethylphenidateATXAtomoxetineReward SystemSubstance Abuse Risk

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI.

Official Title

Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

Quick Facts

Study Start:2019-06-04
Study Completion:2025-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03781765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Pre-pubertal (e.g. Tanner stage 1 or 2)
  2. * Age 7-12 inclusive
  3. * Signed consent/assent
  4. * Parent communicates sufficiently in English to provide informed consent and complete assessment instruments;
  5. * ADHD as determined by computerized DISC (C-DISC) parent interview
  6. * ADHD-Rating Scale-5 total score (interview with parent )
  7. * SNAP ADHD total score (teacher) of 1.5 SD \> age/sex norms
  8. * CD or severe ODD: CD or ODD + 2 symptoms of CD on C-DISC
  9. * SNAP ODD/CD subscale (parent and teacher) 1.5 SD \> age/sex norms
  1. * Major neurological/medical illness
  2. * History of head injury
  3. * Fetal exposure to alcohol/drugs
  4. * Diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder)
  5. * Current suicidal ideation or past history of suicide attempt
  6. * Wechsler Abbreviated Scale of Intelligence (WASI)75 score \<75
  7. * Prior or current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline)
  8. * Current or past alcohol/drug use (DISC interview; urine toxicology)
  9. * Psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
  10. * Metal in the body that cannot be removed (e.g., braces, metal plate)
  11. * Visual disturbances that may impair task performance
  12. * Precocious puberty (e.g. Tanner stage \>2) or pregnancy
  13. * History of SUD in a 1st degree relative is permitted, and is expected in \~1/2 of the subjects
  14. * Ongoing psychosocial treatment is allowed but should not be initiated during the study

Contacts and Locations

Study Contact

Beth Krone, PhD
CONTACT
212-241-8012
beth.krone@mssm.edu
Jeffrey Newcorn, MD
CONTACT

Principal Investigator

Jeffrey Newcorn, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Iliyan Ivanov, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Jeffrey Newcorn, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Iliyan Ivanov, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-04
Study Completion Date2025-09-25

Study Record Updates

Study Start Date2019-06-04
Study Completion Date2025-09-25

Terms related to this study

Keywords Provided by Researchers

  • fMRI Study
  • MPH
  • Methylphenidate
  • ATX
  • Atomoxetine
  • Reward System
  • Substance Abuse Risk

Additional Relevant MeSH Terms

  • ADHD
  • Attention Deficit Hyperactivity Disorder