CompletedPhase 4

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

United States33 participantsStarted 2019-11-05

Plain-language 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.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in fMRI Measure

Timeframe: baseline and 3 weeks post intervention

Trial details

NCT IDNCT04170738

SponsorJeffrey Newcorn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-08

Results submitted2024-08-07

View on ClinicalTrials.gov More Attention Deficit Disorder With Hyperactivity trials