A Phase 4 interventional study of Adderall in Attention Deficit Disorder With Hyperactivity, Conduct Disorder and Substance Abuse, sponsored by Jeffrey Newcorn. Completed at 1 site in United States. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Jeffrey Newcorn · Phase 4, Interventional, and Basic science
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's enrollment of 33 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Jeffrey Newcorn is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
Drug: Adderall
3 weeks of Adderall
Also known as: Dextroamphetamine-Amphetamine
Change in fMRI Measure
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
Time frame: baseline and 3 weeks post intervention
ADHD Rating Score (ADHD RS)
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.
Time frame: Pretreatment, baseline and Post-Treatment, average 2 weeks
Total Dose of MAS-XR
Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg
Time frame: average 2 weeks
Change in Clinical Global Impression - Improvement (CGI-I)
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.
Time frame: baseline and post treatment, average 2 weeks
| Milestone | High Risk | Low Risk |
|---|---|---|
| Started | 26 | 7 |
| Completed | 11 | 7 |
| Not completed | 15 | 0 |
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
| BOLD signal | High Risk | Low Risk |
|---|---|---|
| Reward Outcome Post-Pre Low>High, Left Amygdala | -0.957100 ± 1.365781 | 0.572517 ± 0.712410 |
| Reward Outcome Post-Pre Low>High, ACC | -0.139000 ± 1.288470 | 1.876717 ± 1.615755 |
| Reward Outcome Post-Pre Low>High, Ventral Striatum | 0.853514 ± 0.475767 | -0.321983 ± 1.075986504 |
| Reward Outcome Post-Pre Low>High, Ventrolateral Pre-Frontal Cortex (VLPFC) | 0.712514 ± 0.944126 | 0.460432 ± 0.744686 |
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.
| score on a scale | High Risk | Low Risk |
|---|---|---|
| ADHRS-total baseline | 43.18 ± 7.264 | 39.86 ± 13.057 |
| ADHRS-total post Tx | 20.36 ± 13.677 | 12.71 ± 5.314 |
| ADHRS-hyper baseline | 20.55 ± 5.298 | 19.71 ± 6.651 |
| ADHRS-hyper post Tx | 10.09 ± 7.355 | 8.86 ± 3.805 |
| ADHRS-InAtt baseline | 22.64 ± 3.906 | 20.14 ± 7.988 |
| ADHRS- InAtt post Tx | 10.27 ± 7.016 | 8.86 ± 3.805 |
Open label trial of MAS XR with flexible dosing and a suggested target of at least 0.5mg/kg
| mg | High Risk | Low Risk |
|---|---|---|
| Total Dose of MAS-XR | 1487.09 ± 2108.303 | 745.00 ± 594.636 |
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.
| score on a scale | High Risk | Low Risk |
|---|---|---|
| Change in Clinical Global Impression - Improvement (CGI-I) | 2.0 ± 0.632 | 2.00 ± 0.577 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Risk | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Low Risk | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | High Risk | Low Risk | Total |
|---|---|---|---|
| Mean | 9.00 ± 1.483 | 10.14 ± 1.345 | 9.44 ± 1.5 |
| Sex: Female, Male(Participants) | High Risk | Low Risk | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 7 | 6 | 13 |
| Race and Ethnicity Not Collected(Participants) | High Risk | Low Risk | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Full Scale IQ (FSIQ)(units on a scale) | High Risk | Low Risk | Total |
|---|---|---|---|
| Mean | 102.45 ± 12.003 | 107.29 ± 11.041 | 104.9 ± 11.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Ran from Nov 2019 to primary completion in Aug 2023, 45 months.
Results were first posted in Aug 2024, 1 year after primary completion.
Of 44 non-industry phase 4 interventional studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 81. This study's 45 months is below that.
Counting every sponsor, half of 62 studies reached it within 38 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adderall
Attention Deficit Disorder with Hyperactivity →
Jeffrey Newcorn