Summary
Amphetamine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ADHD would be drug repurposing rather than first-in-human development. This does not mean it is approved for ADHD. ClinicalTrials.gov lists 8 registered trials linking Amphetamine to ADHD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01552902). It plans or enrolled 549 participants. Registration activity spans 2007 to 2018. The literature layer holds 18 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 4 systematic reviews and 5 clinical trial publications. Publication years run from 2019 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Attention Deficit-Hyperactivity Disorder ranks 305 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous remission by adulthood: 30-70% symptom reduction (depending on definition); functionally impairing ADHD persists into adulthood in 50-65% of childhood cases; DSMIV criteria met in adulthood in ~50%.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 79.0 (trials 29.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 18 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 4 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADORA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01552902 | Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder 2012 | completed | Phase 4 | 549 |
| NCT01328756 | Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) 2011 | completed | Phase 4 | 314 |
| NCT00753012 | Cardiovascular Study of Lisdexamfetamine in Healthy and Hypertensive Attention Deficit Hyperactivity Disorder Adults 2008 | completed | Phase 4 | 24 |
| NCT01106430 | Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate 2010 | completed | Phase 3 | 267 |
| NCT03659929 | Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate 2018 | completed | Phase 3 | 320 |
| NCT01711021 | Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD 2012 | completed | Phase 2 | 110 |
| NCT00736255 | Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study 2007 | completed | Not applicable | 32 |
| NCT02259517 | An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD 2014 | terminated | Not applicable | 38 |
Published literature
- Clinical trial publication d-Amphetamine Transdermal System in Treatment of Children and Adolescents With ADHD: SKAMP Subscale Analysis and Subgroup Analysis from a Pivotal TrialCutler AJ, Komaroff M, Castelli M et al. · Journal of child and adolescent psychopharmacology · 2026 · PMID 41928428
- Clinical trial publication Psychostimulant treatment uniquely reduces left uncinate fasciculus microstructural integrity in ADHD youth with a familial risk for bipolar I disorder: a 12-week DTI studyQin K, Chen W, Lei D et al. · Journal of child psychology and psychiatry, and allied disciplines · 2026 · PMID 40960004
- Clinical trial publication Different Changes in Brain Functional Networks Following 12-Week Psychostimulant Treatment in Attention-Deficit/Hyperactivity Disorder Youth With and Without Familial Risk for Bipolar I DisorderQin K, Pan N, Lei D et al. · Journal of the American Academy of Child and Adolescent Psychiatry · 2026 · PMID 40712681
- Meta-analysis Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity DisorderFarhat LC, Sugaya LS, Bloch MH et al. · Journal of the American Academy of Child and Adolescent Psychiatry · 2026 · PMID 40975435
- Systematic review Tolerance and Tachyphylaxis to Medications for Attention-Deficit/Hyperactivity Disorder (ADHD): A Systematic Review of Empirical StudiesSmith C, Walker H, Parlatini V et al. · CNS drugs · 2026 · PMID 41627718
- Systematic review Therapeutic Reference Ranges for ADHD Drugs in Blood of Children and Adolescents: A Systematic Review by the AGNP TDM-Task ForceHagenkötter SS, Egberts K, Fekete S et al. · Pharmacopsychiatry · 2026 · PMID 41183543
- Cochrane review Effect of amphetamines on blood pressureChan M, Chan JJ, Wright JM · The Cochrane database of systematic reviews · 2025 · PMID 40152309
- Meta-analysis Safety of Stimulants Across Patient Populations: A Meta-AnalysisOliva HNP, Prudente TP, Mayerson TF et al. · JAMA network open · 2025 · PMID 40343695
- Systematic review Challenges in amphetamine medication availability for individuals with ADHD: a narrative review of the current state of evidenceAlotaibi MM, Alrashdi NZ, Alzubaidi B et al. · Frontiers in psychiatry · 2025 · PMID 40771645
- Clinical trial publication Extended-Release Mixed Amphetamine Salts for Comorbid Adult Attention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder: A Pilot, Randomized Double-Blind, Placebo-Controlled TrialLevin FR, Mariani JJ, Pavlicova M et al. · Journal of attention disorders · 2024 · PMID 39051597
- Cochrane review Efficacy and safety of established and off-label ADHD drug therapies for cognitive impairment or attention-deficit hyperactivity disorder symptoms in bipolar disorder: A systematic review by the ISBD Targeting Cognition Task ForceMiskowiak KW, Obel ZK, Guglielmo R et al. · Bipolar disorders · 2024 · PMID 38433530
- Systematic review Stimulant medications in the management of bulimia nervosa and anorexia nervosa in patients with and without comorbid attention deficit hyperactivity disorder: A systematic reviewVickers ML, Chan HY, Elliott S et al. · Eating behaviors · 2024 · PMID 39137484
- Clinical trial publication d-Amphetamine Transdermal System in Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Secondary Endpoint Results and Post Hoc Effect Size Analyses from a Pivotal TrialCutler AJ, Suzuki K, Starling B et al. · Journal of child and adolescent psychopharmacology · 2023 · PMID 37339441
- Cochrane review Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescentsGillies D, Leach MJ, Perez Algorta G · The Cochrane database of systematic reviews · 2023 · PMID 37058600
- Cochrane review ADHD Prescription Medications and Their Effect on Athletic Performance: A Systematic Review and Meta-analysisBerezanskaya J, Cade W, Best TM et al. · Sports medicine - open · 2022 · PMID 35022919
- Cochrane review A review of Cochrane reviews on pharmacological treatment for attention deficit hyperactivity disorderSantos GM, Santos EM, Mendes GD et al. · Dementia & neuropsychologia · 2021 · PMID 35509804
- Meta-analysis Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysisElliott J, Johnston A, Husereau D et al. · PloS one · 2020 · PMID 33085721
- Meta-analysis Efficacy, Acceptability, and Tolerability of Lisdexamfetamine, Mixed Amphetamine Salts, Methylphenidate, and Modafinil in the Treatment of Attention-Deficit Hyperactivity Disorder in Adults: A Systematic Review and Meta-analysisStuhec M, Lukić P, Locatelli I · The Annals of pharmacotherapy · 2019 · PMID 30117329
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Amphetamine approved for ADHD?
Amphetamine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in ADHD would be drug repurposing rather than first-in-human development. This does not mean it is approved for ADHD. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Amphetamine in clinical trials for ADHD?
ClinicalTrials.gov lists 8 registered trials linking Amphetamine to ADHD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01552902). It plans or enrolled 549 participants. Registration activity spans 2007 to 2018.
What does the evidence show for Amphetamine in ADHD?
Amphetamine has both completed registered trials and synthesis-level publications linked to ADHD. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ADORA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.