Disease × agent evidence record

Nicotine for ADHD: evidence, trials and status

Nicotine 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.

8 registered trials 1 recruiting 17 publications Evidence tier A · Strong Score 70.0
Research Tracker › Pairs › ADHD › Nicotine
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Nicotine 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lists 8 registered trials linking Nicotine to ADHD: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01012375). The largest enrolment is 336 participants (NCT06038942). Registration activity spans 2005 to 2023. The literature layer holds 17 publications for this pair: 4 Cochrane reviews, 4 meta-analyses, 3 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1999 to 2025. 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%.

Open in Repurposing ExplorerADHD hubADHD biomarkers & interventionsChEMBLOpen Targets

Evidence table

Evidence tierA · Strong
Evidence score70.0 (trials 20.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other
Linked publications17 (5 clinical trial publications, 4 Cochrane reviews, 4 meta-analyses, 3 systematic reviews, 1 randomised controlled trial publication)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesOpen Targets, ChEMBL
Linked via biomarker / targetADORA1
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 IDTitleStatusPhaseEnrolment
NCT01012375Study to Investigate the Efficacy and Tolerability of AZD1446 in Adult ADHD Patients.
2009
completedPhase 2135
NCT02266784Contingency Management, Quitting Smoking, and ADHD
2014
completedPhase 133
NCT00736255Attention Deficit Hyperactivity Disorder (ADHD) Smoking Cessation Study
2007
completedNot applicable32
NCT06038942Formal Versus Informal Mindfulness Among University Students With Self-reported ADHD, Nonsuicidal Self-injury, or Stress
2023
completedNot applicable336
NCT01123668Neuroimaging of Smokers With and Without Attention Deficit Hyperactivity Disorder (ADHD)
2009
completedNot applicable101
NCT00573248Nicotine and Behavior in Adult ADHD
2005
completedNot applicable78
NCT05584059Pai.ACT Programme for Parents of Children With Special Healthcare Needs - Phase I
2022
recruitingNot applicable150
NCT02599571Effects of Nicotine Reduction on Smoking Behavior in ADHD Smokers
2016
terminatedNot applicable71

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Published literature

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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 Nicotine approved for ADHD?

Nicotine 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 Nicotine in clinical trials for ADHD?

ClinicalTrials.gov lists 8 registered trials linking Nicotine to ADHD: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01012375). The largest enrolment is 336 participants (NCT06038942). Registration activity spans 2005 to 2023.

What does the evidence show for Nicotine in ADHD?

Nicotine 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

Open Source Medicine Foundation. Nicotine for ADHD: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/attention-deficit-hyperactivity-disorder/nicotine.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.