Summary
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. ClinicalTrials.gov lists 8 registered trials linking Nicotine to Anxiety Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 2 (NCT07024992). The largest enrolment is 2598 participants (NCT06957925). Registration activity spans 2011 to 2026. The literature layer holds 12 publications for this pair: 5 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2015 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 Anxiety ranks 535 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: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 71.0 (trials 21.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 12 (5 meta-analyses, 5 clinical trial publications, 2 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 | ADRA1A |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT07024992 | Enhancing Smoking Cessation for African American People Everywhere 2026 | not yet recruiting | Phase 2 | 300 |
| NCT03904186 | Effectiveness of an Integrated Treatment to Address Smoking Cessation and Anxiety/ Depression in People Living With HIV 2019 | completed | Not applicable | 131 |
| NCT01393301 | Integrated Treatment for Smoking Cessation & Anxiety in People With HIV 2011 | completed | Not applicable | 72 |
| NCT06957925 | ABC School Intervention Among Ugandan Adolescents 2023 | completed | Not applicable | 2,598 |
| NCT05376397 | Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) 2021 | completed | Not applicable | 34 |
| NCT04481373 | Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE') 2021 | completed | Not applicable | 75 |
| NCT04143243 | One-day Life Skills Workshop for Veterans With TBI, Pain, and Psychopathology: Evaluating Efficacy and Mechanism of Change 2020 | completed | Not applicable | 176 |
| NCT07499219 | Preliminary Testing and Development of a Short Digital Intervention for Patients on Waiting Lists for Psychological Treatment 2026 | enrolling by invitation | Not applicable | 80 |
Published literature
- Clinical trial publication Personalized chat-based support for smoking cessation among smokers with mental health symptoms in the workplace: A randomized controlled trialYao Y, Luk TT, Lau OS et al. · Addiction (Abingdon, England) · 2025 · PMID 39924464
- Meta-analysis Psychiatric morbidity and gambling disorder: A systematic review and meta-analysis of population-based surveysGaleazzi GM, Marchi M, Castagnini AC · European psychiatry : the journal of the Association of European Psychiatrists · 2025 · PMID 41126668
- Meta-analysis Symptom Provocation and Clinical Response to Transcranial Magnetic Stimulation: A Systematic Review and Meta-AnalysisBello D, Jones M, Gadiyar I et al. · JAMA psychiatry · 2025 · PMID 40465306
- Clinical trial publication Subjective experiences, contexts, and risk perceptions of very low nicotine content cigarettes and electronic cigarettes among people with depression and anxiety disorders who smokeDeAtley T, Harrison A, Cassidy R et al. · Drug and alcohol dependence · 2023 · PMID 36638679
- Meta-analysis Global prevalence of smoking among individuals with obsessive-compulsive disorder and symptoms: a systematic review and meta-analysisAkbari M, Seydavi M, Chasson GS et al. · Health psychology review · 2023 · PMID 36173036
- Systematic review A systematic review of virtual reality therapies for substance use disorders: Impact on secondary treatment outcomesTaubin D, Berger A, Greenwald D et al. · The American journal on addictions · 2023 · PMID 36128667
- Clinical trial publication The effects of reduced nicotine content cigarettes on biomarkers of nicotine and toxicant exposure, smoking behavior and psychiatric symptoms in smokers with mood or anxiety disorders: A double-blind randomized trialFoulds J, Veldheer S, Pachas G et al. · PloS one · 2022 · PMID 36322562
- Clinical trial publication Community-based smoking cessation treatment for adults with high anxiety sensitivity: a randomized clinical trialSmits JAJ, Zvolensky MJ, Rosenfield D et al. · Addiction (Abingdon, England) · 2021 · PMID 34033178
- Clinical trial publication A double-blind randomized clinical trial of high frequency rTMS over the DLPFC on nicotine dependence, anxiety and depressionAbdelrahman AA, Noaman M, Fawzy M et al. · Scientific reports · 2021 · PMID 33452340
- Systematic review A systematic review of suicide and suicide attempts in adolescents with psychotic disordersBarbeito S, Vega P, Sánchez-Gutiérrez T et al. · Schizophrenia research · 2021 · PMID 34332428
- Meta-analysis Childhood Psychiatric Disorders as Risk Factor for Subsequent Substance Abuse: A Meta-AnalysisGroenman AP, Janssen TWP, Oosterlaan J · Journal of the American Academy of Child and Adolescent Psychiatry · 2017 · PMID 28647007
- Meta-analysis Prevalence of psychiatric co-morbidity in treatment-seeking problem gamblers: A systematic review and meta-analysisDowling NA, Cowlishaw S, Jackson AC et al. · The Australian and New Zealand journal of psychiatry · 2015 · PMID 25735959
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 ADRA1A. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for Anxiety Disorders?
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nicotine in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 8 registered trials linking Nicotine to Anxiety Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 2 (NCT07024992). The largest enrolment is 2598 participants (NCT06957925). Registration activity spans 2011 to 2026.
What does the evidence show for Nicotine in Anxiety Disorders?
Nicotine has both completed registered trials and synthesis-level publications linked to Anxiety Disorders. 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 ADRA1A. 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.