Summary
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alcohol Use Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alcohol Use Disorder. ClinicalTrials.gov lists 8 registered trials linking Nicotine to Alcohol Use Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00846859). The largest enrolment is 10000 participants (NCT01252706). Registration activity spans 2009 to 2025. The literature layer holds 10 publications for this pair: 1 Cochrane review, 3 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2012 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 Alcohol Abuse ranks 375 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: 30-40% of people with AUD achieve sustained abstinence without formal treatment at 1 year (natural recovery); but functional impairment, liver damage, and mortality risk accumulate; relapse in 50-60% within 1 year even after treatment.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 69.0 (trials 19.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 10 (5 clinical trial publications, 3 meta-analyses, 1 Cochrane review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACHE |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00846859 | Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals? 2009 | completed | Phase 2 | 162 |
| NCT01784627 | Trial of Computerized SBI to Reduce Teen Alcohol Use 2015 | withdrawn | Phase 1 | — |
| NCT04776278 | Behavioral Economic and Wellness-based Approaches for Reducing Alcohol Use and Consequences Among Emerging Adults 2022 | active, not recruiting | Not applicable | 525 |
| NCT03703258 | Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE) 2021 | completed | Not applicable | 41 |
| NCT06919276 | Nicotine and Cannabis Vape Labeling Experiment - Spring 2025 2025 | completed | Not applicable | 3,048 |
| NCT01386138 | Treating South African Pregnant Women for Methamphetamine 2011 | completed | Not applicable | 60 |
| NCT06880705 | The Trans-Led Care Study 2025 | recruiting | Not applicable | 124 |
| NCT01252706 | Estimation of Alcohol, Substance and Cigarettes Exposure Among Pregnant Women in the Israeli Periphery and Center, and the Contribution of Brief Intervention 2011 | status unknown | Not applicable | 10,000 |
Published literature
- Meta-analysis Global prevalence and risk factors of suicidality among head and neck cancer patients-systematic review and meta-analysisSharma S, Vasudevan SS, Walker N et al. · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025 · PMID 40089588
- Clinical trial publication Treating Alcohol Use Disorder in U.S. Veterans: The Role of Traumatic Brain InjuryJorge RE, Li R, Liu X et al. · The Journal of neuropsychiatry and clinical neurosciences · 2019 · PMID 31117905
- Clinical trial publication Developmental delays and psychiatric diagnoses are elevated in offspring staying in prisons with their mothersKutuk MO, Altintas E, Tufan AE et al. · Scientific reports · 2018 · PMID 29382903
- Clinical trial publication Varenicline for tobacco-dependence treatment in alcohol-dependent smokers: A randomized controlled trialHurt RT, Ebbert JO, Croghan IT et al. · Drug and alcohol dependence · 2018 · PMID 29324248
- Clinical trial publication A Randomized Trial of Contingency Management for Smoking Cessation During Intensive Outpatient Alcohol TreatmentCooney JL, Cooper S, Grant C et al. · Journal of substance abuse treatment · 2017 · PMID 27542442
- Cochrane review Effect of High-Frequency Transcranial Magnetic Stimulation on Craving in Substance Use Disorder: A Meta-AnalysisMaiti R, Mishra BR, Hota D · The Journal of neuropsychiatry and clinical neurosciences · 2017 · PMID 27707195
- Clinical trial publication Cessation of alcohol consumption decreases rate of nicotine metabolism in male alcohol-dependent smokersGubner NR, Kozar-Konieczna A, Szoltysek-Boldys I et al. · Drug and alcohol dependence · 2016 · PMID 27107849
- 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
- Randomized controlled trial Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trialOjo-Fati O, John F, Thomas J et al. · Trials · 2015 · PMID 26320081
- Meta-analysis Prevalence of attention-deficit hyperactivity disorder in substance use disorder patients: a meta-analysis and meta-regression analysisvan Emmerik-van Oortmerssen K, van de Glind G, van den Brink W et al. · Drug and alcohol dependence · 2012 · PMID 22209385
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 ACHE. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for Alcohol Use Disorder?
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Alcohol Use Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Alcohol Use Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nicotine in clinical trials for Alcohol Use Disorder?
ClinicalTrials.gov lists 8 registered trials linking Nicotine to Alcohol Use Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00846859). The largest enrolment is 10000 participants (NCT01252706). Registration activity spans 2009 to 2025.
What does the evidence show for Nicotine in Alcohol Use Disorder?
Nicotine has both completed registered trials and synthesis-level publications linked to Alcohol Use Disorder. 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 ACHE. 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.