Summary
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). ClinicalTrials.gov lists 4 registered trials linking Nicotine to Inflammatory Bowel Disease (Crohn's / UC): 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02345733). The largest enrolment is 128 participants (NCT00132899). Registration activity spans 2005 to 2021. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 systematic reviews, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 1999 to 2022. 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 Inflammatory Bowel Disease ranks 200 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: Disease course unchanged in ~85% of patients at 10 years on standard care; ~23% (CD) and ~12% (UC) relapse within 12 months of thiopurine withdrawal in sustained remission.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 62.5 (trials 12.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 2 systematic reviews, 2 randomised controlled trial publications, 1 meta-analysis) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | ChEMBL |
| Linked via biomarker / target | ADAM17 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02345733 | Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis 2015 | completed | Phase 4 | 20 |
| NCT00132899 | COMMIT (Combination Of Maintenance Methotrexate-Infliximab Trial) 2005 | completed | Phase 3 | 128 |
| NCT02922881 | Microbiota-targeted Diet for Pediatric UC 2017 | completed | Not applicable | 5 |
| NCT04653259 | Digital Nutrition Therapy for Patients With IBD 2021 | status unknown | Not applicable | 44 |
Published literature
- Meta-analysis Risk of ulcerative colitis and Crohn's disease in smokers lacks causal evidencePedersen KM, Çolak Y, Vedel-Krogh S et al. · European journal of epidemiology · 2022 · PMID 34091767
- Systematic review Transdermal nicotine in non-smokers: A systematic review to design COVID-19 clinical trialsDautzenberg B, Levi A, Adler M et al. · Respiratory medicine and research · 2021 · PMID 34153704
- Cochrane review Genetic Factors Interact With Tobacco Smoke to Modify Risk for Inflammatory Bowel Disease in Humans and MiceYadav P, Ellinghaus D, Rémy G et al. · Gastroenterology · 2017 · PMID 28506689
- Cochrane review Systematic review: interventions for abdominal pain management in inflammatory bowel diseaseNorton C, Czuber-Dochan W, Artom M et al. · Alimentary pharmacology & therapeutics · 2017 · PMID 28470846
- Clinical trial publication High smoking cessation rate in Crohn's disease patients after physician advice--the TABACROHN StudyNunes T, Etchevers MJ, Merino O et al. · Journal of Crohn's & colitis · 2013 · PMID 22626507
- Cochrane review Systematic review and meta-analysis of the efficacy and tolerability of nicotine preparations in active ulcerative colitisNikfar S, Ehteshami-Ashar S, Rahimi R et al. · Clinical therapeutics · 2010 · PMID 21353102
- Cochrane review [Transdermal nicotine treatment of ulcerative colitis: a survey of a Cochrane review]Seidelin JB, Nielsen OH · Ugeskrift for laeger · 2006 · PMID 16494804
- Clinical trial publication Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label phase I-II study of toleranceIngram JR, Rhodes J, Evans BK et al. · Inflammatory bowel diseases · 2005 · PMID 16306772
- Clinical trial publication A randomized trial of nicotine enemas for active ulcerative colitisIngram JR, Thomas GA, Rhodes J et al. · Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2005 · PMID 16271342
- Clinical trial publication Plasma fibrinogen in ulcerative colitis: the effect of disease activity and nicotine therapy in a randomised controlled trialIngram JR, Rhodes J, Collins PW et al. · Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver · 2005 · PMID 16169302
- Clinical trial publication Comparative study of enema retention and preference in ulcerative colitisIngram JR, Rhodes J, Evans BK et al. · Postgraduate medical journal · 2005 · PMID 16143691
- Systematic review Review article: smoking cessation as primary therapy to modify the course of Crohn's diseaseJohnson GJ, Cosnes J, Mansfield JC · Alimentary pharmacology & therapeutics · 2005 · PMID 15813828
- Cochrane review Transdermal nicotine for induction of remission in ulcerative colitisMcGrath J, McDonald JW, Macdonald JK · The Cochrane database of systematic reviews · 2004 · PMID 15495126
- Randomized controlled trial Distal ulcerative colitis refractory to rectal mesalamine: role of transdermal nicotine versus oral mesalamineGuslandi M, Frego R, Viale E et al. · Canadian journal of gastroenterology = Journal canadien de gastroenterologie · 2002 · PMID 12045777
- Randomized controlled trial Intra-luminal nicotine reduces smooth muscle tone and contractile activity in the distal large bowelGreen JT, McKirdy HC, Rhodes J et al. · European journal of gastroenterology & hepatology · 1999 · PMID 10563544
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 ChEMBL, in this case via the biomarker or target ADAM17. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for Inflammatory Bowel Disease (Crohn's / UC)?
Nicotine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Inflammatory Bowel Disease (Crohn's / UC) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Inflammatory Bowel Disease (Crohn's / UC). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Nicotine in clinical trials for Inflammatory Bowel Disease (Crohn's / UC)?
ClinicalTrials.gov lists 4 registered trials linking Nicotine to Inflammatory Bowel Disease (Crohn's / UC): 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02345733). The largest enrolment is 128 participants (NCT00132899). Registration activity spans 2005 to 2021.
What does the evidence show for Nicotine in Inflammatory Bowel Disease (Crohn's / UC)?
Nicotine has both completed registered trials and synthesis-level publications linked to Inflammatory Bowel Disease (Crohn's / UC). 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 ChEMBL, in this case via the biomarker or target ADAM17. 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.