{"id":"nicotine-patch","rwe":[{"pmid":"41197178","year":"2026","title":"Effects of nicotine on sleep architecture and ventilatory parameters: Results of the Tab-OSA cross-sectional observational study.","journal":"Sleep medicine"},{"pmid":"41196915","year":"2025","title":"Sex-stratified pharmacovigilance of gastrointestinal events associated with first-line smoking-cessation medicines: Insights from the FAERS database.","journal":"PloS one"},{"pmid":"41190051","year":"2025","title":"Do predictors of abstinence change in the medium- and long-term follow-up of smokers who have quit smoking? A prospective cohort study.","journal":"Tobacco prevention & cessation"},{"pmid":"41134380","year":"2025","title":"Nicotine replacement therapy during the acute phase of aneurysmal subarachnoid hemorrhage.","journal":"Acta neurochirurgica"},{"pmid":"40987452","year":"2025","title":"App-Based Smoking Urge Reduction Intervention for Young Adults: Protocol Combining a Microrandomized Trial and Conventional Between-Subject Randomized Trial.","journal":"JMIR research protocols"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT00143325","NCT02162849","NCT00818207","NCT02501265","NCT00352781","NCT01574703","NCT03722966","NCT03059940","NCT02859142","NCT01456936","NCT04126135"],"aliases":[],"patents":[],"pricing":[],"allNames":"nicotine patch","offLabel":[],"timeline":[{"date":"2010","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit) — Smoking Cessation"},{"date":"2020","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Adaptive Pharmacotherapy for Smoking Cessation) — Nicotine Dependence"},{"date":"2026","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer) — Smoking Cessation"}],"aiSummary":"Nicotine Patch is a nicotine replacement therapy that delivers nicotine transdermally to reduce withdrawal symptoms and cravings during smoking cessation. As a direct nicotine agonist, it provides a controlled, steady dose of nicotine without the combustion byproducts of cigarettes, making it an effective non-smoking alternative for managing the physiological dependence on nicotine.","brandName":"Nicotine Patch","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11","explanation":"Nicotine addiction works through your brain's reward system. When you smoke, nicotine rapidly reaches your brain and binds to nicotinic receptors, creating feelings of pleasure and satisfaction while also relieving uncomfortable withdrawal symptoms like irritability, anxiety, and intense cravings. When you quit smoking suddenly, your brain loses this regular nicotine supply, triggering withdrawal symptoms that make quitting extremely difficult.\n\nThe nicotine patch solves this problem by delivering a steady, consistent amount of nicotine directly through your skin into your bloodstream over several hours. Instead of the dramatic spike-and-crash cycle of smoking, the patch maintains stable nicotine levels throughout the day. This steady supply prevents withdrawal symptoms from developing while you're working on breaking the behavioral habits of smoking itself.\n\nBy separating nicotine replacement from the act of smoking, the patch lets your brain gradually adjust to lower nicotine levels while you build new routines and coping strategies. Most people use patches of decreasing strength over several weeks or months, slowly tapering their nicotine dependence until they can stop completely. This approach addresses the chemical addiction while you address the psychological and behavioral aspects of smoking separately.","oneSentence":"Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"nicotine-patch","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Tobacco Use Cessation","phase":"preclinical","trialId":"","patients":null,"diseaseId":"unknown","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00143325","phase":"Phase 3","title":"An Open Label Study That Compares Varenicline to Transdermal Nicotine Patch for Smoking Cessation","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":730,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"Open-label comparison of standard 12-week regimen of varenicline with standard 10-week regimen of transdermal nicotine patch for smoking cessation."},{"nctId":"NCT02162849","phase":"Phase 4","title":"Reward Sensitivity and Pharmacotherapy for Smoking Cessation","status":"Active Not Recruiting","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":204,"indication":"Tobacco Use Cessation","completionDate":"2028-02","primaryEndpoint":"The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking."},{"nctId":"NCT00818207","phase":"Phase 4","title":"Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1380,"indication":"Smoking Cessation","completionDate":"2010-03","primaryEndpoint":"This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated t"},{"nctId":"NCT02501265","phase":"Phase 2","title":"Adaptive Pharmacotherapy for Smoking Cessation","status":"Completed","sponsor":"Duke University","isPivotal":false,"enrollment":188,"indication":"Nicotine Dependence","completionDate":"2020-07","primaryEndpoint":"The purpose of this study is to assess an \"adaptive\" approach to smoking cessation pharmacotherapy."},{"nctId":"NCT00352781","phase":"N/A","title":"Stop Smoking Therapy for Ontario Patients","status":"Completed","sponsor":"Centre for Addiction and Mental Health","isPivotal":false,"enrollment":1767,"indication":"Smoking","completionDate":"2009-01","primaryEndpoint":"Approximately 2 million Ontarians are current smokers."},{"nctId":"NCT01574703","phase":"Phase 4","title":"Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medication","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":4595,"indication":"Smoking Cessation","completionDate":"2015-07","primaryEndpoint":"Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of "},{"nctId":"NCT03722966","phase":"Phase 2","title":"Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)","status":"Terminated","sponsor":"University of Oklahoma","isPivotal":false,"enrollment":34,"indication":"Smoking Cessation","completionDate":"2022-02","primaryEndpoint":"Varenicline is considered to be a first-line tobacco cessation treatment."},{"nctId":"NCT03059940","phase":"Phase EARLY1","title":"Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer","status":"Active Not Recruiting","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":630,"indication":"Smoking Cessation","completionDate":"2026-06","primaryEndpoint":"The goal of this clinical research study is to offer lung cancer screenings to smokers who want to change their smoking behaviors."},{"nctId":"NCT02859142","phase":"Phase 4","title":"Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation","status":"Completed","sponsor":"University of Chicago","isPivotal":false,"enrollment":122,"indication":"Smoking Cessation","completionDate":"2020-09","primaryEndpoint":"The purpose of this study is to learn if the combination of a study drug and patch is more effective in helping heavy drinkers stop smoking than just the patch alone The study drug, varenicline, has b"},{"nctId":"NCT01456936","phase":"Phase 4","title":"Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subje","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":8144,"indication":"Smoking Cessation","completionDate":"2015-01","primaryEndpoint":"This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to char"},{"nctId":"NCT04126135","phase":"Phase 4","title":"Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy","status":"Completed","sponsor":"Loma Linda University","isPivotal":false,"enrollment":1307,"indication":"Nicotine Addiction","completionDate":"2024-03","primaryEndpoint":"A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health ho"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Transdermal","frequency":"","formulation":"Patch"},"crossReferences":{"chemblId":"CHEMBL3989563"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":5,"trialStats":{"total":26,"withResults":5},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}