{"id":"short-term-varenicline","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT00828113","NCT01320462","NCT00141167","NCT00139750","NCT01162239","NCT00143364","NCT00141206","NCT03365362","NCT03262662"],"aliases":[],"patents":[],"pricing":[],"allNames":"short-term varenicline","offLabel":[],"timeline":[{"date":"2010","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Long-term Varenicline Treatment for Smoking Cessation) — Smoking"},{"date":"2016","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Maintaining Nonsmoking) — Nicotine Dependence"}],"aiSummary":"Varenicline is a small molecule that acts as a partial agonist of the neuronal acetylcholine receptor alpha4/beta2. It has been studied for its potential to treat conditions such as smoking, tobacco use disorder, opioid-use disorder, nicotine dependence, and heavy drinking.","brandName":"Short-Term Varenicline","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"","drugClass":"varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t","explanation":"Varenicline works by attaching to nicotinic receptors in your brain—the same receptors that nicotine normally stimulates. Unlike nicotine itself, which fully activates these receptors and produces a strong reward signal, varenicline only partially activates them. This partial activation is enough to satisfy much of your brain's desire for nicotine stimulation, significantly reducing the intense cravings and withdrawal discomfort that typically make quitting difficult.\n\nAt the same time, varenicline blocks nicotine molecules from fully activating these same receptors. So if you do smoke while taking varenicline, the nicotine won't produce the satisfying, rewarding sensation you're accustomed to. This dual action—reducing cravings while removing the pleasure from smoking—addresses both the physical and behavioral aspects of nicotine addiction, making it easier to stay abstinent.\n\nThis approach is different from nicotine replacement therapy, which simply provides nicotine in a different form without blocking it. Varenicline's ability to both satisfy withdrawal and prevent reward if you slip makes it particularly effective for short-term intensive quit attempts, especially during the critical first weeks when relapse risk is highest.","oneSentence":"varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg t","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"short-term-varenicline","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Tobacco Use Disorder","phase":"preclinical","trialId":"","patients":null,"diseaseId":"unknown","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00828113","phase":"Phase 4","title":"Long-term Varenicline Treatment for Smoking Cessation","status":"Completed","sponsor":"University of Wisconsin, Madison","isPivotal":false,"enrollment":101,"indication":"Smoking","completionDate":"2010-09","primaryEndpoint":"This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation."},{"nctId":"NCT01320462","phase":"N/A","title":"Smoking Cessation Program in the Preadmission Clinic","status":"Completed","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":296,"indication":"Smoking","completionDate":"2017-04","primaryEndpoint":"Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoper"},{"nctId":"NCT00141167","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo for Smoking Ce","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":250,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo for smoking cessation."},{"nctId":"NCT00139750","phase":"Phase 2","title":"12 Week Evaluation of the Safety and Efficacy of 3 Doses of CP-526,555 and Placebo for Smoking Cessa","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":600,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"The purpose of the study is to examine the safety and efficacy and dose-response relationship of three doses of CP-526,555 for 12 weeks compared with placebo for smoking cessation; including post-trea"},{"nctId":"NCT01162239","phase":"Phase 3","title":"Maintaining Nonsmoking","status":"Completed","sponsor":"University of California, San Francisco","isPivotal":false,"enrollment":216,"indication":"Nicotine Dependence","completionDate":"2016-06","primaryEndpoint":"The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful."},{"nctId":"NCT00143364","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1005,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation."},{"nctId":"NCT00141206","phase":"Phase 3","title":"A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1005,"indication":"Smoking Cessation","completionDate":"","primaryEndpoint":"The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation."},{"nctId":"NCT03365362","phase":"Phase 4","title":"A Trial of Directly Observed and Long-term Varenicline","status":"Completed","sponsor":"Albert Einstein College of Medicine","isPivotal":false,"enrollment":243,"indication":"Tobacco Use Disorder","completionDate":"2023-11","primaryEndpoint":"This 2 x 2 factorial, randomized, double-blind, placebo-controlled trial will test two interventions: directly observed medication therapy, and long-term therapy with varenicline among smokers with op"},{"nctId":"NCT03262662","phase":"Phase 3","title":"EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking","status":"Completed","sponsor":"State University of New York at Buffalo","isPivotal":false,"enrollment":320,"indication":"Tobacco Smoking","completionDate":"2021-04","primaryEndpoint":"Varenicline is the most effective smoking cessation therapy available."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL1076903"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"","enrichmentLevel":3,"visitCount":3,"trialStats":{"total":1,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}