{"id":"placebo-tablet-and-nicotine-patch","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Skin irritation at patch application site"},{"rate":"5-15","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"3-8","effect":"Dizziness"},{"rate":"5-10","effect":"Sleep disturbances"},{"rate":"2-5","effect":"Palpitations"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Placebo Tablet and Nicotine Patch","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:02:18.495345+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:02:23.703600+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Placebo Tablet and Nicotine Patch","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:02:24.067608+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3989563/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:02:31.589214+00:00"}},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Nicotine is a psychoactive alkaloid that acts as an agonist at nicotinic acetylcholine receptors, particularly in the ventral tegmental area and nucleus accumbens, reinforcing reward pathways and reducing the discomfort of nicotine withdrawal. The placebo tablet component is used in clinical trials to establish the efficacy of nicotine replacement therapy above baseline. This combination is typically used in research settings to evaluate the comparative effectiveness of nicotine patch therapy for smoking cessation.","oneSentence":"Nicotine from the patch binds to nicotinic acetylcholine receptors in the brain to reduce cravings and withdrawal symptoms during smoking cessation, while the placebo tablet serves as a control comparator.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:01:26.876Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T04:02:33.447789+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"name":"Smoking cessation / nicotine dependence"}]},"trialDetails":[{"nctId":"NCT02162849","phase":"PHASE4","title":"Reward Sensitivity and Pharmacotherapy for Smoking Cessation","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2015-12-14","conditions":"Tobacco Use Cessation","enrollment":204},{"nctId":"NCT02271919","phase":"PHASE4","title":"Varenicline and Combined NRT for Smoking Cessation","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2015-05-14","conditions":"Cigarette Smoker, Tobacco Use Disorder","enrollment":631},{"nctId":"NCT05301660","phase":"EARLY_PHASE1","title":"Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia","status":"UNKNOWN","sponsor":"Sir Run Run Shaw Hospital","startDate":"2022-03-22","conditions":"Schizophrenia","enrollment":80},{"nctId":"NCT02859142","phase":"PHASE4","title":"Varenicline Augmentation of Patch Outcomes in Heavy Drinkers' Smoking Cessation","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2018-03-29","conditions":"Smoking Cessation, Alcohol Drinking","enrollment":122},{"nctId":"NCT04035603","phase":"PHASE2","title":"Multimodal Cue Exposure Therapy for Smoking Cessation","status":"WITHDRAWN","sponsor":"Boston University Charles River Campus","startDate":"2020-10-01","conditions":"Smoking Cessation","enrollment":""},{"nctId":"NCT00000437","phase":"PHASE4","title":"Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)","status":"COMPLETED","sponsor":"The Scripps Research Institute","startDate":"1997-09-26","conditions":"Alcoholism, Smoking","enrollment":60},{"nctId":"NCT01456936","phase":"PHASE4","title":"Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-11","conditions":"Smoking Cessation","enrollment":8144},{"nctId":"NCT01314001","phase":"PHASE3","title":"Pharmacogenetics of Nicotine Addiction Treatment","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2010-12","conditions":"Nicotine Addiction","enrollment":1246},{"nctId":"NCT00308763","phase":"NA","title":"Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals","status":"COMPLETED","sponsor":"University of Tennessee","startDate":"2004-01","conditions":"Tobacco Use Disorder","enrollment":594},{"nctId":"NCT00313105","phase":"PHASE2, PHASE3","title":"Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches","status":"UNKNOWN","sponsor":"University Hospital, Gentofte, Copenhagen","startDate":"2006-04","conditions":"Tobacco Dependence","enrollment":600},{"nctId":"NCT00622752","phase":"PHASE2","title":"Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes","status":"COMPLETED","sponsor":"Evotec Neurosciences GmbH","startDate":"2008-02","conditions":"Smoking Cessation","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"crossReferences":{"chemblId":"CHEMBL3989563"},"_approvalHistory":[],"publicationCount":19,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Nicotrol"],"phase":"marketed","status":"active","brandName":"Placebo Tablet and Nicotine Patch","genericName":"Placebo Tablet and Nicotine Patch","companyName":"The Scripps Research Institute","companyId":"the-scripps-research-institute","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Placebo tablets are used in clinical trials for smoking cessation, tobacco use cessation, and nicotine addiction. Nicotine patches are not mentioned in the provided facts, but Placebo tablets are used alongside varenicline tartrate and bupropion hydrochloride in clinical trials for smoking cessation.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-03-22T00:00:00.000Z","mah":"PFIZER INC","brand_name_local":"NICOTROL","application_number":"NDA020385"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1996-07-03T00:00:00.000Z","mah":"MCNEIL CONS","brand_name_local":"NICOTROL","application_number":"NDA020536"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1997-05-02T00:00:00.000Z","mah":"PFIZER","brand_name_local":"NICOTROL","application_number":"NDA020714"},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T04:02:33.447789+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}