[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100313564":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":12,"locations":32,"responsibleParty":45,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":77,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Group Varenicline","NO_INTERVENTION","Patients randomized to this group will collect polymorphisms at time zero and will receive varenicline for smoking cessation. The polymorphism result will only be known at the end of the protocol. Varenicline dosage 0,5 mg once a day for 3 days, after this 0,5 mg twice a day until seven day .At day eight 1 mg twice a day until complete week twelve.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Group Genetic","ACTIVE_COMPARATOR","The patients randomized to this arm will collect polymorphisms and could receive varenicline or bupropion or both depending on genetic polymorphisms for each one these drugs.\n\nBupropiona dosage 150 mg once a day seven days, after twice a day until complete week twelve. Varenicline dosage 0,5 mg once a day for 3 days, after this 0,5 mg twice a day until seven day .At day eight 1 mg twice a day until complete week twelve.",[18],"Drug: Varenicline Tartrate or bupropion",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Varenicline Tartrate or bupropion","the drug treatment will be chosen related to the polymorphism. If the polymorphism is favorable to varenicline the patient will receive varenicline, If it is favorable to bupropion the patient will receive bupropion, if not favorable to varenicline and bupropion the patient will receive bupropion + varenicline. If the patient has both favorable polymorphisms he will receive bupropion. Bupropiona dosage 150 mg once a day seven days, after twice a day until complete week twelve. Varenicline dosage 0,5 mg once a day for 3 days, after this 0,5 mg twice a day until seven day .At day eight 1 mg twice a day until complete week twelve.",[14],[26],"Varenicline Tartrate and bupropion",[28],{"name":29,"affiliation":30,"role":31},"Jaqueline R Scholz, MD.Phd","Heart Institute - University of São Paulo - Braziil","PRINCIPAL_INVESTIGATOR",[33],{"facility":34,"status":12,"city":35,"state":12,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":12},"Ambulatório de Tratamento Tabagismo - Incor HCFMUSP","São Paulo","05403000","Brazil","BR",{"type":40,"coordinates":41},"Point",[42,43],-46.63611,-23.5475,{"lat":43,"lon":42},{"type":31,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Jaqueline Scholz","Principal Investigator",[49],{"name":50,"class":51},"Fundação de Amparo à Pesquisa do Estado de São Paulo","OTHER_GOV","100313564","phase-4-efficacy-of-the-use-of-genetic-markers-in-the-choice-of-the-pharmacological-treatment-of-smoking-gentsmoking-100313564",false,"NCT03362099","Efficacy of the Use of Genetic Markers in the Choice of the Pharmacological Treatment of Smoking (GENTSMOKING)","Efficacy of Genetic Markers in Choosing Pharmacological Treatment for Smoking Cessation With Bupropion and Varenicline and Its Implications for Combining Drugs: Randomized Control Study.","GENTSMOKING","Inclusion Criteria:\n\n* smoking who wants to quit smoking, stable clinic diseases, depression or anxiety disorder stable for more than 3 months\n\nExclusion Criteria:\n\n* contra indication for varenicline and or bupropion\n* unstable psychiatric disorders.\n* In the treatment of neoplastic diseases.\n* Limitation to attend the medical visits",true,"ALL","18 Years","75 Years",{"count":65,"type":66},361,"ACTUAL","INTERVENTIONAL",[69],"PHASE4","Smoking is the leading cause of avoidable death in the world. Smoking is associated with the development of cardiovascular and respiratory diseases, as well as being considered a leading cause of cancer death. Data show that smokers have increased cardiovascular risk in relation to former smokers, even in comparison with individuals who have had a long and intense history tobacco use.\n\nConsidering this scenario, some drugs are used in tobacco cessation therapy. The first-line anti-smoking treatments approved by the Food and drug administration ( FDA ) are nicotinic reuptake therapy, bupropion ( norepinephrine and dopamine reuptake inhibitor) and varenicline ( partial agonist of nicotinic receptors composed of subunits alpha4Beta2 ). A metanalysis of 16 clinical studies indicated that smokers treated with bupropion had a higher abstinence rate compared to those receiving placebo - Odds ratio (OR ) - of 1,97 for treatment success.\n\nVarenicline is more effective compared to others smoking cessation drugs approved by the FDA, with an OR of 2,27 ( IC 95% 2,02-2,55 ) compared to placebo. However, Varenicline is much more expensive than bupropion.\n\nSignificant advances in genetics have made the variability of the individual response to drugs, as far as efficacy as well as the rate of adverse effects, begin to be specifically investigated through pharmacogenetics studies.",[72,73],"Smoking Cessation","Genetic Predisposition",[75,76],"varenicline","bupropion","COMPLETED","2022-12-16",{"date":80,"type":66},"2022-12-21",{"date":82,"type":66},"2016-11-01",{"date":84,"type":66},"2022-04-15",{"name":5,"class":6},1]