[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100323751":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":31,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":31,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":80,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Corporal Michael J. Crescenz VA Medical Center","FED",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Smoking cessation with varenicline","OTHER","FDA-approved indication of varenicline for smoking cessation",[13],"Drug: Varenicline",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Varenicline","Oral medication approved to facilitate smoking cessation",[9],[21],"CHANTIX",[23],{"name":24,"affiliation":25,"role":26},"Stanley N Caroff, MD","Cpl. Michael J. Crescenz VA Medical Center","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","215-823-4065",null,"stanley.caroff@va.gov",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Rosalind M Berkowitz, MD","rosalind.berkowitz@va.gov",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Corporal Michael J Crescenz VA Medical Center","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-75.16362,39.95238,{"lat":49,"lon":48},[52,53],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},{"type":26,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Stanley N. Caroff, MD","Psychiatrist","100323751","phase-4-smoking-cessation-with-varenicline-in-schizophrenia-antipsychotic-induced-neurological-symptoms-as-correlates-100323751",false,"NCT03495024","Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates","Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response","Inclusion Criteria:\n\n* DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease\n* Glazer-Morgenstern-Doucette criteria for TD\n* Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening\n* An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening\n* Agree to stop smoking by the target date (four weeks after baseline\n* Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline\n\nExclusion Criteria:\n\n* Have untreated or unstable acute medical or psychiatric illnesses\n* Have a history of seizures\n* History of somnambulism\n* Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)\n* Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen\n* Are receiving clozapine or cholinesterase inhibitors\n* Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)\n* Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period\n* Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression\u002Fanxiety score ≥ 8 on the HADS.\n* Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control\n* Use of an investigational drug within 30 days of screening\n* Use of other smoking cessation aids (bupropion, nicotine replacement products)\n* Use of other tobacco products\n* History of allergic reactions to varenicline\n* Lack capacity to provide informed consent","ALL","18 Years","75 Years",{"count":68,"type":69},10,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.",[75,76,77,78,79],"Schizophrenia","Schizoaffective Disorder","Tobacco Smoking","Tardive Dyskinesia","Parkinsonism",[75,81,82,83,84,79],"Schizoaffective disorder","Antipsychotics","Tobacco smoking","Tardive dyskinesia","2019-03-20",{"date":87,"type":88},"2019-03-22","ACTUAL",{"date":90,"type":88},"2019-01-01",{"date":92,"type":69},"2020-06-30",{"name":5,"class":6},1]