{"protocolSection":{"identificationModule":{"nctId":"NCT01111149","orgStudyIdInfo":{"id":"0904M64601"},"secondaryIdInfos":[{"id":"R01DA024674","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA024674"}],"organization":{"fullName":"University of Minnesota","class":"OTHER"},"briefTitle":"Varenicline and Smoking Cessation in Schizophrenia","officialTitle":"Varenicline and Smoking Cessation in Schizophrenia","acronym":"VSCS"},"statusModule":{"statusVerifiedDate":"2014-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-12"},"primaryCompletionDateStruct":{"date":"2012-08","type":"ACTUAL"},"completionDateStruct":{"date":"2012-08","type":"ACTUAL"},"studyFirstSubmitDate":"2010-04-23","studyFirstSubmitQcDate":"2010-04-26","studyFirstPostDateStruct":{"date":"2010-04-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-12-16","resultsFirstSubmitQcDate":"2014-06-02","resultsFirstPostDateStruct":{"date":"2014-07-03","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-07-08","lastUpdatePostDateStruct":{"date":"2014-07-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Minnesota","class":"OTHER"},"collaborators":[{"name":"National Institutes of Health (NIH)","class":"NIH"},{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.","detailedDescription":"There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. The smoking cessation agent bupropion HCl has been tested in schizophrenics, but the results on its efficacy are inconclusive. Recent works by different laboratories have shown the safety and efficacy of varenicline, a partial alpha4beta2 and full alpha7 nicotinic acetylcholine receptor agonist, as a smoking cessation agent. However, to date, no published studies have tested the safety and efficacy of varenicline in treatment of nicotine dependence in schizophrenic patients. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be beneficial to examine its effects in schizophrenic patients. The central hypothesis of this application is that treatment with varenicline will safely increase smoking abstinence rates in schizophrenic patients when compared to those receiving placebo. This central hypothesis will be tested and the objectives of this application accomplished by pursuing two Specific Aims: 1) Treatment with varenicline or bupropion HCl for a period of three months will increase smoking abstinence rates in schizophrenic patents when compared to placebo; and 2) Treatment with varenicline or bupropion HCl for a period of three months will not increase psychosis in schizophrenic patients when compared to placebo. For our General Investigational Plan, we will employ a double-blind randomized placebo controlled study to assess varenicline's safety and efficacy. It is our expectation that we will demonstrate that varenicline is safe and effective in decreasing smoking rates in schizophrenic patients without exacerbating psychotic symptoms. Such outcomes will be significant, because they will offer a new treatment for smoking cessation in this vulnerable population."},"conditionsModule":{"conditions":["Schizophrenia","Smoking Cessation"],"keywords":["Schizophrenia","Smoking cessation","Varenicline","Bupropion"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sugar Pill","type":"PLACEBO_COMPARATOR","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.","interventionNames":["Other: Sugar Pill"]},{"label":"Varenicline","type":"EXPERIMENTAL","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.","interventionNames":["Drug: Varenicline"]},{"label":"Bupropion HCl","type":"ACTIVE_COMPARATOR","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.","interventionNames":["Drug: Bupropion HCl"]}],"interventions":[{"type":"OTHER","name":"Sugar Pill","description":"Sugar pill created and masked by the pharmacy to be used as a control.","armGroupLabels":["Sugar Pill"]},{"type":"DRUG","name":"Varenicline","description":"Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.","armGroupLabels":["Varenicline"],"otherNames":["Chantix"]},{"type":"DRUG","name":"Bupropion HCl","description":"in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study","armGroupLabels":["Bupropion HCl"],"otherNames":["Wellbutrin","Zyban"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Smoking Abstinence - Serum/Urine Measurements","description":"Measured by blood/urine tests for nicotine and its break-down product cotinine.","timeFrame":"Week 12"},{"measure":"Smoking Abstinence - Number of Cigarettes Smoked","description":"Number of cigarettes smoked at week 12 of the study by self-report.","timeFrame":"Week 12"},{"measure":"Smoking Abstinence - Exhaled Carbon Monoxide","description":"Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.","timeFrame":"Week 12"}],"secondaryOutcomes":[{"measure":"Reduction in Smoking","description":"Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12","timeFrame":"Week 12"},{"measure":"Negative Symptoms of Schizophrenia - SANS","description":"Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.","timeFrame":"Week 12"},{"measure":"Impulsivity and Inattention","description":"Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.","timeFrame":"Week 12"},{"measure":"Side Effects","description":"Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.","timeFrame":"Week 12"},{"measure":"Abstinence-related Symptoms - MNWS and FTND","description":"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.\n\nThe Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine.","timeFrame":"Week 12"},{"measure":"Depression","description":"Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.","timeFrame":"Week 12"},{"measure":"Abnormal Movements - BAS and SAS","description":"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.\n\nSimpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity.","timeFrame":"Week 12"},{"measure":"Vital Signs","description":"blood pressure will be measured.","timeFrame":"Week 12"},{"measure":"Vital Signs - Weight","description":"Weight will be measured for each participant. Values listed below are for week 12.","timeFrame":"Week 12"},{"measure":"Vital Signs - Pulse","description":"Pulse will be measured. The values below were measured at week 12 of the study.","timeFrame":"Week 12"},{"measure":"Suicidality","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.","timeFrame":"Week 12"},{"measure":"Positive Symptoms of Schizophrenia (SAPS)","description":"Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.","timeFrame":"Week 12"},{"measure":"General Psychopathology","description":"Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.","timeFrame":"Week 12"},{"measure":"Hit Reaction Time - CPT","description":"The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.","timeFrame":"Week 12"},{"measure":"Variability of Standard Error - CPT","description":"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures \"within respondent\" variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12.","timeFrame":"Week 12"},{"measure":"Detectibility (d') of Continuous Performance Test","description":"The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.","timeFrame":"Week 12"},{"measure":"Response Style Indicator (Beta) for CPT","description":"Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.","timeFrame":"Week 12"},{"measure":"Abstinence Related Symptoms - WISDM","description":"The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.","timeFrame":"Week 12"},{"measure":"Urge to Smoke - MNWS","description":"The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.","timeFrame":"Week 12"},{"measure":"Abnormal Movements - AIMS","description":"Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.","timeFrame":"Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female subjects, 18-75 years old\n* Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria\n* Smoking at least 10 cigarettes per day\n* Weight of at least 100 lbs (45.4 kg)\n* Motivation to quit smoking\n* Stabilized psychotic symptoms\n* Provision of informed consent for testing and treatment\n\nExclusion Criteria:\n\n* Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder\n* Seizure disorder, recent withdrawal from alcohol or anxiolytics\n* History of bulimia nervosa, anorexia nervosa, or dementia\n* History of depression, panic, or bipolar disorders\n* Pregnancy or lactation\n* Prior use of varenicline or bupropion HCl within three months prior to initiation of the study\n* Current use of other smoking cessation treatments\n* Regular use of non-cigarette tobacco products (\\> than once/week)\n* Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months\n* Patients with suicidal ideations or plans\n* Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment\n* History of, or current, alcohol dependence/abuse\n* Current use of monoamine oxidase inhibitors (MAOI)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"S. Hossein Fatemi, M.D., Ph.D.","affiliation":"University of Minnesota","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Minnesota, University of Minnesota Medical Center","city":"Minneapolis","state":"Minnesota","zip":"55455","country":"United States","geoPoint":{"lat":44.97997,"lon":-93.26384}}]},"referencesModule":{"references":[{"pmid":"22514788","type":"BACKGROUND","citation":"Yousefi MK, Folsom TD, Fatemi SH. A Review of Varenicline's Efficacy and Tolerability in Smoking Cessation Studies in Subjects with Schizophrenia. J Addict Res Ther. 2011 Dec 20;S4(1):3045. doi: 10.4172/2155-6105.S4-001."},{"pmid":"18572388","type":"BACKGROUND","citation":"Fatemi SH. Varenicline efficacy and tolerability in a subject with schizophrenia. Schizophr Res. 2008 Aug;103(1-3):328-9. doi: 10.1016/j.schres.2008.05.002. Epub 2008 Jun 24. No abstract available."},{"pmid":"23507358","type":"RESULT","citation":"Fatemi SH, Yousefi MK, Kneeland RE, Liesch SB, Folsom TD, Thuras PD. Antismoking and potential antipsychotic effects of varenicline in subjects with schizophrenia or schizoaffective disorder: a double-blind placebo and bupropion-controlled study. Schizophr Res. 2013 May;146(1-3):376-8. doi: 10.1016/j.schres.2013.02.015. Epub 2013 Mar 16. No abstract available."},{"pmid":"37142273","type":"DERIVED","citation":"Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Enrolled participants were excluded from the trial before assignment to groups if they no longer showed interest in the study or failed drug screens.","recruitmentDetails":"Patients were recruited from 12/15/2009 through 4/03/2012. Fliers advertising the study were placed in medical clinics. Additionally, advertisements were placed in local newspapers City Pages and The Minneapolis Star Tribune.","groups":[{"id":"FG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"FG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"FG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"9"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"BG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"BG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"24"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41.4","spread":"9.8"},{"groupId":"BG001","value":"40.4","spread":"15.9"},{"groupId":"BG002","value":"43","spread":"8.44"},{"groupId":"BG003","value":"41.46","spread":"11.63"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"5"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"19"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"17"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"24"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"24"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Smoking Abstinence - Serum/Urine Measurements","description":"Measured by blood/urine tests for nicotine and its break-down product cotinine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Serum Cotinine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"198.67","spread":"129.84"},{"groupId":"OG001","value":"207","spread":"130.73"},{"groupId":"OG002","value":"213.8","spread":"137.6"}]}]},{"title":"Serum Nicotine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"22.57","spread":"24.23"},{"groupId":"OG001","value":"6","spread":"9.59"},{"groupId":"OG002","value":"15.4","spread":"11.61"}]}]},{"title":"Urine Cotinine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"772","spread":"381.19"},{"groupId":"OG001","value":"699.6","spread":"527.45"},{"groupId":"OG002","value":"614.75","spread":"469.54"}]}]},{"title":"Urine Nicotine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"820","spread":"301.46"},{"groupId":"OG001","value":"613.25","spread":"243.29"},{"groupId":"OG002","value":"412.75","spread":"487.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for Serum Cotinine at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for Serum Nicotine at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for Urine Cotinine at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for Urine Nicotine at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Reduction in Smoking","description":"Successful outcome will be defined as a 50% or greater reduction in self-reported cigarettes per day and a 30% greater reduction in carbon monoxide and cotinine levels. Measured at week 12","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"50% Reduction in Number of Cigarettes Smoked","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"30% Reduction in Carbon Monoxide (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"30% Reduction in Serum Cotinine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}]},{"title":"30% Reduction in Urine Cotinine (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for 50% Reduction in Number of Cigarettes Smoked (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for 30% Reduction in Carbon Monoxide (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for 30% Reduction in Serum Cotinine (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for 30% Reduction in Urine Cotinine (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"}]},{"type":"SECONDARY","title":"Negative Symptoms of Schizophrenia - SANS","description":"Scale for the Assessment of Negative Symptoms (SANS) a well-established test, used to assess the presence of psychosis or negative symptoms of schizophrenia. It consists of 25 questions rated on a scale of 0 (none) to 5 (severe). With a total score range of 0 to 125 points. There are 6 subscales: Affective Flattening or Blunting - (minimum, 0; maximum 35); Inappropriate Affect (minimum, 0; maximum 5); Alogia (minimum 0; maximum 25); Avolition-Apathy (minimum 0; maximum 20); Anhedonia-Asociality (minimum 0; maximum 25); Attention (minimum 0; maximum 15). Each subscale (except for Inappropriate Affect) contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 25). The global questions are included within the Total Composite score. In each case, the larger the score, the more severe the symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"SANS Total Composite (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"5.86","spread":"5.24"},{"groupId":"OG001","value":"17.2","spread":"9.83"},{"groupId":"OG002","value":"6.20","spread":"5.12"}]}]},{"title":"SANS Total Global (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.71","spread":"1.50"},{"groupId":"OG001","value":"3.8","spread":"2.49"},{"groupId":"OG002","value":"1.6","spread":"1.82"}]}]},{"title":"SANS Affective Flattening (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.57","spread":"3.36"},{"groupId":"OG001","value":"7","spread":"3.81"},{"groupId":"OG002","value":"0.8","spread":"1.10"}]}]},{"title":"SANS Alogia (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"1.89"},{"groupId":"OG001","value":"0.6","spread":"1.34"},{"groupId":"OG002","value":"0","spread":"0"}]}]},{"title":"SANS Avolition (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"2.77"},{"groupId":"OG001","value":"3","spread":"3.67"},{"groupId":"OG002","value":"3.6","spread":"3.78"}]}]},{"title":"SANS Anhedonia (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.57","spread":"1.99"},{"groupId":"OG001","value":"5.8","spread":"7.36"},{"groupId":"OG002","value":"1.4","spread":"3.13"}]}]},{"title":"SANS Attention (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0.2","spread":"0.45"},{"groupId":"OG002","value":"0","spread":"0"}]}]},{"title":"Inappropriate Affect (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0.60","spread":"0.88"},{"groupId":"OG002","value":"0.40","spread":"0.89"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Total Composite (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Total Global (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Affective Flattening (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Alogia (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Avolition (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Anhedonia (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SANS Attention (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis of Inappropriate Affect at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Impulsivity and Inattention","description":"Impulsivity and inattention will be measured using the continuous performance test. Individuals were tasked with 359 items divided six blocks (59 in block 1, 60 in blocks 2-6). Omissions result from the failure to respond to target letters. CPT% Omissions measures the percentage of responses that qualify as omissions made during the test. Higher scores indicate increased inattention. Commissions result from responses given to non-targets. CPT% Commissions measures the percentage of responses that qualify as commissions made during the test. Higher scores indicate increased inattention. Perseverations result from reaction time less than 100 ms. CPT% Perseveration % measures the percentage of responses that qualify as perseverations made during the test. The higher the score, the greater impulsivity.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of responses","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"CPT % Omissions (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"5.62","spread":"11.14"},{"groupId":"OG001","value":"0.68","spread":"1.04"},{"groupId":"OG002","value":"2.42","spread":"2.66"}]}]},{"title":"CPT % Commissions (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"36.11","spread":"22.64"},{"groupId":"OG001","value":"25","spread":"37.89"},{"groupId":"OG002","value":"28.33","spread":"21.82"}]}]},{"title":"Perseveration % (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.57","spread":"0.86"},{"groupId":"OG001","value":"1.05","spread":"1.84"},{"groupId":"OG002","value":"0.12","spread":"0.17"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for CPT % Omissions (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for CPT% commissions (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for perseveration % (week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Side Effects","description":"Side effects will be monitored by a physician and/or assistant and recorded (SEP). All patients withdrawn from the study because of emerging side effects will be followed until the side effects are resolved. Each item is scored based on a scale of 0=none; 1=mild; 2=moderate; and 3=severe. Below, the data are shown for participants experiencing symptoms on week 12 of the study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Anxiety","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}]},{"title":"Dizziness","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Mania","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Abnormal Dreams","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Abdominal Pain","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Headache","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}]},{"title":"Insomnia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Nausea","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}]},{"title":"Psychosis","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Dry Mouth","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Chest Pain","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Irregular Heart Beat","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Weakness/Fainting","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Diarrhea","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Vomiting","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Constipation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Confusion","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Irritability","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Drooling","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Cold Sweats","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Blurred Vision","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"Leg Pain/Cramps","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Anxiety at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Dizziness at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Mania at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for abnormal dreams at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Abdominal Pain at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Headache at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Insomnia at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Nausea at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Psychosis at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Dry Mouth at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Chest Pain at Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Irregular Heart Beat at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Weakness/Fainting at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Diarrhea at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Vomiting at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Constipation at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Confusion at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Irritability at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for drooling at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Cold Sweats at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Blurred Vision at week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Leg Pain/Cramps","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Fisher Exact"}]},{"type":"SECONDARY","title":"Abstinence-related Symptoms - MNWS and FTND","description":"Minnesota Nicotine Withdrawal Scale (MNWS), a patient-reported measure of nicotine withdrawal symptoms and cravings. Eight items are listed, including craving for cigarettes, irritability, frustration, or anger, anxiety, etc scored on a five point scale from 0 (normal) to 5 (severe). Patients are asked for responses for the past 24 hours and past seven days (minimum 0, maximum 32; for each subscale). The higher the score, the greater the dependence. Additionally, one question (minimum score 1, maximum score 4 measures the individual's confidence in resisting strong urges to smoke. The higher the score on this question, the greater the individual's confidence in resisting smoking urges.\n\nThe Fagerstrom Test for Nicotine Dependence measures nicotine dependence and consists of six questions with a total minimum score of 0 and a maximum score of 10. The higher the score, the greater the dependence on nicotine.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"FTND (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"4.86","spread":"1.77"},{"groupId":"OG001","value":"5.2","spread":"1.48"},{"groupId":"OG002","value":"4.4","spread":"3.36"}]}]},{"title":"MNWS 24 Hour Total (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"7.29","spread":"7.04"},{"groupId":"OG001","value":"8.2","spread":"7.36"},{"groupId":"OG002","value":"6.60","spread":"4.67"}]}]},{"title":"MNWS 7 day total (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"9.14","spread":"4.98"},{"groupId":"OG001","value":"11","spread":"4.64"},{"groupId":"OG002","value":"5.80","spread":"4.27"}]}]},{"title":"MNWS Resistance (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"2.71","spread":"1.11"},{"groupId":"OG001","value":"3.4","spread":"0.55"},{"groupId":"OG002","value":"2.4","spread":"1.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for FTND (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for MNWS 24 Hour Total (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for MNWS 7 day total (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for MNWS Resistance (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Depression","description":"Beck Depression Inventory (BDI), a self-report rating inventory measuring characteristic attitudes and symptoms of depression consisting of 21 items with each item rated on a four point scale (0=not present to 3=severe). The accepted ranges are as follows: 0 to 9 indicates no depression, 10 to 18 indicates mild to moderate depression, 19 to 29 indicates moderate to severe depression and 30 to 63 indicates severe depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.71","spread":"3.55"},{"groupId":"OG001","value":"8.6","spread":"9.94"},{"groupId":"OG002","value":"5.4","spread":"6.99"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis of Beck Depression Inventory (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Abnormal Movements - BAS and SAS","description":"Barnes Akathisia Scale (BAS), a widely-used measurement of drug-induced akathisia. It consists of 4 questions with questions 1-3 scored on a scale of 0-3 with 0=normal and 3=severe (minimum score 0, maximum score 9; while item 4 is a global clinical assessment of akathisia rated on a scale of 0 (normal) to 5 (severe). The higher the score on each subsclae, the greater the severity of akathisia.\n\nSimpson-Angus Scale (SAS), a 10-item instrument used to evaluate patients experiencing neuroleptic-induced parkinsonism and other extrapyramidal side effects. Items are rated for severity on a 0-4 scale, with 0 being normal and 4 being severe. Minimum = 0; Maximum = 40. The higher the score, the greater the severity.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"SAS (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.24"},{"groupId":"OG001","value":"0.76","spread":"0.76"},{"groupId":"OG002","value":"0.42","spread":"0.8"}]}]},{"title":"BAS Items 1-3 (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.57","spread":"0.98"},{"groupId":"OG001","value":"0.6","spread":"0.89"},{"groupId":"OG002","value":"0.4","spread":"0.89"}]}]},{"title":"BAS Item 4 (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"0.49"},{"groupId":"OG001","value":"0.4","spread":"0.55"},{"groupId":"OG002","value":"0.2","spread":"0.45"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SAS (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BAS items 1-3 (week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BAS item 4 (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Vital Signs","description":"blood pressure will be measured.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mm Hg","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Systolic Blood Pressure (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"116.29","spread":"15.53"},{"groupId":"OG001","value":"122","spread":"7.34"},{"groupId":"OG002","value":"128.4","spread":"32.42"}]}]},{"title":"Diastolic Blood Pressure (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"76.71","spread":"9.94"},{"groupId":"OG001","value":"78.4","spread":"8.14"},{"groupId":"OG002","value":"74.8","spread":"10.71"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for systolic blood pressure (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for diastolic blood pressure (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Vital Signs - Weight","description":"Weight will be measured for each participant. Values listed below are for week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"lbs","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"218.39","spread":"69.64"},{"groupId":"OG001","value":"213.47","spread":"35.2"},{"groupId":"OG002","value":"254.78","spread":"65.50"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Vital Signs - Weight (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"PRIMARY","title":"Smoking Abstinence - Number of Cigarettes Smoked","description":"Number of cigarettes smoked at week 12 of the study by self-report.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of cigarettes smoked","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.71","spread":"22.77"},{"groupId":"OG001","value":"9.4","spread":"5.47"},{"groupId":"OG002","value":"17.1","spread":"17.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Smoking Abstinence - Number of Cigarettes Smoked (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"PRIMARY","title":"Smoking Abstinence - Exhaled Carbon Monoxide","description":"Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"parts per million","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.14","spread":"18.51"},{"groupId":"OG001","value":"17","spread":"13.53"},{"groupId":"OG002","value":"22.6","spread":"19.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Vital Signs - Pulse","description":"Pulse will be measured. The values below were measured at week 12 of the study.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"heart beats per minute","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"82.57","spread":"15.76"},{"groupId":"OG001","value":"87","spread":"13.43"},{"groupId":"OG002","value":"89.2","spread":"18.47"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Vital Signs - Pulse (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Suicidality","description":"The Columbia-Suicide Severity Rating Scale (C-SSRS), is a survey intended to quantify the severity of suicidal ideation and behavior. The questionaire for suicidal ideation consists of 5 questions with yes (1) /no (0) answers. If answers to questions 1 and 2 are no, questions 3-5 are skipped. Minimum of 0; Maximum of 5. The questionaire for suicidal behavior consists of seven questions rated 0 for no and 1 for yes. The minimum score is 0 and the maximum score is 7. In each case, the higher the score, the greater the severity.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Lifetime Suicidal Ideation (week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.71","spread":"1.7"},{"groupId":"OG001","value":"0.8","spread":"0.84"},{"groupId":"OG002","value":"0.4","spread":"0.55"}]}]},{"title":"Lifetime Suicide Attempts (week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"1.29","spread":"1.7"},{"groupId":"OG001","value":"1.2","spread":"1.3"},{"groupId":"OG002","value":"0.4","spread":"0.55"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Lifetime Suicidal Ideation (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Lifetime Suicide Attempts (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Positive Symptoms of Schizophrenia (SAPS)","description":"Scale for the Assessment of Positive Symptoms (SAPS), a well-established test, used to assess the presence of psychotic symptoms of schizophrenia. There are 34 items rated on a scale of 0-5 with 0=none and 5=severe for a minimum score of 0 and a maximum score of 170. There are 4 subscales: Hallucinations (minimum score 0; maximum score 35); Delusions (minimum score 0; maximum score 65); Bizarre Behavior (minimum score 0; maximum score 25); Positive Formal Thought Disorder (minimum score 0; maximum score 45). Each subscale contains one additional question as a Global Rating - or overall measure for that particular subscale. The sum of these questions constitutes the Total Global Score (minimum 0, maximum 20). The values for the Global items are included in the Total Composite score. In each case, the higher the score, the greater the severity of symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"SAPS Total Composite Score - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"3.43","spread":"4.86"},{"groupId":"OG001","value":"7","spread":"7.48"},{"groupId":"OG002","value":"10.6","spread":"7.7"}]}]},{"title":"SAPS Total Global - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"1.29","spread":"1.89"},{"groupId":"OG001","value":"1.2","spread":"1.3"},{"groupId":"OG002","value":"1.8","spread":"1.3"}]}]},{"title":"SAPS Hallucinations - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"3.83"},{"groupId":"OG001","value":"2.2","spread":"2.59"},{"groupId":"OG002","value":"3","spread":"4.12"}]}]},{"title":"SAPS Delusions - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"1.43","spread":"1.9"},{"groupId":"OG001","value":"4.2","spread":"7.36"},{"groupId":"OG002","value":"3.8","spread":"3.56"}]}]},{"title":"SAPS Bizarre Behavior - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0","spread":"0"},{"groupId":"OG002","value":"0.4","spread":"0.55"}]}]},{"title":"SAPS Thought Disorder - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0.6","spread":"1.34"},{"groupId":"OG002","value":"3.4","spread":"5.64"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SAPS Total Composite Score - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis for SAPS Total Global - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SAPS Hallucinations - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Delusions - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for SAPS Bizarre Behavior - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for SAPS Thought Disorder - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"General Psychopathology","description":"Brief Psychiatric Rating Scale (BPRS), an 24-item scale measuring positive symptoms, general psychopathology, and affective symptoms commonly used for schizophrenia with each item rated on a scale of 1-7 with 1=not present and 7=severe. The minimum score is 24 and the maximum score is 168. We have used five subscales as recommended by Dingemans et al., 1995: Positive subscale (minimum score 6; maximum score 42); Negative subscale (minimum score 5; maximum score 35); Depressed subscale (minimum score 5; maximum score 35); Mania subscale (minimum score 6; maximum score 42); and Disorientation subscale (minimum score 2; maximum score 14) . For both the total score and the subscale scores, the higher the score, the greater the symptom severity. We used the BPRS version 4.0. Dingemans PMAJ, Linszen DH, Lenoir ME, Smeets RMW, 1995. Component structure of the expanded Brief Psychiatric Rating Scale (BPRS-E). Psychopharmacology 122:263-267.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"BPRS Total - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"30","spread":"4.47"},{"groupId":"OG001","value":"34.2","spread":"3.96"},{"groupId":"OG002","value":"31.6","spread":"4.28"}]}]},{"title":"BPRS Positive Subscale - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"8.14","spread":"2.73"},{"groupId":"OG001","value":"9","spread":"2.74"},{"groupId":"OG002","value":"8","spread":"2.92"}]}]},{"title":"BPRS Negative Subscale - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"6","spread":"1.15"},{"groupId":"OG001","value":"6.4","spread":"1.67"},{"groupId":"OG002","value":"7.4","spread":"1.52"}]}]},{"title":"BPRS Mania Subscale - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"6.43","spread":"1.13"},{"groupId":"OG001","value":"6.4","spread":"0.55"},{"groupId":"OG002","value":"8","spread":"2.92"}]}]},{"title":"BPRS Disorientation Subscale - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"2","spread":"0"},{"groupId":"OG001","value":"2","spread":"0"},{"groupId":"OG002","value":"2","spread":"0"}]}]},{"title":"BPRS Depression Subscale - Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"7.43","spread":"2.64"},{"groupId":"OG001","value":"10.4","spread":"2.88"},{"groupId":"OG002","value":"6.2","spread":"1.79"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BPRS Total - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BPRS Positive Subscale - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BPRS Negative Subscale - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Mania Subscale - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Disorientation Subscale - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for BPRS Depression Subscale - Week 12","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Hit Reaction Time - CPT","description":"The hit reaction time is the average speed of correct responses for the entire test given in milliseconds. The higher the score, the slower the speed. The standard error is a measure of response speed consistency. The higher the overall standard error, the greater inconsistency in the response speed. The values below were measured at week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milliseconds","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"Hit Reaction Time (week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"42.44","spread":"36.91"},{"groupId":"OG001","value":"67.61","spread":"34.47"},{"groupId":"OG002","value":"63.81","spread":"41.80"}]}]},{"title":"Hit Reaction Time Standard Error (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"7.20","spread":"4.83"},{"groupId":"OG001","value":"6.96","spread":"2"},{"groupId":"OG002","value":"8.79","spread":"3.02"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Hit Reaction Time - CPT (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Variability of Standard Error - CPT","description":"Variability of Standard Error (VSE) is a measure of response speed consistency. VSE measures \"within respondent\" variability. That is, the amount of variability the individual shows in 18 separate segments of the Continuous Performance Test in relation to his or her own overall standard error. Although VSE is a different measure than Overall Standard Error, typically the two measures produce comparable results. The higher the VSE, the greater the inconsistency in the response speed. The values shown below are the VSE for Week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"milliseconds","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.05","spread":"10.99"},{"groupId":"OG001","value":"11.38","spread":"6.84"},{"groupId":"OG002","value":"11.8","spread":"6.01"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Variability of Standard Error - CPT (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Detectibility (d') of Continuous Performance Test","description":"The value d' is a measure of the difference between the signal (non-X) and noise (X) distributions. As such, d' provides a means for assessing an individual's discriminative power since, in general, the greater the difference between the signal and noise distributions, the better the ability to distinguish and detect X and non-X stimuli. The lower the score, the better the detectability. Values shown below are for week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"unitless","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"0.54"},{"groupId":"OG001","value":"1.32","spread":"0.80"},{"groupId":"OG002","value":"1.09","spread":"0.68"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Detectibility (d') of Continuous Performance Test (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Response Style Indicator (Beta) for CPT","description":"Beta represents an individual's response tendency: Some individuals are cautious and choose not to respond very often. Conceptually, such individuals want to make sure they are correct when they give a response. Higher values of Beta reflect this response style. The emphasis is on avoiding commission errors. Other individuals respond more freely to make sure they respond to most or all targets, and they tend to be less concerned about mistakenly responding to a non-target. Lower values of Beta are produced by this response style. Values shown below were obtained at week 12.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Beta","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.95","spread":"0.55"},{"groupId":"OG001","value":"1.41","spread":"1.48"},{"groupId":"OG002","value":"2.92","spread":"4.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for Response Style Indicator (Beta) for CPT (week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Abstinence Related Symptoms - WISDM","description":"The Wisconsin Inventory of Smoking Dependence Motives (WISDM) consists of 68 items regarding smoking. Each item is rated on a scale of 1 (not true of me at all) to 7 (extremely true of me) leading to a minimum score of 68 and a maximum score of 476. The higher the score, the greater the dependence. Four of the items are grouped into a Craving subscale (minimum 4, maximum 28), the greater the score, the greater the craving. Five of the items are grouped into a Cognition subscale (minimum 5, maximum 35), the higher the score, the greater reliance on cigarette smoking for cognitive enhancement. WISDM scoring based on the original article by Piper et al., 2004. A multiple motives approach to tobacco dependence: the Wisconsin inventory of smoking dependence motives (WISDM-68). Journal of Consulting and Clinical Psychology 72:139-154.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"WISDM Total (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"229.14","spread":"93.31"},{"groupId":"OG001","value":"229.4","spread":"52.03"},{"groupId":"OG002","value":"270.6","spread":"181.21"}]}]},{"title":"WISDM Cognition (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"11.57","spread":"8.87"},{"groupId":"OG001","value":"15.4","spread":"5.81"},{"groupId":"OG002","value":"23.2","spread":"16.16"}]}]},{"title":"WISDM Craving (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"15.14","spread":"5.73"},{"groupId":"OG001","value":"14.2","spread":"3.35"},{"groupId":"OG002","value":"18","spread":"11.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for WISDM Total (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for WISDM Cognition (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for WISDM Craving (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Urge to Smoke - MNWS","description":"The Minnesota Nicotine Withdrawal Scale (MNWS) includes two items where individuals are asked to 1) declare the percentage of time they had an urge to smoke (MNWS % Urge to Smoke); and 2) declare the percentage of time they had a strong urge to smoke (MNWS % Strong Urge). For each case, percentages range from 0% to 100% - the higher the percentage, the greater urge to smoke.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of time","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"MNWS % Urge to Smoke (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"36.43","spread":"18.87"},{"groupId":"OG001","value":"47","spread":"22.8"},{"groupId":"OG002","value":"47","spread":"34.21"}]}]},{"title":"MNWS % Strong Urge (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"26.43","spread":"23.4"},{"groupId":"OG001","value":"33","spread":"18.57"},{"groupId":"OG002","value":"32.4","spread":"40.61"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for MNWS % Urge to Smoke (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for MNWS % Strong Urge (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Abnormal Movements - AIMS","description":"Abnormal Involuntary Movement Scale (AIMS), to assess abnormal involuntary movements associated with antipsychotic drugs. There are 10 questions, based on a five-point scale ranging from 0 (none) to 4 (severe). Items 11-14 are yes/no questions that have no impact on the score. The Total Score is the sum of questions 1-7 (minimum = 0; maximum = 28). The severity index consists of one question (item 8; rated 0=none to 4=severe) based on the rater's observation of abnormal movements The AIMS Global Score is the sum of three questions (each item rated 0=none to 4=severe) regarding abnormal movements overall (minimum score 0, maximum score 12). For the total score and subscores, the higher the score, the greater the severity of abnormal movements. Scoring is based on the chapter: Guy W (2000), Abnormal Involuntary Movement Scale (AIMS), in: Handbook of Psychiatric Measures (Rush AJ Jr, et al., eds). APA Publishing: Washington DC: pp. 166-167.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."},{"id":"OG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."},{"id":"OG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}],"classes":[{"title":"AIMS Total (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"1.25"},{"groupId":"OG001","value":"1","spread":"1.41"},{"groupId":"OG002","value":"1.40","spread":"2.19"}]}]},{"title":"AIMS Severity Index (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0.2","spread":"0.45"},{"groupId":"OG002","value":"0.4","spread":"0.89"}]}]},{"title":"AIMS Global Score (Week 12)","categories":[{"measurements":[{"groupId":"OG000","value":"0","spread":"0"},{"groupId":"OG001","value":"0.2","spread":"0.45"},{"groupId":"OG002","value":"0.6","spread":"1.34"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for AIMS Total (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical analysis for AIMS Severity Index (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"},{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Statistical Analysis for AIMS Global Score (Week 12)","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"ANOVA"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Sugar Pill","description":"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.\n\nSugar Pill: Sugar pill created and masked by the pharmacy to be used as a control.","seriousNumAffected":0,"seriousNumAtRisk":7,"otherNumAffected":0,"otherNumAtRisk":7},{"id":"EG001","title":"Varenicline","description":"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.\n\nVarenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.","seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5},{"id":"EG002","title":"Bupropion HCl","description":"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.\n\nBupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study","seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. S. Hossein Fatemi","organization":"University of Minnesota","email":"fatem002@umn.edu","phone":"612-626-3633"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D012559","term":"Schizophrenia"},{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D019967","term":"Schizophrenia Spectrum and Other Psychotic Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000073893","term":"Sugars"},{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D002241","term":"Carbohydrates"},{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}