{"protocolSection":{"identificationModule":{"nctId":"NCT02736474","orgStudyIdInfo":{"id":"MZhao-005"},"organization":{"fullName":"Shanghai Mental Health Center","class":"OTHER"},"briefTitle":"Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia","officialTitle":"Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia"},"statusModule":{"statusVerifiedDate":"2021-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-05","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-07","type":"ACTUAL"},"completionDateStruct":{"date":"2018-07","type":"ACTUAL"},"studyFirstSubmitDate":"2016-03-23","studyFirstSubmitQcDate":"2016-04-12","studyFirstPostDateStruct":{"date":"2016-04-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-01-13","resultsFirstSubmitQcDate":"2021-09-25","resultsFirstPostDateStruct":{"date":"2021-10-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-09-25","lastUpdatePostDateStruct":{"date":"2021-10-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"DU, Jiang","investigatorTitle":"Chief Physician","investigatorAffiliation":"Shanghai Mental Health Center"},"leadSponsor":{"name":"Shanghai Mental Health Center","class":"OTHER"},"collaborators":[{"name":"University of Massachusetts, Worcester","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.","detailedDescription":"This is a randomized, double-blind, and placebo-controlled study. Subjects with evaluation and confirmation that inclusion and exclusion criteria are met, will be treated with naltrexone sustained release 15mg once per day and bupropion sustained release 150mg once per day in the first two weeks, and naltrexone 25mg once per day and bupropion 300mg once per day during the rest of the study.The purpose of this research is to observe the efficacy of Naltrexone and Bupropion on weight loss and smoking cessation compared to placebo."},"conditionsModule":{"conditions":["Obese","Cigarette-smoking","Schizophrenia"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Naltrexone and Bupropion","type":"EXPERIMENTAL","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.","interventionNames":["Drug: Naltrexone","Drug: Bupropion"]},{"label":"Placebo Naltrexone and Bupropion","type":"PLACEBO_COMPARATOR","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.","interventionNames":["Drug: Placebo Naltrexone","Drug: Placebo Bupropion"]}],"interventions":[{"type":"DRUG","name":"Naltrexone","description":"3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.","armGroupLabels":["Naltrexone and Bupropion"]},{"type":"DRUG","name":"Placebo Naltrexone","description":"Placebo Naltrexone created and masked by the pharmacy to be used as a control.","armGroupLabels":["Placebo Naltrexone and Bupropion"]},{"type":"DRUG","name":"Bupropion","description":"1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.","armGroupLabels":["Naltrexone and Bupropion"]},{"type":"DRUG","name":"Placebo Bupropion","description":"Placebo Bupropion created and masked by the pharmacy to be used as a control.","armGroupLabels":["Placebo Naltrexone and Bupropion"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Weight at 24 Weeks","description":"evaluate all participants' weight ，weight in kilograms","timeFrame":"baseline and 24 weeks"}],"secondaryOutcomes":[{"measure":"Numbers of Participants Who Quit Smoking","timeFrame":"24 weeks"},{"measure":"Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks","description":"The visual analogue scale is a scale that is used to gauge smoking craving. Patients can choose a number from 0 to 10 to show their smoking craving, in which \"0\" represents \"no craving\" and \"10\" represents \"intense urge\".","timeFrame":"baseline and 24 weeks"},{"measure":"Depression Status Assessed by Self-rating Depression Scale（SDS）","description":"evaluate all participants' depression status by Self-rating depression scale（SDS)，which has a theoretical value range of 20-80. The SDS total score ranges, with the higher the score representing the higher level of severity of depression.","timeFrame":"24 weeks"},{"measure":"Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）","description":"evaluate all participants' depression status by Self-Rating Anxiety Scale，which has a theoretical value range of 20-80. The SAS total score ranges, with the higher the score representing the higher level of severity of anxiety.","timeFrame":"24 weeks"},{"measure":"Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)","description":"Through a simple 40 to 50 minute talk with the patient, the physician scored 30 different symptoms on a scale of 1-7 to get their PANSS score. The total score range from 30-210. The PANSS total score ranges, with the higher the score representing the higher level of severity of clinical symptoms.","timeFrame":"24 weeks"},{"measure":"Waist Circumference","description":"evaluate all participants' waist circumference，waist circumference in centimeters","timeFrame":"24 weeks"},{"measure":"Change in Fasting Blood Glucose Levels","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Fasting Insulin Levels","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Glycosylated Hemoglobin","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Fasting Triglycerides Levels","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Fasting HDL Cholesterol Levels","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Fasting LDL Cholesterol","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Leptin","timeFrame":"baseline and 24 weeks"},{"measure":"Change in Ghrelin","timeFrame":"baseline and 24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);\n* age between 18 and 65 years old;\n* on stable antipsychotic medication treatment for at least one month;\n* BMI \\> 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or BMI\\>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over 90cm;\n* smoking at least 10 cigarettes daily for one year or longer;\n* desire to lose weight and quit smoking.\n\nExclusion Criteria:\n\n* Binge eating or other eating disorders;\n* Current use of weight loss or antidiabetic medications;\n* Current substance use (except nicotine or caffeine);\n* Elevated hepatic transaminase levels (\\>2.5x normal range);\n* Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;\n* History of seizure disorder;\n* History of unstable cardiac problems or other unstable medication conditions;\n* Being pregnant or nursing (for women).","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jiang Du, PhD","affiliation":"Chief Physician","role":"PRINCIPAL_INVESTIGATOR"}]},"referencesModule":{"references":[{"pmid":"29563871","type":"DERIVED","citation":"Lyu X, Du J, Zhan G, Wu Y, Su H, Zhu Y, Jarskog F, Zhao M, Fan X. Naltrexone and Bupropion Combination Treatment for Smoking Cessation and Weight Loss in Patients With Schizophrenia. Front Pharmacol. 2018 Mar 5;9:181. doi: 10.3389/fphar.2018.00181. eCollection 2018."}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"FG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"10"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"BG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.3","spread":"5.7"},{"groupId":"BG001","value":"54.1","spread":"8.4"},{"groupId":"BG002","value":"54.2","spread":"7.0"}]}]}]},{"title":"Sex/Gender, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"male","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Han","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"22"}]}]}]},{"title":"illness time duration","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.8","spread":"4.6"},{"groupId":"BG001","value":"25.9","spread":"9.1"},{"groupId":"BG002","value":"27.9","spread":"7.8"}]}]}]},{"title":"smoking time duration","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.6","spread":"7.9"},{"groupId":"BG001","value":"29.8","spread":"9.8"},{"groupId":"BG002","value":"29.2","spread":"8.7"}]}]}]},{"title":"breath CO level","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"ppm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27.1","spread":"23.2"},{"groupId":"BG001","value":"27.7","spread":"15.6"},{"groupId":"BG002","value":"27.4","spread":"19.3"}]}]}]},{"title":"number of cigarettes smoked per week","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cigarettes per week","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"72.5","spread":"5.7"},{"groupId":"BG001","value":"77.6","spread":"21.1"},{"groupId":"BG002","value":"75.1","spread":"15.3"}]}]}]},{"title":"smoking craving","description":"The visual analogue scale is a scale that is used to gauge smoking craving. Patients can choose a number from 0 to 10 to show their smoking craving, in which \"0\" represents \"no craving\" and \"10\" represents \"intense urge\".","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.3","spread":"1.0"},{"groupId":"BG001","value":"7.0","spread":"1.4"},{"groupId":"BG002","value":"6.6","spread":"1.3"}]}]}]},{"title":"body weight","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"74.7","spread":"11.8"},{"groupId":"BG001","value":"80.2","spread":"11.8"},{"groupId":"BG002","value":"77.5","spread":"10.4"}]}]}]},{"title":"BMI","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"26.8","spread":"2.0"},{"groupId":"BG001","value":"28.5","spread":"3.7"},{"groupId":"BG002","value":"27.6","spread":"3.0"}]}]}]},{"title":"waist circumference","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"cm","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"94.9","spread":"4.5"},{"groupId":"BG001","value":"99.8","spread":"6.8"},{"groupId":"BG002","value":"97.4","spread":"6.2"}]}]}]},{"title":"HbA1c","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"percentage of HbA1c","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.1","spread":"0.6"},{"groupId":"BG001","value":"6.3","spread":"1.8"},{"groupId":"BG002","value":"6.2","spread":"1.2"}]}]}]},{"title":"fasting glucose","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.5","spread":"1.1"},{"groupId":"BG001","value":"5.5","spread":"2.2"},{"groupId":"BG002","value":"5.5","spread":"1.7"}]}]}]},{"title":"HDL","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0.9","spread":"0.2"},{"groupId":"BG001","value":"0.8","spread":"0.1"},{"groupId":"BG002","value":"0.9","spread":"0.2"}]}]}]},{"title":"LDL","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.8","spread":"0.8"},{"groupId":"BG001","value":"2.4","spread":"0.9"},{"groupId":"BG002","value":"2.6","spread":"0.8"}]}]}]},{"title":"insulin","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"pmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"106.8","spread":"65.8"},{"groupId":"BG001","value":"84.5","spread":"60.4"},{"groupId":"BG002","value":"95.7","spread":"62.5"}]}]}]},{"title":"Triglyceride","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"mmol/l","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2.3","spread":"1.1"},{"groupId":"BG001","value":"1.5","spread":"0.6"},{"groupId":"BG002","value":"1.9","spread":"0.9"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Weight at 24 Weeks","description":"evaluate all participants' weight ，weight in kilograms","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"kilogram","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"5.3"},{"groupId":"OG001","value":"-0.9","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Numbers of Participants Who Quit Smoking","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},{"type":"SECONDARY","title":"Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks","description":"The visual analogue scale is a scale that is used to gauge smoking craving. Patients can choose a number from 0 to 10 to show their smoking craving, in which \"0\" represents \"no craving\" and \"10\" represents \"intense urge\".","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"2.9"},{"groupId":"OG001","value":"-1.9","spread":"3.1"}]}]}]},{"type":"SECONDARY","title":"Depression Status Assessed by Self-rating Depression Scale（SDS）","description":"evaluate all participants' depression status by Self-rating depression scale（SDS)，which has a theoretical value range of 20-80. The SDS total score ranges, with the higher the score representing the higher level of severity of depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.4","spread":"8.2"},{"groupId":"OG001","value":"33.6","spread":"7.2"}]}]}]},{"type":"SECONDARY","title":"Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）","description":"evaluate all participants' depression status by Self-Rating Anxiety Scale，which has a theoretical value range of 20-80. The SAS total score ranges, with the higher the score representing the higher level of severity of anxiety.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31.1","spread":"6.9"},{"groupId":"OG001","value":"28.8","spread":"4.2"}]}]}]},{"type":"SECONDARY","title":"Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)","description":"Through a simple 40 to 50 minute talk with the patient, the physician scored 30 different symptoms on a scale of 1-7 to get their PANSS score. The total score range from 30-210. The PANSS total score ranges, with the higher the score representing the higher level of severity of clinical symptoms.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.5","spread":"15.0"},{"groupId":"OG001","value":"57.2","spread":"18.9"}]}]}]},{"type":"SECONDARY","title":"Waist Circumference","description":"evaluate all participants' waist circumference，waist circumference in centimeters","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cm","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.6","spread":"5.7"},{"groupId":"OG001","value":"101.3","spread":"6.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Blood Glucose Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/l","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","spread":"1.5"},{"groupId":"OG001","value":"1.0","spread":"1.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Insulin Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pmol/l","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"74.4"},{"groupId":"OG001","value":"11.0","spread":"35.3"}]}]}]},{"type":"SECONDARY","title":"Change in Glycosylated Hemoglobin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage of hemoglobin","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.05","spread":"0.6"},{"groupId":"OG001","value":"0.4","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting Triglycerides Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/l","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-1.0","spread":"0.9"},{"groupId":"OG001","value":"-0.4","spread":"0.6"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting HDL Cholesterol Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/l","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"1.1"},{"groupId":"OG001","value":"0.0","spread":"0.1"}]}]}]},{"type":"SECONDARY","title":"Change in Fasting LDL Cholesterol","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mmol/l","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.4","spread":"0.7"},{"groupId":"OG001","value":"-0.2","spread":"0.7"}]}]}]},{"type":"SECONDARY","title":"Change in Leptin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/ml","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.2","spread":"5.9"},{"groupId":"OG001","value":"10.6","spread":"7.1"}]}]}]},{"type":"SECONDARY","title":"Change in Ghrelin","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/ml","timeFrame":"baseline and 24 weeks","groups":[{"id":"OG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study."},{"id":"OG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"352.2","spread":"296.6"},{"groupId":"OG001","value":"254.8","spread":"106.4"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"4.76","timeFrame":"The 24-week study time period","eventGroups":[{"id":"EG000","title":"Naltrexone and Bupropion","description":"Naltrexone 3 tablets（15mg） once per day and Bupropion 1 capsule（150mg） once per day in the first two weeks. Then Naltrexone 5 tablets（25mg） once per day and Bupropion 2 capsules（300mg） once per day during the rest of the study.\n\nNaltrexone: 3 tablets（15mg） once per day in the first two weeks，then Naltrexone 5 tablets（25mg） once per day during the rest of the study.\n\nBupropion: 1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.","deathsNumAffected":0,"deathsNumAtRisk":11,"seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":6,"otherNumAtRisk":11},{"id":"EG001","title":"Placebo Naltrexone and Bupropion","description":"Placebo Naltrexone 3 tablets+Placebo Bupropion 1 capsule once per day in the first two weeks. Then Placebo Naltrexone 5 tablets+Placebo Bupropion 2 capsule once per day during the rest of the study.\n\nPlacebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control.\n\nPlacebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.","deathsNumAffected":0,"deathsNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":1,"otherNumAtRisk":10}],"otherEvents":[{"term":"dry mouth","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10}]},{"term":"mild abdominal discomfort","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":11},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10}]},{"term":"tachycardia","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":11},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":10}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Chief Physician Dr Du. Jiang Du","organization":"Shanghai Mental Health Center","email":"dujiangdou@163.com","phone":"86-21-64387250"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2015-12-30","uploadDate":"2020-01-13T08:40","filename":"Prot_000.pdf","size":382797},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2015-12-30","uploadDate":"2020-01-13T08:40","filename":"SAP_001.pdf","size":265890}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D009765","term":"Obesity"},{"id":"D000073865","term":"Cigarette Smoking"},{"id":"D012559","term":"Schizophrenia"}],"ancestors":[{"id":"D050177","term":"Overweight"},{"id":"D044343","term":"Overnutrition"},{"id":"D009748","term":"Nutrition Disorders"},{"id":"D009750","term":"Nutritional and Metabolic Diseases"},{"id":"D001835","term":"Body Weight"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D000073869","term":"Tobacco Smoking"},{"id":"D012907","term":"Smoking"},{"id":"D001519","term":"Behavior"},{"id":"D064424","term":"Tobacco Use"},{"id":"D019967","term":"Schizophrenia Spectrum and Other Psychotic Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D009271","term":"Naltrexone"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D009270","term":"Naloxone"},{"id":"D009019","term":"Morphinans"},{"id":"D053610","term":"Opiate Alkaloids"},{"id":"D000470","term":"Alkaloids"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D006572","term":"Heterocyclic Compounds, Bridged-Ring"},{"id":"D006576","term":"Heterocyclic Compounds, 4 or More Rings"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D010616","term":"Phenanthrenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}