Clinical trial NCT02736474: Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
Official title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obese
Cigarette-smoking
Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Worcester
First posted: 2016-04-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);
* age between 18 and 65 years old;
* on stable antipsychotic medication treatment for at least one month;
* 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;
* smoking at least 10 cigarettes daily for one year or longer;
* desire to lose weight and quit smoking.

Exclusion Criteria:

* Binge eating or other eating disorders;
* Current use of weight loss or antidiabetic medications;
* Current substance use (except nicotine or caffeine);
* Elevated hepatic transaminase levels (\>2.5x normal range);
* Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;
* History of seizure disorder;
* History of unstable cardiac problems or other unstable medication conditions;
* Being pregnant or nursing (for women).

Primary outcomes:
measure: Change From Baseline in Weight at 24 Weeks
timeFrame: baseline and 24 weeks
Secondary outcomes:
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
timeFrame: baseline and 24 weeks
measure: Depression Status Assessed by Self-rating Depression Scale（SDS）
timeFrame: 24 weeks
measure: Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）
timeFrame: 24 weeks
measure: Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)
timeFrame: 24 weeks
measure: Waist Circumference
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
Other outcomes:
Locations:
Study officials:
affiliation: Chief Physician
name: Jiang Du, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.