Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia

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.

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.

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).