Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Shanghai Mental Health Center

Status and phase: Completed; Phase 4

Conditions: Obese; Cigarette-smoking; Schizophrenia

Treatments: Drug: Bupropion; Drug: Placebo Naltrexone; Drug: Naltrexone; Drug: Placebo Bupropion

Study type: Interventional

Funder types: Other

Identifiers

NCT02736474

MZhao-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Naltrexone and Bupropion

Experimental group

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.

Treatment:

Drug: Naltrexone

Drug: Bupropion

Placebo Naltrexone and Bupropion

Placebo Comparator group

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.

Treatment:

Drug: Placebo Bupropion

Drug: Placebo Naltrexone