NCT02736474

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obese
• Cigarette-smoking
• Schizophrenia

Interventions

Type	Name	Description
DRUG	Naltrexone	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.
DRUG	Placebo Naltrexone	Placebo Naltrexone created and masked by the pharmacy to be used as a control.
DRUG	Bupropion	1 capsule（150mg） once per day in the first two weeks，then 2 capsules（300mg） once per day during the rest of the study.
DRUG	Placebo Bupropion	Placebo Bupropion created and masked by the pharmacy to be used as a control.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-04-13
• Last updated: 2021-10-22
• Results posted: 2021-10-22