Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736474
• Other study ID #: MZhao-005
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cigarette-smoking
• Obese
• Schizophrenia

Intervention

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.
• Placebo Naltrexone
Placebo Naltrexone created and masked by the pharmacy to be used as a control.
• 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.
• Placebo Bupropion
Placebo Bupropion created and masked by the pharmacy to be used as a control.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	University of Massachusetts, Worcester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Weight at 24 Weeks	evaluate all participants' weight ,weight in kilograms	baseline and 24 weeks
Secondary	Numbers of Participants Who Quit Smoking		24 weeks
Secondary	Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks	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".	baseline and 24 weeks
Secondary	Depression Status Assessed by Self-rating Depression Scale(SDS)	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.	24 weeks
Secondary	Anxiety Status Assessed by Self-Rating Anxiety Scale(SAS)	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.	24 weeks
Secondary	Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)	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.	24 weeks
Secondary	Waist Circumference	evaluate all participants' waist circumference,waist circumference in centimeters	24 weeks
Secondary	Change in Fasting Blood Glucose Levels		baseline and 24 weeks
Secondary	Change in Fasting Insulin Levels		baseline and 24 weeks
Secondary	Change in Glycosylated Hemoglobin		baseline and 24 weeks
Secondary	Change in Fasting Triglycerides Levels		baseline and 24 weeks
Secondary	Change in Fasting HDL Cholesterol Levels		baseline and 24 weeks
Secondary	Change in Fasting LDL Cholesterol		baseline and 24 weeks
Secondary	Change in Leptin		baseline and 24 weeks
Secondary	Change in Ghrelin		baseline and 24 weeks