Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

• Sponsor: Shanghai Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02736474
• Collaborator: University of Massachusetts, Worcester (Other)
• Enrollment: 22
• Arms: 2
• Actual Duration (Months): 26

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obese; Cigarette-smoking; Schizophrenia	Drug: Naltrexone; Drug: Placebo Naltrexone; Drug: Bupropion; Drug: Placebo Bupropion	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naltrexone and Bupropion 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.	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: 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 Comparator: Placebo Naltrexone and Bupropion 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.	Drug: Placebo Naltrexone; Placebo Naltrexone created and masked by the pharmacy to be used as a control.; Drug: Placebo Bupropion; Placebo Bupropion created and masked by the pharmacy to be used as a control.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Weight at 24 Weeks [baseline and 24 weeks]

   evaluate all participants' weight ，weight in kilograms

Secondary Outcome Measures

1. Numbers of Participants Who Quit Smoking [24 weeks]

2. Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks [baseline and 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".

3. Depression Status Assessed by Self-rating Depression Scale（SDS） [24 weeks]

   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.

4. Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS） [24 weeks]

   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.

5. Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS) [24 weeks]

   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.

6. Waist Circumference [24 weeks]

   evaluate all participants' waist circumference，waist circumference in centimeters

7. Change in Fasting Blood Glucose Levels [baseline and 24 weeks]

8. Change in Fasting Insulin Levels [baseline and 24 weeks]

9. Change in Glycosylated Hemoglobin [baseline and 24 weeks]

10. Change in Fasting Triglycerides Levels [baseline and 24 weeks]

11. Change in Fasting HDL Cholesterol Levels [baseline and 24 weeks]

12. Change in Fasting LDL Cholesterol [baseline and 24 weeks]

13. Change in Leptin [baseline and 24 weeks]

14. Change in Ghrelin [baseline and 24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Mental Health Center
• University of Massachusetts, Worcester

Investigators

• Principal Investigator: Jiang Du, PhD, Chief Physician

Study Documents (Full-Text)

• Study Protocol - Dec 30, 2015
• Statistical Analysis Plan - Dec 30, 2015

More Information

Publications

None provided.

• Responsible Party: DU, Jiang, Chief Physician, Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT02736474
• Other Study ID Numbers: MZhao-005
• First Posted: Apr 13, 2016
• Last Update Posted: Oct 22, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; Naltrexone; Bupropion

Study Results

Participant Flow

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Period Title: Overall Study
STARTED	11	11
COMPLETED	11	10
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion	Total
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.3 (5.7)	54.1 (8.4)	54.2 (7.0)
Sex/Gender, Customized (participants) [Number]
male	11 100%	11 100%	22 100%
Race/Ethnicity, Customized (participants) [Number]
Han	11 100%	11 100%	22 100%
Region of Enrollment (participants) [Number]
China	11 100%	11 100%	22 100%
illness time duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.8 (4.6)	25.9 (9.1)	27.9 (7.8)
smoking time duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.6 (7.9)	29.8 (9.8)	29.2 (8.7)
breath CO level (ppm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ppm]	27.1 (23.2)	27.7 (15.6)	27.4 (19.3)
number of cigarettes smoked per week (cigarettes per week) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cigarettes per week]	72.5 (5.7)	77.6 (21.1)	75.1 (15.3)
smoking craving (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	6.3 (1.0)	7.0 (1.4)	6.6 (1.3)
body weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	74.7 (11.8)	80.2 (11.8)	77.5 (10.4)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.8 (2.0)	28.5 (3.7)	27.6 (3.0)
waist circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	94.9 (4.5)	99.8 (6.8)	97.4 (6.2)
HbA1c (percentage of HbA1c) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of HbA1c]	6.1 (0.6)	6.3 (1.8)	6.2 (1.2)
fasting glucose (mmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/l]	5.5 (1.1)	5.5 (2.2)	5.5 (1.7)
HDL (mmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/l]	0.9 (0.2)	0.8 (0.1)	0.9 (0.2)
LDL (mmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/l]	2.8 (0.8)	2.4 (0.9)	2.6 (0.8)
insulin (pmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pmol/l]	106.8 (65.8)	84.5 (60.4)	95.7 (62.5)
Triglyceride (mmol/l) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmol/l]	2.3 (1.1)	1.5 (0.6)	1.9 (0.9)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Weight at 24 Weeks
Description	evaluate all participants' weight ，weight in kilograms
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [kilogram]	0.2 (5.3)	-0.9 (3.1)

2. Secondary Outcome

Title	Numbers of Participants Who Quit Smoking
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Number [participants]	0 0%	0 0%

3. Secondary Outcome

Title	Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks
Description	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".
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	-1.0 (2.9)	-1.9 (3.1)

4. Secondary Outcome

Title	Depression Status Assessed by Self-rating Depression Scale（SDS）
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	39.4 (8.2)	33.6 (7.2)

5. Secondary Outcome

Title	Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	31.1 (6.9)	28.8 (4.2)

6. Secondary Outcome

Title	Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)
Description	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.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [score on a scale]	52.5 (15.0)	57.2 (18.9)

7. Secondary Outcome

Title	Waist Circumference
Description	evaluate all participants' waist circumference，waist circumference in centimeters
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [cm]	98.6 (5.7)	101.3 (6.6)

8. Secondary Outcome

Title	Change in Fasting Blood Glucose Levels
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [mmol/l]	0.5 (1.5)	1.0 (1.6)

9. Secondary Outcome

Title	Change in Fasting Insulin Levels
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [pmol/l]	3.5 (74.4)	11.0 (35.3)

10. Secondary Outcome

Title	Change in Glycosylated Hemoglobin
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [percentage of hemoglobin]	0.05 (0.6)	0.4 (1.1)

11. Secondary Outcome

Title	Change in Fasting Triglycerides Levels
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [mmol/l]	-1.0 (0.9)	-0.4 (0.6)

12. Secondary Outcome

Title	Change in Fasting HDL Cholesterol Levels
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [mmol/l]	0.0 (1.1)	0.0 (0.1)

13. Secondary Outcome

Title	Change in Fasting LDL Cholesterol
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [mmol/l]	-0.4 (0.7)	-0.2 (0.7)

14. Secondary Outcome

Title	Change in Leptin
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [ng/ml]	9.2 (5.9)	10.6 (7.1)

15. Secondary Outcome

Title	Change in Ghrelin
Time Frame	baseline and 24 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Naltrexone and Bupropion	Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
Measure Participants	11	10
Mean (Standard Deviation) [pg/ml]	352.2 (296.6)	254.8 (106.4)

Adverse Events

Time Frame	The 24-week study time period
Arm/Group Title	Naltrexone and Bupropion		Placebo Naltrexone and Bupropion
Arm/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. 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. 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 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. Placebo Naltrexone: Placebo Naltrexone created and masked by the pharmacy to be used as a control. Placebo Bupropion: Placebo Bupropion created and masked by the pharmacy to be used as a control.
All Cause Mortality
	Naltrexone and Bupropion		Placebo Naltrexone and Bupropion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Serious Adverse Events
	Naltrexone and Bupropion		Placebo Naltrexone and Bupropion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Naltrexone and Bupropion		Placebo Naltrexone and Bupropion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/11 (54.5%)		1/10 (10%)
Cardiac disorders
tachycardia	0/11 (0%)	0	1/10 (10%)	1
Gastrointestinal disorders
dry mouth	5/11 (45.5%)	5	0/10 (0%)	0
mild abdominal discomfort	1/11 (9.1%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.