Naltrexone and Bupropion Combination on Obese,Smoking Pat... | NCT02736474

Naltrexone and Bupropion Combination on Obese,Smoking Pat... | NCT02736474 | Trialant

Sponsor/Collaborators Module

Name	Class
University of Massachusetts, Worcester	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Naltrexone and Bupropion	Experimental	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 Drug: Bupropion
Placebo Naltrexone and Bupropion	Placebo Comparator	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 Drug: Placebo Bupropion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Naltrexone	Drug	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.	Naltrexone and Bupropion

Outcomes Module

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

Secondary Outcomes

Measure	Description	Time Frame
Numbers of Participants Who Quit Smoking		24 weeks
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".

Name	Affiliation	Role
Jiang Du, PhD	Chief Physician	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29563871	Derived	Lyu X, Du J, Zhan G, Wu Y, Su H, Zhu Y, Jarskog F, Zhao M, Fan X. Naltrexone and Bupropion Combination Treatment for Smoking Cessation and Weight Loss in Patients With Schizophrenia. Front Pharmacol. 2018 Mar 5;9:181. doi: 10.3389/fphar.2018.00181. eCollection 2018.

Arm/Group Information

ID	Title	Description
FG000	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. 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.
FG001	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. 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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00011 subjects FG00111 subjects
COMPLETED		FG00011 subjects FG00110 subjects
NOT COMPLETED		FG0000 subjects FG0011 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0000 subjects FG0011 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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. 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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Weight at 24 Weeks

evaluate all participants' weight ，weight in kilograms

Posted

Mean

Standard Deviation

kilogram

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	Placebo Naltrexone and Bupropion

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
dry mouth	Gastrointestinal disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Physician Dr Du. Jiang Du	Shanghai Mental Health Center	86-21-64387250		dujiangdou@163.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 30, 2015	Jan 13, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 30, 2015	Jan 13, 2020	SAP_001.pdf

Condition Browse Module

ID	Term
D009765	Obesity
D000073865	Cigarette Smoking
D012559	Schizophrenia

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

ID	Term
D009271	Naltrexone
D016642	Bupropion

ID	Term
D009270	Naloxone
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571

smoking craving

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".

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG0006.3± 1.0 BG0017.0± 1.4 BG0026.6± 1.3

Secondary

Numbers of Participants Who Quit Smoking

Posted

Number

participants

24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Secondary

Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks

Posted

Mean

Standard Deviation

score on a scale

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG000-1.0± 2.9 OG001-1.9± 3.1

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.

Posted

Mean

Standard Deviation

score on a scale

24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00039.4± 8.2 OG00133.6± 7.2

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.

Posted

Mean

Standard Deviation

score on a scale

24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00031.1± 6.9 OG00128.8± 4.2

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.

Posted

Mean

Standard Deviation

score on a scale

24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00052.5± 15.0 OG00157.2± 18.9

Secondary

Waist Circumference

evaluate all participants' waist circumference，waist circumference in centimeters

Posted

Mean

Standard Deviation

24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG00098.6± 5.7 OG001101.3± 6.6

Secondary

Change in Fasting Blood Glucose Levels

Posted

Mean

Standard Deviation

mmol/l

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000.5± 1.5 OG0011.0± 1.6

Secondary

Change in Fasting Insulin Levels

Posted

Mean

Standard Deviation

pmol/l

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0003.5± 74.4 OG00111.0± 35.3

Secondary

Change in Glycosylated Hemoglobin

Posted

Mean

Standard Deviation

percentage of hemoglobin

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000.05± 0.6 OG0010.4± 1.1

Secondary

Change in Fasting Triglycerides Levels

Posted

Mean

Standard Deviation

mmol/l

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG000-1.0± 0.9 OG001-0.4± 0.6

Secondary

Change in Fasting HDL Cholesterol Levels

Posted

Mean

Standard Deviation

mmol/l

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0000.0± 1.1 OG0010.0± 0.1

Secondary

Change in Fasting LDL Cholesterol

Posted

Mean

Standard Deviation

mmol/l

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG000-0.4± 0.7 OG001-0.2± 0.7

Secondary

Change in Leptin

Posted

Mean

Standard Deviation

ng/ml

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0009.2± 5.9 OG00110.6± 7.1

Secondary

Change in Ghrelin

Posted

Mean

Standard Deviation

pg/ml

baseline and 24 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00011 OG00110

Title

Denominators

Categories

Title	Measurements
	OG000352.2± 296.6 OG001254.8± 106.4