Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

NCT ID: NCT02736474

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: 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.

Bupropion

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

Placebo Naltrexone

Intervention Type: DRUG

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

Placebo Bupropion

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo Naltrexone

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

Intervention Type: 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.

Intervention Type: DRUG

Placebo Bupropion

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

DU, Jiang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Du, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief Physician

References

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.

Reference Type: DERIVED

PMID: 29563871 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MZhao-005

Identifier Type: -

Identifier Source: org_study_id