Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

NCT02736474 | Completed Phase 4 Results

• 1 other identifier: MZhao-005
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obese; Cigarette-smoking; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Weight at 24 Weeks

  evaluate all participants' weight ，weight in kilograms

  baseline and 24 weeks

Secondary Outcomes (14)

• Numbers of Participants Who Quit Smoking

  24 weeks

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

  baseline and 24 weeks

• Depression Status Assessed by Self-rating Depression Scale（SDS）

  24 weeks

• Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS）

  24 weeks

• Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS)

  24 weeks

Study Arms (2)

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

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

Placebo Naltrexone DRUG

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

Placebo Naltrexone and Bupropion

Bupropion 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.

Naltrexone and Bupropion

Placebo Bupropion DRUG

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

Placebo Naltrexone and Bupropion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• University of Massachusetts, Worcester: collaborator

Related Publications (1)

• 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.

  PMID: 29563871 DERIVED

MeSH Terms

Conditions

Obesity; Cigarette Smoking; Schizophrenia

Interventions

Naltrexone; Bupropion

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Chief Physician Dr Du. Jiang Du
• Organization: Shanghai Mental Health Center

dujiangdou@163.com

86-21-64387250

Study Officials

• Jiang Du, PhD

  Chief Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 22, 2021
• Results First Posted: October 22, 2021

Record last verified: 2021-09