Phase 4
Completed N=22
Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia
Obese · Cigarette-smoking · Schizophrenia
Source: ClinicalTrials.gov NCT02736474 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Change From Baseline in Weight at 24 Weeks — 0.2; -0.9 kilogram
◆ Published Evidence
Established
27citations · ~3 / year
Naltrexone and Bupropion Combination Treatment for Smoking Cessation and Weight Loss in Patients With Schizophrenia.
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.
Linked Publications
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Naltrexone and Bupropion Combination Treatment for Smoking Cessation and Weight Loss in Patients With Schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight at 24 Weeks |
0.2; -0.9 | — |
| SECONDARY Numbers of Participants Who Quit Smoking |
0; 0 | — |
| SECONDARY Changes From Baseline Craving for Nicotine Assessed by Visual Analog Scales (VAS) at 24 Weeks |
-1.0; -1.9 | — |
| SECONDARY Depression Status Assessed by Self-rating Depression Scale（SDS） |
39.4; 33.6 | — |
| SECONDARY Anxiety Status Assessed by Self-Rating Anxiety Scale（SAS） |
31.1; 28.8 | — |
| SECONDARY Clinical Symptoms Assessed by the Positive and Negative Syndrome Scale (PANSS) |
52.5; 57.2 | — |
| SECONDARY Waist Circumference |
98.6; 101.3 | — |
| SECONDARY Change in Fasting Blood Glucose Levels |
0.5; 1.0 | — |
| SECONDARY Change in Fasting Insulin Levels |
3.5; 11.0 | — |
| SECONDARY Change in Glycosylated Hemoglobin |
0.05; 0.4 | — |
| SECONDARY Change in Fasting Triglycerides Levels |
-1.0; -0.4 | — |
| SECONDARY Change in Fasting HDL Cholesterol Levels |
0.0; 0.0 | — |
| SECONDARY Change in Fasting LDL Cholesterol |
-0.4; -0.2 | — |
| SECONDARY Change in Leptin |
9.2; 10.6 | — |
| SECONDARY Change in Ghrelin |
352.2; 254.8 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02736474) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.