Hong 2011.
Methods | RCT, USA. Pts recruited from the community. | |
Participants | 69 pts (43 smokers) with a diagnosis of schizophrenia or schizoaffective disorder. All received antipsychotic medications and they were clinically stable for at least 4 wks. Aged between 18 and 60. Exclusion criteria included: (1) pts were undergoing smoking cessation therapy; (2) major medical conditions; (3) atrioventricular block as identified by ECG; (4) renal insufficiency. Interest in quitting smoking is not required. No TQD set. Among 43 smokers, 27 were males. Mean age 42.2. Average CPD 18. |
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Interventions | 1. Varenicline 0.5mg daily for 1 wk then 0.5mg twice daily for 7 wks (total 8 wks) 2. Placebo for 8 wks Both groups did not receive any additional intervention. |
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Outcomes | Abstinence not defined or measured. Reduction of smoking measured by reduction of CPD and reduction of the expired CO level. Measurement taken at wk 1, 2, 4, 6, 8 and 10. Effects on mental state measured by BPRS, SANS, HAM‐D and CGI. | |
Source of funding | Stanley Medical Research Institute, NIH, Neurophysiology Core of the University of Maryland General Clincial Research Centre | |
Primary aim of the study | Effect of varenicline on neurobiological and cognitive biomarkers in schizophrenia | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation was not described. |
Allocation concealment (selection bias) | Unclear risk | No description of allocation concealment in the reports. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated |
Selective reporting (reporting bias) | Low risk | All expected outcomes |
Other bias | Low risk |