Martinotti 2007.
| Methods | Randomised controlled open study | |
| Participants | 84 participants; mean age 40.3; 81% male; 39.3% secondary school of education; 16.4 years on average the duration of alcohol misuse; 21 on average the OCDS score; 8.5 daily drinks on average; 14.8 mean years of addiction Inclusion criteria: detoxified alcohol dependent with history of alcohol use disorders of at least three years, currently meeting clinical criteria for alcohol dependence (DSM‐IV) using SCID interview, who declared their commitment to the goal of total abstinence Exclusion criteria: severe physical illness; evidence of mental disorders severely interfering with their cognitive capacity or reality test; individuals regularly taking anticonvulsants, antidepressants or antipsychotics; pregnant or lactating participants; history of severe adverse events or well‐known hypersensitivity to oxcarbazepine or naltrexone; previous treatment with oxcarbazepine or naltrexone |
|
| Interventions | (1) Oxcarbazepine low dosage, 28 participants; (2) oxcarbazepine full dosage, 29 participants; (3) naltrexone, 27 participants Drug dose: oxcarbazepine low dosage, 600 to 900 mg/d; oxcarbazepine full dosage, 1500 to 1800 mg/d; naltrexone 50 mg/d All participants were offered a supportive self‐help group alternatively run by counsellors and psychologists, with a frequency of two days per week for the duration of the study Setting: outpatient Duration: 12 weeks. Country of origin: Italy |
|
| Outcomes | Primary outcome was divided into four different variables (alcohol free, minor relapse, major relapse, dropout); craving and psychiatric symptoms were considered as secondary endpoints | |
| Notes | Participants were required to be detoxified before randomisation and declaring their commitment to the goal of total abstinence | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated system used. Random assignment achieved in a non–centre‐specific manner with an interactive voice‐response central randomisation service. Random assignment stratified according to the presence of a co‐morbid psychiatric diagnosis |
| Allocation concealment (selection bias) | High risk | Open study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Primary and secondary efficacy analyses were performed on the intent‐to‐treat population, which included all randomly assigned patients who took at least one dose of study medication." To take care of missing data, the last observation carried forward method was also applied |
| Blinding of participants and personnel (performance bias) all outcomes | High risk | Unblinded study |
| Blinding of outcome assessment (detection bias) subjective | High risk | Unblinded study |
| Blinding of outcome assessment (detection bias) objective | Low risk | Outcome measurement not likely to be influenced by lack of blinding |