Martinotti 2010.
Methods | Randomised controlled double‐blind study | |
Participants | 59 participants; mean age 40.3 years; 80% males; 8.5 daily drinks on average; 14.8 mean years of addiction Inclusion criteria: history of alcohol use disorders of at least three years; daily alcohol intake of at least six units; currently meeting clinical criteria for alcohol dependence (DSM‐IV; APA 2000); commitment to the goal of total abstinence Exclusion criteria: having a severe physical illness or evidence of mental disorder severely interfering with cognitive capacity; regularly taking anticonvulsants, antidepressants or antipsychotics; pregnancy or lactation; history of severe adverse reaction, well‐known hypersensitivity to or previous treatment with pregabalin or naltrexone |
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Interventions | (1) Pregabalin, 31 participants; (2) naltrexone, 28 participants Drug dose: pregabalin, 150 to 450 mg/d; naltrexone, 50 mg/d All participants were offered a supportive self‐help group alternatively run by counsellors and psychologists two days per week for the duration of the study Setting: outpatient Duration: 12 weeks. Country of origin: Italy |
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Outcomes | Primary outcomes: maintenance of abstinence and relapse to drinking Secondary outcomes: number of abstinent days; number of heavy drinking days; time to first drink (duration of abstinence); alcohol craving; safety (electrocardiogram, urinalysis, haematological and clinical chemical analyses of blood samples) |
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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 stratified according to the presence of a co‐morbid psychiatric diagnosis |
Allocation concealment (selection bias) | Low risk | Quote: "All study personnel in contact with the participants were unaware of the randomisation sequence" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Efficacy analyses performed on intent‐to‐treat population. Last observation carried forward (LOCF) method also applied to take into account missing data |
Blinding of participants and personnel (performance bias) all outcomes | Low risk | Tablets identical in appearance. Quote: "All study personnel in contact with the participants were unaware of the randomisation sequence" |
Blinding of outcome assessment (detection bias) subjective | Low risk | Quote: "All study personnel in contact with the participants were unaware of the randomisation sequence" |
Blinding of outcome assessment (detection bias) objective | Low risk | Quote: "All study personnel in contact with the participants were unaware of the randomisation sequence" |