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
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
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)
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"