Florez 2008.

Methods	Randomised controlled open study
Participants	102 participants; mean age 46.7 years; 85% male; 82% only elementary school education; 69% married; 48% employed; 73% reporting more than 700 ethanol grams per week; OCDS score 17 on average Inclusion criteria: meeting ICD‐10 criteria for alcohol dependence (WHO 1992); having an ethanol intake of at least 210 grams per week for men and 140 grams per week for women assessed with the EuropASI (Kokkevi 1995) Exclusion criteria: younger than 18 or older than 65 years of age; current diagnosis of dependence or abuse of other substances except nicotine; current psychiatric diagnosis other than personality disorders; any clinically significant medical condition that in the opinion of the researchers would adversely affect safety or study participation; inability to give full informed consent; not speaking Spanish or Galician; clinical history of mental retardation; pregnancy or breast‐feeding; not having a significant other to provide accurate daily alcohol‐related information to researchers
Interventions	(1) Topiramate, 51 participants; (2) naltrexone, 51 participants Drug dose: topiramate up to 200 to 400 mg/d; naltrexone 50 mg/d All participants received individualised psychological therapy based on Relapse Prevention Model (Carroll 1996 b) Setting: outpatient Duration: six months. Country of origin: Spain
Outcomes	Efficacy was defined according to the following categories: Abstinence: no alcohol intake reported during previous three months. No problems reported (problems defined as a score of four or more on any of the EuropASI scales) Moderate drinking without problems: reported drinking of less than 40 g of ethanol per day for men and less than 30 g for women, with no more than two days on which heavier drinking was reported. No problems reported Moderate drinking with problems: same as previous, but problems reported Heavy drinking without problems: reported drinking greater than moderate drinking on three or more occasions per quarter. No problems reported Heavy drinking with problems: same as previous but problems reported Participants in groups three, four and five and dropouts were considered as relapsed
Notes	For those who needed detoxification, treatment with clorazepate was used. Treatment with naltrexone or topiramate was started after detoxification was completed
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation carried out through a computer programme
Allocation concealment (selection bias)	High risk	Open study
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data on all participants analysed on an intent–to‐treat basis. Dropouts assumed to have resumed heavy drinking on the day after their last contact
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