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Objective: The project was designed to compare the effectiveness of brief intervention (BI) versus simple advice (SA) in the secondary prevention of hazardous alcohol consumption.Methods: A randomized controlled trial with a 12-month follow-up was conducted. A total of 74 community-based primary care practices (328 physicians) located in 13 Spanish autonomous regions were recruited initially. Out of 546 men screened, only 229 were randomized into BI (n = 104) and SA (n = 125); 44.6% of practices finalized the study. The interventions on the BI group consisted of a 15-minute counselling visit carried out by physicians which included: (i) alcohol quantification, (ii) information on safe limits, (iii) advice, (iv) drinking limits agreement, (v) self-informative booklet with drinking diary record and (vi) unscheduled reinforcement visits. The SA group spent 5 minutes which included (i), (ii) and (iii).Results: There were no significant differences between both groups at baseline on alcohol use, age, socioeconomic status and CAGE score. After the 12-month follow-up there was a significant decrease in frequency of excessive drinkers (67% of BI group reached targeted consumption, versus 44% of SA; P < 0.001) as well as weekly alcohol intake reduction (BI reached 52 versus 32% in SA; P < 0.001). A trend to improve outcome with the number of reinforcement visits was found with BI. The only predictor of success was the initial alcohol consumption level.Conclusions: Brief intervention is more effective than simple advice to reduce alcohol intake on adult men who attend primary care services in Spain. [ABSTRACT FROM AUTHOR]