United Kingdom multicentre acamprosate study (UKMAS): A 6-month prospective study of acamprosate versus placebo in preventing relapse after withdrawal from alcohol

A 6-month randomized controlled study of acamprosate versus placebo in prev enting relapse following withdrawal from alcohol was undertaken in 20 centr es throughout the UK. Patients diagnosed as alcohol-dependent and detoxifie d within the preceding 5 weeks were randomly assigned to treatment with eit her acamprosate (A) 666 mg three times/day or identical placebo (P). A tota l of 664 patients were screened; 581 were entered into the treatment phase. One-third were episodic drinkers, 84% were male, 44% were unmarried and 48 % were unemployed. Medication was first taken on average 24 days after the start of detoxification; 32% of patients had already relapsed by this time. The 6-month study period was completed by 35% of patients; adverse events led to withdrawal of a further 14% (A) and 9% (P) respectively. Compliance was poor in that, by the end of the second week, only 57% of patients were judged to be taking at least 90% of their tablets. The mean total of abstin ent days achieved was 77 (A) and 81 (P). Complete abstinence for 6 months w as achieved by 12% (A) and 11% (P); drinking remained within controlled lim its in a further 3% (A) and 6% (P). An effect of acamprosate on consumption was not seen when subgroups, including those defined by the Leach typology , were analysed separately. However, the mean percentage reduction in cravi ng for alcohol measured on a visual analogue scale was greater in the acamp rosate, than placebo, patients at week 2 and week 4 (P < 0.001) and the mea n decrease in the Hamilton Anxiety score at the 4th week was greater in the acamprosate than placebo patients (P = 0.017). In comparison with other pu blished trials of acamprosate, patients started study medication after a lo nger time following detoxification, had more often recommenced drinking bef ore medication was started and had a higher drop-out rare, and this might h ave contributed to the lack of a treatment effect in this study.