Acamprosate and relapse prevention in the treatment of alcohol dependence:A placebo-controlled study

The objective of this study was to compare acamprosate with placebo in the treatment of alcohol-dependent patients during a 6-month post-detoxificatio n treatment and a 3-month medication-free follow-up. Patients (n = 330) wer e detoxified and randomized to treatment with acamprosate (1998 mg/day) or placebo within an out-patient programme including medical counselling, psyc hotherapy and self-help groups. The main outcome criterion was drinking beh aviour as assessed by: abstinence/relapse ratio, cumulative abstinence dura tion (CAD) and the period of continued abstinence. Anxiety, depression and craving were also monitored. Intention to treat (ITT) statistical principle s were followed. Twenty-five per cent of patients dropped out over the firs t 6 months. At the end of the treatment period, the abstinence rate was 57. 9% for acamprosate and 45.2% for placebo (P = 0.03). The CAD was 110 +/- 77 days for acamprosate and 89 +/- 77 days for placebo (P = 0.016). Patients on acamprosate had a higher continuous abstinence rate and experienced less severe relapses. No differential effect was noted for anxiety, depression or craving. Treatment remained positive, but not significant, 3 months afte r termination of study medication. No significant difference in adverse eve nts was noted between treatment groups. Acamprosate treatment over 180 days was consistently more effective than placebo to maintain abstinence and to diminish relapse severity.