DOUBLE-BLIND RANDOMIZED MULTICENTRE TRIAL OF ACAMPROSATE IN MAINTAINING ABSTINENCE FROM ALCOHOL

A prospective placebo-controlled, randomized double-blind study of Acamprosate at two dose levels in alcohol-dependent patients followed up for 12 months was performed. After detoxification, each of the 538 patients included was randomly assigned to one of three groups: 177 patients received placebo, 188 received Acamprosate at 1.3 g/day (low dose group) and 173 received 2.0g/day (high dose group) for 12 months. This was followed by a single blind 6 month period on placebo. The patients' mean age was 43.2 ± 8.6 years. Their mean daily alcohol intake was high (nearly 200g/day) and of long duration (9.5 ± 7.1 years). Abstinence figures followed the order high dose>low dose>placebo. The difference was significant at 6 months ( P ≤ 0.02) but not at 12 months ( P = 0.096). The number of days of continuous abstinence after detoxification was 153 ± 197 for the high-dose group versus 102 ± 165 for the placebo group ( P = 0.005), with the lose-dose group reporting 135 ± 189 days. Clinic attendance was significantly better in the Acamprosate groups than in the placebo group at 6 months ( P = 0.002) and 12 months ( P = 0.005). During the 6-month post-treatment period, no increased relapse rate or residual drug effect was observed. The side effect profile for Acamprosate was good compared with controls with only diarrhoea being reported more frequently ( P <0.01). This study confirms the pharmacological efficacy of Acamprosate and its good acceptability. As an adjunct to psychotherapy, this study supports the inclusion of Acamprosate in a strategy for treating alcoholism.