© 1995 Medical Council on Alcohol
research-article
DOUBLE-BLIND RANDOMIZED MULTICENTRE TRIAL OF ACAMPROSATE IN MAINTAINING ABSTINENCE FROM ALCOHOL
Centre d'Alcoologie, Hôpital Fournier 36 quai de la Bataille. F-54035 Nancy cedex
1Clinique des Maladies Mentales et de l'Encéphale. Hôpital Sainte-Anne Service du Pr Samuel-Lajeunesse. 100 rue de la Santé, F-75674 Paris cedex 14, France
2 MEDIANS, Waverley, School Hill, Wargrave, Reading RG10 8DY, UK
3Laboratoire de Pharmacologie, Faculté de Médecine avenue de la Forêt de Haye, F-54500 Vandoeuvre, France
4 ITEM, 93 avenue de Fontaineblav, F-94297 Le Kremlin-Bicêtre, France
*Author to whom correspondence should at addressed
Received 11 May 1994; first review notified 12 August 1994; accepted 8 September 1994
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.
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