Research on Acamprosate

• Paille, F. M., Guelfi, J. D., Perkins, A. C., Royer, R. J., Steru, L., & Parot, P. (1995). Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Alcohol and Alcoholism, 30(2), 239–247.

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 diarrhea 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.

• Pelc, I., Ansoms, C., Lehert, P., Fischer, F., Fuchs, W., Landron, F., et. al. (2002). The European NEAT Program: An integrated approach using acamprosate and psychosocial support for the prevention of relapse in alcohol-dependent patients with a statistical modeling of therapy success prediction. Alcoholism: Clinical and Experimental Research, 26(10), 1529–1538.

Background: A multi-center, prospective study was conducted in five European countries to observe outcome in alcohol misusers treated for 24 weeks with acamprosate and various psychosocial support techniques, within the setting of standard patient care. Methods: Patients diagnosed as alcohol dependent using DSM-III-R criteria were treated, for 24 weeks, with acamprosate and appropriate psychosocial support. Potential predictor variables were recorded at inclusion. Drinking behavior was monitored throughout; the proportion of cumulative abstinence days was the principal outcome measure. The influence of baseline clinical and demographic variables on outcome was assessed using multiple regression analysis. Adverse events were recorded systematically. Results: A total of 1,289 patients were recruited; 1,230 took at least one dose of the drug and provided at least one set of follow-up data; 543 (42.1%) patients were observed for the full 24-week period. The overall proportion of cumulative abstinence days was 0.48. Multiple physical and psychiatric comorbidities and a history of drug addiction were negatively correlated with outcome, as were, to a lesser extent, multiple previous episodes of detoxification, unemployment, and living alone. Older age and stable employment were positively associated with outcome. The difference in the unadjusted proportion of cumulative abstinence days between countries was significant (p <0.001) but less so when adjusted for the predictive factors identified in the multivariate model (p <0.019). Overall, outcome was not influenced by the nature of the psychosocial support provided. Adverse events were generally mild, with gastrointestinal disorders, which occurred in 21.5% of patients, being the most frequent. Conclusions: This open-label study confirms the efficacy and safety of acamprosate in the treatment of alcohol dependence in the setting of standard patient care. Treatment benefit was observed irrespective of the nature of the psychosocial support provided. Predictors of the response to treatment were identified; their heterogeneous distribution within the study population explained, at least in part, the differences in outcome between countries.