Dose Ranging Study Summaries

3.2.1. Paille et al. (France 1989-1992) (Published 1995) (8).

Although preliminary open-dose ranging studies had been performed earlier (Poinso et al. unpublished data, from Merck/Lipha, France 1986), the first double-blind dose ranging study was initiated in 1989 by Paille et al. (8). Five hundred thirty-eight alcohol-dependent patients were administered either 1332 mg or 1998 mg of acamprosate or placebo daily for 12 mo and were then followed for an additional period of 6 mo during which all patients received placebo. The study demonstrated enhanced efficacy with no increase in adverse events for patients treated at the higher dose of acamprosate. The mean cumulative abstinence duration (CAD) of the patients receiving 1998 mg acamprosate was 223 d; for 1332 mg acamprosate, 198 d; and for placebo, 173 d. The difference between the 1998-mg acamprosate group and placebo reached statistical significance (p = 0.0005), whereas differences between the 1332-mg acamprosate and placebo groups failed to achieve significance (p = 0.055). Another criteria, continuous abstinence, showed greatest efficacy for the 1998-mg dose of acamprosate and the lowest for placebo. Although many patients dropped out during the last 6 mo of placebo follow-up, it nevertheless appeared that the treatment advantage observed during the first 12 mo was maintained. Interestingly, craving and y-glutamyl transferase (GGT) levels did not significantly differ between the two active medication groups.

This study of 188 alcohol-dependent patients tested the same dose range as in the study by Paille et al. in France, but covered a period of 3 mo and included a placebo follow-up period following the active treatment period. The differences between the acamprosate and placebo treatments significantly favored the active medication. Although trends identical to these found in the Paille et al. study were noted (i.e., better efficacy and equal numbers of adverse regardless of dose), differences between the two acamprosate dosages were less pronounced. The study also found fewer dropouts in the acam-prosate groups than in the placebo-treated group.

3.2.3. Mason et al. (United States 1997-1999)

This study included one group of patients receiving 2 g acamprosate per day and a smaller group receiving 3 g acamprosate per day. The results of this study are not released yet.

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