P: 45%

P: 112

P: 21

Note: A = acamprosate; P = placebo; CAD = cumulative abstinence duration.

Note: A = acamprosate; P = placebo; CAD = cumulative abstinence duration.

acute weaning treatment. The latter study resulted in some patients (32%) relapsing between the acute weaning phase and inclusion into the acamprosate study.

Most earlier studies differentiated medication dosage according to body weight (1998 mg/d for patients over 60 kg and 1332 mg/d for patient under 60 kg), but this practice proved to be nonessential and has been altered in some countries to dosage regimens irrespective of body weight.

Psychosocial support and treatment protocols in the European studies were not manual driven, and participating centers were allowed to follow local clinical practices as usual with the simple addition of the double-blinded test medication. The exception was the US study, where a manual for the psychosocial therapy was used. Several open-label studies were also conducted that provided additional information on the usage of psychosocial programs with acamprosate, including the NEAT studies (6) and the Micado study (7).

In all investigations, the study medication was withdrawn at the end of the study period without tapering dosages. All of the projects except for two of them (see Table 1) continued to evaluate patients after study drug withdrawal for periods varying between 6 wk and 1 yr.

Outcome assessment in all studies was primarily considered total abstinence, rather than controlled or reduced drinking. Outcome measures included trials to first drink, proportion of patients drinking, abstinent throughout the study period, and cumulative number of abstinent days.

3.1. General Results

A total of 4523 patients were included in the 17 European double-blind studies; 2371 received acamprosate and 2152 received placebo. Between 16% and 31% of patients were females, and the mean age was 42.79 yr. No race differentiation was recorded.

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