Objective: To determine abstinence rates and to obtain safety data during the use of integrated therapy with acamprosate and the main established psychotherapeutic intervention programmes in the treatment of alcohol dependence.
Design: Non-blind, parallel-group, multicentre, phase IV study.
Setting: Naturalistic setting reflecting the clinical use of acamprosate in outpatient treatment of alcoholics in Germany.
Patients: 753 patients meeting the DSM-III-R criteria for alcohol dependence. At study entry, patients had to be abstinent for 1 to 4 weeks, and those who relapsed within the first 14 days of treatment were withdrawn from the study.
Interventions: All patients received acamprosate 1332 to 1998 mg/day according to bodyweight and were assigned to one of the following treatment groups: individual psychotherapy, group psychotherapy, behavioural therapy, brief intervention or family therapy. The patients were followed for 24 weeks.
Outcome measures: The principal outcome criterion was the time to the first drink. Secondary outcome measures were cumulative abstinence duration and craving. Adverse events were recorded systematically and classified according to World Health Organization adverse reaction terminology.
Results: The mean time to first drink was 81.5 days. 236 (33.5%) patients were continuously abstinent during the study. The discontinuation rate in the study was 49%, and the cumulative abstinence duration was 61%. Abstinence and discontinuation rates in this study were similar to those found in placebo-controlled clinical trials. Craving fell to scores of less than 50 on the Lübecker Craving Scale within 2 weeks of treatment initiation. There were no significant differences between the different psychosocial support treatment arms concerning time to first relapse or abstinence rates. Linear regression analysis showed severity of alcohol dependence according to DSM-III-R criteria to be associated with treatment outcome (p = 0.003). The most common adverse clinical events during the first 2 weeks of treatment were diarrhoea (69 patients), pruritus (37 patients), headache (28 patients) and fatigue (16 patients). Acamprosate was discontinued in nine patients (1%) because of severe adverse events; only two cases were clearly linked to treatment (diarrhoea and dermatitis). One death occurred during the study (status asthmaticus).
Conclusions: Abstinence rates with integrated acamprosate and psychosocial support in a naturalistic setting are similar whatever the psychosocial support used, and similar to those seen in placebo-controlled clinical trials of acamprosate. The safety profile of acamprosate was good.