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A Double-blind, Placebo-Controlled Study

Falk Kiefer, MD; Holger Jahn, MD; Timo Tarnaske; Hauke Helwig; Peer Briken, MD; Rüdiger Holzbach, MD; Philipp Kämpf, MD; Robert Stracke, MD; Michael Baehr, PhD; Dieter Naber, MD; Klaus Wiedemann, MD

Arch Gen Psychiatry. 2003;60:92-99.

Background  Naltrexone and acamprosate have been shown to be effective in relapse prevention of alcoholism via different pharmacologic mechanisms. Since it remains uncertain whether both substances are equally efficient and whether a combination of both drugs potentiates the efficacy, we conducted the first published controlled study comparing and combining both compounds.

Methods  After detoxification, 160 patients with alcoholism participated in a randomized, double-blind, placebo-controlled protocol. Patients received naltrexone, acamprosate, naltrexone plus acamprosate, or placebo for 12 weeks. Patients were assessed weekly by interview, self-report, questionnaires, and laboratory screening. Time to first drink, time to relapse, and the cumulative abstinence time were the primary outcome measures.

Results  Naltrexone, acamprosate, and the combined medication were significantly more effective than placebo. Comparing the course of nonrelapse rates between naltrexone and acamprosate, the naltrexone group showed a tendency for a better outcome regarding time to first drink and time to relapse. The combined medication was most effective with significantly lower relapse rates than placebo and acamprosate but not naltrexone.

Conclusions  The results of this study support the efficacy of pharmacotherapeutic strategies in the relapse prevention of alcoholism. Naltrexone and acamprosate, especially in combination, considerably enhance the potential of relapse prevention.

From the Department of Psychiatry (Drs Kiefer, Jahn, Briken, Holzbach, Kämpf, Naber, and Wiedemann and Messrs Tarnaske and Helwig) and the Pharmacy (Dr Baehr), University Hospital of Hamburg, and Northern Hospital of Hamburg (Dr Stracke), Hamburg, Germany.

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