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August 1996

Relapse Prevention by AcamprosateResults From a Placebo-Controlled Study on Alcohol Dependence

Author Affiliations

From the Psychiatric Clinic, Rheinisch Westfälische Technische Hochschule, Aachen, Germany (Dr Sass); the Psychiatric Hospital, University of Munich (Germany) (Dr Soyka); the Department of Psychiatry, University of Tübingen (Germany) (Dr Mann); and the Max Planck-Institute of Psychiatry, Munich (Dr Zieglgänsberger). Members of the Prevention of Relapse With Acamprosate in the Management of Alcoholism Study Group appears on page 679.

Arch Gen Psychiatry. 1996;53(8):673-680. doi:10.1001/archpsyc.1996.01830080023006

Background  The effectiveness acamprosate (calcium bisacetylhomotaurinate) as a treatment to maintain abstinence in alcohol-dependent patients was assessed for 1 year.

Methods:  After short-term detoxification, 272 patients participated in a randomized, double-blind, placebo-controlled study. Patients received routine counseling and either the study medication or placebo for 48 weeks; they were followed up for another 48 weeks without medication. Statistical analysis was performed according to the intention-to-treat principle.

Results:  Patients who were receiving acamprosate showed a significantly higher continuous abstinence rate within the first 60 days of treatment compared with patients who were assigned to placebo treatment (67% vs 50%) until completion of the treatment period (43% vs 21%, log rank P=.005), and they had a significantly longer mean abstinence duration of 224 vs 163 days, or 62% vs 45% days abstinent (P<.001); however, there was no difference in psychiatric symptoms. Of the patients who were receiving acamprosate, 41% had dropped out, whereas 60% of the placebo-treated patients dropped out of the study. Few side effects (mainly diarrhea and headache) were recorded. At the end of a further 48 weeks without receiving study medication, 39% and 17% of the acamprosate- and placebo-treated patients, respectively, had remained abstinent (P=.003).

Conclusion:  Acamprosate proved to be a safe and effective aid in treating alcohol-dependent patients and in maintaining the abstinence of patients during 2 years.