Relapse prevention by acamprosate. Results from a placebo-controlled study on alcohol dependence.
BACKGROUND
The effectiveness of 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).


CONCLUSIONS
Acamprosate proved to be a safe and effective aid in treating alcohol-dependent patients and in maintaining the abstinence of patients during 2 years.
Sass
H
H
Psychiatric Clinic, Rheinisch Westfalische Technische Hochschule, Aachen, Germany.
Soyka
M
M
Mann
K
K
Zieglgänsberger
W
W
D000077443:Acamprosate; D000328:Adult; D000368:Aged; D000428:Alcohol Drinking / Q000517:prevention & control; D000437:Alcoholism / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D010919:Placebos; D012008:Recurrence; D016019:Survival Analysis; D013654:Taurine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013695:Temperance; D016896:Treatment Outcome
D010919:Placebos; D013654:Taurine; D000077443:Acamprosate