Long-term efficacy of sertraline in the prevention of alcoholic relapses in alcohol-dependent patients:: A single-center, double-blind, randomized, placebo-controlled, parallel-group study

Background: Alcoholism may be related to dysfunction of the serotonergic system in some patients. Therapy with a selective serotonin reuptake inhibitor (SSRI) may help to reduce alcohol consumption in these patients. Objective: The aim of this study was to examine the long-term efficacy of the SSRI sertraline in preventing alcoholic relapse and in increasing the number of abstinent days after alcohol withdrawal in alcohol-dependent patients. Methods: Male patients who met the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised (DSM-III-R) diagnostic criteria for alcohol dependence with no concurrent disorders on Axis 1 participated in this single-center, double-blind, randomized, placebo-controlled, parallel-group study. All of the patients had been withdrawn from alcohol for 7 to 21 days when included in the study during their inpatient treatment and were followed up for 6 months with monthly assessments. Patients were given either two 50-mg capsules of sertraline hydrochloride daily (100 mg/d) or 2 placebo capsules daily. Results: A total of 59 patients (mean [SD] age, 43.8 [8.5] years) were enrolled (30 in the sertraline group and 29 in the placebo group). The 2 groups differed significantly in terms of the mean (SD) number of abstinent days (sertraline, 125.5 [60.6] days; placebo, 91.9 [66.4] days; P = 0.047). Although the percentage of relapse was lower in the sertraline group in all monthly assessments, the difference in percentage of relapse between the 2 groups reached statistical significance only at month 4 (P = 0.027). Conclusions: Sertraline seems to increase the number of abstinent days and thus has a preventive effect on alcoholic relapse. However, this finding needs to be supported by further controlled studies.