Background: This study evaluates the serotonergic antidepressant nefazodone (SSRI) vs placebo (PL) and specific cognitive-behavioral therapy (CBT) vs nondirective group counseling (GC) for relapse prevention in alcohol dependence in a large, prospective, randomized and placebo-controlled, double-blind study at three German university centers.
Methods: Male patients fulfilling at least five criteria for alcohol dependence according to DSM-IV and ICD-10 were eligible, after detoxification, for one of the following treatment combinations: SSRI+CBT, SSRI+GC, PL+CBT, and PL+GC. The SSRI or PL were administered throughout the evaluation period of 15 months. CBT or GC was applied during the first 12 weeks as group therapy according to operationalized manuals. The main outcome measures (assessed at 3 and 12 months of treatment) were the cumulative number of abstinent days, the amount of ethanol consumed during specified evaluation periods of 3 and 12 months, the number of relapses, and the duration of time until first relapse.
Results: After 12 weeks of treatment, no statistically significant differences in any outcome measure were observed between the four treatment combinations. After 52 weeks, the only significant difference was observed in the amount of ethanol consumed, with the SSRI+GC group showing higher intake.
Conclusions: The results of this carefully designed clinical trial suggest that the four treatment combinations do not differ substantially in their efficacy in relapse prevention of nondepressed, severely alcohol-dependent patients. Nefazodone may even promote ethanol drinking in a subset of patients. Cognitive-behavioral therapy as performed in this study was associated with little additional benefit compared with structured GC.