Combination treatment with nefazodone and cognitive-behavioral therapy for relapse prevention in alcohol-dependent men: a randomized controlled study.
BACKGROUND
This study evaluated the serotonergic antidepressant nefazodone versus placebo and specific cognitive-behavioral therapy (CBT) versus nondirective group counseling (GC) for relapse prevention in alcohol dependence in a large prospective, randomized, and placebo-controlled double-blind study at 3 German university centers.


METHODS
242 male patients fulfilling at least 5 criteria for alcohol dependence according to DSM-IV and ICD-10 were eligible, after detoxification, for one of the following treatment combinations: nefazodone + CBT, nefazodone + GC, placebo + CBT, and placebo + GC. Either nefazodone or placebo was administered throughout the evaluation period of 15 months. Either 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 were observed between the 4 treatment combinations in any outcome measure. After 52 weeks, the only significant difference was observed in the amount of ethanol consumed, with the nefazodone + GC group showing higher alcohol intake than the other 3 groups.


CONCLUSIONS
The results from this carefully designed clinical trial suggest that the 4 treatment combinations do not differ substantially in their efficacy for relapse prevention in nondepressed, severely alcohol-dependent patients. Nefazodone might even increase the risk of consuming a larger amount of ethanol per relapse in a subset of patients. CBT as performed in this study was associated with little additional benefit compared with structured GC.
Wetzel
Hermann
H
Department of Psychiatry, University of Mainz, Mainz, Germany.
Szegedi
Armin
A
Scheurich
Armin
A
Lörch
Bernd
B
Singer
Peter
P
Schläfke
Detlef
D
Sittinger
Helmut
H
Wobrock
Thomas
T
Müller
Matthias J
MJ
Anghelescu
Ion
I
Hautzinger
Martin
M
D000328:Adult; D000437:Alcoholism / Q000517:prevention & control* / Q000523:psychology / Q000628:therapy; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003376:Counseling; D003936:Diagnosis, Computer-Assisted; D006801:Humans; D008297:Male; D010879:Piperazines; D010919:Placebos; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D055502:Secondary Prevention; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*
D010879:Piperazines; D010919:Placebos; D014230:Triazoles; C051752:nefazodone