Placebo-controlled trial of fluoxetine as an adjunct to relapse prevention in alcoholics.
OBJECTIVE
The authors tested the hypothesis that fluoxetine, when used in combination with relapse prevention psychotherapy, directly reduces relapse frequency and severity for alcoholics.


METHODS
The authors conducted a randomized, placebo-controlled trial of fluoxetine (up to a maximum of 60 mg/day) for 12 weeks in combination with weekly psychotherapy for 101 alcohol-dependent subjects who were not selected on the basis of comorbid major depression. Outcomes were measured at the end of treatment and 6 months after treatment.


RESULTS
Placebo-treated subjects were more complaint with the medication regimen and remained in the study longer than fluoxetine-treated subjects. There was significantly less alcohol consumption in both groups during treatment than before treatment. These effects persisted during the posttreatment period. Although fluoxetine treatment had no significant effects on alcohol consumption, it reduced Hamilton Depression Rating Scale scores more than placebo treatment among subjects with current major depression.


CONCLUSIONS
Fluoxetine at a dose of 60 mg/day is probably not of use for relapse prevention in alcoholics with mild to moderate alcohol dependence and no comorbid depression. In alcoholics with major depression, the drug may reduce depressive symptoms. Subsequent studies with fluoxetine should probably focus on more severely alcohol-dependent subjects or those with comorbid depression.
Kranzler
H R
HR
Department of Psychiatry, University of Connecticut Health Center, Farmington 06030-2103.
Burleson
J A
JA
Korner
P
P
Del Boca
F K
FK
Bohn
M J
MJ
Brown
J
J
Liebowitz
N
N
D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D000437:Alcoholism / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D003131:Combined Modality Therapy; D015897:Comorbidity; D003866:Depressive Disorder / Q000188:drug therapy / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010349:Patient Compliance; D010919:Placebos; D011613:Psychotherapy; D012008:Recurrence; D012720:Severity of Illness Index; D016896:Treatment Outcome
D010919:Placebos; D005473:Fluoxetine