Oxcarbazepine--efficacy and tolerability during treatment of alcohol withdrawal: a double-blind, randomized, placebo-controlled multicenter pilot study.
OBJECTIVE
Alcohol withdrawal syndrome (AWS) is a serious complication of alcohol dependence and often requires intensive medical treatment. Antiepileptic drugs (AEDs) have been shown to be as efficacious in the treatment of AWS in several controlled trials as benzodiazepines and superior to placebo in relieving alcohol withdrawal symptoms. Oxcarbazepine (OXC), a newer anticonvulsive drug, has a favorable safety profile over carbamazepine (CBZ) and other older AEDs due to its excellent efficacy and better side-effect profile.


METHODS
The efficacy and tolerability of OXC versus placebo were investigated in 50 inpatients during a 6-day treatment of alcohol withdrawal in a 4-site, double-blind, randomized, placebo-controlled pilot study. The amount of rescue medication of clomethiazole (CLO) capsules needed was chosen as the primary variable. The data were collected between May 2003 and September 2004.


RESULTS
No initial differences were found regarding sociodemographic data and alcohol-related parameters, indicating successful randomization. No differences were found in the need for rescue medication CLO, decrease of withdrawal symptoms, or craving for alcohol between the OXC and the placebo group. Subjectively experienced side effects, normalization of vegetative parameters, craving, or improvement of psychopathological parameters were not different between the groups.


CONCLUSIONS
Despite the negative finding, which may be attributable to the design of the study, OXC still poses an interesting alternative to CBZ and other drugs because other studies have found it not only as efficient but also as having no addictive potential, while additionally possessing an anti-craving effect. Therefore, well-designed investigations with larger cohorts are required to further elucidate this issue.
Koethe
Dagmar
D
Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.
Juelicher
Antje
A
Nolden
Brit M
BM
Braunwarth
Wolf-Dietrich
WD
Klosterkötter
Joachim
J
Niklewski
Günter
G
Wodarz
Norbert
N
Klatt
Jan
J
Burtscheidt
Wilhelm
W
Gaebel
Wolfgang
W
Markus Leweke
F
F
D000328:Adult; D000437:Alcoholism / Q000523:psychology / Q000534:rehabilitation; D016739:Behavior, Addictive / Q000188:drug therapy / Q000523:psychology; D002220:Carbamazepine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D000431:Ethanol / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
C476610:oxcarbamazepine; D002220:Carbamazepine; D000431:Ethanol