Efficacy and safety of levetiracetam for the prevention of alcohol relapse in recently detoxified alcohol-dependent patients: a randomized trial.
BACKGROUND
Antiepileptics have been shown to reduce alcohol intake or to prevent relapse in patients with alcoholism.


OBJECTIVE
To investigate if the new antiepileptic levetiracetam (LEV) prevents relapse after detoxification compared with placebo in patients with alcohol dependence.


METHODS
Two hundred one patients were included in the prospective, randomized, double-blind, multicenter, placebo-controlled trial. After detoxification treatment and a screening period of 7 days, patients were randomized to treatment with LEV or placebo. Medication was administered in a fixed-dose schedule for 16 weeks. Primary outcome parameters were the overall rate and time to relapse with heavy drinking. Secondary outcome parameters were time to the first drink, craving, adherence, tolerability, and safety data (mean corpuscular volume, serum alanine aminotransferase, serum aspartate aminotransferase, γ-glutamyltransferase).


RESULTS
The rate of relapse and the time to relapse did not differ significantly between both groups, but less patients treated with LEV terminated treatment early compared with patients receiving placebo. Tolerability and safety data were similar in the LEV group compared with placebo.


CONCLUSIONS
Our data do not support a significant effect of LEV on relapse prevention in patients with alcohol dependence during the first 16 weeks of abstinence.
Department of Psychiatry and Psychotherapy, Charité-Universitätsmedizin Berlin, Charité Campus Mitte, Berlin, Germany.
Christoph
C
Richter
Susanne
S
Effenberger
Tom
T
Bschor
Udo
U
Bonnet
Christian
C
Haasen
Ulrich W
UW
Preuss
Andreas
A
Heinz
Anna
A
Förg
Katharina
K
Volkmar
Till
T
Glauner
Martin
M
Schaefer
D000293:Adolescent; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000188:drug therapy* / Q000517:prevention & control*; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D016739:Behavior, Addictive / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D008875:Middle Aged; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D055502:Secondary Prevention
D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam