New Therapeutic Options for Alcohol Dependence: Long-Acting Intramuscular Formulations of Naltrexone
J Clin Psychiatry 2006;67(suppl 14):30-34
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Results of oral therapy for alcohol dependence have been inconsistent, in part because of poor
medication adherence. A newly approved, extended-release intramuscular formulation of naltrexone
(XR-NTX) may have advantages over oral formulations in terms of adherence. One randomized,
double-blind, placebo-controlled trial demonstrated that treatment with XR-NTX significantly decreased
the number of heavy-drinking days compared with placebo treatment among patients who had
a current DSM-IV diagnosis of alcohol dependence. Another trial, of a different investigational longacting
intramuscular formulation of naltrexone (poly [DL-] lactide polymer; DL-NTX), found that
time to first drinking day was significantly greater among alcohol-dependent (DSM-IV) subjects using
DL-NTX than among those using placebo. Time to first drinking day and cumulative abstinent
days were significantly greater among alcohol dependent (DSM-IV) subjects using DL-NTX than
among those using placebo. However, the primary outcome measure, cumulative non-heavy drinking
days, was not significantly different between the DL-NTX and the placebo groups. Treatment with
long-acting intramuscular formulations of naltrexone is generally well tolerated. Nausea, headache,
injection-site reactions, and fatigue are the most common adverse events.