Early Treatment Response in Alcohol Dependence With Extended-Release Naltrexone
J Clin Psychiatry 2008;69(2):190-195
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: We sought to determine the time course for onset of
effect of intramuscular injectable extended-release naltrexone (XR-NTX), which
has demonstrated efficacy for alcohol dependence.
Method: A post hoc analysis of a randomized, double-blind,
placebo-controlled, multicenter study was conducted. In the study, actively
drinking men and women who met DSM-IV-TR criteria for alcohol dependence were
randomly assigned to receive injections of XR-NTX 380 mg (N = 205) or 190 mg (N
= 210) or placebo (N = 209) every 4 weeks for 24 weeks. Patients also received
12 sessions of standardized, low-intensity psychosocial intervention. Drinking
data were analyzed by month and, during the first month, by day to explore the
time course for onset of effect on heavy drinking days in patients receiving
XR-NTX versus placebo. The study data were collected between February 2002 and
Results: During the first month following injection, patients
receiving XR-NTX 380 mg had 37% fewer heavy drinking days versus placebo (p <
.01). By day 2, a significant reduction in the median number of drinks consumed
per day was observed in patients given XR-NTX 380 mg compared with placebo (p <
.05). By day 3, XR-NTX 380 mg resulted in a significant reduction in the
percentage of patients reporting heavy drinking compared with placebo (p <
.05); this reduction was maintained throughout the study. A dose-response
effect was observed, with intermediate results for XR-NTX 190 mg.
Conclusion: XR-NTX 380 mg provided a rapid onset of
therapeutic effect in the first 2 days after the first injection that was
sustained throughout the 24-week trial. Potential clinical implications of the
rapid, early onset of effect of this medication's delivery system for patients
who are dependent on alcohol include facilitation of early engagement in
treatment, motivation to continue treatment, and focus on the goals established