Efficacy and Tolerability of Long-Acting Injectable Naltrexone for Alcohol Dependence: A Randomized Controlled Trial
CONTEXT Alcohol dependence is a common disorder associated with significant morbidity and mortality. Naltrexone, an opioid antagonist, has been shown to be effective for treatment of alcohol dependence. However, adherence to daily oral pharmacotherapy can be problematic, and clinical acceptance and...
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Veröffentlicht in: | JAMA : the journal of the American Medical Association 2005-04, Vol.293 (13), p.1617-1625 |
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Zusammenfassung: | CONTEXT Alcohol dependence is a common disorder associated with significant
morbidity and mortality. Naltrexone, an opioid antagonist, has been shown
to be effective for treatment of alcohol dependence. However, adherence to
daily oral pharmacotherapy can be problematic, and clinical acceptance and
utility of oral naltrexone have been limited. OBJECTIVE To determine efficacy and tolerability of a long-acting intramuscular
formulation of naltrexone for treatment of alcohol-dependent patients. DESIGN, SETTING, AND PARTICIPANTS A 6-month, randomized, double-blind, placebo-controlled trial conducted
between February 2002 and September 2003 at 24 US public hospitals, private
and Veterans Administration clinics, and tertiary care medical centers. Of
the 899 individuals screened, 627 who were diagnosed as being actively drinking
alcohol-dependent adults were randomized to receive treatment and 624 received
at least 1 injection. INTERVENTION An intramuscular injection of 380 mg of long-acting naltrexone (n = 205)
or 190 mg of long-acting naltrexone (n = 210) or a matching volume
of placebo (n = 209) each administered monthly and combined with
12 sessions of low-intensity psychosocial intervention. MAIN OUTCOME MEASURE The event rate of heavy drinking days in the intent-to-treat population. RESULTS Compared with placebo, 380 mg of long-acting naltrexone resulted in
a 25% decrease in the event rate of heavy drinking days (P = .03) and 190 mg of naltrexone resulted in a 17% decrease
(P = .07). Sex and pretreatment abstinence
each showed significant interaction with the medication group on treatment
outcome, with men and those with lead-in abstinence both exhibiting greater
treatment effects. Discontinuation due to adverse events occurred in 14.1%
in the 380-mg and 6.7% in the 190-mg group and 6.7% in the placebo group.
Overall, rate and time to treatment discontinuation were similar among treatment
groups. CONCLUSIONS Long-acting naltrexone was well tolerated and resulted in reductions
in heavy drinking among treatment-seeking alcohol-dependent patients during
6 months of therapy. These data indicate that long-acting naltrexone can be
of benefit in the treatment of alcohol dependence. |
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ISSN: | 0098-7484 1538-3598 |
DOI: | 10.1001/jama.293.13.1617 |