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An injectable, extended-release form of the opioid receptor antagonist naltrexone, approved by the FDA for treatment of alcohol dependence in 2006, was approved in 2010 for prevention of relapse to opioid dependence as well. The 2010 approval was based largely on a manufacturer-sponsored, double-blind trial that has now been published.
Investigators in Russia (where opioid agonist maintenance therapy is not available) randomized 250 patients to intramuscular injections of naltrexone (380 mg) or placebo every 4 weeks for 24 weeks. Patients (mean age, 30; 89% men) had been opioid dependent for an average of 10 years, had completed up to 30 days of inpatient detoxification, and were opioid-free for at least 7 days. Patients self-reported opioid…