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• W2012974586 abstract "In The Lancet, Evgeny Krupitsky and colleagues 1 Krupitsky E Nunes EV Ling W Illeperuma A Gastfriend DR Silverman BL Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011; (published online April 28.)https://doi.org/10.1016/S0140-6736(11)60358-9 Summary Full Text Full Text PDF Scopus (381) Google Scholar report on the use of injectable naltrexone for treatment of opioid dependence. Their report comes some months after the US Food and Drug Administration (FDA) approved use of the preparation for opioid-dependent patients on the basis of the same findings. The study by Krupitsky and colleagues suggests the strong potential of a once-monthly, extended-release formulation of injectable naltrexone for opioid addiction—the median proportion of weeks of confirmed abstinence was 90·0% in the depot naltrexone group compared with 35·0% in the placebo group (treatment effect 55% [95% CI 15·9–76·1], p=0·0002). The study is also striking, however, for the questions it raises about the FDA's approval processes and clinical trial ethics. Factors requiring scrutiny include paucity of efficacy data, adequacy of risk assessment (particularly of overdose risk in treatment dropouts), and the questionable ethics of a placebo-controlled trial when an accepted standard of treatment exists. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trialXR-NTX represents a new treatment option that is distinct from opioid agonist maintenance treatment. XR-NTX in conjunction with psychosocial treatment might improve acceptance of opioid dependence pharmacotherapy and provide a useful treatment option for many patients. Full-Text PDF" @default.
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• W2012974586 date "2011-04-01" @default.
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• W2012974586 title "Concerns about injectable naltrexone for opioid dependence" @default.
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• W2012974586 doi "https://doi.org/10.1016/s0140-6736(10)62056-9" @default.
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