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Concerns about injectable naltrexone for opioid dependence, Wolfe Carrieri et al, The Lancet, 28 April 2011

Date: 01 May 2011

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In the latest volume of The Lancet, Evgeny Krupitsky and colleagues 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.

However, leading harm reduction specialists and doctors have raised concerns about the study and the FDA process in a commentary published in the same edition of the journal. According to Wolfe, Carrieri et al “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

Krupitsky et al ‘Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial

Wolfe, Carrieri et al ‘Concerns about injectable naltrexone for opioid dependence

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