Depot naltrexone use for opioid dependence in Australia : large-scale use of an unregistered medication in the absence of data on safety and efficacy

Editorial: We believe that the safety and efficacy of new treatments for drug dependence should be assessed by randomised controlled trials before they are used in routine clinical practice. We also believe that it is ethically questionable to engage in widespread use of pharmacological treatment that may hold patient risks outside drug regulatory systems, and in the absence of any monitoring of treatment quality or adverse events.Both principles have been abrogated in Australia over recent years, with the widespread use of an unregistered form of depot naltrexone for heroin dependence that has not been approved for any therapeutic use in Australia. The waiver of these standard requirements is worrisome, because of concerns about the safety of the drug when used in unselected opioid-dependent patients and a lack of rigorous data on its efficacy.