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STAT Plus: FDA is urged to probe a Louisiana program for ‘illegally’ testing an addiction treatment on inmates

STAT Plus: FDA is urged to probe a Louisiana program for ‘illegally’ testing an addiction treatment on inmates



A consumer advocacy group and more than two dozen academics are demanding regulators investigate Louisiana corrections officials and a small company for testing an implantable version of an addiction treatment on inmates, but without following regulations governing clinical trials.

The pilot program involves sustained-release naltrexone implants, which are surgically inserted under the skin in the stomach. The medication is approved by the Food and Drug Administration as a tablet and injectable to treat alcohol and opioid dependence, but not a surgically implanted form of the drug.

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