[Injectable extended-release naltrexone for XXXX : an open label study of long-term safety and efficacy.]

@entity1 @entity4784
UNASSIGNED: Objective. To evaluate efficacy and safety of injectable extended-release naltrexone (XR-NTX, Vivitrol), an opioid receptor antagonist, in the treatment of @entity4784 , we carried out a 1-year open-label extension study. Material and methods. The study followed the initial 6-month randomized, double-blind, PBO-controlled investigation of XR-NTX, used in dose 380 mg, as a treatment for @entity4784 . The study was conducted at 13 clinical sites in Russia. The main measurements were monthly urine samples (efficacy) and adverse events (safety). Results and   onclusion. The open-label extension included 114 @entity1 (67 continued on XR-NTX and 47 switched from placebo). Overall, 62.3% (95% CI: 52.7%, 71.2%) of @entity1 completed the extension. Urine testing revealed that 50.9% (41.5%, 60.4%) were abstinent from opioids at all assessments during the 1-year open-label phase. Adverse events were reported by 21.1% of @entity1 . Elevations in liver function tests occurred in 16.7% of @entity1 . No severe adverse events were reported. The data obtained demonstrate the long-term safety and efficacy of XR-NTX in opioid dependent @entity1 .
