• Evgeny Krupitsky, Edward V Nunes, Walter Ling, David R Gastfriend, Asli Memisoglu, and Bernard L Silverman.
• Bekhterev Research Psychoneurological Institute and St. Petersburg State Pavlov Medical University, Bekhtereva Street 3, St. Petersburg, Russian Federation. kruenator@gmail.com
• Addiction. 2013 Sep 1; 108 (9): 1628-37.

AimsTo describe drug use and safety with intramuscular injectable extended-release naltrexone (XR-NTX) in opioid dependence during a 1-year open-label extension phase.DesignFollowing 6 months of randomized, double-blind, placebo (PBO)-controlled injections given every 28 days, patients receiving XR-NTX 380 mg continued and PBO patients were switched to open-label XR-NTX, with monthly individual drug counseling, for a further year.SettingThirteen clinical sites in Russia.ParticipantsAdult opioid-dependent outpatients.MeasurementsMonthly urine samples; reports of craving and functioning; adverse events.FindingsFor the open-label extension (n = 114), 67 continued on XR-NTX and 47 switched from PBO during the double-blind phase to XR-NTX during the open-label phase. Overall, 62.3% (95% CI: 52.7%, 71.2%) completed the extension. Discontinuation occurred most commonly because of withdrawal of consent (18.4%) and loss to follow-up (11.4%); two patients discontinued as a result of lack of efficacy and one because of adverse events. 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 reported by 21.1% of patients were judged to be study drug-related. Injection site reactions were infrequent (6.1%) and the majority were mild. Elevations in liver function tests occurred for 16.7% of patients, but none of these elevations was judged to be clinically significant. No patients died, overdosed or discontinued as a result of severe adverse events.ConclusionsDuring a 1-year open-label extension phase of injectable XR-NTX for the prevention of relapse in opioid dependence, 62.3% of patients completed the phase and 50.9% were abstinent from opioids. No new safety concerns were evident.© 2013 Society for the Study of Addiction.

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