{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:58:53Z","timestamp":1787317133083,"version":"build-2736575974"},"reference-count":26,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2013,5,24]],"date-time":"2013-05-24T00:00:00Z","timestamp":1369353600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Addiction"],"published-print":{"date-parts":[[2013,9]]},"abstract":"Abstract<\/jats:title>\n \n Aims<\/jats:title>\n \n To describe drug use and safety with intramuscular injectable extended\u2010release naltrexone (\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n ) in opioid dependence during a 1\u2010year open\u2010label extension phase.\n <\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n \n Following 6 months of randomized, double\u2010blind, placebo (PBO)\u2010controlled injections given every 28 days, patients receiving\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n 380\u2009mg continued and PBO patients were switched to open\u2010label\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n , with monthly individual drug counseling, for a further year.\n <\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n \n Thirteen clinical sites in\n R<\/jats:styled-content>\n ussia.\n <\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Adult opioid\u2010dependent outpatients.<\/jats:p>\n <\/jats:sec>\n \n Measurements<\/jats:title>\n Monthly urine samples; reports of craving and functioning; adverse events.<\/jats:p>\n <\/jats:sec>\n \n Findings<\/jats:title>\n \n For the open\u2010label extension (\n n<\/jats:italic>\n \u2009=\u2009114), 67 continued on\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n and 47 switched from PBO during the double\u2010blind phase to\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n during the open\u2010label phase. Overall, 62.3% (95%\n CI<\/jats:styled-content>\n : 52.7%, 71.2%) completed the extension. Discontinuation occurred most commonly because of withdrawal of consent (18.4%) and loss to follow\u2010up (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\u2010year open\u2010label phase. Adverse events reported by 21.1% of patients were judged to be study drug\u2010related. 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.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n During a 1\u2010year open\u2010label extension phase of injectable\n XR<\/jats:styled-content>\n \u2010\n NTX<\/jats:styled-content>\n 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.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/add.12208","type":"journal-article","created":{"date-parts":[[2013,5,24]],"date-time":"2013-05-24T04:26:41Z","timestamp":1369369601000},"page":"1628-1637","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":113,"title":["Injectable extended\u2010release naltrexone (\n XR<\/scp>\n \u2010\n NTX<\/scp>\n ) for opioid dependence: long\u2010term safety and effectiveness"],"prefix":"10.1111","volume":"108","author":[{"given":"Evgeny","family":"Krupitsky","sequence":"first","affiliation":[{"name":"Bekhterev Research Psychoneurological Institute and St. Petersburg State Pavlov Medical University St. Petersburg Russian Federation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward V.","family":"Nunes","sequence":"additional","affiliation":[{"name":"New York State Psychiatric Institute and Department of Psychiatry Columbia University New York City NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Ling","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Biobehavioral Sciences University of California Los Angeles Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Gastfriend","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asli","family":"Memisoglu","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard L.","family":"Silverman","sequence":"additional","affiliation":[{"name":"Alkermes, Inc. Waltham MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2013,5,24]]},"reference":[{"key":"e_1_2_6_2_1","volume-title":"Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings","author":"Substance Abuse and Mental Health Services Administration","year":"2010"},{"key":"e_1_2_6_3_1","unstructured":"UNODC.World Drug Report 2010 (United Nations Publication Sales No. E.10.XI.13).2010. Available at:http:\/\/www.unodc.org\/documents\/wdr\/WDR_2010\/World_Drug_Report_2010_lo\u2010res.pdf(accessed 22 August 2012). 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