{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T09:16:49Z","timestamp":1791191809354,"version":"4.1.0"},"reference-count":48,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2011,10,12]],"date-time":"2011-10-12T00:00:00Z","timestamp":1318377600000},"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":[[2012,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p><jats:bold>Aims\u2003<\/jats:bold> To provide controlled data on direct induction with buprenorphine\/naloxone (BNX) versus indirect buprenorphine (BPN)\u2010to\u2010BNX induction.<\/jats:p><jats:p><jats:bold>Design\u2003<\/jats:bold> Phase 4, prospective, randomized, active\u2010drug controlled, parallel\u2010group trial consisting of a 2\u2010day, double\u2010blind, double\u2010dummy induction phase followed by 26 days of open\u2010label treatment with BNX.<\/jats:p><jats:p><jats:bold>Setting\u2003<\/jats:bold> Nineteen sites in 10 European countries from March 2008 to December 2009.<\/jats:p><jats:p><jats:bold>Participants\u2003<\/jats:bold> A total of 187 opioid\u2010dependent men and women \u226515 years of age.<\/jats:p><jats:p><jats:bold>Measurements\u2003<\/jats:bold> The primary objective was assessment of patient response to direct and indirect BNX induction [proportion of patients receiving the scheduled 16\u2010mg BNX dose on day 3 (i.e. first day post\u2010induction)]. Secondary assessments included illicit drug use, treatment retention and compliance, withdrawal scale scores, and safety.<\/jats:p><jats:p><jats:bold>Findings\u2003<\/jats:bold> Patient response to direct\u2010 versus indirect\u2010BNX induction was similar [direct 91.4% (85\/93) versus indirect 90.4% (85\/94); 95% confidence interval (CI): \u22127.3%, 9.2%]. Rapid dose induction (16\u2003mg of BPN equivalent on day 2) was acceptable and 72% of patients completed treatment (day 28). There were no significant differences in secondary measures across groups. An average BNX maintenance dose of 15.3\u2003mg across groups was associated with substantial reductions in illicit opioid use and no self\u2010reported intravenous misuse. Treatment compliance and retention rates were similar (98.5% and 81.3%, respectively). Treatment\u2010emergent adverse event rates were comparable: 75% versus 74% for direct\u2010 versus indirect\u2010induction groups, respectively.<\/jats:p><jats:p><jats:bold>Conclusions\u2003<\/jats:bold> Direct buprenorphine\/naloxone induction was a safe and effective strategy for maintenance treatment of opioid dependence. Response to high\u2010dose direct buprenorphine\/naloxone induction appears to be similar to indirect buprenorphine\u2010to\u2010buprenorphine\/naloxone induction and was not associated with reports of intravenous buprenorphine\/naloxone misuse.<\/jats:p>","DOI":"10.1111\/j.1360-0443.2011.03577.x","type":"journal-article","created":{"date-parts":[[2011,7,12]],"date-time":"2011-07-12T21:06:13Z","timestamp":1310504773000},"page":"142-151","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine\/naloxone induction in heroin\u2010dependent individuals"],"prefix":"10.1111","volume":"107","author":[{"given":"Leslie","family":"Amass","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vilma","family":"Pukeleviciene","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilis","family":"Subata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ant\u00f3nio Rocha","family":"Almeida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Chiara","family":"Pieri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"D'Egidio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zdenka","family":"Stankova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ant\u00f3nio","family":"Costa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bobby P.","family":"Smyth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Slavko","family":"Sakoman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Wei","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Strang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,10,12]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200411190-00010"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)61311-2"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/508184"},{"key":"e_1_2_8_5_2","first-page":"43","volume-title":"The Chemistry of Mind\u2010Altering Drugs: History, Pharmacology, and Cultural Context","author":"Perrine D. 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