{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T14:11:22Z","timestamp":1775743882937,"version":"3.50.1"},"reference-count":24,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,11,20]],"date-time":"2018-11-20T00:00:00Z","timestamp":1542672000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Indivior Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pacific Psychiatry"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The purpose of the study is to evaluate the efficacy and safety of buprenorphine\/naloxone sublingual tablets for the treatment of opioid dependence in Chinese adults.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, double\u2010blind, placebo\u2010controlled study included four periods: induction (3\u20105\u00a0days), stabilization (7\u201021\u00a0days), randomization\/treatment (6\u00a0weeks), and postmedication follow\u2010up (1\u00a0week). A total of 442 participants with opioid dependence were enrolled; 260 were randomized to buprenorphine\/naloxone or placebo. The primary outcome was retention in treatment, defined as the time from randomization to treatment completion or treatment failure. Secondary outcomes included maximum consecutive days of abstinence from opioids, self\u2010reported craving and opioid withdrawal symptoms, and urine drug screen results. Safety assessments included adverse event reporting, electrocardiograms, clinical laboratory tests, vital signs, and prior\/concomitant medications.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The median treatment retention time (95% confidence internal) with buprenorphine\/naloxone was 32\u00a0days (26\u201038) versus 6\u00a0days (5\u20108) for placebo, with a Cox hazard ratio of 0.28 (95% confidence interval, 0.21\u20100.38; <jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.0001). The median maximum consecutive days of abstinence (95% confidence interval) was: buprenorphine\/naloxone, 21\u00a0days (26\u201038); placebo, 5\u00a0days (5\u20108) with a Cox hazard ratio of 0.38 (95% confidence interval, 0.25\u20100.60; <jats:italic>P\u00a0&lt;<\/jats:italic>\u00a00.0001). Withdrawal and craving symptoms were significantly milder with buprenorphine\/naloxone versus placebo (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001). Urine drug screen results indicated significantly lower opioid usage in the buprenorphine\/naloxone group compared with placebo (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001). The most commonly reported adverse events in the buprenorphine\/naloxone group during treatment were aspartate aminotransferase increased and nasopharyngitis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>Efficacy and safety results from this clinical trial support a positive benefit\u2010risk ratio for buprenorphine\/naloxone sublingual tablet use in the treatment of an opioid\u2010dependent Chinese population.<\/jats:p><\/jats:sec>","DOI":"10.1111\/appy.12344","type":"journal-article","created":{"date-parts":[[2018,11,21]],"date-time":"2018-11-21T01:15:22Z","timestamp":1542762922000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Treatment of opioid dependence with buprenorphine\/naloxone sublingual tablets: A phase 3 randomized, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"11","author":[{"given":"XuYi","family":"Wang","sequence":"first","affiliation":[{"name":"The Second Xiangya Hospital of Central South University  Changsha China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haifeng","family":"Jiang","sequence":"additional","affiliation":[{"name":"Shanghai Mental Health Center Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Zhao","sequence":"additional","affiliation":[{"name":"Shanghai Mental Health Center Shanghai Jiao Tong University School of Medicine  Shanghai China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jing","family":"Li","sequence":"additional","affiliation":[{"name":"West China Hospital of Sichuan University  Sichuan Sheng China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Gray","sequence":"additional","affiliation":[{"name":"Indivior PLC  Slough UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lixia","family":"Sheng","sequence":"additional","affiliation":[{"name":"Beijing An Ding Hospital Capital Medical University  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Li","sequence":"additional","affiliation":[{"name":"Wuhan Mental Health Center  Wuhan China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiaodong","family":"Li","sequence":"additional","affiliation":[{"name":"Huayou Healthcare  Guangzhou China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walter","family":"Ling","sequence":"additional","affiliation":[{"name":"University of California at Los Angeles  Los Angeles CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Li","sequence":"additional","affiliation":[{"name":"Medical Research &amp; Biometrics Center, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, and Peking Union Medical College  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Hao","sequence":"additional","affiliation":[{"name":"The Second Xiangya Hospital of Central South University  Changsha China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,11,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/313549"},{"key":"e_1_2_8_3_1","volume-title":"Annual report on drug control in China","author":"China National Narcotic Control Committee","year":"2016"},{"key":"e_1_2_8_4_1","first-page":"205","article-title":"Traditional Chinese and Indian medicine in the treatment of opioid\u2010dependence: A review","volume":"3","author":"Doosti F.","year":"2013","journal-title":"Avicenna Journal of Phytomedicine"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200544070-00001"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/QAI.0b013e3182097537"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0376-8716(98)00008-8"},{"key":"e_1_2_8_8_1","unstructured":"Handford C. 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