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We tested whether outpatient antagonist treatment with naltrexone could achieve similar results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Open\u2010label, non\u2010inferiority randomized trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Six US HIV primary care clinics.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Intervention<\/jats:title><jats:p>HIV clinic\u2010based extended\u2010release naltrexone (XR\u2010NTX; <jats:italic>n<\/jats:italic>\u2009=\u200955) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; <jats:italic>n<\/jats:italic>\u2009=\u200959).<\/jats:p><\/jats:sec><jats:sec><jats:title>Measurements<\/jats:title><jats:p>Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA\u2009\u2264\u2009200 copies\/ml) at 24\u2009weeks and secondary outcomes included past 30\u2010day use of opioids at 24\u2009weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Fewer XR\u2010NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR\u2010NTX (52.7%) and TAU (49.2%) [risk ratio (RR)\u2009=\u20091.064; 95% confidence interval (CI)\u2009=\u20090.748, 1.514] at 24\u2009weeks. Non\u2010inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre\u2010specified margin of 0.75 in intention\u2010to\u2010treat (ITT) analysis. The main secondary outcome of past 30\u2010day opioid use was comparable for XR\u2010NTX versus TAU (11.7 versus 14.8\u2009days; mean difference\u2009=\u2009\u22123.1; 95% CI\u2009=\u2009\u20138.7, 1.1) in ITT analysis. Among those initiating medication, XR\u2010NTX resulted in fewer days of opioid use compared with TAU in the past 30\u2009days (6.0 versus 13.6, mean difference\u2009=\u2009\u22127.6; 95% CI\u2009=\u2009\u201313.8, \u22120.2).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic\u2010based extended\u2010release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended\u2010release naltrexone used fewer opioids than those who received treatment as usual.<\/jats:p><\/jats:sec>","DOI":"10.1111\/add.15836","type":"journal-article","created":{"date-parts":[[2022,2,7]],"date-time":"2022-02-07T10:18:25Z","timestamp":1644229105000},"page":"1961-1971","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["HIV clinic\u2010based extended\u2010release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non\u2010blinded, randomized non\u2010inferiority trial"],"prefix":"10.1111","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5556-3597","authenticated-orcid":false,"given":"P. 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