A randomized comparison of extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults with opioid use disorder

A randomized comparison of extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults with opioid use disorder
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DOI:
10.1016/j.jsat.2020.108076
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发表时间:
2020-10-01
影响因子:
3.9
通讯作者:
McCrady, Barbara
McCrady, Barbara
中科院分区:
医学2区
文献类型:
--
作者:
Farabee, David;Condon, Timothy;McCrady, Barbara

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阿片类药物使用在涉及司法的成年人中的高流行率使监狱成为启动阿片类药物使用障碍(OUD)治疗的特殊环境,但提供这些干预措施的最佳策略仍然没有得到很好的理解。本研究的目的是进行一项随机对照试验,以评估延长释放纳洛酮(XR-NTX,Vivitrol(R); Alkermes Inc)单独或与患者导航(XR-NTX + PN)结合治疗OUD囚犯的有效性。我们将135名患有中度至重度OUD的被判刑监狱囚犯随机分为(1)XR-NTX;(2)XR-NTX + PN;或(3)加强药物教育的常规治疗(ETAU),每一种都在出狱前开始。我们计划在发布后1、3、6和12个月进行随访数据评估。主要结局为阿片类药物使用(基于时间轴随访访谈和成瘾严重程度指数)和释放后6个月OUD符合CIDI DSM-5标准。我们还测量了治疗依从性、艾滋病毒风险和累犯率。XR-NTX参与者平均接受了7次注射中的2.26次,而XR-NTX + PN参与者平均接受了2.93次注射(Cohen d = 0.33,95% CI:-0.09至0.74)。XR-NTX + PN组36%的患者至少参加了一次释放后PN治疗。我们发现,从监狱释放后6个月,任何阿片类药物使用的主要结局(ETAU:17%,XR-NTX:16%,XR-NTX + PN:29%)和过去30天的OUD(ETAU:8%,XR-NTX:11%,XR-NTX + PN:10%)的研究条件没有显著差异。两组之间再次被捕和艾滋病毒风险的次要结果也相似,除了在12个月时XR-NTX条件下的性相关艾滋病毒风险较低。本研究未显示XR-NTX或XR-NTX + PN在阿片类药物使用或累犯结局方面相对于ETAU的上级结局。然而,它确实强调了在监狱中开始治疗的OUD患者坚持XR-NTX和PN干预的困难。
The high prevalence of opioid use among justice-involved adults make jails an exceptional setting to initiate opioid use disorder (OUD) treatment, but optimal strategies for delivering these interventions are still not well understood. The objective of this study was to conduct a randomized controlled trial to assess the effectiveness of extended-release naltrexone (XR-NTX, Vivitrol (R); Alkermes Inc) alone or in conjunction with patient navigation (XR-NTX + PN) for jail inmates with OUD. We randomized a sample of 135 sentenced jail inmates with moderate to severe OUD to (1) XR-NTX only; (2) XR-NTX + PN; or (3) enhanced treatment-as-usual (ETAU) with drug education, each initiated prior to release from jail. We scheduled follow-up data assessments at 1, 3, 6, and 12 months post-release. Primary outcomes were opioid use (based on Timeline Followback Interview and Addiction Severity Index) and meeting CIDI DSM-5 criteria for OUD 6 months postrelease. We also measured treatment adherence, HIV risk, and recidivism. XR-NTX participants received a mean of 2.26 of 7 possible injections compared to XR-NTX + PN participants, who received a mean of 2.93 injections (Cohen's d = 0.33, 95% CI: -0.09 to 0.74). Thirty-six percent of patients in XR-NTX + PN attended at least one postrelease PN session. We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%). Secondary outcomes of rearrest and HIV risk also were similar across groups, with the exception of lower sex-related HIV risk among those in the XR-NTX condition at 12 months. This study did not show superior outcomes of XR-NTX or XR-NTX + PN with regard to opioid use or recidivism outcomes, relative to ETAU. It did, however, highlight the difficulties with adherence to XR-NTX and PN interventions in OUD patients initiating treatment in jail.