PDF(Pubmed)
Abstract：
BACKGROUND: There is uncertainty about whether criminal legal involvement (CLI) impacts the effectiveness of medications for opioid use disorder (MOUD). We aimed to determine whether CLI modifies the association between buprenorphine-naloxone (BUP-NX) vs. extended-release naltrexone (XR-NTX) and MOUD treatment outcomes.
METHODS: We conducted a secondary analysis of X:BOT, a 24-week multi-center randomized controlled trial comparing treatment outcomes between BUP-NX (n = 287) and XR-NTX (n = 283) in the general population. We used baseline Additional Severity-Index Lite responses to identify patients with recent CLI (n = 342), defined as active CLI and/or CLI in the past 30 days, and lifetime incarceration (n = 328). We explored recent CLI and lifetime incarceration as potential effect modifiers of BUP-NX vs. XR-NTX effectiveness on relapse, induction, and overdose. We conducted both intention-to-treat and per-protocol analyses for each outcome.
RESULTS: In intention-to-treat analyses, recent CLI modified the effect of BUP-NX vs. XR-NTX on odds of successful induction (p = 0.03) and hazard of overdose (p = 0.04), but it did not modify the effect on hazard of relapse (p = 0.23). All participants experienced lower odds of successful induction with XR-NTX compared to BUP-NX, but the relative likelihood of successful induction with BUP-NX was lower than XR-NTX among individuals with recent CLI (OR: 0.25, 95 % CI: 0.13-0.47, p < 0.001) compared to those without recent CLI (OR: 0.04, 95 % CI: 0.01-0.19, p < 0.001). Participants with recent CLI experienced similar hazard of overdose with XR-NTX and BUP-NX (HR: 1.12, 95 % CI: 0.42-3.01, p = 0.82), whereas those without recent CLI experienced greater hazard of overdose with XR-NTX compared to BUP-NX (HR: 12.60, 95 % CI: 1.62-98.03, p = 0.02). In per-protocol analyses, recent CLI did not modify the effect of MOUD on hazard of overdose (p = 0.10) or relapse (p = 0.41). Lifetime incarceration did not modify any outcome.
CONCLUSIONS: Compared to individuals without recent CLI, individuals with recent CLI experienced decreased relative effectiveness of BUP-NX compared to XR-NTX for induction and overdose outcomes. This highlights the importance of considering the impact of recent CLI on opioid use disorder treatment outcomes. Future research should explore the mechanisms through which recent CLI modifies MOUD effectiveness and aim to improve MOUD effectiveness for individuals with recent CLI.
METHODS: We conducted a secondary analysis of X:BOT, a 24-week multi-center randomized controlled trial comparing treatment outcomes between BUP-NX (n = 287) and XR-NTX (n = 283) in the general population. We used baseline Additional Severity-Index Lite responses to identify patients with recent CLI (n = 342), defined as active CLI and/or CLI in the past 30 days, and lifetime incarceration (n = 328). We explored recent CLI and lifetime incarceration as potential effect modifiers of BUP-NX vs. XR-NTX effectiveness on relapse, induction, and overdose. We conducted both intention-to-treat and per-protocol analyses for each outcome.
RESULTS: In intention-to-treat analyses, recent CLI modified the effect of BUP-NX vs. XR-NTX on odds of successful induction (p = 0.03) and hazard of overdose (p = 0.04), but it did not modify the effect on hazard of relapse (p = 0.23). All participants experienced lower odds of successful induction with XR-NTX compared to BUP-NX, but the relative likelihood of successful induction with BUP-NX was lower than XR-NTX among individuals with recent CLI (OR: 0.25, 95 % CI: 0.13-0.47, p < 0.001) compared to those without recent CLI (OR: 0.04, 95 % CI: 0.01-0.19, p < 0.001). Participants with recent CLI experienced similar hazard of overdose with XR-NTX and BUP-NX (HR: 1.12, 95 % CI: 0.42-3.01, p = 0.82), whereas those without recent CLI experienced greater hazard of overdose with XR-NTX compared to BUP-NX (HR: 12.60, 95 % CI: 1.62-98.03, p = 0.02). In per-protocol analyses, recent CLI did not modify the effect of MOUD on hazard of overdose (p = 0.10) or relapse (p = 0.41). Lifetime incarceration did not modify any outcome.
CONCLUSIONS: Compared to individuals without recent CLI, individuals with recent CLI experienced decreased relative effectiveness of BUP-NX compared to XR-NTX for induction and overdose outcomes. This highlights the importance of considering the impact of recent CLI on opioid use disorder treatment outcomes. Future research should explore the mechanisms through which recent CLI modifies MOUD effectiveness and aim to improve MOUD effectiveness for individuals with recent CLI.
摘要：
背景：关于刑事法律参与（CLI）是否会影响阿片类药物使用障碍（MOUD）药物的有效性存在不确定性。我们的目的是确定CLI是否改变丁丙诺啡-纳洛酮（BUP-NX）与纳曲酮缓释（XR-NTX）和MOUD治疗结果。
方法：我们对X：BOT，一项为期24周的多中心随机对照试验,比较普通人群中BUP-NX(n=287)和XR-NTX(n=283)的治疗结果.我们使用基线附加严重程度指数精简版反应来识别最近患有CLI的患者（n=342），定义为活动CLI和/或过去30天的CLI，终身监禁（n=328）。我们探索了最近的CLI和终身监禁作为BUP-NX与XR-NTX对复发的有效性，归纳法,和过量。我们对每个结果进行了意向治疗和符合方案分析。
结果：在意向治疗分析中，最近的CLI修改了BUP-NX与XR-NTX成功诱导的几率（p=0.03）和过量用药的危险（p=0.04），但它并没有改变对复发风险的影响(p=0.23).与BUP-NX相比，所有参与者使用XR-NTX成功诱导的几率均较低，但与近期未发生CLI的患者相比,BUP-NX成功诱导的相对可能性低于XR-NTX(OR:0.25,95%CI:0.13-0.47,p<0.001)(OR:0.04,95%CI:0.01-0.19,p<0.001).近期CLI的参与者经历了类似的XR-NTX和BUP-NX过量的危险（HR：1.12，95％CI：0.42-3.01，p=0.82），与BUP-NX相比,近期无CLI的患者服用XR-NTX的过量风险更大(HR:12.60,95%CI:1.62-98.03,p=0.02).在符合方案的分析中，近期CLI未改变MOUD对用药过量(p=0.10)或复发(p=0.41)的影响.终身监禁并没有改变任何结果。
结论：与最近没有CLI的个体相比，与XR-NTX相比,近期有CLI的个体在诱导和过量结局方面的相对有效性下降.这突出了考虑近期CLI对阿片类药物使用障碍治疗结果的影响的重要性。未来的研究应探索最近的CLI修改MOUD有效性的机制，并旨在提高近期CLI患者的MOUD有效性。
方法：我们对X：BOT，一项为期24周的多中心随机对照试验,比较普通人群中BUP-NX(n=287)和XR-NTX(n=283)的治疗结果.我们使用基线附加严重程度指数精简版反应来识别最近患有CLI的患者（n=342），定义为活动CLI和/或过去30天的CLI，终身监禁（n=328）。我们探索了最近的CLI和终身监禁作为BUP-NX与XR-NTX对复发的有效性，归纳法,和过量。我们对每个结果进行了意向治疗和符合方案分析。
结果：在意向治疗分析中，最近的CLI修改了BUP-NX与XR-NTX成功诱导的几率（p=0.03）和过量用药的危险（p=0.04），但它并没有改变对复发风险的影响(p=0.23).与BUP-NX相比，所有参与者使用XR-NTX成功诱导的几率均较低，但与近期未发生CLI的患者相比,BUP-NX成功诱导的相对可能性低于XR-NTX(OR:0.25,95%CI:0.13-0.47,p<0.001)(OR:0.04,95%CI:0.01-0.19,p<0.001).近期CLI的参与者经历了类似的XR-NTX和BUP-NX过量的危险（HR：1.12，95％CI：0.42-3.01，p=0.82），与BUP-NX相比,近期无CLI的患者服用XR-NTX的过量风险更大(HR:12.60,95%CI:1.62-98.03,p=0.02).在符合方案的分析中，近期CLI未改变MOUD对用药过量(p=0.10)或复发(p=0.41)的影响.终身监禁并没有改变任何结果。
结论：与最近没有CLI的个体相比，与XR-NTX相比,近期有CLI的个体在诱导和过量结局方面的相对有效性下降.这突出了考虑近期CLI对阿片类药物使用障碍治疗结果的影响的重要性。未来的研究应探索最近的CLI修改MOUD有效性的机制，并旨在提高近期CLI患者的MOUD有效性。
