Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.
Randomized controlled pilot trial of naloxone-on-release to prevent post-prison opioid overdose deaths.
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DOI：
10.1111/add.13668
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发表时间：
2017-03
期刊：
影响因子：
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通讯作者：
Bird SM
中科院分区：
文献类型：
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作者：
Parmar MK;Strang J;Choo L;Meade AM;Bird SM
纳洛酮是一种阿片类药物拮抗剂，用于阿片类药物过量后的紧急复苏。有海洛因注射史的囚犯在出狱后不久就有很高的与毒品有关的死亡风险。纳洛酮调查估计（N-ALIVE）试点试验（ISRCTN 34044390）测试了在英格兰向合格囚犯随机提供纳洛酮释放（NOR）的可行性措施。平行组随机对照初探性试验。英国监狱共有1685名成人海洛因注射者，随机化前至少被监禁7天，自上次N-ALIVE释放后3个月内和6个月以上释放。使用1：1最小化，囚犯在释放时随机接受含有纳洛酮的单次“救援”注射的包装或没有注射器的对照包装。根据先前的预期对关键可行性结局进行了测试：参与（14所英国监狱; 2800名囚犯），同意（随机化75%），返回的囚犯自我问卷（RPSQ：207），NOR携带（前4周75%）和过量存在（80%）。监狱（16）和囚犯（1685）愿意参与[知情同意率，95%置信区间（CI）= 70-74%];收到218份RPSQ; NOR携带（95% CI = 63-79%）和药物过量（95% CI = 75-84%）符合预期。我们在30个月内将842名随机分配到NOR组，将843名随机分配到对照组，但提前停止，因为只有三分之一的NOR给药是前囚犯。在2014年12月9日之前释放的1557名随机化受试者中，登记了9例释放后12周内的死亡。在监狱人群中进行大型随机试验是可行的。在监狱释放前提供带回家的紧急纳洛酮可能是一种挽救生命的临时措施，以防止前囚犯和更广泛人群中的海洛因过量死亡。
Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Parallel‐group randomized controlled pilot trial. English prisons. A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population.