Mortality during and following treatment with extended-release naltrexone based on data from two clinical trials

IF 3.9 2区医学 Q1 PSYCHIATRY

Drug and alcohol dependence Pub Date : 2025-06-11 DOI:10.1016/j.drugalcdep.2025.112737

L. Gjersing , L. Tanum , B. Weimand , K.K. Solli

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引用次数: 0

Abstract

Aims

To examine mortality during and in the first year following extended-release naltrexone (XR-NTX) treatment in patients with opioid use disorder (OUD).

Design

A prospective registry study.

Setting

Two clinical trials in Norway.

Participants

A total of 268 XR-NTX patients from two clinical trials conducted from 2013 to 2022.

Measurements

Data from the inclusion interviews were cross-linked with data from the Norwegian Cause of Death Registry. Mortality during treatment was estimated for the first 30 days following a XR-NTX injection, while mortality following treatment cessation was examined from day 31 after the final XR-NTX injection until death or censoring. Surviving individuals were censored at 365 days. Crude mortality rates (CMR) and 95 % Confidence Intervals (CI) were calculated per 100 person-years (PY). We used the Kaplan-Meier method to estimate the survival functions and the log-rank test to compare survival distributions across different groups; male (no/yes), age (<30 years, 30–39 years, >39 years), injecting drug use (IDU) (no/yes), lifetime non-fatal overdose (no/yes), and treatment duration for six months (no/yes).

Findings

Overall, there was only one non-drug-related death during treatment. In the year following treatment cessation,12 individuals died; two within the first 30 days. Ten of these deaths were from accidental poisonings. The overall CMR was 4.6 (95 % CI 2.5–7.5) per 100 PY,

Conclusion

The XR-NTX patients in the two clinical trials appeared to be protected from overdose death while in treatment but faced an elevated mortality risk in the year following treatment cessation.

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基于两项临床试验数据的缓释纳曲酮治疗期间和之后的死亡率

目的研究阿片类药物使用障碍（OUD）患者缓释纳曲酮（XR-NTX）治疗期间和治疗后第一年的死亡率。设计前瞻性注册研究。在挪威进行两项临床试验。参与者：来自2013年至2022年进行的两项临床试验的268例XR-NTX患者。测量方法纳入访谈的数据与挪威死因登记处的数据交叉链接。在注射XR-NTX后的前30天估计治疗期间的死亡率，而在最后一次注射XR-NTX后的第31天检查停止治疗后的死亡率，直到死亡或审查。幸存的人在365天内被审查。计算每100人年（PY）的粗死亡率（CMR）和95%置信区间（CI）。我们使用Kaplan-Meier法估计生存函数，并使用log-rank检验比较不同组间的生存分布；男性（否/是），年龄（<；30岁，30 - 39岁，>；39岁），注射吸毒（IDU）（否/是），终生非致命性药物过量（否/是），治疗时间6个月（否/是）。总体而言，在治疗期间只有一例与药物无关的死亡。在停止治疗后的一年中，有12人死亡；两个在前30天内。其中10人死于意外中毒。总体CMR为4.6 (95% CI 2.5-7.5) / 100 PY。结论两项临床试验中的XR-NTX患者在治疗期间似乎没有过量死亡，但在停止治疗后的一年内面临更高的死亡风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug and alcohol dependence 医学-精神病学

CiteScore

7.40

自引率

7.10%

发文量

409

审稿时长

41 days

期刊介绍： Drug and Alcohol Dependence is an international journal devoted to publishing original research, scholarly reviews, commentaries, and policy analyses in the area of drug, alcohol and tobacco use and dependence. Articles range from studies of the chemistry of substances of abuse, their actions at molecular and cellular sites, in vitro and in vivo investigations of their biochemical, pharmacological and behavioural actions, laboratory-based and clinical research in humans, substance abuse treatment and prevention research, and studies employing methods from epidemiology, sociology, and economics.