对阿片类药物使用障碍的长效纳尔特雷克松植入物 (iSTEP-N):首次在人身上进行I期试验
Journal of addiction medicine
|January 26, 2026
概括
在健康的成年人中,iSTEP-N植入物在12周内显示了持续的治疗性纳尔特雷克松水平. 这种新的生物可吸收植入物显示出改善成治疗的坚持有希望.
科学领域:
- 药理学 药理学是指药理学的学科.
- 药物输送系统 药物输送系统
- 临床试验 临床试验
背景情况:
- 阿片类药物使用障碍 (OUD) 是一个重大的公共卫生危机.
- 纳尔特雷是一种有效的阿片类抗体,但每天口服配方的坚持是具有挑战性的.
- 需要新的输送系统来改善长期的纳尔特雷克森守和治疗结果.
研究的目的:
- 评估iSTEP-N的安全性和药理动力学,这是一种新的生物可吸收的皮下纳尔特雷克森植入物.
- 评估12周内纳尔特雷释放概况和血度.
- 确定iSTEP-N提供持续治疗性纳尔特雷克松暴露的潜力.
主要方法:
- 进行了一项单中心,随机,双盲,安慰剂控制,单次上升剂量试验.
- 16名健康成年人接受了4.8g的纳尔特雷克松植入物,9.6g的纳尔特雷克松植入物或安慰剂.
- 安全结果和血纳尔特雷克松度被监测了12周.
主要成果:
- 9.6g的iSTEP-N剂量使得血纳尔特雷克松在2.0 ng/mL的阿片类药物阻断值以上维持了12周.
- 4.8克的剂量提供了6周的治疗水平.
- 大约22%的植入物药物含量在12周内释放;没有严重的不良事件报告,尽管50%的9.6g组经历过渡性血清瘤.
结论:
- 9.6g的iSTEP-N植入物显示了持续的治疗性纳尔特雷克松暴露12周,具有良好的安全性.
- 植入物释放的药物含量不到四分之一,这表明可能有更长的作用时间.
- 需要进一步的研究来评估OUD患者的长期疗效,安全性和可行性.
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