Norwegian Centre for Addiction Research, University of Oslo, Oslo, Norway.
Department of Research and Development in Mental Health, Akershus University Hospital, Loerenskog, Norway.
Addiction. 2018 Oct;113(10):1840-1849. doi: 10.1111/add.14278. Epub 2018 Jun 22.
This is a follow-up study of a previously published randomized clinical trial conducted in Norway that compared extended-release naltrexone (XR-NTX) to buprenorphine-naloxone (BP-NLX) over 3 months. At the conclusion of the trial, participants were offered their choice of study medication for an additional 9 months. While BP-NLX was available at no cost through opioid maintenance treatment programmes, XR-NTX was available only through study participation, accounting for why almost all participants chose XR-NTX in the follow-up. The aim of this follow-up study was to compare differences in outcome between adults with opioid dependence continuing XR-NTX and those inducted on XR-NTX for a 9-month period, on measures of effectiveness, safety and feasibility.
In this prospective cohort study, participants were either continuing XR-NTX, changed from BP-NLX to XR-NTX or re-included into the study and inducted on XR-NTX treatment.
Five urban, out-patient addiction clinics in Norway.
Opioid-dependent adults continuing (n = 54) or inducted on (n = 63) XR-NTX.
XR-NTX administrated as intramuscular injections (380 mg) every fourth week.
Data on retention, use of heroin and other illicit substances, opioid craving, treatment satisfaction, addiction-related problems and adverse events were reported every fourth week.
Nine-month follow-up completion rates were 51.9% among participants continuing XR-NTX in the follow-up and 47.6% among those inducted on XR-NTX. Opioid abstinence rates were, respectively, 53.7 and 44.4%. No significant group differences were found in use of heroin and other opioids.
Opioid-dependent individuals who elect to switch from buprenorphine-naltrexone treatment after 3 months to extended-release naltrexone treatment for 9 months appear to experience similar treatment completion and abstinence rates and similar adverse event profiles to individuals who had been on extended-release naltrexone from the start of treatment.
这是先前在挪威进行的一项随机临床试验的后续研究，该研究比较了 3 个月的缓释纳曲酮（XR-NTX）和丁丙诺啡-纳洛酮（BP-NLX）。试验结束时，为参与者提供了他们选择的研究药物，再使用 9 个月。虽然 BP-NLX 通过阿片类药物维持治疗计划免费提供，但 XR-NTX 只能通过研究参与获得，这就是为什么在随访中几乎所有参与者都选择 XR-NTX 的原因。本后续研究的目的是比较继续使用 XR-NTX 的阿片类药物依赖成年人与接受 XR-NTX 9 个月诱导治疗的成年人在疗效、安全性和可行性方面的差异。
在这项前瞻性队列研究中，参与者要么继续使用 XR-NTX，要么从 BP-NLX 转为 XR-NTX，要么重新纳入研究并接受 XR-NTX 治疗。
挪威五个城市的门诊成瘾诊所。
继续（n=54）或开始（n=63）使用 XR-NTX 的阿片类药物依赖成年人。
每周四肌内注射 XR-NTX（380mg）。
每四周报告一次保留率、海洛因和其他非法药物的使用情况、阿片类药物渴求、治疗满意度、成瘾相关问题和不良事件的数据。
继续在随访中使用 XR-NTX 的参与者的 9 个月随访完成率为 51.9%，开始使用 XR-NTX 的参与者为 47.6%。阿片类药物戒断率分别为 53.7%和 44.4%。未发现两组在海洛因和其他阿片类药物使用方面存在显著差异。
选择在 3 个月后从丁丙诺啡-纳洛酮治疗转为 9 个月的缓释纳曲酮治疗的阿片类药物依赖个体，似乎具有相似的治疗完成率和戒断率，以及与从治疗开始就使用缓释纳曲酮的个体相似的不良事件谱。
