Brenna Ida Halvorsen, Waleur Karin Merethe, Benth Jūratė Šaltytė, Solli Kristin K, Mordal Jon, Løberg Else-Marie, Weimand Bente, Tanum Lars
Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway.
Department of Clinical Psychology, Faculty of Psychology, University of Bergen, Bergen, Norway.
Eur Addict Res. 2025;31(1):1-12. doi: 10.1159/000541431. Epub 2024 Nov 4.
The treatment efficacy of extended-release naltrexone (XR-NTX) for opioid use disorder (OUD) has been demonstrated in several studies, but not in naturalistic settings where opioid agonist treatment (OAT) is freely accessible. This study aimed to examine the different treatment outcomes of XR-NTX in a setting where the participants freely chose XR-NTX as a treatment option instead of OAT.
This was a 24-week open-label clinical prospective cohort study conducted in an outpatient setting at five hospitals in Norway. The study included 161 participants aged 18-65 years with OUD. Intramuscular injections of XR-NTX were administered every 4 weeks for 24 weeks. Measurements included retention in treatment, reasons for treatment discontinuation, days of use of opioids, other illicit substances and alcohol, level of heroin craving, treatment satisfaction, and adverse events (AEs).
Of 161 included participants, the mean age was 38 years, and 24% were women; 138 received at least one dose of the study medication (modified intention-to-treat [MITT] population), and mean time in treatment was 18.1 weeks (95% CI: 16.8-19.4). The majority of the MITT population (84; 60.9%) completed 24 weeks of treatment in the study. There was a significant decrease in the overall use of opioids (p < 0.001) and the use of alcohol, and other illicit substances were low. The participants generally reported high treatment satisfaction and low heroin cravings. Those who completed the 24 weeks of treatment reported significantly fewer days of opioid use (p < 0.001) and higher treatment satisfaction (p < 0.001) than those who discontinued treatment before 24 weeks. No serious AEs were directly related to XR-NTX use.
This study demonstrated high retention rates, decreased opioid use, and low use of other illicit substances and alcohol. Participants also reported low cravings for heroin and high treatment satisfaction. Completion of the full 24-week treatment resulted in lower opioid use and increased treatment satisfaction compared to those who discontinued treatment before 24 weeks. The observed higher retention and reduced opioid use, compared to other studies, may be attributed to participants' strong motivation for opioid abstinence facilitated by XR-NTX treatment.
多项研究已证实缓释纳曲酮(XR-NTX)对阿片类物质使用障碍(OUD)的治疗效果,但在可自由获取阿片类激动剂治疗(OAT)的自然环境中尚未得到证实。本研究旨在探讨在参与者自由选择XR-NTX而非OAT作为治疗方案的环境中,XR-NTX的不同治疗结果。
这是一项在挪威五家医院门诊进行的为期24周的开放标签临床前瞻性队列研究。该研究纳入了161名年龄在18至65岁之间的OUD患者。每4周进行一次肌肉注射XR-NTX,共持续24周。测量指标包括治疗留存率、治疗中断原因、阿片类物质使用天数、其他非法物质和酒精使用情况、海洛因渴求程度、治疗满意度以及不良事件(AE)。
在161名纳入的参与者中,平均年龄为38岁,24%为女性;138人接受了至少一剂研究药物(改良意向性治疗[MITT]人群),平均治疗时间为18.1周(95%CI:16.8 - 19.4)。大多数MITT人群(84人;60.9%)完成了研究中的24周治疗。阿片类物质的总体使用量显著下降(p < 0.001),酒精使用量也下降,且其他非法物质的使用量较低。参与者普遍报告治疗满意度高,海洛因渴求程度低。完成24周治疗的参与者报告的阿片类物质使用天数显著少于(p < 0.001)在24周前中断治疗的参与者,且治疗满意度更高(p < 0.001)。没有严重不良事件与使用XR-NTX直接相关。
本研究表明留存率高、阿片类物质使用减少、其他非法物质和酒精使用量低。参与者还报告海洛因渴求程度低且治疗满意度高。与在24周前中断治疗的参与者相比,完成完整24周治疗的参与者阿片类物质使用量更低,治疗满意度更高。与其他研究相比,观察到的更高留存率和阿片类物质使用减少可能归因于XR-NTX治疗促进了参与者对阿片类物质戒断的强烈动机。