High induction rate onto extended-release naltrexone for people with opioid use disorder: experiences from a Norwegian naturalistic study.

IF 3.2 2区 医学 Q1 SUBSTANCE ABUSE
Jon Mordal, Farid Juya, Line Holtan, John-Kåre Vederhus, Arild Opheim, Ida H Brenna, Asle E Enger, Bente Weimand, Kristin Klemmetsby Solli, Lars Tanum
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引用次数: 0

Abstract

Background: For people with opioid use disorder (OUD), extended-release naltrexone (XR-NTX) is an effective antagonist treatment option. However, successful opioid tapering and abstinence is a prerequisite for XR-NTX induction and has repeatedly been reported as a major barrier to effective treatment. The aims of this study were to describe XR-NTX induction rates, reasons for incomplete induction, and extraordinary complications reported during the induction phase. We also compared sociodemographic and clinical variables among those who did and did not complete induction onto XR-NTX.

Methods: This naturalistic, multicenter, and open-label Norwegian study of XR-NTX included men and women aged 18-65 who had severe OUD. Most participants were referred to inpatient medically managed opioid withdrawal and received individualized pharmacological and psychosocial treatment according to clinical assessment and national guidelines. After opioid withdrawal, the participants underwent a minimum of three opioid-free days prior to XR-NTX induction. Variables were collected through baseline assessments and a retrospective patient chart review. XR-NTX induction completers and non-completers were compared via bivariate and logistic regression analyses.

Results: Of 129 participants with recent opioid use at inclusion, 106 (82%) completed XR-NTX induction. Induction was initiated in an inpatient setting for 116 participants (90%) and extraordinary complications were noted for 19 (15%) patients. Withdrawal symptoms and ambivalence were the most common reasons for non-completion, each noted in 75% of the cases. As compared with those who successfully completed induction, non-completers more often reported lifetime hepatitis (78% vs. 52%, p = 0.017), had a longer period of current substance use (mean 119 vs. 54 months, p = 0.001), and more frequently used methadone prior to study inclusion (43% vs. 8%, p < 001). In logistic regression analyses, methadone use was the only significant factor and was negatively associated with completion (odds ratio 0.20, 95% confidence interval = 0.05-0.72, p = 0.014).

Conclusion: The results demonstrate the safety, efficacy and tolerability of a Norwegian opioid withdrawal and XR-NTX induction procedure. Although the present induction rate was high, our findings indicate that methadone users need special attention and tailored interventions regarding opioid withdrawal management and XR-NTX induction.

Trial registration: The study is registered at clinicaltrials.gov (NCT03647774).

阿片类药物使用障碍患者缓释纳曲酮诱导率高:来自挪威自然主义研究的经验。
背景:对于阿片类药物使用障碍(OUD)患者,缓释纳曲酮(XR-NTX)是一种有效的拮抗剂治疗选择。然而,成功的阿片类药物逐渐减少和戒断是XR-NTX诱导的先决条件,并且一再被报道为有效治疗的主要障碍。本研究的目的是描述XR-NTX诱导率,诱导不完全的原因,以及在诱导阶段报告的异常并发症。我们还比较了完成和未完成XR-NTX诱导的患者的社会人口学和临床变量。方法:这项自然、多中心、开放标签的挪威XR-NTX研究纳入了年龄在18-65岁的严重OUD患者。大多数参与者被转介到住院接受药物管理的阿片类药物戒断,并根据临床评估和国家准则接受个性化的药理学和社会心理治疗。在阿片类药物戒断后,参与者在XR-NTX诱导前至少经历了三天的无阿片类药物治疗。通过基线评估和回顾性患者病历回顾收集变量。通过双变量和逻辑回归分析比较XR-NTX诱导完成者和非完成者。结果:在纳入时近期使用阿片类药物的129名参与者中,106名(82%)完成了XR-NTX诱导。116名参与者(90%)在住院环境中进行了诱导,19名患者(15%)出现了异常并发症。戒断症状和矛盾心理是不完成治疗的最常见原因,分别出现在75%的病例中。与成功完成诱导的患者相比,未完成诱导的患者更常报告终身肝炎(78%对52%,p = 0.017),当前药物使用时间更长(平均119个月对54个月,p = 0.001),并且在纳入研究之前更频繁地使用美沙酮(43%对8%,p)结论:结果证明了挪威阿片类药物戒断和XR-NTX诱导过程的安全性,有效性和耐受性。虽然目前的诱导率很高,但我们的研究结果表明,美沙酮使用者需要特别关注和量身定制的阿片类药物戒断管理和XR-NTX诱导干预措施。试验注册:该研究已在clinicaltrials.gov注册(NCT03647774)。
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
Addiction Science & Clinical Practice
Addiction Science & Clinical Practice Psychology-Clinical Psychology
CiteScore
3.90
自引率
10.80%
发文量
64
审稿时长
28 weeks
期刊介绍: Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings. Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use. Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations. Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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