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用于阿片类物质使用障碍的缓释丁丙诺啡治疗:一项关于反应与体验的混合方法研究

Extended-release buprenorphine treatment for opioid use disorder: A mixed-methods study of response and experience.

作者信息

Lowry Natalie, McKechnie Andrew, Day Edward, Gilvarry Eilish, Cowden Fiona, Evans Rachel, Locke Rosie, Murray Robbie, Vanderwaal Rob, Johnstone Stacey, Hoare Zoe, Kelleher Michael, Mitcheson Luke, Marsden John

机构信息

Addictions Department, School of Academic Psychiatry, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Lambeth Drug and Alcohol Service, South London and Maudsley NHS Foundation Trust, London, UK.

出版信息

Addiction. 2025 Jun 20. doi: 10.1111/add.70106.

DOI:10.1111/add.70106
PMID:40538333
Abstract

BACKGROUND AND AIMS

An investigation of 24 weeks of extended-release buprenorphine (BUP-XR; Sublocade®) treatment for adults with opioid use disorder (OUD). Study aims were to characterise variations in clinical response, investigate personal factors influencing BUP-XR experience and identify opportunities to tailor treatment interventions.

DESIGN

A convergent parallel mixed-methods evaluation embedded in a five-centre, phase 3, randomised controlled trial of BUP-XR versus daily oral methadone or sublingual buprenorphine.

SETTING

Four of five National Health Service addictions treatment clinics in England and Scotland from the trial.

PARTICIPANTS

Participants were recruited after they completed the 24-week endpoint. Forty-nine participants (31%) from the trial completed the qualitative interview.

MEASUREMENTS

Three outcome measures from the trial's dataset were used descriptively: (1) fortnightly clinic visit administered TimeLine Follow-Back interview and urine drug screen data on use of non-medical opioids, cocaine and benzodiazepines; (2) the frequency version of the 11-item Craving Experience Questionnaire administered at baseline and endpoint; and (3) the Structured Clinical Interview for DSM-5 disorders for diagnosis of early OUD and cocaine use disorder (CUD) remission. Data visualisation (by heatmap) identified drug use response sub-groups. A topic-guided, semi-structured qualitative interview was analysed by Interactive Categorisation.

FINDINGS

Three response sub-groups were identified: Group 1 [14 (28.5%) of 49 participants] had the highest level of response, characterised by continuous abstinence from opioids, cocaine and benzodiazepines, improvements in craving control and mental and physical health in the majority, and a high level of remission and satisfaction with care; Group 2 [14 (28.5%) of 49 participants] had the next level of response, characterised by continuous abstinence from opioids, but some with opioid craving and some with compensatory use of cocaine and benzodiazepine to cope with anxiety and stress; Group 3 [21 (43.0%) of 49 participants] were not continuously abstinent from opioids during follow-up, the majority had dual OUD and CUD at trial enrolment, some reported breakthrough opioid withdrawal symptoms during follow-up, the majority reported improvements in mental health, but many reported opioid and cocaine cravings and compensatory use of cocaine and benzodiazepines.

CONCLUSIONS

There appears to be variation in response and experience of extended-release buprenorphine during the first six months of treatment, depending on substance use and physical health. This highlights the need for tailored treatment plans based on differing individual needs.

摘要

背景与目的

对长效丁丙诺啡(BUP-XR;商品名Sublocade®)治疗阿片类物质使用障碍(OUD)成人患者24周进行研究。研究目的是描述临床反应的差异,调查影响BUP-XR治疗体验的个人因素,并确定调整治疗干预措施的机会。

设计

一项收敛平行混合方法评估,嵌入一项五中心、3期、BUP-XR与每日口服美沙酮或舌下含服丁丙诺啡的随机对照试验。

地点

来自该试验的英格兰和苏格兰五家国民保健服务成瘾治疗诊所中的四家。

参与者

参与者在完成24周终点后被招募。试验中的49名参与者(31%)完成了定性访谈。

测量

描述性地使用了试验数据集中的三项结果测量指标:(1)每两周诊所就诊时进行的时间线回溯访谈以及关于非医疗用阿片类物质、可卡因和苯二氮䓬使用情况的尿液药物筛查数据;(2)在基线和终点时进行的11项渴望体验问卷的频率版本;(3)用于诊断早期OUD和可卡因使用障碍(CUD)缓解情况的DSM-5障碍结构化临床访谈。通过热图进行数据可视化识别出药物使用反应亚组。通过交互式分类法对主题引导的半结构化定性访谈进行分析。

结果

确定了三个反应亚组:第1组[49名参与者中的14名(28.5%)]反应水平最高,其特征为持续戒除阿片类物质、可卡因和苯二氮䓬,大多数人在渴望控制、身心健康方面有所改善,缓解率高且对护理满意度高;第2组[49名参与者中的14名(28.5%)]反应水平次之,其特征为持续戒除阿片类物质,但有些人有阿片类物质渴望,有些人通过使用可卡因和苯二氮䓬来应对焦虑和压力进行代偿性使用;第3组[49名参与者中的21名(43.0%)]在随访期间未持续戒除阿片类物质,大多数人在试验入组时患有双重OUD和CUD,有些人在随访期间报告有突破性阿片类物质戒断症状,大多数人报告心理健康有所改善,但许多人报告有阿片类物质和可卡因渴望以及可卡因和苯二氮䓬的代偿性使用。

结论

在治疗的前六个月,长效丁丙诺啡的反应和体验似乎存在差异,这取决于物质使用情况和身体健康状况。这突出了根据不同个体需求制定个性化治疗计划的必要性。

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本文引用的文献

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Buprenorphine, Pain, and Opioid Use in Patients Taking High-Dose Long-Term Opioids: A Randomized Clinical Trial.丁丙诺啡、疼痛与长期服用高剂量阿片类药物患者的阿片类药物使用:一项随机临床试验
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