Schulte Bernd, Lehmann Kirsten, Schmidt Christiane Sybille, Rühling Elke, Weber Bernd, Schäfer Ingo, Reimer Jens, Verthein Uwe
Department of Psychiatry, Centre for Interdisciplinary Addiction Research of Hamburg University (ZIS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Praxiszentrum Friedrichsplatz, Competence Center for Addiction Medicine, Kassel, Germany.
Front Psychiatry. 2020 Dec 8;11:580863. doi: 10.3389/fpsyt.2020.580863. eCollection 2020.
Once-weekly or once-monthly injectable depot buprenorphine is a new opioid substitution treatment (OST) medication that provides clinically relevant plasma concentrations without daily peaks. Together with a high tolerability and acceptance reported by patients, the prolonged release of injectable depot buprenorphine might have beneficial implications on the patients' quality of life and social participation. The primary objective of this prospective non-interventional observational study is to evaluate the effects of subcutaneous injectable depot buprenorphine on the quality of life of patients in routine OST care in Germany. Secondary outcomes like illicit substance use, psychological distress, social participation and activity are assessed to provide an overall evaluation toward addiction recovery. The present study is a non-randomized prospective observational study with a control group (treatment-as-usual). To ensure comparability between both patient groups, suitable control patients ( = 213) from the same OST unit will be matched pairwise to each patient treated with injectable depot buprenorphine ( = 213). Matching variables are gender, duration of OST, take-home prescription and psychosocial functioning (according to the Global Assessment of Functioning scale). Primary study endpoint is the difference of change in quality of life, assessed with the recently developed Opioid Substitution Treatment Quality of Life scale (OSTQOL), within the depot buprenorphine group between baseline and month 12. The primary analysis will be carried out according to the intention-to-treat principle (ITT) by comparing OSTQOL mean scores using dependent -tests. For secondary analyses, group comparisons will be done by mixed model approaches with baseline OSTQOL score and the (pairwise) cluster term as covariates. The study combines clinical, routine OST care data with relevant patient reported outcome data. The pairwise matching allows conclusions on effects of different OST medications. The study findings will provide new insights in the addiction recovery processes of OST patients treated with depot buprenorphine. The study protocol has been approved by the Ethics Committee of the Hamburg Chamber of Physicians (Ärztekammer Hamburg) (reference number: PV7078). The study results will be disseminated through peer-reviewed publications and presentations on scientific conferences. German Clinical Trials Register DRKS-ID: DRKS00020797.
每周一次或每月一次注射用长效丁丙诺啡是一种新型阿片类药物替代治疗（OST）药物，可提供具有临床意义的血浆浓度且无每日峰值。患者报告其具有高耐受性和接受度，注射用长效丁丙诺啡的缓释可能对患者的生活质量和社会参与产生有益影响。这项前瞻性非干预性观察研究的主要目的是评估皮下注射用长效丁丙诺啡对德国常规OST治疗中患者生活质量的影响。评估非法物质使用、心理困扰、社会参与和活动等次要结局，以对成瘾康复进行全面评估。本研究是一项有对照组（常规治疗）的非随机前瞻性观察研究。为确保两组患者具有可比性，将来自同一OST单位的合适对照患者（n = 213）与接受注射用长效丁丙诺啡治疗的每位患者（n = 213）进行配对。匹配变量包括性别、OST持续时间、带回家的处方以及心理社会功能（根据功能综合评定量表）。主要研究终点是在长效丁丙诺啡组中，使用最近开发的阿片类药物替代治疗生活质量量表（OSTQOL）评估的基线至第12个月生活质量变化的差异。主要分析将根据意向性分析原则（ITT），通过使用相关t检验比较OSTQOL平均得分来进行。对于次要分析，将采用混合模型方法，以基线OSTQOL得分和（配对）聚类项作为协变量进行组间比较。该研究将临床、常规OST护理数据与患者报告的相关结局数据相结合。配对匹配有助于得出不同OST药物效果的结论。研究结果将为接受长效丁丙诺啡治疗的OST患者的成瘾康复过程提供新的见解。研究方案已获得汉堡医师协会伦理委员会（Ärztekammer Hamburg）批准（参考编号：PV7078）。研究结果将通过同行评审出版物和在科学会议上的报告进行传播。德国临床试验注册DRKS-ID：DRKS00020797。
