Alcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Alcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
BMJ Open. 2024 Aug 3;14(8):e082553. doi: 10.1136/bmjopen-2023-082553.
Supervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of time-limited SIOT using injectable hydromorphone delivered in an existing Australian public opioid treatment programme, with secondary outcomes of safety, cost, changes in drug use and other health outcomes. If feasible, the goal is to scale up the intervention to be more widely available in Australia.
Between 20 and 30 participants will be offered two times per day hydromorphone to inject under direct observation, in addition to their current opioid agonist treatment (OAT), for up to 2 years. At the end of 2 years of supervised hydromorphone treatment, participants will be continued on standard OAT only. Informed consent will be obtained from all participants included in the study. This is a single-site, uncontrolled, open-label study where quantitative and qualitative interview data will be collected at baseline, 12 months and lastly at 3 months following their final hydromorphone dose. The main outcome measures are feasibility, as assessed by recruitment, retention and participation in treatment, and acceptability to participants, clinic staff and other stakeholders assessed by qualitative interviews. Secondary outcome measures of safety, as assessed by adverse events, and cost will also be assessed, as well as a range of other drug and health outcomes.
This study received ethical approval from the St Vincent's Hospital Human Research Ethics Committee (2019/ETH00418). This will be the first study of time-limited SIOT in the Australian setting. All results will be submitted to peer-reviewed journals, scientific conferences and local practice meetings. A preliminary report on outcomes will also be presented to local health policy makers. A consumer and community forum will also be held to feedback results to a broader audience.
ACTRN12621001729819.
监督下注射阿片类药物治疗（SIOT）是一种针对阿片类药物依赖者的循证干预措施，这些人对现有的治疗方法无效。本项目将主要评估在现有的澳大利亚公共阿片类药物治疗计划中使用注射氢吗啡酮进行有限时间的 SIOT 的可行性和可接受性，次要结果包括安全性、成本、药物使用变化和其他健康结果。如果可行，目标是将干预措施扩大到澳大利亚更广泛的范围。
将为 20 至 30 名参与者提供每天两次注射氢吗啡酮，在直接观察下，除了他们目前的阿片类激动剂治疗（OAT）外，最多 2 年。在 2 年监督下氢吗啡酮治疗结束时，参与者将仅继续接受标准 OAT。所有纳入研究的参与者都将获得知情同意。这是一项单站点、非对照、开放标签研究，将在基线、12 个月和最后一次接受最后一剂氢吗啡酮后 3 个月收集定量和定性访谈数据。主要结局指标是可行性，通过招募、保留和参与治疗来评估，参与者、诊所工作人员和其他利益相关者的可接受性通过定性访谈来评估。安全性的次要结局指标，如不良事件评估，以及成本也将被评估，以及一系列其他药物和健康结果。
这项研究得到了圣文森特医院人类研究伦理委员会的伦理批准（2019/ETH00418）。这将是澳大利亚首次进行有限时间 SIOT 的研究。所有结果都将提交给同行评议的期刊、科学会议和当地实践会议。还将向当地卫生政策制定者提交一份关于结果的初步报告。还将举行消费者和社区论坛，向更广泛的受众反馈结果。
ACTRN12621001729819。
