National Addiction Centre, King's College London, London, UK.
Biostatistics and Health Informatics, King's College London, London, UK.
BMC Public Health. 2023 Aug 24;23(1):1608. doi: 10.1186/s12889-023-16445-6.
Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide 'community members', who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions.
A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design.
There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact.
ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021.
在全球范围内，阿片类药物的使用每年导致超过 10 万人过量死亡。纳洛酮已被证明能有效逆转阿片类药物过量，并且被批准为阿片类药物过量的紧急解毒剂。携带纳洛酮回家（THN）计划已经推出，为可能观察到阿片类药物过量的“社区成员”提供纳洛酮套件，并培训他们识别过量和给予纳洛酮。THN 计划的可接受性和可行性已经得到证明，但社区成员给予纳洛酮的实际效果尚不清楚。近年来，几种浓缩纳洛酮鼻喷雾剂制剂（除了注射制剂，如prenoxad）的批准，可能会提高可接受性和更广泛提供的范围。本研究旨在确定 THN（所有制剂）在现实条件下的有效性。
这是一项欧洲多国前瞻性队列研究，旨在评估社区成员在六个月的随访期内使用 THN 逆转阿片类药物过量的情况。从参与减少伤害和药物治疗的地点获得 THN 的参与者将被招募到研究中，并随访六个月。我们特别感兴趣的是那些获得 THN 并目睹阿片类药物过量的社区成员的经验。在六个月期间目睹阿片类药物过量的所有参与者（目标约 600 人）将被要求参加关于该事件的结构化访谈。其中，将邀请 60 人参加定性访谈。浓缩鼻用纳洛酮 Nyxoid 的上市后疗效研究（PAES）已纳入研究设计。
评估 THN 的实际效果存在许多挑战。不可能使用随机试验设计，招募获得 THN 的社区成员将取决于分发 THN 套件的招募地点，而参与者收到的 THN 类型将取决于法规以及当地的临床和政策决策者。在六个月的研究期间，对这部分可能是流动人口的人群进行随访将是一项挑战，但我们计划通过定期短信提醒和工作人员联系来保持与参与者的联系。
ClinicalTrials.gov 标识符：NCT05072249。注册日期：2021 年 10 月 8 日。
