Center for Injury Research and Policy at the Abigail Wexner Research Institute at Nationwide Children's Hospital, 575 Children's Crossroad, Columbus, OH, 43215, USA.
Department of Pediatrics, College of Medicine, The Ohio State University, 370 W. 9th Avenue, Columbus, OH, 43210, USA.
Trials. 2024 Sep 4;25(1):587. doi: 10.1186/s13063-024-08440-y.
Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips can identify fentanyl and some fentanyl analogs in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. Fentanyl test strips are a promising harm reduction strategy; however, little is known about the real-world acceptability and impact of fentanyl test strip use. This study investigates fentanyl test strip distribution and education as a harm reduction strategy to prevent overdoses among people who use drugs.
The research team will recruit 2400 individuals ≥ 18 years with self-reported use of illicit drugs or drugs purchased on the street within the past 6 months. Recruitment will occur at opioid overdose education and naloxone distribution programs in 16 urban and 12 rural Ohio counties. Participating sites will be randomized at the county level to the intervention or non-intervention study arm. A brief fentanyl test strip educational intervention and fentanyl test strips will be provided to participants recruited from sites in the intervention arm. These participants will be eligible to receive additional fentanyl test strips for 2 years post-enrollment. Participants recruited from sites in the non-intervention arm will not receive fentanyl test strip education or fentanyl test strips. All participants will be followed for 2 years post-enrollment using biweekly, quarterly, and 6-month surveys. Primary outcomes include (1) identification of perceived barriers and facilitating factors associated with incorporating fentanyl test strip education and distribution into opioid overdose education and naloxone distribution programs; (2) differences in knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for reducing overdose risk between the intervention and non-intervention groups; and (3) differences in non-fatal and fatal overdose rates between the intervention and non-intervention groups.
Findings from this cluster randomized controlled trial will contribute valuable information about the feasibility, acceptability, and impact of integrating fentanyl test strip drug checking in rural and urban communities in Ohio and help guide future overdose prevention interventions.
ClinicalTrials.gov NCT05463341. Registered on July 19, 2022. https://clinicaltrials.gov/study/NCT05463341.
阿片类药物相关死亡是俄亥俄州和全国范围内的主要死亡原因，越来越多的过量用药归因于芬太尼。快速芬太尼检测条可在尿液样本中识别芬太尼和一些芬太尼类似物，并且越来越多地用于在使用前检查非法药物中是否存在芬太尼。芬太尼检测条是一种有前途的减少伤害策略；然而，人们对芬太尼检测条使用的实际可接受性和影响知之甚少。本研究调查了芬太尼检测条的分发和教育作为一种减少伤害策略，以预防使用非法药物的人群中的药物过量。
研究团队将招募 2400 名年龄在 18 岁及以上、自我报告在过去 6 个月内使用过非法药物或街头购买的药物的个体。招募工作将在俄亥俄州 16 个城市和县和 12 个农村县的阿片类药物过量教育和纳洛酮分发计划中进行。参与的地点将按县一级随机分配到干预或非干预研究臂。在干预臂的地点招募的参与者将接受简短的芬太尼检测条教育干预和芬太尼检测条。这些参与者将有资格在入组后 2 年内获得额外的芬太尼检测条。在非干预臂的地点招募的参与者将不会接受芬太尼检测条教育或芬太尼检测条。所有参与者将在入组后 2 年内通过每两周、每季度和每 6 个月的调查进行随访。主要结局包括：(1)确定将芬太尼检测条教育和分发纳入阿片类药物过量教育和纳洛酮分发计划中相关的可感知障碍和促进因素；(2)干预组和非干预组在测试药物中芬太尼的知识和自我效能方面的差异，以及降低过量风险的策略；(3)干预组和非干预组非致命和致命药物过量率的差异。
这项聚类随机对照试验的结果将提供有关在俄亥俄州农村和城市社区整合芬太尼检测条药物检测的可行性、可接受性和影响的宝贵信息，并有助于指导未来的药物过量预防干预措施。
ClinicalTrials.gov NCT05463341。注册于 2022 年 7 月 19 日。https://clinicaltrials.gov/study/NCT05463341。
