Off-label Use of Rapid Response Fentanyl Test Strips as an Opioid Overdose Prevention Strategy

标签外使用快速反应芬太尼试纸作为阿片类药物过量预防策略

• 批准号: 9884388
• 负责人: JUDITH FEINBERG
• 金额: $ 65.76万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9884388
• 关键词: Address; Adopted; Adverse reactions; Applied Research; Behavior; Canada; Cessation of life; Characteristics; Communicable Diseases; Communities; Confidential Information; Consumption; Data; Death Rate; Drug usage; Drug user; Environment; Epidemiologist; Fentanyl; Floods; Funding; Heroin; Illicit Drugs; Injecting drug user; Instruction; Interview; Knowledge; Lead; Learning; Literature; Medical; Methods; Modeling; Naloxone; National Institute of Drug Abuse; Needle-Exchange Programs; North Carolina; Odds Ratio; Outcome; Overdose; Persons; Pharmaceutical Preparations; Physicians; Pilot Projects; Predisposition; Pregnancy Tests; Prevention program; Prevention strategy; Principal Investigator; Prospective Studies; Reporting; Respondent; Risk; Sampling; Sampling Studies; Scholarship; Site; System; Technology; Testing; Time; United States; United States National Institutes of Health; West Virginia; analog; base; behavioral health; behavioral outcome; cohort; combat; community based participatory research; cost; drug market; drug testing; drug use behavior; epidemiology study; experience; first responder; illicit drug use; mortality; novel therapeutics; off-label use; opioid epidemic; opioid mortality; opioid overdose; overdose death; overdose prevention; overdose risk; point of care; prescription opioid; prevent; recruit; response; service delivery; socioeconomics

PROJECT SUMMARY/ABSTRACT DESCRIPTION: See instructions. This must contain a summary of the proposed activity suitable for dissemination to the public (no proprietary/confidential information). It should be a self-contained description of the project and contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields. DO NOT EXCEED THE SPACE PROVIDED. We propose a mixed-methods study to investigate the positive and negative consequences of fentanyl test strip (FTS) use by people who inject drugs (PWID). Overdose (OD) deaths involving illicitly made fentanyl (IMF) increased 540% in the United States from 2013–2016 and another 45.2% from 2016–2017, with IMF- involved deaths outnumbering heroin and prescription opioid deaths for the first time in 2016. The rapid proliferation of IMF in the illicit drug market has led to a heightened risk environment characterized by adulterated products of unknown purity and potency. While naloxone is a proven secondary OD prevention strategy by preventing fatalities among OD victims, in the wake of the IMF flooding the drug markets, we now need primary OD prevention strategies to prevent ODs from occurring in the first place. Over the past 3 years, community-based organizations in the U.S. and Canada have started to distribute FTS as a primary OD prevention strategy. FTS are comparable to point-of-care pregnancy tests in that after a drug solution comes into contact with the test strip, the strip displays one or two red lines, denoting positive or negative results. FTS cost about $1, making them a reasonable cost to OD prevention programs. Little is known about the positive and negative consequences of PWID using FTS. This application proposes a rigorous prospective study of PWID, guided by Zinberg’s Drug, Set, and Setting model. The specific aims are as follows: Aim 1: To assess positive behavioral health consequences associated with FTS use in a cohort of PWID in North Carolina (N=350) and West Virginia (N=350). Aim 2: To assess negative behavioral health consequences associated with FTS use in a cohort of PWID in North Carolina and West Virginia. Aim 3: To conduct qualitative interviews with PWID (n=100) to learn how Drug, Set, and Setting factors influence the use of FTS, drug purchasing and drug use behavior, and OD risk. To achieve these aims, we will recruit a sample of 700 PWID from two syringe service program sites: Greensboro, NC, and Morgantown, WV. West Virginia had the highest fentanyl OD death rate in the U.S. in 2017, and North Carolina had the second highest rate increase (2016–2017) in fentanyl OD deaths. For Aims 1 and 2, we will collect quantitative data pertaining to FTS use and drug, set, and setting factors at baseline, 6 months, and 12 months. For Aim 3, we will purposively sample a subset of 100 PWID from the quantitative cohort. The study is led by Multiple Principal Investigators, Jon Zibbell, a National Institute of Drug Abuse (NIDA)-funded medical anthropologist with many years of experience studying IMF, and Judith Feinberg, an NIDA-funded infectious disease physician with experience studying integrated service delivery systems. The team also includes Alex Kral, an NIDA-funded community-based research epidemiologist with many years of experience studying OD, and Stephen Tueller, an NIH-funded statistician. Findings from the proposed study will contribute to the scientific literature on opioid OD prevention and help inform current prevention strategies in response to the OD crisis.

项目摘要/摘要 说明：请参阅说明。它必须包含适合向公众传播的拟议活动的摘要(否 专有/机密信息)。它应该是对项目的独立描述，并包含对目标和方法的声明 受雇的。它应该为在相同或相关领域工作的其他人提供信息。不要超过所提供的空间。 我们提出了一项混合方法研究，以调查芬太尼试验的阳性和阴性后果。 注射吸毒者使用禁药(FTS)(PWID)。与非法制造的芬太尼有关的过量死亡 2013-2016年美国国际货币基金组织(IMF)增长了540%，2016-2017年又增长了45.2%，其中IMF- 2016年，死亡人数首次超过海洛因和处方阿片类药物死亡人数。The Rapid 国际货币基金组织在非法药物市场的扩散导致风险环境加剧，其特点是 纯度和效力不明的掺假产品。虽然纳洛酮是一种已被证实的二次过量预防 通过防止吸毒受害者死亡的战略，在国际货币基金组织涌入毒品市场之后，我们现在 需要主要的药物过量预防策略，以从一开始就防止药物过量的发生。在过去3年中 多年来，美国和加拿大的社区组织已经开始将FTS作为主要的 药物过量的预防策略。FTS与护理点怀孕测试的可比性在于，在药物溶液之后 与测试条接触时，测试条显示一条或两条红线，表示正或负 结果。FTS的成本约为1美元，这使它们成为预防吸毒计划的合理成本。人们对此知之甚少 使用FTS的PWID的积极和消极后果。这个应用程序提出了一个严格的 PwID的前瞻性研究，由Zinberg的药物、SET和设定模型指导。具体目标如下 如下：目标1：评估与FTS使用相关的积极行为健康后果 北卡罗来纳州(N=350)和西弗吉尼亚州(N=350)的PWID。目标2：评估消极行为健康 与北卡罗来纳州和西弗吉尼亚州PWID队列中FTS使用相关的后果。目标3：实现 与PWID(n=100)进行定性访谈，以了解药物、设置和设置因素如何影响 FTS的使用、药物购买和使用行为、服药风险。为达致这些目标，我们会聘请一名 来自两个注射器服务项目地点的700例PWID样本：北卡罗来纳州格林斯伯勒和西弗吉尼亚州摩根敦。西 2017年，弗吉尼亚州是美国芬太尼服药过量死亡率最高的州，北卡罗来纳州排名第二 芬太尼过量死亡的最高增长率(2016-2017)。对于目标1和目标2，我们将收集定量数据 关于FTS的使用和药物、设定和设定因素在基线、6个月和12个月。对于目标3，我们 将有目的地从定量队列中抽取100个PWID的子集。这项研究是由多个 首席研究员乔恩·齐贝尔，美国国家药物滥用研究所(NIDA)资助的医学人类学家 有多年研究国际货币基金组织和朱迪思·范伯格的经验，这是一种由NIDA资助的传染病 具有研究综合服务交付系统经验的医生。该团队还包括亚历克斯·克拉尔，一名 NIDA资助的社区研究流行病学家，具有多年研究OD的经验，以及 美国国立卫生研究院资助的统计学家斯蒂芬·图勒说。这项拟议研究的发现将有助于科学研究 关于阿片类药物过量预防的文献，并有助于为应对药物过量危机的当前预防战略提供信息。