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 描述：请参阅说明。这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，并包含目标和方法的说明 雇用。对于在同一或相关领域工作的其他人来说，它应该有用。不要超过提供的空间。 我们提出了一项混合方法研究，以研究芬太尼检测的正面和负面后果 注射药物（PWID）的人使用条纹（FTS）。过量（OD）死亡涉及非法芬太尼 （IMF）美国从2013 - 2016年增长了540％，从2016 - 2017年增加了45.2％，其中IMF- 2016年第一次涉及死亡人数超过海洛因和处方药。 IMF在非法药物市场中的扩散导致了风险环境的增长，其特征是 纯度和效力的掺假产品。纳洛酮是一种被证明的次要OD预防 战略通过防止OD受害者的死亡，在国际货币基金组织淹没毒品市场之后，我们现在 首先需要预防OD预防策略，以防止OD发生。在过去的3个 多年来，美国和加拿大的基于社区的组织已开始分配FTS作为主要组织 预防策略。 FT与护理点妊娠试验相当，因为在药物溶液之后 与测试条接触，该条带显示一两个红线，表示正或负面 结果。 FTS的成本约为1美元，使其成为预防计划的合理成本。对 使用FTS PWID的积极和负面后果。该申请提出严格的 PWID的前瞻性研究，在Zinberg的药物，设定和设置模型的指导下。具体目的是 以下内容：目标1：评估与FT使用相关的积极行为健康后果 北卡罗来纳州的PWID（n = 350）和西弗吉尼亚州（n = 350）。目标2：评估负面行为健康 与FTS在北卡罗来纳州和西弗吉尼亚州的PWID队列中使用有关的后果。目标3：到 对PWID（n = 100）进行定性访谈，以了解药物，设定和设定因素如何影响 使用FT，药物购买和吸毒行为以及OD风险。为了实现这些目标，我们将招募 来自两个注射器服务程序网站的700个PWID样本：北卡罗来纳州格林斯伯勒和西弗吉尼亚州摩根敦。西方 弗吉尼亚州在2017年美国的芬太尼OD死亡率最高，北卡罗来纳州的第二个 芬太尼OD死亡率最高（2016- 2017年）。对于目标1和2，我们将收集定量数据 与FTS的使用和药物，设定和设定因子有关，在基线，6个月和12个月中。对于目标3，我们 将主要从定量队列中取样100个pWID的子集。该研究由多个领导 美国国家药物滥用研究所（NIDA）资助的医学人类学家乔恩·齐布尔（Jon Zibbell）首席研究人员 具有多年的IMF研究经验，以及NIDA资助的传染病朱迪思·费恩伯格（Judith Feinberg） 具有研究综合服务输送系统的经验。该团队还包括Alex Kral， 由NIDA资助的基于社区的研究流行病学家，拥有多年的研究OD的经验， NIH资助的统计学家Stephen Tueller。拟议研究的发现将有助于科学 有关预防阿片类药物的文献，并有助于响应OD危机的当前预防策略。