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: 10202538
• 负责人: JUDITH FEINBERG
• 金额: $ 59.12万
• 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/10202538
• 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; Time; United States; United States National Institutes of Health; West Virginia; analog; base; behavioral health; behavioral outcome; cohort; combat; community based research; cost; drug market; drug testing; drug use behavior; epidemiology study; experience; fentanyl overdose; 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; test strip

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.

项目概要/摘要 描述：参见说明。这必须包含适合向公众传播的拟议活动的摘要（无 专有/机密信息）。它应该是项目的独立描述，并包含目标和方法的陈述 受雇。它应该为在相同或相关领域工作的其他人提供信息。请勿超出所提供的空间。 我们提出了一项混合方法研究来调查芬太尼测试的积极和消极后果 注射吸毒者 (PWID) 使用脱衣杆 (FTS)。涉及非法制造芬太尼的过量 (OD) 死亡 （国际货币基金组织）2013-2016 年美国增加了 540%，2016-2017 年又增加了 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。 国际货币基金组织在非法药物市场的扩散导致了风险环境的加剧，其特点是 纯度和效力未知的掺假产品。虽然纳洛酮是一种经过验证的 OD 二级预防方法 在国际货币基金组织大量涌入毒品市场之后，我们现在采取了防止 OD 受害者死亡的策略 需要主要的 OD 预防策略，从一开始就防止 OD 的发生。过去3 多年来，美国和加拿大的社区组织已开始将 FTS 作为主要分发方式 OD预防策略。 FTS 与药物溶液后的即时妊娠测试相当 与试纸接触，试纸显示一两条红线，表示阳性或阴性 结果。 FTS 的成本约为 1 美元，对于 OD 预防计划来说是一个合理的成本。鲜为人知的是 使用 FTS 分析吸毒者的积极和消极后果。本申请提出了严格的 以 Zinberg 的药物、设置和设置模型为指导的注射吸毒者前瞻性研究。具体目标如下 目标 1：评估与使用 FTS 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：评估负面行为健康状况 北卡罗来纳州和西弗吉尼亚州一群吸毒者中使用 FTS 的后果。目标 3： 对吸毒者 (n=100) 进行定性访谈，了解药物、环境和环境因素如何影响吸毒者 FTS 的使用、药品购买和用药行为以及 OD 风险。为了实现这些目标，我们将招募 700 名注射吸毒者的样本来自两个注射器服务计划地点：北卡罗来纳州格林斯博罗和西弗吉尼亚州摩根敦。西方 2017年，弗吉尼亚州芬太尼OD死亡率全美最高，北卡罗来纳州排名第二 芬太尼 OD 死亡人数增幅最高（2016 年至 2017 年）。对于目标 1 和 2，我们将收集定量数据 与 FTS 使用以及基线、6 个月和 12 个月时的药物、设定和设定因素有关。对于目标 3，我们 将有目的地从定量队列中抽取 100 名吸毒者的子集。该研究由多个 首席研究员乔恩·齐贝尔 (Jon Zibbell)，国家药物滥用研究所 (NIDA) 资助的医学人类学家 拥有多年研究 IMF 和 Judith Feinberg 的经验，研究 NIDA 资助的传染病 具有研究综合服务提供系统经验的医生。该团队还包括 Alex Kral， NIDA 资助的社区研究流行病学家，拥有多年研究 OD 的经验，以及 斯蒂芬·图勒 (Stephen Tueller)，美国国立卫生研究院 (NIH) 资助的统计学家。拟议研究的结果将有助于科学 有关阿片类药物 OD 预防的文献，有助于为当前应对 OD 危机的预防策略提供信息。