Counterfeit Pharmaceuticals: Increased Risks in the Era of Novel Synthetic Opioids and Other Designer Drugs

假冒药品：新型合成阿片类药物和其他设计药物时代的风险增加

基本信息

批准号：
10506025
负责人：
Raminta Daniulaityte
金额：
$ 23.57万
依托单位：
ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10506025
关键词：
Address Area Arizona Behavior Behavioral Benzodiazepines Characteristics Contrast Media Data Designer Drugs Disease Outbreaks Drug usage Drug user Epidemic Fentanyl Focus Groups Harm Reduction Health Personnel Heroin Illicit Drugs Individual Intervention Interview Knowledge Link Liquid Chromatography Methods Opioid Outcome Overdose Overdose reduction Pathway interactions Patient Self-Report Pattern Persons Pharmaceutical Preparations Pharmacologic Substance Pharmacology Policies Population Powder dose form Prevention Property Recording of previous events Research Resources Risk Risk Behaviors Route Safety Sampling Seizures Signal Transduction Street Drugs Time Toxicology U-47700 Urine Work Xanax analog base carfentanil community based research drug market ethnic minority population experience illicit drug use innovation interdisciplinary approach interdisciplinary collaboration mortality novel opioid epidemic opioid use overdose risk pill preference prescription opioid psychologic racial and ethnic disparities recruit response social culture social structure social vulnerability synthetic opioid tandem mass spectrometry trafficking

项目摘要

PROJECT SUMMARY Non-pharmaceutical fentanyl and other novel synthetic opioids (NSO) have contributed to unprecedented increases in overdose mortality in the U.S. A rapid surge in the availability of counterfeit pharmaceutical drugs signals a new wave of the NSO spread, and it presents unique challenges and increased risks to a broad population of users. More research is urgently needed to characterize the toxicological features and the initiation pathways, patterns of use, and overdose risk behaviors related to the use of counterfeit pills that mimic prescription opioids, benzodiazepines, and other drugs. The study will be conducted in Arizona (AZ), characterized as a “ground zero” in terms of the new waves of the evolving NSO epidemic. The study builds on a collaborative partnership with Sonoran Prevention Works, a leading grassroots harm reduction organization in AZ. The overall purpose of the proposed study is to characterize drug use experiences and overdose risks associated with the rapidly growing counterfeit pharmaceutical drug (opioids, benzodiazepines) spread in AZ. The study will recruit a sample of 60 individuals in the Phoenix, AZ metro area, stratified into two groups by their current (past 7 days) use of a) non-prescribed pharmaceutical opioids and/or counterfeit opioid pills; 2) non-prescribed benzodiazepine and/or counterfeit benzodiazepine pills (n=30). We will aim to engage ethnic minority groups to identify ethnic/racial disparities and vulnerabilities related surging availability of counterfeit drugs in AZ. The Specific Aims are: Aim 1: Characterize how local drug market conditions, individual vulnerabilities, and broader social and structural factors influence drug use experiences and overdose risks associated with counterfeit opioid and benzodiazepine pill use through in-depth qualitative interviews with persons who use illicit drugs (N=60) in Phoenix, AZ. Aim 2: Conduct urine toxicology analysis using liquid- chromatography-tandem mass spectrometry (LC-MS/MS)-based methods to identify fentanyl, fentanyl analogs, other NSOs, designer benzodiazepines, and other prescription and illicit drugs and assess the concordance with self-reported use of these drugs (N=60). Aim 3: Identify priority intervention and policy response strategies to reduce overdose-related risks of counterfeit pills through focus groups with key stakeholders (N=20), including harm reduction coordinators, grassroots organizations of persons who use drugs, treatment providers, and policymakers. The study is highly significant because it will provide timely data on the growing counterfeit pharmaceutical drug use in the U.S. The proposed research is innovative because of: a) interdisciplinary approach and partnership with a grassroots harm reduction organization, b) integration of qualitative interview data and toxicological analyses, c) compare and contrast drug use experiences and overdose risks associated with the counterfeit opioid and counterfeit benzodiazepine use. d) assessment of potential overlap between the novel synthetic opioid and designer benzodiazepine outbreaks.

项目概要非药物芬太尼和其他新型合成阿片类药物 (NSO) 为前所未有的美国服药过量死亡率增加假冒药品的供应量迅速增加标志着 NSO 传播的新一波浪潮，它给广泛的群体带来了独特的挑战和增加的风险迫切需要更多的研究来表征毒理学特征和启动。与使用模仿的假药相关的途径、使用模式和过量风险行为处方阿片类药物、苯二氮卓类药物和其他药物该研究将在亚利桑那州 (AZ) 进行。该研究建立在新一波不断演变的 NSO 流行病的基础上。与 Sonoran Prevention Works 建立合作伙伴关系，Sonoran Prevention Works 是该地区领先的基层减害组织 AZ。拟议研究的总体目的是描述药物使用经历和过量用药的特征。与快速增长的假冒药品（阿片类药物、苯二氮卓类药物）相关的风险该研究将在亚利桑那州菲尼克斯都市区招募 60 名个体作为样本，分为两部分。按当前（过去 7 天）使用 a) 非处方药物阿片类药物和/或假冒阿片类药物的情况进行分组药丸；2) 非处方苯二氮卓类药物和/或假冒苯二氮卓类药丸（n=30）。少数族裔群体识别族裔/种族差异和脆弱性亚利桑那州的假药情况具体目标是：目标 1：描述当地药品市场状况、个体情况。脆弱性以及更广泛的社会和结构因素影响吸毒经历和过量风险通过深入定性访谈，了解与假冒阿片类药物和苯二氮卓类药物使用相关的问题亚利桑那州菲尼克斯使用非法药物的人 (N=60) 目标 2：使用液体进行尿液毒理学分析。基于色谱-串联质谱 (LC-MS/MS) 的方法来鉴定芬太尼、芬太尼类似物、其他 NSO、设计苯二氮卓类药物以及其他处方药和非法药物，并评估与自我报告使用这些药物的情况 (N=60) 目标 3：确定优先干预措施和政策应对策略通过与主要利益相关者（N=20）的焦点小组合作，减少假药过量相关的风险，包括减少危害协调员、吸毒者基层组织、治疗提供者和这项研究非常重要，因为它将提供有关不断增长的假货的及时数据。拟议的研究具有创新性，因为：a) 跨学科与基层减少伤害组织的方法和伙伴关系，b) 定性访谈的整合数据和毒理学分析，c) 比较和对比药物使用经验和相关的过量风险 d) 评估假冒阿片类药物和假冒苯二氮卓类药物之间的潜在重叠。新型合成阿片类药物和设计苯二氮卓类药物的爆发。