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

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

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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.

项目摘要非药物芬太尼和其他新型合成阿片类药物（NSO）已导致前所未有的在美国，过量死亡率的提高迅速增加了伪造药物发出新的NSO传播浪潮，并提出了独特的挑战，并增加了风险用户人口。迫切需要进行更多的研究来表征毒理学特征和主动性途径，使用模式和与使用模仿假药有关的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）进行从不断发展的NSO流行病的新波角度来看为“地面零”。该研究以与Sonoran预防工作的合作伙伴关系，这是一个领先的基层减少基层伤害组织 AZ。拟议的研究的总体目的是表征药物使用经验和过量与快速增长的假药药物（阿片类药物，苯二氮卓类药物）相关的风险在亚利桑那州传播。该研究将招募AZ Metro地区60个人的样本，分为两个通过当前（过去7天）使用A）非处方药药物和/或伪造阿片类药物药丸； 2）非处方苯二氮卓和/或假冒苯二氮卓类药物（n = 30）。我们将旨在参与少数民族群体以识别种族/种族分布和漏洞相关的浪潮亚利桑那州伪造毒品。具体目的是：目标1：表征当地药物市场状况如何脆弱性以及更广泛的社会和结构因素会影响毒品使用经验和过量风险与假冒阿片类药物和苯二氮卓类药物的使用相关在亚利桑那州凤凰城使用非法药物（n = 60）的人。目标2：使用液体进行尿液毒理学分析色谱串联质谱（LC-MS/MS）的基于芬太尼，芬太尼类似物的方法，其他NSO，设计师苯二氮卓类药物以及其他处方和非法药物，并评估与一致的一致性这些药物的自我报告使用（n = 60）。目标3：确定优先干预和政策响应策略通过与关键利益相关者（n = 20）的焦点小组，减少与过量相关的假药风险，包括损害减少协调员，使用毒品的人的基层组织，治疗提供者和决策者。这项研究非常重要，因为它将提供有关伪造日期的及时数据美国的药品使用拟议的研究具有创新性，因为：a）跨学科与基层减少危害组织的方法和合作伙伴关系，b）定性面试的整合数据和毒理学分析，c）比较和对比毒品使用经验以及相关的过量风险使用伪造的阿片类药物和假冒苯二氮卓类药物的使用。 d）评估潜在重叠的评估新型的合成阿片类药物和设计师苯二氮卓爆发。