An Examination of Concomitant Non-Medical Use of Gabapentin and Opioids.

加巴喷丁和阿片类药物同时非医疗用途的检查。

• 批准号: 10510127
• 负责人: Mance E. Buttram
• 金额: $ 27.45万
• 依托单位: UNIVERSITY OF ARKANSAS AT FAYETTEVILLE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10510127
• 关键词: Address; Anxiety; Behavioral; Black race; Buprenorphine; Case Study; Cause of Death; Characteristics; Chemosensitization; Client; Communities; Dangerousness; Data; Decision Modeling; Development; Dose; Drug Metabolic Detoxication; Ecology; Epidemiology; Epilepsy; Ethnography; Fentanyl; Funding; GTP-Binding Protein alpha Subunits, Gs; Gender; Goals; Health Personnel; Hispanic; Hydrocodone; Individual; Interview; Label; Laws; Medical Examiners; Methadone; Methodology; Motivation; National Institute of Drug Abuse; Neuralgia; Neurology; Opioid; Oxycodone; Pain management; Participant; Patients; Pharmaceutical Preparations; Placebos; Population; Primary Health Care; Probability; Provider; Psychiatry; Public Health; Public Policy; Recording of previous events; Relapse; Report (document); Reporting; Research; Research Personnel; Risk Factors; Route; Sampling; Schedule; Social Environment; Strategic Planning; Substance Use Disorder; Surveys; Symptoms; Testing; Therapeutic; Time; United States Food and Drug Administration; Urine; Ventilatory Depression; Withdrawal Symptom; Woman; Work; analog; behavior influence; design; ethnic difference; gabapentin; gamma-Aminobutyric Acid; health knowledge; illicit opioid; innovation; medication-assisted treatment; men; nonmedical use; opioid agonist therapy; opioid epidemic; opioid overdose; opioid use disorder; opioid user; opioid withdrawal; prescription monitoring program; prescription opioid; preventive intervention; protective factors; psychosocial; racial and ethnic; reduce symptoms; social; social culture; substance use treatment; theories; treatment center

Project Summary/Abstract Gabapentin is widely prescribed in neurology, psychiatry, and primary healthcare for the treatment of epilepsy and neuralgia, as well as off- label during treatment for opioid use disorder (OUD) to mitigate withdrawal symptoms, manage pain, and address patient anxiety. From 2002-2015, prescriptions for gabapentin tripled, and gabapentin-involved opioid overdoses have also increased in recent years. As a result, starting in 2017, multiple states reclassified gabapentin to Schedule V under state-controlled substances laws. In 2019, the Food and Drug Administration required labeling changes for gabapentin that included a warning of potential respiratory depression when used with opioids medications. Limited reports document non-medical use (NMU) of gabapentin, especially among opioid users and individuals receiving medication assisted treatment (MAT) for OUD. Gabapentin is non-medically used to potentiate the euphoric effects of opioids, including MAT medications buprenorphine and methadone, as well as to self-treat OUD symptoms. Aside from these brief reports, systematic studies examining the concomitant NMU of gabapentin and opioids are lacking. At the same time, research documents the therapeutic benefits of administering gabapentin to individuals in treatment for substance use disorder. Studies have shown that individuals receiving daily doses of gabapentin reported decreased symptoms of withdrawal and gabapentin works well in combination with methadone for opioid detoxification. Given the growing reports of NMU of gabapentin, especially NMU co-occurring with opioids and MAT; the accepted use of prescribed gabapentin among treatment clients; and the dearth of systematic data examining the concomitant NMU of gabapentin and opioids, the proposed exploratory R21 study seeks to examine this phenomenon. The study will utilize a social ecology theory-driven design to investigate motivations for concomitant NMU, gender and racial/ethnic differences, and histories of MAT and prescribed gabapentin. The following specific aims will be accomplished: 1) Assess demographic, sociocultural, and psychosocial characteristics across three social ecological domains (intrapersonal, interpersonal, and community) which influence concomitant NMU of gabapentin/opioids; and routes of administration, modes of acquisition, and consequences (n=150); 2) Construct and ethnographic decision model (EDM) of the decision to initiate concomitant NMU of gabapentin/opioids (n=60); and 3) Examine NMU of gabapentin in combination with MAT, including motivations, effects, and consequences (n=30). The sample will be collected among individuals entering treatment for OUD and will include approximately equal numbers of men and women, as well as, and Black, Hispanic, and white individuals. The study will advance Goal 1 of NIDA’s strategic plan by identifying environmental, behavioral, and social causes and consequences of concomitant NMU of gabapentin and opioids and it will be informative for OUD treatment providers and prescribers and aid in the development of prevention and intervention strategies. This exploratory study is innovative in its use of EDM methodology.

项目概要/摘要 加巴喷丁在神经病学、精神病学和初级保健领域被广泛用于治疗癫痫 和神经痛，以及阿片类药物使用障碍 (OUD) 治疗期间的标签外治疗以减轻戒断症状 症状、控制疼痛并解决患者焦虑。从 2002 年到 2015 年，加巴喷丁的处方增加了两倍， 近年来，与加巴喷丁相关的阿片类药物过量也有所增加。结果，从2017年开始， 多个州根据国家管制物质法将加巴喷丁重新归类为附表 V。 2019年， 美国食品和药物管理局要求对加巴喷丁的标签进行更改，其中包括潜在的警告 与阿片类药物一起使用时会抑制呼吸。有限报告记录非医疗用途 (NMU) 加巴喷丁，尤其是阿片类药物使用者和接受药物辅助治疗 (MAT) 的个人 为乌德琴。加巴喷丁在非医学上用于增强阿片类药物（包括 MAT）的欣快作用 丁丙诺啡和美沙酮药物，以及自我治疗 OUD 症状。除了这些简短的 报告称，缺乏对加巴喷丁和阿片类药物联合 NMU 的系统研究。在 与此同时，研究证明了加巴喷丁对治疗中的个体的治疗益处 用于物质使用障碍。研究表明，每日接受加巴喷丁剂量的个体报告 减少戒断症状，​​加巴喷丁与美沙酮联合治疗阿片类药物效果良好 排毒。鉴于加巴喷丁 NMU 的报道越来越多，特别是 NMU 与阿片类药物同时发生， 垫;治疗对象接受处方加巴喷丁的使用；以及缺乏系统数据 拟议的探索性 R21 研究旨在检查加巴喷丁和阿片类药物的伴随 NMU 检查这个现象。该研究将利用社会生态学理论驱动的设计来调查 伴随 NMU 的动机、性别和种族/民族差异，以及 MAT 和处方的历史 加巴喷丁。将实现以下具体目标： 1) 评估人口、社会文化和 跨三个社会生态领域（内部、人际和社会）的心理社会特征 社区）影响加巴喷丁/阿片类药物的伴随 NMU；以及给药途径、模式 获得和后果（n=150）； 2）构建决策的人种学决策模型（EDM） 启动加巴喷丁/阿片类药物联合 NMU（n=60）； 3) 检查加巴喷丁组合的 NMU MAT，包括动机、效果和后果 (n=30)。样本将采集于 接受 OUD 治疗的个体将包括大约相同数量的男性和女性，因为 以及黑人、西班牙裔和白人。该研究将通过以下方式推进 NIDA 战略计划的目标 1： 确定加巴喷丁伴随 NMU 的环境、行为和社会原因和后果 和阿片类药物，它将为 OUD 治疗提供者和处方者提供信息，并为开发提供帮助 的预防和干预策略。这项探索性研究的创新之处在于 EDM 方法的使用。