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

项目总结/摘要 加巴喷丁被广泛用于神经病学、精神病学和初级卫生保健，用于治疗癫痫 和神经痛，以及阿片类药物使用障碍（OUD）治疗期间的标签外使用，以减轻戒断 症状，管理疼痛，并解决患者的焦虑。从2002年到2015年，加巴喷丁的处方增加了两倍， 近年来，加巴喷丁涉及的阿片类药物过量也有所增加。因此，从2017年开始， 多个州将加巴喷丁重新归类为国家管制物质法下的附表V。2019年 美国食品和药物管理局要求加巴喷丁的标签变更，其中包括潜在的警告 与阿片类药物一起使用时的呼吸抑制。有限报告记录非医疗用途（NMU） 加巴喷丁，特别是在阿片类药物使用者和接受药物辅助治疗（MAT）的个人中 对于OUD。加巴喷丁非医学用途，用于增强阿片类药物（包括MAT）的欣快感 药物丁丙诺啡和美沙酮，以及自我治疗OUD症状。除了这些简短的 报告，缺乏检查加巴喷丁和阿片类药物的伴随NMU的系统研究。在 与此同时，研究记录了加巴喷丁对治疗中的个体的治疗益处， 药物使用障碍研究表明，接受每日剂量加巴喷丁的人报告说， 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 解毒鉴于加巴喷丁NMU的报告越来越多，特别是NMU与阿片类药物同时发生， MAT;治疗客户中接受处方加巴喷丁的使用;以及缺乏系统数据 检查加巴喷丁和阿片类药物的伴随NMU，拟议的探索性R21研究旨在 研究这一现象。本研究将以社会生态学理论为主导设计， 伴随NMU的动机、性别和种族/民族差异以及MAT和处方药的历史 加巴喷丁将实现以下具体目标：（1）评估人口、社会文化和 三个社会生态领域的心理社会特征（自我、人际和 影响加巴喷丁/阿片类药物的伴随NMU;以及给药途径、 获得和后果（n=150）; 2）决策的结构和民族志决策模型（EDM） 开始加巴喷丁/阿片类药物的伴随NMU（n=60）;和3）检查加巴喷丁与阿片类药物的组合的NMU MAT，包括动机，效果和后果（n=30）。样本将在以下地点收集： 进入OUD治疗的个人，将包括大约相同数量的男性和女性， 以及黑人、西班牙裔和白色人。该研究将通过以下方式推进NIDA战略计划的目标1： 确定加巴喷丁的伴随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， 预防和干预战略。这项探索性的研究是创新的，在其使用EDM方法。

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.