Standard versus High Dose ED-Initiated Buprenorphine Induction

标准剂量与高剂量 ED 引发的丁丙诺啡诱导

• 批准号: 10801950
• 负责人: Gail D'Onofrio
• 金额: $ 128.6万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-06 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10801950
• 关键词: Acceleration; Accident and Emergency department; Adult; Alcohols; Buprenorphine; Cessation of life; Clinical; Clinical Trials; Development; Dose; Double-Blind Method; Drug usage; Emergency Department patient; Emergency department visit; Enrollment; Ethnic Origin; Evaluation; Fentanyl; Gender; Geography; HIV/HCV; Health Personnel; Health Services Accessibility; Healthcare Systems; Hepatitis C Transmission; High Prevalence; Home; Hour; Individual; Insurance Coverage; Intervention; Methadone; Opioid; Opioid agonist; Outcome; Overdose; Participant; Patient Care; Patients; Pharmaceutical Preparations; Pharmacotherapy; Process; Prospective Studies; Protocols documentation; Quality of life; Race; Randomized; Recommendation; Safety; Sampling Studies; Site; Stimulant; Surveys; Telephone; Testing; Therapeutic; Visit; Withdrawal; Withdrawal Symptom; addiction; analytical method; comparative; craving; fentanyl use; follow-up; housing instability; illicit drug use; illicit opioid; improved; improved outcome; medication for opioid use disorder; mortality; opioid agonist therapy; opioid overdose; opioid use; opioid use disorder; opioid withdrawal; patient engagement; polysubstance use; primary outcome; public health priorities; sedative; social health determinants; synthetic opioid; web site

Abstract Drug overdoses in the U.S. increased to over 107,000 in the year ending January 2022 including > 80,000 involving opioids, representing a 24% increase from the prior year. Despite improved outcomes and decreased all-cause mortality among individuals with opioid use disorder (OUD) who receive opioid agonist treatment, only 11% of individuals with OUD receive medications for opioid use disorder. Narrowing the treatment gap by expanding access to treatment beyond specialized drug treatment settings is a public health priority, and the Emergency Department (ED), offering access 24 hours, 7 days a week, 365 days a year, is a logical point of intervention. ED patients have a disproportionately high prevalence of OUD, and for many, the ED is the primary or only access point in the healthcare system. There are currently no controlled, prospective studies comparing dosing strategies for buprenorphine induction in the ED. We propose a multisite randomized double-blind, double-dummy, clinical trial of ED patients with moderate to severe OUD (N=360) from 4 geographically diverse EDs to compare Standard ED Dose Induction (SDI; 8 mg) with High Dose Induction (HDI; 24 mg) to evaluate AIM 1: Engagement in continuing OUD treatment at 10 days and AIM 2: Differences in outcomes of craving, tolerability, withdrawal symptoms, and use of illicit drugs. We hypothesize that patients assigned to the HDI group will be more likely to be engaged in OUD treatment at 10 days post ED enrollment (primary outcome), and will describe less craving, less withdrawal symptoms and less use of illicit drugs during the 10 days post ED buprenorphine induction. Additional outcomes will be the development of ED protocols, and evaluation of safety, feasibility, and acceptability. The primary outcome of engagement in treatment at 10 days as well as treatment at day 30 will be verified by the treating clinician. Assessment of craving, withdrawal symptoms and use of illicit drugs will be obtained by daily Qualtrics phone surveys. The planned study sample and the proposed analytical methods will allow for additional meaningful exploratory evaluations of potential differential effects of gender, race, ethnicity, housing instability, insurance status, and use of fentanyl, and other polysubstance use such as stimulants, sedatives, and alcohol. An accelerated achieves potentially treatment induction process that therapeutic buprenorphine levels in less than 3-4 hours compared to the typical 2-3 days could increase safety during the crucial gap between ED discharge and engagement in continuation by limiting illicit opioid use and encouraging follow up visits for OUD treatment.

抽象的 截至 2022 年 1 月的一年中，美国吸毒过量人数增加至超过 107,000 起，其中超过 80,000 起 涉及阿片类药物，较上年增加 24%。尽管结果有所改善并减少 接受阿片类激动剂治疗的阿片类药物使用障碍 (OUD) 患者的全因死亡率， 只有 11% 的 OUD 患者接受治疗阿片类药物使用障碍的药物治疗。缩小治疗差距 扩大专业戒毒治疗机构之外的治疗机会是一项公共卫生优先事项， 急诊科 (ED) 每年 365 天、每周 7 天、24 小时提供服务，是 干涉。 ED 患者的 OUD 患病率异常高，对于许多人来说，ED 就是 医疗保健系统中的主要或唯一接入点。目前尚无对照、前瞻性研究 比较急诊室中丁丙诺啡诱导的剂量策略。我们 提出 一个 多中心随机化 对 4 名患有中度至重度 OUD 的 ED 患者（N=360）进行双盲、双模拟临床试验 不同地区的 ED 比较标准 ED 剂量诱导（SDI；8 mg）与高剂量诱导 （HDI；24 毫克）评估 AIM 1：参与持续 10 天 OUD 治疗和 AIM 2：差异 渴望、耐受性、戒断症状和使用非法药物的结果。我们假设患者 分配到 HDI 组的人更有可能在 ED 入组后 10 天接受 OUD 治疗 （主要结果），并将描述在治疗期间较少的渴望、较少的戒断症状和较少的非法药物使用 ED 丁丙诺啡诱导后 10 天。其他成果将是 ED 协议的制定， 以及安全性、可行性和可接受性的评估。 10岁时参与治疗的主要结果 天数以及第 30 天的治疗将由治疗临床医生核实。评估渴望、戒断 症状和非法药物的使用情况将通过每日 Qualtrics 电话调查获得。计划的研究样本 拟议的分析方法将允许对潜在的进行更多有意义的探索性评估 性别、种族、民族、住房不稳定、保险状况和芬太尼使用的不同影响，以及 其他多物质使用，如兴奋剂、镇静剂和酒精。加速的 达到 潜在地 治疗 归纳过程 与典型的 2-3 天相比，丁丙诺啡在不到 3-4 小时内即可达到治疗水平 提高 ED 出院和继续参与之间关键间隙的安全性 通过限制非法阿片类药物的使用并鼓励对 OUD 治疗进行随访。