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.

摘要 在截至2022年1月的一年里，美国的药物过量增加到超过107,000人，其中包括80,000人 涉及阿片类药物，比前一年增加了24%。尽管结果有所改善，但 接受阿片激动剂治疗的阿片使用障碍(OUD)患者的全因死亡率， 只有11%的OUD患者接受阿片类药物使用障碍的治疗。通过以下方式缩小治疗差距 扩大专门药物治疗以外的治疗机会是公共卫生的优先事项， 急诊科(ED)，一年365天，一周7天，每天24小时提供服务，这是一个合乎逻辑的点 干预。ED患者有不成比例的高OUD患病率，对许多人来说，ED是 医疗保健系统中的主要或唯一接入点。目前还没有对照的前瞻性研究。 比较丁丙诺啡在ED中的给药策略。我们 提议 一个 多站点随机化 中重度勃起功能障碍(N=360)患者的双盲、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)和高剂量诱导 (HDI；24 mg)评估目标1：在10天后继续接受OUD治疗的参与度和目标2：差异 在渴望、耐受性、戒断症状和使用非法药物的结果中。我们假设病人 分配到HDI组的人在ED登记后10天更有可能参与OUD治疗 (主要结果)，并将描述减少渴望，减少戒断症状和减少非法药物的使用 丁丙诺啡诱导后10d。其他成果将是制定ED方案， 以及安全性、可行性和可接受性的评估。在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。对渴求、戒断的评估 非法药物的症状和使用情况将通过每天Qualtrics的电话调查获得。计划中的研究样本 拟议的分析方法将允许对潜力进行更有意义的探索性评估 性别、种族、民族、住房不稳定、保险状况和芬太尼的使用的不同影响，以及 其他多种物质的使用，如兴奋剂、镇静剂和酒精。一种加速的 成就 潜在 治疗 诱导过程 与通常的2-3天相比，治疗性丁丙诺啡水平在3-4小时内可以 在放电和持续接合之间的关键间隙期间提高安全性 通过限制非法阿片类药物的使用和鼓励后续就诊进行OUD治疗。