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 截至2022年1月的一年，美国的药物过量增加到超过107，000，其中包括> 80，000 涉及阿片类药物，比上一年增加了24%。尽管结果有所改善， 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患者接受阿片类药物使用障碍的药物治疗。缩小治疗差距， 将获得治疗的机会扩大到专业戒毒治疗环境之外是一项公共卫生优先事项， 急诊科（艾德），提供访问24小时，每周7天，一年365天，是一个合乎逻辑的点， 干预艾德患者的OUD患病率高得不成比例，对许多人来说，艾德是 医疗保健系统中的主要或唯一接入点。目前没有对照的前瞻性研究 比较ED中丁丙诺啡诱导的给药策略。我们 提出 一 多中心随机化 一项双盲、双模拟、临床试验，在患有中度至重度OUD的艾德患者（N=360）中进行， 地理位置不同的ED，以比较标准艾德剂量诱导（SDI; 8 mg）与高剂量诱导 (HDI; 24 mg），以评价AIM 1：10天时继续OUD治疗的参与和AIM 2：差异 在渴望，耐受性，戒断症状和使用非法药物的结果。我们假设病人 分配到HDI组的患者在艾德入组后10天更有可能参与OUD治疗 （主要结局），并将描述在治疗期间减少渴望，减少戒断症状和减少使用非法药物 艾德丁丙诺啡诱导后10天。其他成果将是制定艾德协议， 以及安全性、可行性和可接受性的评价。10岁时参与治疗的主要结局 第30天的治疗以及第30天的治疗将由治疗临床医生验证。对渴望、戒断的评估 症状和使用非法药物将通过每日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潜在风险进行额外的有意义的探索性评估。 性别、种族、民族、住房不稳定性、保险状况和芬太尼使用的不同影响，以及 其他多种物质的使用，如兴奋剂、镇静剂和酒精。加速 实现 潜在 治疗 诱导过程， 与典型的2-3天相比，在少于3-4小时内的治疗性丁丙诺啡水平可 在艾德出院和继续参与之间的关键间隙期间增加安全性 通过限制非法阿片类药物的使用和鼓励OUD治疗的随访。