Ketamine for the treatment for opioid use disorder and suicidal ideation in the emergency department

氯胺酮用于治疗急诊科阿片类药物使用障碍和自杀意念

• 批准号: 10646993
• 负责人: Peter R Chai
• 金额: $ 22.38万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10646993
• 关键词: Accident and Emergency department; Acute; Acute Pain; Address; Admission activity; Adverse effects; Agitation; Alcohols; Anesthetics; Animals; Back; Behavior Therapy; Behavioral Mechanisms; Blood Pressure; COVID-19 pandemic; Cardiovascular system; Caring; Cocaine use disorder; Data; Diastolic blood pressure; Disease; Dose; Double-Blind Method; Eligibility Determination; Emergency department crowding; Emergency department visit; Event; Face; Feeling suicidal; Foundations; Goals; Heart Rate; Human; Incidence; Individual; Infusion procedures; Intervention; Intravenous; Ketamine; Link; Mental Depression; Mental disorders; Methods; Monitor; National Institute of Drug Abuse; Opioid; Opioid Receptor; Outcome; Outcome Assessment; Overdose; Pain; Participant; Patients; Pharmaceutical Preparations; Pharmacotherapy; Placebo Control; Placebos; Prevalence; Prevention; Psychiatric therapeutic procedure; Psychotherapy; Public Health; Randomized; Relapse; Reporting; Research; Safety; Saline; Sedation procedure; Serious Adverse Event; Substance Use Disorder; Suicide; Suicide attempt; Symptoms; Tachycardia; Testing; Toxicology; Visit; addiction; alcohol use disorder; antidepressant effect; arm; behavior change; comorbidity; completed suicide; craving; depressive symptoms; design; drug misuse; efficacy trial; emergency settings; experience; follow-up; hemodynamics; hypertensive; improved; improved outcome; innovation; interest; medication for opioid use disorder; opioid overdose; opioid use; opioid use disorder; opioid withdrawal; overdose death; pharmacologic; prevent; primary outcome; randomized placebo controlled trial; randomized trial; safety assessment; safety outcomes; screening; screening, brief intervention, referral, and treatment; secondary outcome; side effect; substance misuse; suicidal; timeline; treatment-resistant depression

Project summary Emergency departments (ED) in the US have experienced a significant increase in admissions for opioid-related overdoses and suicide attempts during the COVID pandemic. Individuals with opioid use disorder (OUD) have a lifetime prevalence of suicide attempts exceeding 40%, along with elevated odds of a completed suicide. Among the 100,000 drug-related overdose deaths in 2021—the largest number ever recorded in a 12-month period— 30% or more of such events may in fact be suicides. In 2017, there were over 960,000 ED visits in the US for a non-fatal overdose, making the ED a critical setting in which to intervene. Behavioral interventions like Screening, Brief Intervention, and Referral to Treatment (SBIRT) in the ED improve alcohol outcomes, but multiple trials have failed to show any benefit of SBIRT for individuals with OUD. Structural barriers like ED crowding and lack of follow up for addiction and psychiatric treatment also mar efforts to treat these diseases. Despite the increased utilization of medications for OUD (MOUD) in the ED setting, most patients still do not receive MOUD in the ED, and among those who do, the majority do not continue treatment after discharge. Therefore, there is a critical need for research to identify treatments that can be delivered effectively and sustainably in the ED for individuals with OUD particularly for those who are endorsing suicidal ideation. Ketamine has garnered interest due to its potential in treating psychiatric disorders, rapidly diminishing depressive and suicidal symptoms among individuals with treatment-resistant depression. Sub-anesthetic doses of ketamine administered in either single or multiple sessions in conjunction with psychotherapy has shown beneficial effects for patients with alcohol, opioid, and cocaine use disorders. A major advantage of ketamine is that it is already an accepted pharmacotherapy used routinely in the ED for procedural sedation, agitation, and acute pain. If ketamine could be used as an effective pharmacotherapy for OUD and suicidal ideation in the ED, the approach would be consistent with Screening, Treatment Initiation, and Referral (STIR) which may be more beneficial than the traditional SBIRT approach. However there remains a significant gap in understanding the safety of ED-initiated ketamine for those with OUD in the ED. To fill this need, we propose to conduct a pilot, double-blind, placebo- controlled randomized trial with the primary aim of assessing the safety of administering ketamine in the ED to OUD patients who are endorsing suicidal ideation. Those who are eligible will be randomly assigned to receive either a single infusion of ketamine or saline placebo. Vital signs, side effects, psychiatric adverse effects, opioid withdrawal, and cravings for opioids and ketamine will be monitored closely throughout the ED admission. As a secondary aim, we will determine the preliminary efficacy of ketamine on opioid- and suicide-related outcomes. Mechanisms of behavior change will be explored. If successful, this line of research will help establish the safety of ketamine administration for OUD in the ED, and facilitate the design of a larger efficacy trial.

项目概要 美国急诊科 (ED) 因阿片类药物相关的入院人数大幅增加 患有阿片类药物使用障碍 (OUD) 的人在新冠疫情期间服药过量和自杀未遂。 终生自杀未遂率超过 40%，自杀成功率也很高。 2021 年，有 10 万人因吸毒过量死亡——这是 12 个月期间有记录以来的最高数字—— 30% 或更多的此类事件实际上可能是自杀。2017 年，美国急诊室就诊人数超过 960,000 人次。 非致命的药物过量，使急诊室成为进行筛查等行为干预的关键场所。 急诊科的简短干预和转诊治疗 (SBIRT) 可改善酒精结果，但多项试验 未能证明 SBIRT 对患有 OUD 的结构性障碍（如 ED 拥挤和缺乏）的患者有任何好处。 尽管成瘾和精神治疗的后续行动有所增加，但也损害了治疗这些疾病的努力。 在急诊室使用 OUD 药物 (MOUD)，大多数患者在急诊室仍然没有接受 MOUD， 在那些接受治疗的人中，大多数出院后没有继续治疗，因此存在一个关键问题。 需要进行研究以确定可以在急诊室为个人有效且可持续地提供的治疗方法 与 OUD 特别是那些支持自杀意念的人相比，氯胺酮因其它的作用而引起了人们的兴趣。 治疗精神疾病的潜力，迅速减少抑郁和自杀症状 患有难治性抑郁症的个体，无论单次服用亚麻醉剂量的氯胺酮。 或与心理治疗相结合的多次疗程对酗酒患者显示出有益的效果， 阿片类药物和可卡因使用障碍。氯胺酮的一个主要优点是它已经被接受。 急诊科常规使用的药物疗法用于镇静、躁动和急性疼痛（如果氯胺酮可以）。 用作治疗 ED 中 OUD 和自杀意念的有效药物疗法，该方法是 与筛查、治疗启动和转诊 (STIR) 一致，这可能比常规治疗更有益 然而，对于 ED 发起的安全性的理解仍然存在很大差距。 为了满足这一需求，我们建议进行一项试点、双盲、安慰剂治疗。 对照随机试验，主要目的是评估在急诊科使用氯胺酮的安全性 那些有自杀意念的 OUD 患者将被随机分配接受治疗。 单次输注氯胺酮或生理盐水安慰剂。生命体征、副作用、精神不良反应、阿片类药物。 在急诊室入院期间，将密切监测戒断情况以及对阿片类药物和氯胺酮的渴望。 次要目标是，我们将确定氯胺酮对阿片类药物和自杀相关结果的初步疗效。 如果成功，这方面的研究将有助于建立安全性。 急诊科 OUD 氯胺酮给药的研究，并有助于设计更大规模的疗效试验。