Ketamine for the treatment for alcohol use disorder in the emergency department: A pilot double-blind, placebo-controlled randomized clinical trial

氯胺酮在急诊科治疗酒精使用障碍：一项试点双盲、安慰剂对照随机临床试验

• 批准号: 10703512
• 负责人: Peter R Chai
• 金额: $ 21.26万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-12 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10703512
• 关键词: Abstinence; Accident and Emergency department; Acute; Acute Pain; Address; Admission activity; Adverse effects; Agitation; Alcohol withdrawal syndrome; Alcohols; American; Anesthetics; Back; Behavior Therapy; Behavioral Mechanisms; Benzodiazepines; Biological Markers; Blood Pressure; Caring; Chronic; Cocaine use disorder; Country; Diastolic blood pressure; Dissociative Anesthetics; Dose; Double-Blind Method; Drug Metabolic Detoxication; Economic Burden; Emergency Medicine; Emergency department visit; Ensure; Evidence based treatment; Exclusion; Foundations; Funding; Goals; Heart Rate; Heavy Drinking; Hospitals; Incidence; Individual; Infusion procedures; Inpatients; Intervention; Intravenous; Ketamine; Medical; Mental disorders; Monitor; N-Methylaspartate; National Institute on Alcohol Abuse and Alcoholism; Outcome; Participant; Patients; Pharmacotherapy; Placebos; Positioning Attribute; Property; Psychiatrist; Psychosocial Assessment and Care; Psychotherapy; Public Health; Randomized; Relapse; Reporting; Research; Research Personnel; Research Project Grants; Risk; Safety; Saline; Sedation procedure; Serious Adverse Event; Serum; Symptoms; Tachycardia; United States National Institutes of Health; Urine; Withdrawal; addiction; adverse drug reaction; alcohol abuse therapy; alcohol craving; alcohol use disorder; alcohol-related death; antagonist; behavior change; brief intervention; craving; depressive symptoms; design; drinking; efficacy evaluation; efficacy trial; eligible participant; epidemiology study; experience; follow up assessment; hypertensive; implementation strategy; improved; innovation; interest; opioid use disorder; patient engagement; phosphatidylethanol; primary outcome; psychiatric comorbidity; randomized placebo controlled trial; randomized placebo-controlled clinical trial; safety assessment; screening; screening, brief intervention, referral, and treatment; secondary outcome; side effect; success; suicidal; time use; treatment-resistant depression

Project Summary Abstract An estimated 15 million Americans have an alcohol use disorder (AUD), resulting annually in 95,000 deaths from alcohol-related causes and 250 billion dollars in economic burden. Yet, epidemiologic studies have consistently found that the vast majority of those with AUD are not receiving any evidence-based treatments. One of the consequences of an untreated AUD is the need for medical treatment to address the acute and chronic effects of heavy drinking, which has resulted in the number of alcohol-related emergency department (ED) visits to increase by 61.6% from 3.1 million to 5.0 million. This makes the ED an important and timely setting to engage individuals with AUD to enter addiction treatment as evidenced by the success of behavioral interventions like Screening, Brief Intervention and Referral to Treatment (SBIRT). However, SBIRT has not been as impactful for those with severe AUD, and it has been difficult for many EDs to successfully implement and sustain brief interventions. As such, more effective strategies that can be implemented in the ED setting to address AUD are critically needed. Ketamine has emerged as a potential treatment option for AUD. 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 AUD in the ED, the approach would be consistent with Screening, Treatment Initiation, and Referral (STIR) which may be more beneficial for patients with severe AUD than the traditional SBIRT approach. However there remains a significant gap in understanding the safety of ED-initiated ketamine in improving AUD-related outcomes for those who seek detoxification. To fill this need, we propose to conduct a pilot double-blind placebo-controlled randomized clinical trial with the primary aim of assessing the safety of administering ketamine in the ED to AUD patients seeking admission to an inpatient detoxification unit. All participants will receive the hospital’s standard detoxification treatment which also includes intensive psychosocial support. Participant selection will focus on ensuring the exclusion of those with potential medical and psychiatric co-morbidities that pose a risk when administered ketamine. Eligible participants will be randomly assigned to receive either a single infusion of ketamine or saline placebo in the ED. Vital signs, adverse effects, alcohol withdrawal, and craving for alcohol and ketamine will be monitored closely throughout the trial. As an exploratory aim, we will assess alcohol-related outcomes as well as mechanisms of behavior change. If successful, this line of research will help establish the safety of ketamine administration for AUD in the ED, and facilitate the design of an adequately powered efficacy trial.

项目摘要

项目成果

The possible clinical utility of the alcohol biomarker phosphatidylethanol for managing suspected alcohol withdrawal in hospitalized patients: A case report.

酒精生物标志物磷脂酰乙醇在治疗住院患者疑似酒精戒断方面的可能临床效用：病例报告。

• DOI: 10.1111/ajad.13516
• 发表时间: 2024
• 期刊: The American journal on addictions
• 作者: Edinoff,AmberN;Hathaway,DavidB;MartinezGarza,David;Rosen,JordanH;Suzuki,Joji
• 通讯作者: Suzuki,Joji