Oral v Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism

医院口服纳曲酮与注射纳曲酮：治疗酒精中毒的效果比较

• 批准号: 9539171
• 负责人: RICHARD SAITZ
• 金额: $ 81.78万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-25 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9539171
• 关键词: Accident and Emergency department; Accreditation; Acute; Address; Adherence; Adopted; Alcohol consumption; Alcohol dependence; Alcoholism; Alcohols; Behavioral; Caring; Cause of Death; Characteristics; Clinical; Cost Effectiveness Analysis; Counseling; Disease; Dose; Effectiveness; Emergency Situation; Enrollment; FDA approved; General Hospitals; Half-Life; Health; Health Care Costs; Heavy Drinking; Hospital Departments; Hospitalization; Hospitals; Hour; Injectable; Injections; Inpatients; Intervention; Joints; Knowledge; Link; Measures; Medical; Naltrexone; Oral; Outcome; Patient Preferences; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Prevalence; Professional Organizations; Quality of Care; Randomized; Randomized Controlled Trials; Risk; Risk Factors; Specialist; Tablets; Testing; Time; Translating; Urban Hospitals; Visit; Work; alcohol abuse therapy; alcohol consequences; alcohol intervention; alcohol misuse; alcoholism therapy; alternative treatment; base; care costs; clinically relevant; comparative effectiveness; cost; cost effective; cost effectiveness; cost outcomes; design; disability; drinking; effective therapy; effectiveness trial; follow-up; health care service utilization; high risk; hospital readmission; improved; innovation; inpatient service; interest; medical specialties; medically necessary care; practice setting; primary outcome; public health relevance; randomized trial; response; screening guidelines; standard care; standard of care; treatment program

DESCRIPTION (provided by applicant): As many as 40% of general medical hospital admissions are linked to alcohol, and alcohol dependence (AD) is a risk factor for readmission (a marker of poor quality of care for which hospitals are financially penalized). Yet most inpatients with AD receive no effective treatment, leaving them vulnerable to both alcohol-specific consequences, and the deleterious effects of untreated AD on medical conditions and related healthcare utilization. Pharmacotherapy for AD (oral tablet naltrexone, PO-NTX; extended-release injectable naltrexone, XR-NTX) has efficacy but unlike treatments for other medical conditions routinely started at hospital discharge it is rarely prescribed. In addition, litle is known about the effectiveness of pharmacotherapy under real-world conditions compared to other clinically available options, and clinicians have little evidence upon which to base decisions to prescribe a costly (per dose) monthly injection or a daily tablet (that may be less adhered to). Therefore, this proposal (in response to PAS-10-273 Clinically Relevant Comparative Effectiveness of Alcoholism Treatments) aims to test the effectiveness of beginning XR-NTX and PO-NTX for AD in medical inpatients at the time of hospital discharge in a pragmatic comparative effectiveness randomized trial. In the Alcohol Dependence hospital Treatment (ADOPT) study, inpatients will receive counseling in the hospital and at follow-up that is feasible in medical settings, and be randomly assigned to monthly XR-NTX, daily PO- NTX or no medication. The primary outcome is percent heavy drinking days; additional outcomes of interest include alcohol consequences, medical healthcare utilization (hospital and emergency department), AD treatment utilization, and costs. The main hypotheses are that 1) XR-NTX will have greater effectiveness than PO-NTX and 2) than no medication, and that 3) PO-NTX will have greater effectiveness than no medication on drinking, consequences and utilization. Cost-effectiveness analysis will compare the costs and outcomes of the three alternatives. Patient factors that moderate effectiveness will be explored. The study is innovative in its design as a pragmatic comparative effectiveness trial, and because it addresses a question that is unanswered but highly relevant. It is timely in that a national accreditation body recently implemented quality performance measures of AD treatment at hospital discharge despite the absence of evidence for effectiveness in that circumstance. The significance of the study is that results will provide guidance for clinicians and policymakers regarding initiation of pharmacotherapy for alcohol dependence for patients at high risk for costly health consequences who largely receive no effective care at the time of hospital discharge.

描述（由申请人提供）：多达40%的综合医疗医院入院与酒精有关，酒精依赖（AD）是再次入院的风险因素（医院受到经济处罚的护理质量差的标志）。然而，大多数AD住院患者没有得到有效的治疗，使他们容易受到酒精特异性后果的影响，以及未经治疗的AD对医疗条件和相关医疗保健利用的有害影响。AD的药物治疗（口服纳洛酮片剂，PO-NTX;缓释注射纳洛酮，XR-NTX）具有疗效，但与出院时常规开始的其他医疗条件治疗不同，很少开处方。此外，与其他临床可用的选择相比，在现实世界条件下药物治疗的有效性知之甚少，临床医生几乎没有证据可以根据决定开出昂贵的（每剂量）每月注射或每日片剂（可能不太坚持）。因此，本提案（响应PAS-10-273酒精中毒治疗的临床相关比较有效性）旨在在一项实用的比较有效性随机试验中，在出院时对内科住院患者开始XR-NTX和PO-NTX治疗AD的有效性进行测试。在酒精依赖医院治疗（ADOPT）研究中，住院患者将在医院和在医疗环境中可行的随访时接受咨询，并随机分配至每月XR-NTX、每日PO-NTX或无药物治疗。主要结果是重度饮酒天数百分比;其他关注的结果包括酒精后果、医疗保健利用率（医院和急诊科）、AD治疗利用率和成本。主要假设是：1）XR-NTX比PO-NTX更有效，2）比没有药物更有效，3）PO-NTX在饮酒、后果和利用方面比没有药物更有效。成本效益分析将比较三种备选办法的成本和结果。将探讨影响疗效的患者因素。这项研究是创新的设计，作为一个务实的比较有效性试验，因为它解决了一个问题，是没有答案，但高度相关。这是及时的，因为一个国家认证机构最近在出院时实施了AD治疗的质量性能指标，尽管在这种情况下缺乏有效性的证据。这项研究的意义在于，研究结果将为临床医生和政策制定者提供指导，指导他们为那些在出院时基本上没有得到有效护理的高风险患者启动酒精依赖药物治疗。

项目成果

Cannabis and cocaine use, drinking outcomes, and quality of life in general hospital inpatients with alcohol use disorder.

综合医院住院酒精使用障碍患者的大麻和可卡因使用、饮酒结果和生活质量。

• DOI: 10.1080/08897077.2022.2074592
• 发表时间: 2022
• 期刊: Substance abuse
• 影响因子: 3.5
• 作者: Romero-Rodríguez,Esperanza;Chen,ClaraA;Dukes,KimberlyA;Hartlage,Kaitlin;Palfai,TiborP;Magane,KaraM;Samet,JeffreyH;Saitz,Richard
• 通讯作者: Saitz,Richard