Development of the Stimulant Use Disorder Severity Scale

兴奋剂使用障碍严重程度量表的制定

基本信息

批准号：
10608337
负责人：
BRIAN D. KILUK
金额：
$ 16.38万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2023-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10608337
关键词：
Address Adopted Ambulatory Care Award Caring Characteristics Clinical Clinical Research Clinical Trials Complex Comprehension Development Diagnosis Diagnostic Diagnostic and Statistical Manual of Mental Disorders Disease Drug Evaluation Drug usage Electronics Enrollment Evaluation Feedback Individual Instruction Interview Language Link Measurement Measures Mental disorders Methods Outcome Outcome Measure Participant Patient Outcomes Assessments Patient Self-Report Patient-Focused Outcomes Patients Pharmaceutical Preparations Procedures Psychometrics Qualifying Quality of life Research Sampling Self Administration Severities Structure Substance Addiction Substance Use Disorder Substance of Abuse Sum Symptoms Testing Time Training Validity and Reliability Work addiction clinical care clinical development clinical outcome assessment cognitive interview cost diagnostic criteria drug development drug use behavior electronic patient reported outcomes improved improved outcome indexing instrument novel opioid epidemic opioid use opioid use disorder response stimulant use disorder tool tool development treatment research

项目摘要

7. PROJECT SUMMARY/ABSTRACT The development of new medications to reduce the burden caused by opioid use disorder (OUD) is a high priority in addressing the opioid crisis. However, the currently available tools and endpoints to evaluate and approve new medications to treat opioid use is an impediment to medication development. Measures of change in the diagnostic criteria (i.e., symptoms) of OUD have rarely been used as indicators of improvement from treatment, despite this approach being standard practice for other psychiatric disorders. There is preliminary evidence from multiple clinical trials that change in Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnostic threshold and criteria counts has potential utility as a clinically meaningful outcome. However, the only validated assessments for measuring the presence and severity of DSM-5 OUD are clinician-administered, semi-structured interviews, requiring extensive training and cost making them impractical for broad use. In this project, we propose to develop a new clinical outcome assessment that is an electronically-administered, patient self-report instrument directly linked to DSM-5 diagnostic criteria for measuring the severity of OUD, the ‘Opioid Use Disorder Severity Scale’ (OUDSS). The specific aims are to: (1) generate a pool of self-report items based on structured clinical interviews for OUD and existing items banks of substance use disorder severity to create an electronic, self-administered instrument directly linked to the diagnostic criteria in DSM-5; (2) evaluate the content validity and administration procedures of the OUDSS through one-on-one qualitative interviews with 20 patients with OUD; and (3) evaluate the reliability and validity of the OUDSS in a diverse sample of 300 individuals seeking/enrolled in outpatient treatment to determine construct validity, test-retest reliability, and ability to detect change. Development and evaluation of the OUDSS will follow the FDA Guidance for Patient Reported Outcome (PRO) measures. Because of the rigorous methods required for development of a PRO instrument, we are targeting OUD rather than general substance use disorders for development during the period of this award. As DSM-5 diagnostic criteria are equivalent across substances of abuse, the OUDSS could be modified for other specific substances (or substance use disorders in general) with minimal effort. A validated, easy to administer, electronic PRO measuring OUD severity would be a significant contribution to treatment research, clinical care, and medication development.

7. 项目概要/摘要开发新药物以减轻阿片类药物使用障碍 (OUD) 造成的负担是一项艰巨的任务然而，目前可用的工具和终点来评估和解决阿片类药物危机。批准治疗阿片类药物使用的新药物是药物开发的一个障碍。 OUD 诊断标准（即症状）的变化很少被用作改善指标尽管这种方法是治疗其他精神疾病的标准做法。来自多个临床试验的初步证据改变了精神诊断和统计手册疾病 (DSM) 诊断阈值和标准计数具有作为临床意义的潜在实用性然而，这是衡量 DSM-5 OUD 的存在和严重程度的唯一经过验证的评估。是临床医生管理的半结构化访谈，需要大量培训和成本在这个项目中，我们建议开发一种新的临床结果评估，即一种新的临床结果评估。电子管理的患者自我报告仪器直接与 DSM-5 诊断标准相关测量 OUD 的严重程度，即“阿片类药物使用障碍严重程度量表”(OUDSS)。具体目标是：（1）根据结构化临床访谈生成自我报告项目库 OUD 和物质使用障碍严重程度的现有项目库创建一个电子的、自我管理的仪器直接与DSM-5中的诊断标准挂钩；（2）评估内容效度和效度；通过对 20 名 OUD 患者进行一对一定性访谈来了解 OUDSS 的管理程序； (3) 在 300 人的不同样本中评估 OUDSS 的信度和效度寻求/参加门诊治疗以确定结构有效性、重测可靠性和能力检测变化。 OUDSS 的开发和评估将遵循 FDA 患者报告结果指南 (PRO) 由于开发 PRO 仪器需要严格的方法，因此我们的目标是。 OUD 而不是一般物质使用障碍在该奖项期间发展为 DSM-5。各种滥用物质的诊断标准是相同的，可以针对其他具体情况修改 OUDSS 一种经过验证的、易于管理的物质（或一般的物质使用障碍）。电子 PRO 测量 OUD 严重程度将对治疗研究、临床护理、和药物开发。

项目成果

期刊论文数量（2）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review.

阿片类药物使用障碍新兴治疗的临床试验设计挑战和机遇：综述。

DOI：
10.1001/jamapsychiatry.2022.4020
发表时间：
2023
期刊：
JAMA psychiatry
影响因子：
25.8
作者：
Kiluk,BrianD;Kleykamp,BetheaA;Comer,SandraD;Griffiths,RolandR;Huhn,AndrewS;Johnson,MatthewW;Kampman,KyleM;Pravetoni,Marco;Preston,KenzieL;Vandrey,Ryan;Bergeria,CeciliaL;Bogenschutz,MichaelP;Brown,RandallT;Dunn,KellyE
通讯作者：
Dunn,KellyE

Detecting change in psychiatric functioning in clinical trials for cocaine use disorder: sensitivity of the Addiction Severity Index and Brief Symptom Inventory.