Identification of a Meaningful Cocaine Use Outcome Measure

确定有意义的可卡因使用结果衡量标准

• 批准号: 9750045
• 负责人: KATHLEEN M. CARROLL
• 金额: $ 37.16万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9750045
• 关键词: Abstinence; Address; Behavior Therapy; Behavioral; Clinical; Clinical Treatment; Clinical Trials; Cocaine; Conduct Clinical Trials; Connecticut; Consensus; Data; Data Analyses; Data Set; Databases; Development; Disease; Drug Screening; Drug usage; Employment; Funding Opportunities; Growth; Individual; Intervention; Interview; Lead; Legal; Level of Evidence; Link; Measures; Mental Health; Meta-Analysis; Modeling; National Institute of Drug Abuse; Outcome; Outcome Measure; Patient Self-Report; Pattern; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Psychometrics; Randomized Clinical Trials; Screening Result; Severities; Statistical Methods; Time; Treatment outcome; United States Food and Drug Administration; Universities; Urine; addiction; base; behavioral clinical trial; clinically significant; cocaine use; experience; follow-up; functional outcomes; illicit drug use; innovation; instrument; physical conditioning; psychosocial; public health relevance; response; sound; success

PROJECT SUMMARY/ABSTRACT The identification of a valid and meaningful indicator of a successful outcome from the treatment of cocaine use disorders has been hindered by the lack of an association between reductions in cocaine use and a functional outcome measure that is sensitive to change. This R21/33 proposal submitted in response to NIDA Funding Opportunity PA-15-099 (Reductions in Illicit Drug Use and Functional Outcomes), seeks to address this issue by pooling data across 13 clinical trials of treatments for cocaine use disorders and using the dataset to empirically derive a new instrument for measuring functional outcomes that is sensitive to change. This new measure will be used to identify and validate changes in cocaine use that are associated with improvement in functional outcomes. The specific aims of each phase of this proposal are as follows: R21 Phase: 1. Create a large pooled database of more than 2,000 unique cocaine dependent individuals participating in one of 13 clinical trials conducted at Yale and the University of Connecticut. In all trials, measures of cocaine use were collected by both self-report and urine drug screens at least weekly during treatment, as well as during a 6- to 12-month follow-up period (>80% data availability). 2. Conduct an integrative data analysis to empirically derive a new measure of functioning covering a broad range of domains (e.g., mental health, physical health, criminality/legal problems, employment) that is psychometrically sensitive to change. R33 Phase: 1. We will determine the levels of change on the developed functional outcome measure from pre-treatment through follow-up period that correspond to cocaine use trajectories identified through latent growth mixture models. This will establish whether improvements in functioning are associated with `reduction'-based cocaine use patterns. 2. Validate the relationship between cocaine use patterns and functional outcomes using two reserved trials within the pooled data (n=442 and 358, respectively) to replicate the levels of change on functional outcomes corresponding to various cocaine use trajectories. This rich database will allow us to capitalize on advanced psychometric and statistical methods to produce a functional outcome measure that would be of high scientific and clinical utility, as well as provide a level of evidence to support non-abstinence measures of cocaine use as a meaningful outcome for clinical trials.

项目摘要/摘要 确定可卡因治疗成功的有效和有意义的指标 使用障碍的原因是缺乏可卡因使用减少与 对变化敏感的功能结果衡量标准。这份R21/33提案是对NIDA的回应 资助机会PA-15-099(减少非法药物使用和功能结果)，旨在解决 这个问题是通过汇集13个治疗可卡因使用障碍的临床试验的数据并使用数据集来解决的 从经验上推导出一种新的工具，用于测量对变化敏感的功能结果。这是一项新的 将使用措施来识别和验证可卡因使用方面的变化，这些变化与 功能结果。本提案各阶段的具体目标如下： R21阶段： 1.创建一个大型集合数据库，其中包含2000多名参与 耶鲁大学和康涅狄格大学进行的13项临床试验之一。在所有试验中，测量 在治疗期间，至少每周通过自我报告和尿液药物筛查收集可卡因使用情况，因为 以及6至12个月的跟踪期(80%的数据可用性)。 2.进行综合数据分析，经验性地得出涵盖广泛的功能的新衡量标准 一系列领域(例如，精神健康、身体健康、犯罪/法律问题、就业) 心理测量学上对变化很敏感。 R33阶段： 1.我们将确定已开发的功能结果测量与治疗前相比的变化程度 通过与通过潜伏生长混合物确定的可卡因使用轨迹相对应的随访期 模特们。这将确定功能的改善是否与以减少为基础的 可卡因的使用模式。 2.使用两个预留试验验证可卡因使用模式与功能结果之间的关系 在池化数据内(分别n=442和358)，以复制功能上的变化级别 与各种可卡因使用轨迹相对应的结果。 这个丰富的数据库将使我们能够利用先进的心理测量和统计方法来产生 具有很高的科学和临床实用价值的功能结果衡量标准，以及提供 证据支持可卡因使用的非禁欲措施，作为临床试验的有意义的结果。