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.

项目总结/摘要 确定可卡因治疗成功的有效和有意义的指标 可卡因使用减少与滥用之间缺乏联系， 对变化敏感的功能结果测量。此R21/33提案是针对NIDA提交的 PA-15-099（减少非法药物使用和功能成果）旨在解决 通过汇集13项可卡因使用障碍治疗临床试验的数据， 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。这个新 将使用一项措施来确定和验证可卡因使用的变化，这些变化与改善 功能性成果。本建议每一阶段的具体目标如下： R21阶段： 1.创建一个大型汇总数据库，其中包含2，000多名独特的可卡因依赖者， 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， 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， 以及在6至12个月的随访期内（>80%的数据可用性）。 2.进行综合数据分析，根据经验得出一个新的功能衡量标准， 域的范围（例如，心理健康、身体健康、犯罪/法律的问题、就业）， 对变化的心理敏感度 R33阶段： 1.我们将确定从治疗前开始的已开发功能结局指标的变化水平 通过潜在增长混合物确定的可卡因使用轨迹对应的随访期 模型这将确定功能的改善是否与基于“减少”的 可卡因使用模式 2.使用两个保留试验验证可卡因使用模式与功能结果之间的关系 在合并数据中（分别为n=442和358），以复制功能变化水平 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， 功能结局指标，具有较高的科学和临床实用性，并提供 证据支持可卡因使用的非戒断措施作为临床试验的一个有意义的结果。