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: 10000866
• 负责人: BRIAN D. KILUK
• 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 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10000866
• 关键词: Abstinence; Address; Behavior Therapy; Behavioral; Clinical; Clinical Treatment; Clinical Trials; Cocaine; Conduct Clinical Trials; Connecticut; Consensus; Data; Data Analyses; Data Pooling; 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; 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.

项目概要/摘要 确定可卡因治疗成功结果的有效且有意义的指标 由于可卡因使用减少与可卡因使用减少之间缺乏关联，使用障碍受到阻碍。 对变化敏感的功能结果测量。此 R21/33 提案是响应 NIDA 提交的 资助机会 PA-15-099（减少非法药物使用和功能结果）旨在解决 该问题通过汇集 13 项可卡因使用障碍治疗临床试验的数据并使用数据集来解决 凭经验得出一种新的工具来衡量对变化敏感的功能结果。这个新的 该措施将用于确定和验证可卡因使用的变化，这些变化与改善 功能结果。本提案各阶段的具体目标如下： R21相： 1. 创建一个包含 2,000 多名独特可卡因依赖者参与的大型数据库 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 个月的随访期间（>80% 的数据可用性）。 2. 进行综合数据分析，以实证方式得出涵盖广泛的功能的新衡量标准 一系列领域（例如心理健康、身体健康、犯罪/法律问题、就业） 心理测量对变化敏感。 R33相： 1. 我们将确定治疗前开发的功能结果测量的变化水平 通过与通过潜在增长混合物确定的可卡因使用轨迹相对应的后续时期 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. 使用两项保留试验验证可卡因使用模式与功能结果之间的关系 在汇总数据（分别为 n=442 和 358）中复制功能变化水平 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来生成 具有高度科学和临床实用性的功能结果测量，并提供一定水平的 支持可卡因使用的非戒断措施作为临床试验的有意义的结果的证据。