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.

项目摘要/摘要 通过可卡因的治疗方法确定有效而有意义的指标 由于可卡因使用的减少与A之间缺乏关联，因此使用了使用障碍 对变化敏感的功能结果度量。该R21/33提交的提案是针对NIDA提交的 资金机会PA-15-099（非法药物使用和功能结果的减少）试图解决 通过在13个可卡因使用障碍治疗的临床试验中汇总数据并使用数据集 从经验上得出一种测量对变化敏感的功能结果的新工具。这个新 措施将用于识别和验证与改善相关的可卡因使用变化 功能结果。该提案的每个阶段的具体目的如下： R21阶段： 1。创建一个大型合并数据库，该数据库由2,000多个独特的可卡因依赖人参加 在耶鲁大学和康涅狄格大学进行的13次临床试验之一。在所有试验中， 自我报告和尿液药物筛查至少在治疗期间每周都会收集可卡因 以及6到12个月的随访期（> 80％的数据可用性）。 2.进行综合数据分析，以凭经验得出涵盖广泛的功能的新量度 领域范围（例如心理健康，身体健康，犯罪/法律问题，就业） 对改变的心理敏感。 R33阶段： 1。我们将根据预处理确定开发功能结果度量的变化水平 在随访期间，与可卡因使用轨迹相对应，通过潜在生长混合物鉴定 型号。这将确定功能的改进是否与“减少”基于“减少”有关 可卡因使用模式。 2。使用两个预留试验来验证可卡因使用模式与功能结果之间的关系 在汇总的数据中（分别为n = 442和358），以复制功能上的更改级别 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高级心理测量和统计方法来产生 功能性结果度量将具有高度科学和临床实用性，并提供一定程度的水平 支持可卡因用作临床试验的有意义的结果的证据。