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
基本信息
- 批准号:9750045
- 负责人:
- 金额:$ 37.16万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AbstinenceAddressBehavior TherapyBehavioralClinicalClinical TreatmentClinical TrialsCocaineConduct Clinical TrialsConnecticutConsensusDataData AnalysesData SetDatabasesDevelopmentDiseaseDrug ScreeningDrug usageEmploymentFunding OpportunitiesGrowthIndividualInterventionInterviewLeadLegalLevel of EvidenceLinkMeasuresMental HealthMeta-AnalysisModelingNational Institute of Drug AbuseOutcomeOutcome MeasurePatient Self-ReportPatternPharmaceutical PreparationsPharmacological TreatmentPharmacotherapyPhasePsychometricsRandomized Clinical TrialsScreening ResultSeveritiesStatistical MethodsTimeTreatment outcomeUnited States Food and Drug AdministrationUniversitiesUrineaddictionbasebehavioral clinical trialclinically significantcocaine useexperiencefollow-upfunctional outcomesillicit drug useinnovationinstrumentphysical conditioningpsychosocialpublic health relevanceresponsesoundsuccess
项目摘要
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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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KATHLEEN M. CARROLL其他文献
KATHLEEN M. CARROLL的其他文献
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{{ truncateString('KATHLEEN M. CARROLL', 18)}}的其他基金
Research Core Psychotherapy Devleopment Research Center
研究核心 心理治疗发展研究中心
- 批准号:
8742765 - 财政年份:2014
- 资助金额:
$ 37.16万 - 项目类别:
Administrative Core Psychotherapy Development Research Center
行政核心心理治疗发展研究中心
- 批准号:
8742764 - 财政年份:2014
- 资助金额:
$ 37.16万 - 项目类别:
Neural mechanisms of CBT in cocaine dependence
可卡因依赖中 CBT 的神经机制
- 批准号:
8914560 - 财政年份:2013
- 资助金额:
$ 37.16万 - 项目类别:
Neural mechanisms of CBT in cocaine dependence (Gender Differences Supplement)
可卡因依赖中 CBT 的神经机制(性别差异补充)
- 批准号:
8803086 - 财政年份:2013
- 资助金额:
$ 37.16万 - 项目类别:
Neural mechanisms of CBT in cocaine dependence
可卡因依赖中 CBT 的神经机制
- 批准号:
8731378 - 财政年份:2013
- 资助金额:
$ 37.16万 - 项目类别:
Neural mechanisms of CBT in cocaine dependence
可卡因依赖中 CBT 的神经机制
- 批准号:
8708818 - 财政年份:2013
- 资助金额:
$ 37.16万 - 项目类别:
Neural mechanisms of CBT in cocaine dependence
可卡因依赖中 CBT 的神经机制
- 批准号:
8534513 - 财政年份:2013
- 资助金额:
$ 37.16万 - 项目类别:
Computer Based Training in CBT for Spanish-Speaking Substance Users
为西班牙语药物使用者提供基于计算机的 CBT 培训
- 批准号:
9231403 - 财政年份:2012
- 资助金额:
$ 37.16万 - 项目类别:
A Stage I Study of Computer Based Training in CBT for Alcohol Use Disorders
基于计算机的酒精使用障碍 CBT 培训的第一阶段研究
- 批准号:
8503575 - 财政年份:2012
- 资助金额:
$ 37.16万 - 项目类别:
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