Adherence Monitoring for Substance Abuse Clinical Trials

药物滥用临床试验的依从性监测

• 批准号: 8315218
• 负责人: ODILE H CLAVIER
• 金额: $ 14.95万
• 依托单位: CREARE, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8315218
• 关键词: Adherence; Affect; Algorithms; Biological Markers; Biological Markers; Blood; Blood Circulation; Blood specimen; California; Cellular Phone; Chronic; Clinical; Clinical Trials; Clinical effectiveness; Computer software; Crime Victims; Data; Databases; Development; Devices; Disease; Dose; Drug Addiction; Drug abuse; Drug user; Effectiveness; Electronics; Engineering; Enrollment; Ensure; Evaluation; Family; Frequencies; Funding; Government; Hand; Head; Health; Illicit Drugs; Justice; Laboratory Research; Law Enforcement; Lead; Licensing; Link; Measurement; Measures; Medical center; Methods; Monitor; National Institute of Drug Abuse; Neuropsychological Tests; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Phase; Placebos; Principal Investigator; Publishing; Qualifying; Quality of life; Records; Regimen; Relative (related person); Reporting; Research Institute; Research Personnel; Resolution; Safety; Societies; Specific qualifier value; Substance abuse problem; System; Techniques; Technology; Testing; Time; Urine; Vehicle crash; addiction; base; clinically relevant; commercialization; data sharing; design; dosage; drug abuse chemotherapy; effective therapy; efficacy testing; experience; human study; human subject; image processing; medication compliance; monitoring device; neurocognitive test; pill; prototype; substance abuse treatment; substance abuser; urinary

DESCRIPTION (provided by applicant): The evaluation and selection of safe and effective pharmacotherapies for drug abuse and addiction is performed through clinical trials that rely on patients taking the studied medication at the specified time and frequency. To ensure accurate efficacy measures, adherence to the prescribed regimen must be known. Creare proposes to develop an adherence monitoring system to report both timing and dosage information in near-real time during these clinical trials. The Creare system includes confirmatory biomarkers to ensure accuracy of the adherence measures. It can be combined with other assessments linked to dosing time that provide additional measures of efficacy of the test compound over time. During Phase I, we will demonstrate the feasibility of our monitoring system by implementing an initial prototype, performing a pilot human subject test to demonstrate feasibility, and designing a prototype system for implementation and testing during Phase II. The Creare team is well qualified to successfully develop and commercialize this system thanks to algorithms and software Creare has previously developed for image processing, neuropsychological testing, data sharing, and assessment. Our clinical collaborator, Dr. John Mendelson, head of the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute (APRL- CPMCRI) has extensive experience in clinical trials with illicit drug users and pioneered the methods used in our proposed system. PUBLIC HEALTH RELEVANCE: Chronic drug abuse affects not only the health of the users, but also the quality of life of their families, the lives of crime victims, and car crashes caused y drivers under the influence of illicit drugs, and it weighs heavily on the law enforcement agencies and justice system. The proposed real-time, cellular phone-based medication adherence measure will greatly increase the accuracy of clinical trials for substance abuse pharmacotherapies likely to increase effective treatment options for substance abusers, thereby reducing the burden of substance abuse disorders on our society.

描述（由申请人提供）：通过临床试验评价和选择药物滥用和成瘾的安全有效药物治疗，这些临床试验依赖于患者在规定的时间和频率服用研究药物。为了确保准确的疗效测量，必须了解对处方方案的依从性。Creare建议开发一个依从性监测系统，在这些临床试验期间近实时地报告时间和剂量信息。Creare系统包括确证性生物标志物，以确保依从性测量的准确性。它可以与与给药时间相关的其他评估组合，这些评估提供了测试化合物随时间推移的功效的额外测量。在第一阶段，我们将通过实施初步原型，进行人体试验以证明可行性，并设计原型系统以在第二阶段实施和测试，来证明我们的监测系统的可行性。Creare团队完全有资格成功开发和商业化该系统，这要归功于Creare之前开发的用于图像处理、神经心理学测试、数据共享和评估的算法和软件。我们的临床合作者John Mendelson博士是加州太平洋医学中心研究所（APRL- CPMCRI）成瘾和药理学研究实验室的负责人，他在非法药物使用者的临床试验方面拥有丰富的经验，并开创了我们提出的系统中使用的方法。 公共卫生相关性：慢性药物滥用不仅影响使用者的健康，而且影响其家庭的生活质量、犯罪受害者的生活以及驾驶员在非法药物的影响下造成的车祸，并对执法机构和司法系统造成沉重负担。拟议的基于手机的实时药物依从性措施将大大提高药物滥用药物治疗临床试验的准确性，可能会增加药物滥用者的有效治疗选择，从而减轻药物滥用障碍对我们社会的负担。