Adherence Monitoring for Substance Abuse Clinical Trials

描述(由申请人提供)：对药物滥用和成瘾的安全有效的药物疗法的评估和选择是通过临床试验进行的，这些临床试验依赖于患者在指定的时间和频率服用所研究的药物。为了确保准确的疗效测量，必须知道是否遵守规定的方案。Creare建议开发一种依从性监测系统，在这些临床试验期间近乎实时地报告时间和剂量信息。Creare系统包括确认性生物标记物，以确保遵守措施的准确性。它可以与其他与给药时间有关的评估相结合，提供测试化合物随时间推移的有效性的额外衡量标准。在第一阶段，我们将通过实施初始原型、进行试验性人体受试性测试以证明可行性，并在第二阶段设计用于实施和测试的原型系统来证明我们的监测系统的可行性。由于Creare之前开发的用于图像处理、神经心理测试、数据共享和评估的算法和软件，Creare团队完全有资格成功地开发和商业化该系统。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，并开创了我们建议的系统中使用的方法。 公共卫生相关性：长期滥用药物不仅影响吸毒者的健康，还影响其家人的生活质量、犯罪受害者的生活，以及非法药物影响下司机造成的车祸，并对执法机构和司法系统造成沉重压力。拟议的基于手机的实时用药依从性措施将大大提高药物滥用药物疗法临床试验的准确性，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。

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.