Adherence Monitoring for Substance Abuse Clinical Trials

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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.