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, as well as many other diseases and disorders, 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 a mobile adherence monitoring system to record 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. The system allows for ecological momentary assessments linked to dosing time that provide additional measures of efficacy and drug safety of the test medication over time. During Phase I, we demonstrated the feasibility of our monitoring system by implementing an initial prototype and performing a pilot human subject test to demonstrate feasibility. During Phase II, we will further develop and integrate the hardware and software components of our system, and test the system in the laboratory and in a cohort of subjects on opiate substitution therapy. The Creare team is extremely well qualified to successfully develop and commercialize this system thanks to algorithms, software, and hardware Creare has previously developed for image processing, neuropsychological testing, data sharing, and mobile hearing 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.