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.
In 2011, 22.5 million Americans 12 years or older used illicit drugs on a regular basis;the economics of such widespread illicit drug use impose a huge cost on our society. One of the National Institute on Drug Abuse's primary objectives is to develop successful treatments for drug abuse and addiction and improve treatment accessibility and implementation. The proposed real-time, cell phone-based mobile adherence monitoring system will greatly increase the accuracy and efficiency of clinical trials for substance abuse pharmacotherapies, thereby increasing the likelihood that effective treatment options for substance abusers will be developed and reduce the burden of substance abuse disorders on our society.