Yale University and Mayo Clinic received a grant for up to $5.3 million over two years by the U.S. Food and Drug Administration to study opioid prescription and use, according to a July press release.
The study will be carried out by the Center of Excellence in Regulatory Science and Innovation, a joint effort between Yale, Mayo Clinic and the FDA. The research will be conducted in collaboration with Regional Health of Rapid City, South Dakota and the University of Alabama at Birmingham.
“We hope that the data we generate with the study can inform future interventions by the government and other agencies to mitigate the risks associated with opioid use,” said Joseph Ross, professor of medicine and public health at Yale and principal investigator of the study.
The study aims to understand how patients use opioids in the real world by gathering data about their use of prescribed opioids to manage acute pain; how they experience pain and respond to opioids; and how they dispose of these medications after use. The study will enroll 1,200 patients who will be followed for 180 days.
“As part of the FDA’s ongoing efforts to advance our public health goals, confront the opioid crisis and help support appropriate clinical practice, it’s important that objective, evidence-based prescribing guidelines are developed to help assure the proper use of opioid analgesics for the treatment of acute pain in appropriate patients,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a Yale press release published on July 30.
Using a novel patient-centered health data sharing platform, Hugo, the study will collect responses from participants through questionnaires. Additionally, patients will use their patient portal accounts to connect their electronic medical records and pharmacy data when possible.
Patients will also use personal digital devices to gather additional insights into their activity and sleep patterns during the study period. At the end of the study, the Center will collect data on what patients did with their unused opioids.
“This will help us find answers to important public health questions, such as what happens when patients continue to have pain but run out of pills? Or, what happens when they finish having pain but still have prescription left over?” Ross said.
The study arose after the congressional SUPPORT Act required the FDA to generate a database of real-world opioid users to better understand the risks associated with opioid pain treatment and the risk factors associated with long-term use.
Ross added that the project will bring together researchers from various departments at the Yale School of Medicine, including the departments of internal medicine and emergency medicine.
“We are one of the four Centers of Excellence funded by the FDA when they have outstanding questions or concerns and need data and scholarship to address them,” he explained.
The other Centers are based at Johns Hopkins, University of Birmingham and University of California at San Francisco in a joint project with Stanford.
According to the National Institute on Drug Abuse, roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
Ishana Aggarwal | firstname.lastname@example.org