Nearly one-third of Americans suffer from chronic noncancer pain, a condition often treated with opioids. The effectiveness of this chronic opioid therapy is currently unclear and exposes individuals to potential risks, including opioid abuse after therapy.

A new $9 million study, led by RTI International, aims to provide strategies for reducing opioid use among patients who are not benefitting from it while ensuring access to those who are benefitting. RTI will collaborate with the Mid-South Clinical Data Research Network which is centered at Vanderbilt University Medical Center and includes Duke University Health System and the University of North Carolina at Chapel Hill.

"This project will help patients better understand the risks, benefits and uncertainties associated with opioid use, which is needed for informed consent and is critical given the status of the opioid epidemic," said Lauren McCormack, PhD, Vice President of RTI's Public Health Research Division who will lead the study.

More than 1,000 patients from North Carolina and Tennessee, states with high opioid use rates, will be enrolled in the study. Researchers will compare two interventions to evaluate their effect on opioid dosage, physical functioning and pain-related outcomes.

One intervention involves a shared decision-making process where patients and clinicians make evidence-based decisions together that align with the patients' preferences and values. This approach requires strong communication between the patient and provider about the risks and benefits of treatment options.

The other intervention uses motivational interviewing as a goal-oriented counseling technique to enhance an individual's motivation for behavior change. This involves cognitive behavioral therapy in group sessions to foster more positive thoughts, emotions and behaviors to help manage pain.

Both intervention groups will also receive care based on the Centers for Disease Control and Prevention's new guidelines for treating opioid patients, including patient selection for opioid use, goal setting, active monitoring, and reducing misuse and abuse.

"This project was selected for PCORI funding for its potential to fill an important gap in our understanding of long-term opioid therapy and to give people living with chronic pain useful information to help them weigh the effectiveness and safety of their care options," said PCORI Executive Director Joe Selby, MD, MPH. "We look forward to following the study's progress and working with RTI International to share the results."

The study funded through a PCORI funding announcement specifically focused on long-term opioid use for people with chronic pain. There is a shortage of high-quality evidence demonstrating the safety and effectiveness of long-term opioid therapy for the management of chronic pain, and to date no large-scale studies have assessed strategies for managing and reducing chronic opioid use in real-world clinical settings.

Principal Investigators from partner institutions include UNC Chapel Hill's Paul Chelminski, MD, Duke's Li-Tzy Wu, ScD, and Vanderbilt's Kristin Archer, PhD will collaborate with McCormack and RTI opioid expert, Mark Edlund, MD, PhD.

"This clinical trial is intended to retrofit pain management and align it with the sensible recommendation that chronic pain therapy incorporate a strong behavioral medicine component," explained Chelminski, director of the Physician Assistant Program in UNC's Department of Allied Health Sciences, and general internist in the Internal Medicine Clinic.

The team will receive input from an advisory panel that includes patients and advocates.

RTI International's award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. RTI has an extensive portfolio of research that helps policymakers make informed decisions about the prevention and treatment of opioid-use disorders. To learn more, visit RTI's Opioid Research webpage.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI's funding, visit www.pcori.org. http://www.pcori.org/funding/opportunities