A new $9 million study led by RTI International with input from researchers at Duke University and the University of North Carolina at Chapel Hill will test new ways of reducing opioid use among patients who are not benefitting from the pain-killing drugs.

RTI will collaborate with the Mid-South Clinical Data Research Network, based at Vanderbilt University Medical Center and include the Duke University Health System ans well as UNC.

“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, Ph.D., vice president of RTI’s Public Health Research Division, who will lead the study.

The study will enroll more than 1,000 patients from North Carolina and Tennessee who have used opioids long term for non-cancer chronic pain. Researchers will compare two interventions to evaluate their effect on opioid dosage, physical functioning and pain-relief.

How study to be handled

Half the patients will receive specific behavioral therapies for chronic pain and motivational interviewing, a goal-oriented counseling technique to enhance an individual’s desire for behavioral change. This involves cognitive behavioral therapy in group sessions to foster more positive thoughts, emotions and behaviors to help manage pain.

The other half will receive individualized therapy plans based on a shared decision-making approach in which patients and their clinicians together discuss the risks and benefits of therapeutic options and the patients’ preferences and values.

Both 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.

Principal investigators from partner institutions include UNC’s Paul Chelminski, M.D., Duke’s Li-Tzy Wu, Sc.D., and Vanderbilt’s Kristin Archer, Ph.D. They will collaborate with McCormack and RTI opioid expert Mark Edlund, M.D., Ph.D. The team will receive input from an advisory panel that includes patients and advocates.

The study will be funded by the nonprofit Patient-Centered Outcomes Research Institute (PCORI) of Washington, D.C. PCORI, set up by Congress in 2010, funds research that provides patients, caregivers and clinicians evidence-based information for making better-informed healthcare decisions.

Finding effective way to treat chronic pain

“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, M.D., MPH.

“People living with pain, family caregivers, clinicians, policy makers and others are interested in finding the most effective ways to alleviate chronic pain, a very real problem, while also minimizing or avoiding the harms that can come with long-term use of opioids,” Selby said. “By supporting this research, we’re looking at strategies for effective pain care that address the areas of greatest concern to those living with chronic pain, such as quality of life and risks and consequences of addiction.”

According to RTI, 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.”

Nearly one-third of Americans suffer from chronic noncancer pain and are often treated with opioids. The effectiveness of chronic opioid therapy is unclear, and long-term use of the drugs exposes individuals to potential risks, including opioid abuse and addiction after therapy.