RTI International will lead a $9 million study to better understand the benefits and risks of opioid use.
Nearly one-third of Americans suffer from chronic non-cancer pain, a condition often treated with opioids, an RTI press release stated. The effectiveness of this chronic opioid therapy is currently unclear and exposes individuals to potential risks, including opioid abuse after therapy.
The RTI International study aims to provide strategies for reducing opioid use among patients who are not benefiting from it while ensuring access to those who are benefiting. 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, vice president of RTI’s Public Health Research Division, who will lead the study.
Opioids, used to treat moderate to severe pain, include prescription drugs like Oxycodone and hydrocodone (also called Vicodin), morphine and methadone, according to the Centers for Disease Control and Prevention (CDC). Fentanyl is a synthetic opioid pain reliever. It is many times more powerful than other opioids and is approved for treating severe pain, typically advanced cancer pain, the CDC states.
Heroin also is an opioid, but is illegal.
The CDC states that the number of overdose deaths involving opioids (including prescription opioids and heroin) has quadrupled since 1999. From 2000 to 2015 more than half a million people died from drug overdoses; 91 Americans die every day from an opioid overdose, the CDC states.
“We now know that overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths,” the CDC website states.
In the RTI International 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 RTI release stated.
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.pco
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 [Patient-Centered Outcomes Research Institute] 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. “We look forward to following the study’s progress and working with RTI International to share the results.”
Principal Investigators from partner institutions include UNC’s Paul Chelminski, Duke’s Li-Tzy Wu, and Vanderbilt’s Kristin Archer, who will collaborate with McCormack and RTI opioid expert Mark Edlund, M.D.
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.