Dolor receives PCORI funding for opioid study

GIM Associate Professor, Rowena Dolor, MD, and Li-Tzy Wu, RN, ScD, MA of Duke Psychiatry are on a research team who recently received a funding award from the Patient Centered Outcomes Research Institute (PCORI). The funding is for a collaborative project involving Duke, UNC Chapel Hill, and Vanderbilt University and RTI International to reduce opioid use while managing chronic pain. 

“Physicians are trying to learn how to safely prescribe opioids,” Dolor said. “Any trial that can teach people to self-manage pain without relying solely on opioid pain relievers is important.”

“Physicians are trying to learn how to safely prescribe opioids. Any trial that can teach people to self-manage pain without relying solely on opioid pain relievers is important.”

Here is the project summary: 

Background and Significance
Up to one-third of Americans suffer from chronic noncancer pain (CNCP). Opioids are often used to treat CNCP, and once on chronic opioid therapy, individuals are unlikely to discontinue. Evidence for the effectiveness of chronic opioid therapy to treat CNCP is “insufficient” and it exposes individuals to known risks. Strategies are needed to reduce or eliminate chronic opioid therapy in patients who are not benefiting from it while ensuring access for those who are benefiting.

Study Aims
This study examines the comparative effectiveness of two approaches to managing CNCP patients who are on chronic opioid therapy: a guideline-concordant pharmacotherapy approach integrated with shared decision making (SDM) (Arm 1) compared with a guideline-concordant pharmacotherapy approach integrated with motivational interviewing (MI) and cognitive behavioral therapy for chronic pain (CBT-CP) (Arm 2). The project team will examine the differential impact of the two approaches on several outcomes. The project’s specific aims are:

• Aim 1: To examine whether CNCP patients who receive guideline-concordant pharmacotherapy integrated with an MI+CBT-CP intervention (Arm 2) have greater opioid dose reduction relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with an SDM intervention (Arm 1).
• Aim 2: To examine whether CNCP patients who receive guideline-concordant pharmacotherapy integrated with an MI+CBT-CP intervention (Arm 2) have greater rates of opioid discontinuation relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with an SDM intervention (Arm 1).
• Aim 3: To examine whether CNCP patients who receive guideline-concordant pharmacotherapy integrated with an MI+CBT-CP intervention (Arm 2) have improved physical functioning relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with an SDM intervention (Arm 1).
• Aim 4: To examine whether CNCP patients who receive guideline-concordant pharmacotherapy integrated with an MI+CBT-CP intervention (Arm 2) have lower pain scores relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with an SDM intervention (Arm 1).

Study Description and Intervention
The project team will employ a multisite, pragmatic trial using real-time randomization to study arms:

• Arm 1:  Arm 1 patients will receive guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for CNCP, plus SDM to explore and compare treatment options, assess a patient’s values and preferences, and reach a shared decision.
• Arm 2:  Arm 2 patients will receive the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for CNCP, plus MI to enhance motivation for opioid dose reduction or cessation, and group CBT-CP for pain coping skills.

The study is a collaboration between RTI International, the University of North Carolina Health System, the Duke University Health System, and the Vanderbilt University Health System. The research team is part of the Mid-South Clinical Data Research Network (CDRN), which is a PCORI Patient-Centered Clinical Research Network (PCORnet). The study will include opioid patients from North Carolina and Tennessee, as these are areas of the country with high rates of opioid use.   

The project team will enroll 530 patients in each study arm for a total enrollment of 1,060. This sample size will provide robust power to detect clinically important differences in reduction of opioid use between the two study arms. Secondary outcomes will include physical functioning and pain interference scores.  

Patient-reported outcomes will be measured via patient survey at three time points: at study entry, at three months, and at 12 months. Analyses will include longitudinal (mixed effects) models to compare the change from baseline to three months, and to 12 months, in outcomes between the two study arms. The project team will explore differences in the intervention effect according to participant characteristics such as age, sex, baseline pain level, baseline opioid dose, and the presence of physical comorbidities, mental health comorbidities, and a history of substance abuse. Qualitative research methods will be used to obtain patient input on their experiences. 

A study advisory committee (SAC) will guide the study. The SAC includes CNCP patients, advocacy organizations, experts in pain management, a state government entity, and a payer organization. Study results will be disseminated through peer-reviewed publications and a range of other innovative strategies.

Project Details

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.