Addressing the Intersections of Chronic Pain and OUD: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) Research Network

Abstract

The appearance of both chronic pain (CP) and opioid use disorder (OUD)/opioid misuse is common, can bidirectionally affect treatment outcomes, and can be challenging to treat. The successful treatment of these conditions can be further complicated by co-occurring hazardous alcohol use, general anxiety disorder, and/or major depressive disorder, and calls for the need to attend to the whole health of the patient. Health systems providing care for these individuals are often fragmented, and suffer from limited resources, expertise, and communication. The National Institute on Drug Abuse, with support from the National Institutes of Health Helping to End Addiction Long-term (HEAL) Initiative, funded the Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network in 2021 to address the needs of this complex population. With continuous collaboration with community partners, the network supports 11 unique clinical trials and a Coordination and Dissemination Center which are described in this commentary. This article introduces the scientific rationale and structure of the network and highlights the themes connecting the trials together to collectively create data-driven and actionable solutions for individuals with co-occurring CP and OUD/opioid misuse.

Background

The ongoing opioid epidemic and the chronic pain (CP) crisis represent significant public health problems with unmet needs. The opioid epidemic has been characterized by 4 distinct waves of opioid use: (1) the overprescribing of prescription opioids to manage pain; (2) the transition from prescription to illicit opioids, such as heroin; and (3) the increased prevalence of powerful synthetic opioids, like fentanyl, in the drug supply.¹ The United States is now experiencing a fourth wave where overdose deaths increasingly involve stimulant use, and overdose reversal has become more complicated given the increasing prevalence of xylazine.^2–4 An estimated 5 million individuals have an opioid use disorder (OUD) and 8.7 million Americans misuse opioids, where misuse was defined as use in any way not directed by a provider. In 2023, over 100 000 Americans have died from an overdose, representing the highest annual number of deaths on record.⁵

More than 50 million Americans suffer from CP, defined as the presence of pain for at least 3 months. Approximately 11 million individuals have high impact CP that interferes with daily life or work activities.⁶ CP treatment, disability, and loss of productivity are estimated to cost $635 billion annually in the United States.⁷ Both opioid overprescribing and restricted prescribing due to misinterpretation or misapplication of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain have led to unintended consequences for many who live with CP. People with pain may rely on opioids for pain relief in the absence of other effective treatments, and some turn to misuse or to illicit drug use for pain relief as healthcare professionals reduce or eliminate access to opioids for pain management. Approximately half of the individuals who have an OUD also experience CP.^8–10 Among individuals who misuse prescription opioids, hydrocodone products represented the most common misused prescription drug and the primary motivation for use was to alleviate physical pain.¹¹

Effective care for patients who have co-occurring CP and OUD may be further complicated by additional comorbid mental health or substance use disorders. A significant number of individuals self-medicate their pain with alcohol or meet criteria for alcohol use disorder.¹² Furthermore, the prevalence of general anxiety disorder and major depressive disorder is high among individuals with co-occurring OUD and CP.¹³ Patients who have these co-occurring diagnoses often have worse pain intensity and health outcomes.¹⁴ In addition, the co-prescribing of certain medications for treating these conditions may elevate risk of respiratory depression when they are combined with opioids, presenting additional challenges for effective CP and OUD treatment. For these reasons, the development of integrated treatments, integrated care delivery models, and implementation strategies should not ignore these comorbidities and actionable solutions must attend to treating the whole patient.

Health service provision for patients with both CP and OUD is fragmented in the United States. Providers in pain and primary care clinics have evidence-based pain management treatments for patients with CP, such as opioid or nonopioid medications, complementary medicine approaches, and other nonpharmacological pain management strategies. They also have tools to assess and monitor patient responses to opioid analgesics and compliance with treatment agreements to assure safe opioid prescription use. However, if a patient exhibits opioid misuse or OUD symptoms, the patient may be discharged from that provider and referred to OUD treatment programs.^15,16 Meanwhile, evidenced-based behavioral treatments and Food and Drug Administration (FDA)-approved medications for OUD (MOUDs) exist but addiction treatment providers often lack the capacity, expertise, and resources to manage co-occurring CP. For these reasons, medical professionals providing health services for co-occurring CP and OUD experience significant barriers. At the same time, patients are frustrated due to multidimensional stigma, distrust of the medical system, and abandonment by health systems. To address these complex issues, the overall goal of the Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) research network is to evaluate and implement patient-centered and integrated treatments and models of care that are safe, effective, and accessible to patients with co-occurring CP and OUD.

Network Mission

The guiding vision for the network is to generate evidence-based, patient-centered solutions for integrated management of co-occurring CP and OUD and rapidly disseminate knowledge to key stakeholders to influence population health. To achieve this vision, there are 5 distinct goals. The first is to invest in a wide range of approaches and maximize sustainability by leveraging diverse healthcare settings across a range of geographic locations in the United States and engaging different racial and ethnic communities. While this program emphasizes CP and OUD/opioid misuse as the primary outcomes, the second goal of the network is to attend to the whole patient for whom treating co-occurring psychiatric disorders and/or other harmful substance may affect treatment goals. To this end, the network encourages broader inclusion criteria so that these patients are included in the trials and these complexities are measured via extensive data collection. The third goal is to address health disparities and health system inequities that threaten access to life-saving treatments. African American, Native Americans, and Latinx populations are less likely to receive MOUDs, naloxone, and proper pain treatment.^17–19 Overdose deaths in these communities have increased at an alarming rate during the COVID-19 pandemic.^20,21 Furthermore, compared to men, women experience similar challenges in accessing treatment and receiving validation for their CP.^22,23 The fourth goal is to maximize the potential for the IMPOWR interventions to become incorporated into standard practice. To achieve this goal, researchers are required to partner with individuals with lived/living experience (PWLEs) to ensure that the developed interventions are addressing their needs. Engagement with private/public partners (PPPs) who have the capacity to change policy, clinical practice, and payment is also a requirement to facilitate uptake of these treatments in routine care. The final goal is to strengthen the next generation of clinicians and research scientists by encouraging co-leadership on the clinical trials and other mentoring opportunities.

Network Science and Structure

The network funded 11 unique trials that can be grouped based on the thematic similarities in the proposed intervention, which are care delivery models, behavioral treatment approaches, and MOUD dosing strategies (see Table 1). Four centers were initially funded to support 2 to 3 unique clinical trials embedded within each center. Two additional independent trials were funded at a later date and integrated into the IMPOWR network due to the scientific overlap between the individual trials and the network. Each center also has the capacity to support pilot studies. These smaller studies were intended to offer additional mentoring opportunities to early-stage investigators, quickly respond to emerging needs or policy changes, and support additional cross-network collaborations.

Table 1.

This table describes the 11 unique trials funded within the IMPOWR Research network.

Institution (PI leads)	Project Title	Project PI	Intervention	MOUD	Health Setting	Geographic Diversity
Yale University DA055310 William Becker, David Fiellin, Declan Barry	Pain CHAMP	Will Becker Anne Black	Pharmacist-Physician Collaborative Care	Buprenorphine	Primary Care (VA)	IA, TX, NV, GA, PA, VA, AZ, CO, OR
	SC-POWR	Declan Barry	Multimodal stepped care	Methadone and Buprenorphine	Opioid Treatment Program	CT
University of Pittsburgh DA055311 Jessica Merlin, Erin Winstanley, Megan Hamm	Engagement Project	Erin Winstanley; Jessica Merlin; Hailey Bulls (ESI)	Pain self-management & Buprenorphine initiation	Buprenorphine	Primary Care	PA, WV
	Retention Project	Jessica Merlin; Erin Winstanley; Shari Rogal (ESI)	Pain self-management & patient-oriented buprenorphine dosing	Buprenorphine	Office Based Addiction Treatment	PA, WV, OR, MD
Montefiore/Einstein DA055437 Joanna Starrels, Julia Arnstein, Vilma Gabby	B-STRONG	Shadi Nahvi; Joanna Starrels	Yoga; Physical Therapy	Methadone	Opioid Treatment Program	NY
	VOICES	Vilma Gabby; Hector Perez (ESI)	Acceptance Commitment Therapy + Care management smartphone app	Buprenorphine	Primary Care	NY
	BISHOP	Aaron Fox	Microdosing vs standard induction	Buprenorphine	Hospital	NY
University of New Mexico DA055301 Katie Witkiewitz, Mateo Pearson	HOPE	Margo Hurlocker (ESI)	Acceptance Commitment Therapy + Mindfulness	Buprenorphine	Opioid Treatment Program	NM, MI
	OPTIC	Kamilla Venner; Angel Vasquez (ESI)	Implementation strategies for clinician facing motivational interviewing in Indigenous communities	All	Primary Care	MN, CA, WA
Johns Hopkins University DA056045 Kelly Dunn	DOSE	Kelly Dunn	TAU vs split dosing	Methadone	Opioid Treatment Program	MD
Rutgers University DA056537 Nina Cooperman; Eric Garland	IMPOWR-MORE	Nina Cooperman; Eric Garland	MORE vs Scripted Mindfulness vs TAU	Methadone	Opioid Treatment Program	NJ, UT

Abbreviations: Pain CHAMP, Pain Care at Home to Amplify Function; SC-POWR, Stepped Care for Patients to Optimize Whole Recovery; B-STRONG, Back Strengthening Onsite for General Wellness; VOICE, Access Your Virtual Opioid Use Disorder Integrate Chronic Pain Treatment; BISHOP, Buprenorphine Initiation Strategies in Hospitals to Optimize Pain; HOPE, Healing Opioid misuse and Pain through Engagement; OPTIC, Opioid and Pain Treatment in Indigenous Communities; DOSE, Divided or Single Exposure; MORE, Mindfulness-Oriented Recovery Enhancement; ESI, Early Stage Investigator; TAU, Treatment-as-usual; PI, principal investigator; MOUD, medications for opioid use disorder; IMPOWR, Integrative Management of Chronic Pain and OUD for Whole Recovery.

Almost half of the projects have an early-stage investigator co-lead and a majority of the projects are targeting underserved populations, which speaks to some of the goals subserving the vision for the overall network. For example, the trials from the University of Pittsburgh center aim to develop interventions tailored to the Latinx and African American communities, and recruits from rural areas. In addition, the Opioid and Pain Treatment in Indigenous Communities (OPTIC) trial culturally tailors motivational interviewing to address integrated CP and OUD treatment in American Indian and Alaska Native health systems. Across the OUD cascade of care,²⁴ 3 projects target treatment initiation while 8 projects emphasize retention in treatment. As a network, there is an emphasis on implementation science to maximize the potential that the evidence-based interventions will be incorporated into routine care, with 8 trials utilizing a hybrid effectiveness-implementation design. Most of the proposed interventions have data supporting its initial efficacy in treating OUD or CP, but the bundled delivery or tailoring of these services are under investigation in these trials. For these reasons, trials that leverage a hybrid effectiveness-implementation design predominately selected a Type 1 approach to gather preliminary information on implementation challenges and solutions.²⁵ These trials will be executed in 104 sites across 26 states in the continental United States to reflect geographic diversity (Table 1). These trials will recruit from opioid treatment programs, hospitals, and primary care offices, which represent health settings that are predominately visited by this population.

The network also supports a single Coordination and Dissemination Center (C&DC) which is expected to provide coordination, infrastructure, and other supports for the network and broader research and clinical practice community. Specifically, the C&DC assisted in harmonizing the common data elements (CDEs) to be collected at baseline and at 6-month follow-up across every trial. Collectively, IMPOWR will collect 804 variables across 60 distinct CDE measures with an emphasis on attending to the whole health of the patient, social determinants of health, stigma/discrimination, cost-effectiveness evaluations, and implementation science.²⁶ In addition, the C&DC is expected to create user-friendly and audience-appropriate educational materials and content designed to enhance treatment of concurrent CP and OUD. Examples of these resources include educational content on reducing stigma and health disparities in OUD and CP, a workshop series on diverse topics of interest relevant to different stakeholder audiences, and other products that bridge OUD/opioid misuse and CP expertise. Last, the C&DC is tasked with creating a single screening tool for CP and OUD/opioid misuse to minimize the need for practitioners and researchers to utilize multiple existing screening tools. Across these activities within the C&DC and the broader IMPOWR network, the C&DC is expected to translate broader network findings into resources of interest to external stakeholders.

Network Partners

Patients and other key stakeholder groups are the consumers of the data generated by National Institutes of Health-funded clinical trials. Meaningful engagement and collaboration with these partners throughout the research process, including research design, conduct, and dissemination of study findings, have the potential to improve the quality of care, maximize implementation, and sustain utilization of these interventions. There are varying degrees in which partners can be folded into the research process, which depend on the goal, time, and resources dedicated to this partnership.²⁷ The IMPOWR network operates collaboratively by bringing researchers and partners together on equal footing to identify and solve problems. Specifically, partnerships with the PPPs have the potential to alter clinical care guidelines, prioritize changes in healthcare system operations, change local and national policies around CP and OUD care management, inform changes to coverage and reimbursement policies, and amplify advocacy for this patient population. A summary of our dynamic partners is shown in Figure 1.

Figure 1.

IMPOWR Partner Representation from Inaugural Executive Committee Meeting.

The partners with lived/living experience have a personal history of chronic pain, opioid use disorder, or both. The public/private partners and partner organizations include payors, care takers, health care providers spanning multiple disciplines, policymakers, advocacy groups, and professional organizations that create clinical care guidelines.

PWLEs bring incredible contributions to the research enterprise that are uniquely reflective of their lived/living experience with CP and OUD/misuse, response to treatment interventions, interactions with the healthcare system, and experiences with navigating insurance coverage. Furthermore, patient preferences are often ignored when there is misalignment between the goals of the medical provider and the patient, and these experiences can inform best practices for navigating difficult conversations. The network adopted several guiding principles to create a safe and trusting space for PWLEs to share their stories and vocalize their needs. To address economic inequities, compensation is provided for their expertise, wisdom, and intellectual contributions throughout the development, execution, and interpretation of study findings. There is an explicit commitment to enabling shared decision-making among the researchers and PWLEs, recognizing that their input is just as important and valid. The IMPOWR network ensures several PWLEs are present to minimize marginalization, avoid PWLE tokenism, and acknowledge that patient perspectives reflect their personal journey and does not represent an entire population.

IMPOWR is intentionally designed to support accountability and transparency with frequent updates and opportunities to gather their expert input. Each research center has a community advisory board (CAB) with representation from PPPs and PWLEs. The cadence of the CAB meetings varies from center to center, and centers may convene their CABs to respond to trial-specific challenges that arise over time. There are several ways in which PPPs and PWLEs have participated throughout each phase of the research process (see Figure 2). For example, the PWLEs enriched the framework for harmonizing data collection across the trials, review pilot studies and provide recommendations for funding, and serve on the IMPOWR Executive Committee (described below). Together, the continual involvement of PWLEs maximizes the potential that the study design is pragmatic and addresses the needs of the people who benefit the most from research, and the involvement of PPPs has the potential to facilitate system and policy change.

Figure 2.

Illustrative examples of how the network engages with PPPs and PWLEs through the research process.

Abbreviations: PPPs, private/public partners; PWLEs, partner with individuals with lived/living experience.

IMPOWR Executive Committee

While CABs provide trial-specific recommendations, representatives from each trial and the C&DC will form the IMPOWR Executive Committee to provide network-wide guidance. Membership on this committee includes 1 research scientist, 1 PWLE, and 1 PPP from each trial. The goals of the executive committee are to provide guidance and oversight on the research, stakeholder engagement, and dissemination efforts of the network. The decision to include the community partners was intentional to ensure that all steps of the research process would integrate their important perspectives and maximize the translational potential of the clinical trials.

Following the kickoff meeting, the Executive Committee meets annually to receive updates on the clinical trials and pilot studies and brainstorm solutions to address challenges that may arise. For example, several trials faced challenges with initial recruitment and enrollment, so the Executive Committee have shared lessons learned and offered actionable solutions. Furthermore, the network leverages the Executive Committee to respond to dynamic changes in the OUD and CP treatment landscape. Since the network launch in 2021, there have been national policy changes related to MOUD prescribing in response to the COVID-19 pandemic and changes in national prescribing guidelines. At each meeting, the agenda has dedicated time to hear from our PPPs and PWLEs separately. The resulting dynamic discussions among PPPs, PWLEs, and research scientists allows the group to strategize about how research and data can be leveraged to address their emerging needs. One powerful example of how PWLE and PPP input influenced the science was observed through their contributions to the IMPOWR CDE library. They added demographic variables to acknowledge a broader spectrum of gender and sexual identity and also advocated for the importance of measuring social determinants of health, a history of trauma, and stigma in the clinical trials. These insights have strengthened the network science to measure important socioenvironmental factors and other components that are meaningful to them.

Conclusions

While challenging, safe and effective strategies can be pursued to address the needs of individuals living with co-occurring CP and OUD. Evidence generated by this network will explore how MOUDs can be combined with behavioral, pharmacological, and complementary medicine approaches to improve treatment adherence and recovery outcomes. In addition, best models for integrated care and implementation strategies will be evaluated to maximize sustained access to quality care from a healthcare system perspective. The collective perspectives of scientists, patients, health system leaders, practitioners, policy experts, and payors working together within the IMPOWR network have the potential to develop data-driven best practices to improve the health of this population.

Highlights.

• Approximately half of individuals with an opioid use disorder (OUD)/opioid misuse experience chronic pain (CP).

• Treatment of co-occurring OUD/opioid misuse and CP is fragmented and may be further complicated by the presence of alcohol use disorder and other psychiatric conditions.

• The Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) research network supports efficacy and hybrid effectiveness-implementation study designs that examine models of coordinated care, medications for OUD (MOUD) in combination with behavioral and complementary pain medicine approaches, and different MOUD dosing strategies.

• IMPOWR collaborates with individuals with lived/living experience and other community partners to address barriers that may affect the implementation of these evidence-based treatments into standard practice.