Funded Projects

People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.

Given the severity of the current opioid crisis, there is a pressing need to maximize the effectiveness of our interventions and increase retention in medication for opioid use disorder (MOUD) treatment. Measurement-based care (MBC), in which patient progress is regularly and systematically assessed to aid in treatment decisions, is a promising approach. Assessment tools are needed that can be administered quickly and that yield information that can be used to suggest improvements in treatment. In this study, the Investigator will conduct a series of analyses with data from the Brief Addiction Monitor (BAM), which has been selected for a national MBC initiative within the Veterans Administration. The goal of the work will be to derive and validate two new scales from the BAM. One scale is intended for use in opioid use disorder (OUD) specialty care programs. The second version is intended for use in primary care–based MOUD.

The U.S. is in the midst of a devastating opioid epidemic. Since 1999, the number of overdose (OD) deaths involving opioids has quadrupled. These trends are magnified among American Indians/Alaska Natives (AI/ANs) compared to other racial/ethnic groups. AI/ANs are second only to Whites in the rate of OD mortality (8/100,000 versus 12/100,000 deaths, respectively). Medications for opioid use disorder (OUD; i.e., methadone, buprenorphine and naltrexone) are considered the most effective treatment, reducing mortality and increasing abstinence and retention. However, numerous barriers limit the uptake of medications for OUD in tribal communities and within urban treatment settings serving AI/AN individuals. This is a two-phase formative research study to develop and test an implementation intervention for programs to provide medications to treat OUD specifically with AI/AN consumers. The objective of Phase I (12 months) is to develop a culturally centered implementation intervention to integrate medications for opioid use disorder (MOUD) into health care/addiction specialty settings. The objective of Phase II (24 months) is to conduct a preliminary test of the implementation intervention at four sites serving AI/AN communities. Community-based participatory research (CBPR) methods will be used throughout both phases. This study will help with decreasing stigma and increase the utilization of MOUD in health care settings that serve AI/AN populations.

This project provides protected time for training and research activities that are required for an independent scientific career in delivering evidence-based treatments for people with opioid use disorder. The increasing presence of fentanyl in the drug supply creates challenges for the use of buprenorphine, because both patients and physicians want to avoid causing withdrawal. This research will interview both patients and physicians to understand their concerns and experiences and work with them to develop a buprenorphine induction toolkit to help balance the advantages of buprenorphine treatment against concerns about the potential presence of unknown fentanyl. 

Pain is a common problem for people with end-stage renal disease that receive hemodialysis. Opioid use rates in this population are almost three times that of the general U.S. population over 65, putting them at significant risk for addiction. This research is testing treatments to manage chronic pain in this patient population. This project will develop educational materials to overcome barriers to telehealth toward enhancing research participation by American Indian/Alaska Native communities.

Chronic low back pain (CLBP) is a problem affecting millions of Americans. Psychosocial approaches are efficacious for addressing the multidimensional nature of CLBP. Three of the most widely implemented nonpharmacological techniques for CLBP management are cognitive therapy (CT), mindfulness meditation (MM), and behavioral activation (BA). However, there is a critical lack of research examining if these techniques work via the mechanisms specified by theory. Ecological momentary assessment (EMA) and ActiGraph technology embedded within a randomized controlled trial, consisting of daily measures of process and outcome, is ideal for testing mechanism models both during treatment and during the critical period following treatment. The current proposal seeks to utilize EMA and ActiGraph to examine if changes in cognitive content, cognitive process, and activity level are mechanisms specific to CT, MM, and BA, respectively, for reducing pain interference. Elucidating the mechanisms of pain coping skills will lead to streamlined CLBP interventions.

The Helping to End Addiction Long-term? (HEAL) Initiative’s Early Phase Pain Investigation Clinical Network (EPPIC-Net) is a unique opportunity to impact the management of pain, through expeditious discovery and validation of biomarkers and analgesic therapies, and in-depth phenotyping. The University of Washington’s (UW) Division of Pain Medicine (UW Pain; “hub”) includes four core clinical sites. Committed spokes include specialty care clinics, primary care clinics, external academic medical centers, and health systems. To achieve the goals of the HEAL Initiative’s EPPIC-Net, the study group will (1) establish UW EPPIC-Net hub and spokes infrastructure, provide scientific leadership and administrative oversight, and apply expertise in design and conduct of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies; (2) develop policies and procedures for rapid design, initiation, recruitment, conduct, and closure of high-quality multidisciplinary Phase 2 clinical trials and biomarker validation studies for specific pain conditions at UW Pain EPPIC-Net hub and spokes; and (3) establish mechanisms for communication, education and training, and performance assessment of the UW-EPPIC-Net hub and spokes, to assure efficient and timely utilization of resources to most effectively recruit research participants into EPPIC-Net.

Medication-assisted treatment (MAT) represents the gold-standard intervention for opioid use disorder (OUD). However, only 20% of Americans with OUD received any formal or informal addiction treatment in the past year. Lack of access and engagement in MAT is driving poor OUD outcomes, especially in rural areas lacking specialty addiction services. The Advancing Integrated Mental Health Solutions (AIMS) Center at the University of Washington has successfully helped over a thousand primary care clinics across the country implement collaborative care for mental health disorders. The study will determine whether collaborative care can be used to successfully treat mental health disorders and OUD concurrently in primary care settings. Clinics offering collaborative care will randomize sites to add OUD to their collaborative care program or remain unchanged. Clinics not offering collaborative care will randomize sites to implementing collaborative care for OUD and mental health disorders simultaneously or for mental health disorders only.

Head and neck cancer is particularly susceptible to nociceptive and neuropathic pains because it is dense with sensitive anatomic structures and richly innervated. Transcranial magnetic resonance imaging–guided focused ultrasound (FUS) is a new stereotactic modality capable of delivering high-intensity energy through the intact human skull with submillimeter precision. This clinical trial will target the spinothalamic and spinoreticular pain circuits by unilateral FUS mesencephalotomy, an effective procedure for cancer pain but limited by the accuracy of its era. The primary aim is to assess the safety and preliminary effectiveness in six head and neck cancer patients with opioid-resistant pain. Researchers will investigate the potential mechanism of pain relief as the mesencephalotomy target involves the confluence of the ascending and descending pain systems. Aims 2 and 3 will investigate these systems with electrophysiology specific for the spinothalamic tract and carfentenil positron emission tomography imaging that measures the brain’s endogenous opioids.

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies. 

This project's goal is to develop a completely noninvasive, precise, and durable treatment option for low back pain (LBP). Focused ultrasound (FUS) is a lower-risk, completely noninvasive modality that enables the delivery of spatially confined acoustic energy to a small tissue region (dorsal root ganglion [DRG]) under magnetic resonance (MR) imaging guidance to treat axial low back pain by neuromodulation. The central goal of this study is to demonstrate neuromodulation of the DRG with FUS to decrease nerve conduction; this treatment can be used to attenuate pain sensation. This exploratory study will demonstrate FUS neuromodulation of the DRG in pigs as assessed by somatosensory evoked potential and perform unique behavioral assessments indicative of supraspinal pain sensation, with the ultimate goal of translating this technology to patients with LBP. FUS could potentially replace current invasive or systemically detrimental treatment modalities.

Many people with opioid use disorder (OUD) also have a serious mental illness and other chronic conditions, which can be difficult for individuals and primary care providers to manage. A chronic disease self-management program is an established health care model in which peers help to educate patients about their condition(s) and build problem-solving skills to manage their health. Such programs have been effective in other populations and settings, but they have not been adapted for primary care patients who have OUD and SMI. This project will adapt and test a chronic disease self-management program for this population to understand its feasibility, acceptability, impact, and how best to put such programs into place widely in primary care settings.

Low back pain (LBP) is a common and costly condition. Spinal manipulative therapy (SMT) is a common mind-body intervention for individuals with LBP. Studies that have supported SMT have generally found relatively small treatment effects. The prior work of this research team has identified two mechanisms explaining the therapeutic effects of SMT: a reduction in spinal stiffness and improved activation of the lumbar multifidus muscle. Our research team has also developed accurate, non-invasive methods to measure these effects and their response to SMT. Our overall goal is to optimize SMT treatment protocols for patients with LBP. In this project, we will use innovative methodology to efficiently evaluate the effects of various individual treatment components toward an overall effect. Results of this project will provide optimized SMT protocols that will be ready for application in future randomized controlled trials examining the efficacy and effectiveness of SMT.