Funded Projects

A large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.

Patients choosing treatment with medications for opioid use disorder as part of their recovery pathway often have difficulties staying on these medications for extended periods of time. Currently, no established evidence-based interventions are available to help. This project will leverage the impact of two widely used recovery support services: peer recovery support services and recovery housing. Delivered by community-based peers with lived recovery experience, the intervention will include assertive outreach, which encourages people in recovery between episodes of care to continue treatment and return to care after treatment dropout and/or resumed opioid use. This research will also examine whether these services can enhance benefits offered by the supportive recovery housing living environment.

A large number of probationers/parolees with opioid use disorder have limited access to effective treatment. This study is the first random clinical trial in the United States that will assess the effectiveness of buprenorphine treatment using MedicaSafe, a system composed of secure pre-packaged buprenorphine/naloxone cartridges, designed to be dispensed by a SmartKey device that enables clinicians to track patient adherence. The study will initiate treatment at a community corrections office compared to referral to a community program. The public health impact of the proposed study would be widespread, as this model of care could be implemented throughout many areas of the United States with high rates of opioid use disorder in their probation/parolee populations that lack access to methadone treatment.

A key marker of inflammation in Osteoarthritis (OA) is accompanied by significantly increased sensory innervation within the diseased joint. This study aims to validate the hypothesis that defective bone resorbing cells are responsible for the enlarged bone cavity, giving rise to the inflammatory marker causing further increases in levels sensory innervation and resulting in increased OA pain perception.

Shoulder pain occurs in many patients who are recovering from a stroke. In addition to impairments in the ability to move, persistent shoulder pain contributes to depression, and often reduces quality of life. Although the cause of post-stroke shoulder pain is complex and not completely understood, it is thought to arise in part to damage of muscles and surrounding connective tissues (myofascial tissues) in the shoulder. This project will use advanced medical imaging techniques to create biomarkers of that can reliably identify myofascial tissues. The research will then test the ability of these biomarkers to monitor, and ultimately predict treatment responses in patients with post-stroke shoulder pain in the context of a randomized controlled clinical trial.

The parent U19, “Southwest Hub for American Indian Youth Suicide Prevention,” builds capacity among local tribal governments, investigators, interventionists, and service providers across three Southwestern states to: 1) identify at-risk youth and gather robust local data through surveillance; 2) provide regular monitoring and brief interventions to close gaps in continuity of care; and 3) convene regularly for shared learning, policy development, and dissemination of best practices. The parent U19 includes an innovative SMART trial study design. The purpose of this supplement is to gather data on opioid use. Our supplement aims are to: 1) expand suicide surveillance in the Southwest Hub to include opioid use as a potential precipitant, facilitator, and risk factor for subsequent suicidal behavior; 2) explore community beliefs about correlates of risk, protective factors, and behavior functions of opioid abuse in Native American youth; and 3) examine opioid use among SMART trial participants.

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.

Physical therapy is the recommended treatment for patients with low back pain and is a cost-effective method for improving pain and reducing disability. However, only 7-13% of patients receive physical therapy services. Access is particularly limited in rural communities due to lack of provider availability, transportation, and missed work time. These factors have contributed to more low back pain-related disability and opioid use among rural populations. Physical therapy delivered through telemedicine may improve access by reducing patient-reported barriers. This randomized clinical trial will compare an innovative, patient-centered telemedicine version of physical therapy to a currently used psychologically based educational approach for rural patients with chronic low back pain. The research will match individual patients to a treatment approach based on their psychosocial risk of poor outcomes.

Temporomandibular joint (TMJ) disorders, which affect the joint connecting the lower jaw and the skull, are common and difficult chronic pain conditions. Pain management strategies that harness the body’s own pain relief mechanisms (including placebo effects in which pain relief cannot be attributed to a specific treatment), can reduce the severity and duration of TMJ-related chronic pain. Although research suggests that placebo effects may have a genetic basis, few, if any, genetic studies have examined this possibility in individuals with TMJ disorders. This project will use in-depth genetic, sociodemographic, clinical, and psychological data collected from adults with chronic TMJ disorders to better understand how the placebo effect works.

Currently, there are no adequate therapies for abdominal pain in patients with Irritable Bowel Syndrome (IBS), a gastrointestinal disorder affecting 14-20% of the US population. More than 40% of IBS patients regularly use opioid narcotics. An alternative treatment for IBS that has been shown to be an effective pain management strategy is electroacupuncture. However its drawbacks include infrequent administration, unclear mechanistic understanding, and lack of methodology optimization. This study will use a noninvasive method of transcutaneous electrical acustimulation (TEA) by replacing needles with surface electrodes and testing acupoints that target peripheral nerves. Based on prior mechanistic and clinical studies, two stimulation parameters and effective acupoints will be tested. In the UG3 phase, the TEA device and a cell phone app will be optimized for use in IBS abdominal pain, and an acute clinical study will determine the best stimulation locations and parameters. During the UH3 phase, an early feasibility clinical study will be performed in 160 IBS patients in treating abdominal pain. Participants will self-administer the therapy at home/work and will be randomized across four treatment groups to determine the therapeutic potential of the TEA system.

Chronic opioid use has well known effects on sleep quality, including disordered breathing during sleep and other abnormalities related to circadian rhythms. However, little is known about the relationship between sleep-related symptoms and non-medical opioid use among individuals being treated for opioid use disorder. This longitudinal study aims to identify biological pathways that may account for these associations. The research will first determine associations of sleep and proxy measures of circadian rhythms with non-medical opioid use. Second, they will investigate emotional processes associated with sleep/circadian symptoms and opioid treatment outcomes.

The opioid overdose epidemic is increasingly affecting urban, poor and predominantly minority populations in the U.S., including Washington, D.C., as indicated by rapidly increasing overdoses clustered in medically underserved, economically disadvantaged, largely African American areas of the District and many of the nation’s other largest cities. This study seeks to (1) develop, implement and conduct a preliminary evaluation of an integrated, community-based collaborative care model, employing peer recovery coaches and telepsychiatry services, to improve utilization and effectiveness of MOUD in Federally Qualified Health Centers (FQHCs) and (2) use a community-based participatory research approach to develop, implement and conduct a preliminary evaluation of outreach, engagement and recovery support interventions in nontraditional community settings (e.g., grassroots community groups, churches or religious organizations, soup kitchens, black barber shops or nail or hair salons).