Funded Projects

NOFO Title: NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24)
NOFO Number: RFA-AT-17-002
Summary:

The Pain Management Collaboratory Coordinating Center (PMC3) will 1) provide national leadership and technical expertise in all aspects of research supporting the design and execution of high-impact demonstration projects that conduct cost-effective, large-scale, pragmatic clinical trials on non- pharmacological approaches for pain management and other comorbid conditions in veteran or military health care systems and 2) make data, tools, best practices, and resources from these and other projects available to facilitate research partnerships in VA and DoD health systems. The aims are to: 1) develop, adapt, and adopt technical policy guidelines and best practices for the effective design and conduct of pragmatic trials; 2) work collaboratively with and provide operational, technical, design, and other support to demonstration project teams to develop, initiate, and implement a research protocol; and 3) disseminate NIH–DoD–VA Pain Management Collaboratory–endorsed policies and best practices and lessons learned within military and veteran health care systems.

NOFO Title: HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM)(UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-AT-19-004
Summary:

The opioid crisis has underscored the urgency of alleviating patients’ chronic low back pain (cLBP) with effective therapies, including evidence-based nonpharmacologic approaches. Mindfulness-based stress reduction (MBSR) is now recommended by the American College of Physicians for initial treatment of cLBP. A pragmatic clinical trial (PCT) will inform health care decision makers about whether this program can be implemented in a real-life clinical setting and measure its impact on outcomes. The OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness) program will integrate and test an evidence-based mindfulness clinical pain program for patients with cLBP in the primary care provider (PCP) setting. It will be conducted with three health care system sites. Four hundred and fifty persons ? 18 years of age with cLBP will be randomized to OPTIMUM + PCP Usual Care or PCP Usual Care.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Effective medications for opioid use disorder (MOUD) are approved by the Food and Drug Administration for the treatment of people with opioid use disorder; however, only a small fraction of patients who would benefit from these medications actually use them. Several reasons contribute to low MOUD use, including lack of insurance; lack of knowledge about the medications, both among patients and providers; stigma associated with MOUD; and social norms. Innovative methods are needed to help increase MOUD use. One such option is peer-led interventions that might increase patients’ interest in MOUD. One existing peer-led intervention is the Harnessing Online Peer Education (HOPE) online community intervention that has been designed to reduce stigma and increase health behavior change among stigmatized populations, such as people living with HIV. This project will investigate whether and how HOPE can be adapted for people with opioid use disorder. It will assess whether HOPE can effectively increase MOUD requests, MOUD uptake, and sustained adherence to MOUD as well as reduce overdose rates.  

NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005

NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011
Summary:

Sickle cell disease is an inherited blood disorder affecting about 100,000 Americans and over 20 million people worldwide. It is caused by a mutation in the gene for beta-globin that results in the characteristic sickled shape of red blood cells, life-long severe pain, and shortened lifespan. Painful episodes that require hospitalization and, in many cases, opioid treatment, are a hallmark of sickle cell disease. The source of these painful episodes remains unclear, and it is also unknown why pain severity varies so much among affected individuals. This project will identify novel, non-opioid targets to reduce sickle cell-related pain and search for biomarkers to help clinicians predict which individuals are at risk for increased pain, thereby improving health outcomes for people with sickle cell disease.

NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003
Summary:

Pain in the muscles and surrounding connective tissue (myofascial pain) is a significant and poorly understood health concern affecting hundreds of millions of Americans. There is a great need for tools to assess changes to myofascial tissues in individuals with chronic pain as well as to measure the effect of commonly used therapies. This project will use three imaging tools to look at differences between shoulder tissue in people with myofascial pain compared to those without pain. Using a machine learning approach, this research aims to develop a biomarker signature for myofascial pain, which will be evaluated in a randomized controlled clinical trial based on its ability to predict patient responses to myofascial pain treatments.

NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

This application will develop and execute a sequential multiple assignment randomized trial (SMART) design to test two forms of behavioral economics intervention to promote medication-assisted treatment (MAT) for opioid use disorder. The two interventions, in person, brief motivational interviewing and substance-free activities intervention (BMI+SFAS), initially will be tested for satisfaction and acceptability with participants who are initiating buprenorphine-naloxone treatment and then be tested by SMART for its ability to promote MAT adherence. This innovative SMART design that tests two psychosocial interventions to increase adherence to MAT initiation is likely to have a significant impact on engagement of opioid use disorder patients in treatment and address an underserved population with opioid use disorder who is resistant to MAT adherence.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

Buprenorphine-naloxone is known to work for the treatment of Opioid Use Disorder (OUD). However, despite its success in treating OUD, retention for these kinds of medication-assisted treatments (MATs) for OUD is notoriously low, having a dropout rate of approximately 50 percent within the first 6 months. One factor known to negatively impact a person?s adherence to treatment is stigma. This includes, not only stigma associated with having OUD, but also that of multiple stigmatized identities, including stigma associated with race. The goal of this supplement award is to decrease OUD- and race-related stigma in low income African American communities using a Behavioral Economics Stigma Reduction intervention that functions at the intrapersonal, interpersonal, and community levels. The investigators will work at the individual level to address stigma in untreated individuals who present with OUD at local community or faith organizations through stigma reduction counseling and tangible rewards for treatment uptake. To assess the interpersonal stigma, referred family members or support persons of these individuals will also be enrolled to receive stigma reduction and supportive skills counseling. Finally, a stigma reduction campaign will be developed and administered to the community via social media and billboards. Community members? substance use stigma will be compared before and after the campaign.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

Office-based opioid treatment (OBOT) with buprenorphine/naloxone prevents overdose deaths. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for opioid use disorder (OUD) treatment in most U.S. counties. Mindfulness-based interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention while reducing rates of relapse and overdose deaths. Current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project proposes to adapt, refine, and compare the effectiveness of the 6-month Mindful Recovery OUD Care Continuum delivered within group-based opioid treatment (GBOT) versus standard GBOT alone.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

Buprenorphine has been shown to be is an effective method for treating Opioid Use Disorder (OUD). However, despite its success, treatment retention rates are notoriously low ? about half of those seeking treatment will have dropped out within the first 6 months. One factor known to negatively impact treatment adherence is stigma. This stigma derives from not only being viewed as individuals with OUD, but even as individuals seeking medications for OUD as these medications often include other forms of opioids. Additionally, individuals with OUD often suffer from other conditions, including psychiatric illness, leading them to live with multiple stigmatized identities. This study will develop tools to assess stigma associated with OUD, seeking medical treatment for OUD, and mental health. This knowledge will then be used to adapt the parent award?s mobile Health intervention intended to overcome stigma barriers and increase adherence to buprenorphine treatment for OUD.

NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003
Summary:

Myofascial pain syndrome is a prevalent and debilitating condition and can aggravate other conditions such as sickle cell disease. This project will use total body imaging using positron emission tomography/computed tomography (TB-PET/CT) to identify and monitor this pain syndrome and potential treatments over time. The research will use TB-PET/CT to assess myofascial tissue effects of chronic low back pain and sickle cell disease pain. The first phase of the project will assess health changes observed by TB-PET/CT imaging in painful and non-painful myofascial tissues compared to healthy myofascial tissue. The second phase of the research will be a randomized, controlled longitudinal interventional study to evaluate the effectiveness of acupuncture on myofascial pain syndrome, using TB-PET/CT imaging to assess changes.

NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193
Summary:

Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA  Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment.