Funded Projects

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: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Understanding municipal policies that influence implementation of effective evidence-based practices (EBPs) as well as effective strategies for working with municipal groups may inform local efforts to translate EBPs. Just as important, engaging with local stakeholders may help to facilitate the long-term sustainability of EBPs. This can only occur if diverse local actors in municipal governance are thinking about health and behavioral health in the context of municipal planning and policy. Building from research related opioid use disorder and the risk environment, built environment, and zoning, this research will work to support coalition-based approach currently implemented by the HEALing Communities Study. The research aims to develop an understanding of local policies that may affect implementation of community action plans in the HEALing Communities Study Massachusetts communities.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Expanding access to naloxone in the community through the pharmacy can be a critical mechanism for extending this lifesaving medication’s reach. This study will partner with two large retail pharmacy chains and integrate two interventions that provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high risk for an opioid overdose. The interventions will be combined into a cohesive educational program, implemented in 160 community pharmacies and tested for effectiveness. Study findings will create a generalizable, evidence-based training and toolkit for pharmacists caring for patients who use prescribed or illicit opioids, in more than 40 states adopting or expanding pharmacy naloxone.

NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036
Summary:

Opioid use disorders (OUDs) in pregnancy are a U.S. public health crisis; the current standard of care is treatment with an opioid agonist such as buprenorphine (BPH), which has an associated risk for neonatal abstinence syndrome (NAS) and possible long-term neurodevelopmental consequences. As a novel treatment option for OUD in pregnancy, naltrexone would not expose the developing fetus to opioids, greatly reducing the risk for NAS and potentially improving maternal and infant outcomes. This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with OUDs, evaluating comprehensive mother-infant outcomes throughout the pregnancy and first year after birth. It will enroll 50 pregnant women stabilized pre-pregnancy on extended-release naltrexone (XR-NTX) and 50 comparison women on BPH from Boston Medical Center and the University of North Carolina in this multi-center prospective comparative cohort study.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Risk for opioid use disorder (OUD) often begins in adolescence and young adulthood. Engaging and retaining adolescents and young adults (collectively, “youth”) in early, effective treatment is critical for improving the life course trajectory of addiction. For adults with OUD, office-based opioid treatment (OBOT) with a collaborative care approach that includes behavioral therapy optimizes patient engagement and retention in care. Collaborative care OBOT is especially promising for youth, who can receive treatment from a trusted primary care provider in the same familiar setting they receive their usual medical care. To date, however, OBOT has not been formally adapted for treating youth. The central objective of this project is to develop and pilot an enhanced OBOT model for youth that is developmentally appropriate and family centered. The multidisciplinary nature of our team, which includes expertise in advanced biostatistical analysis, qualitative research, intervention development, developmental psychology, and implementation and improvement science, will maximize the chances of filling an important gap in the provision of youth specific evidence-based OUD interventions.

NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (R01 - Clinical Trial Not Allowed)
NOFO Number: RFA-HL-19-028
Summary:

Among the most common symptoms experienced by individuals suffering with opioid use disorder (OUD) are severe sleep and circadian disruptions. The relationship between opioid dependence and sleep and circadian systems is not well understood. A circadian-dependent mechanism has been shown to modulate fentanyl reward-related behaviors in the nucleus accumbens (NAc). The study team will use a combination of behavioral, slice electrophysiology, and molecular approaches to 1) investigate the role of the circadian transcription factor NPAS2 in medium spiny neurons with dopamine 1 (D1R-MSNs); 2) assess the impact of fentanyl on synaptic plasticity at D1R-MSNs and investigate whether NPAS2 mediates the potentiation of excitatory synapses at specific diurnal phases; 3) elucidate the cell-type-specific NPAS2-dependent transcriptional mechanisms of fentanyl-seeking and relapse behaviors; and 4) investigate whether NPAS2 rescue and buprenorphine medication-assisted treatment (MAT) improve fentanyl-induced sleep disturbances. This study will define the role for circadian-dependent transcriptional mechanisms and uncover the therapeutic potential of NPAS2 for opioid dependence and relapse.

NOFO Title: HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-AT-19-007
Summary:

Washington state used federal Opioid-STR funding to develop the Washington State Hub and Spoke Model (H&S), an integrated care model to expand access to OUD medications by incorporating primary care and substance use treatment programs, referral organizations, nurse care managers, and care navigators. Based on the initial success, Washington provided more funding and developed a second-generation, low-barrier H&S model, to place medication initiation sites in nontraditional settings, such as emergency departments, syringe exchanges, jails, and homeless shelters, and to have community partners offer OUD medication maintenance. The study will determine the implementation and effectiveness of the new H&S model, maintaining a hybrid effectiveness-implementation approach, and utilizing social network analysis to understand how H&S networks develop to serve the OUD population. The findings will demonstrate what makes the H&S model effective for increasing OUD medication treatment, improving outcomes for people with OUD, and reaching individuals who may not seek treatment.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.

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

Throughout clinical pain research, there is a need to increase the workforce of researchers familiar with individualized treatment strategies known as precision pain medicine. This mentoring award will leverage EPPIC-Net’s Clinical Coordinating Center resources to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected clinician-researcher  will mentor early career investigators and provide them with hands-on training activities and other skill-building experiences in clinical pain research, with a focus on precision pain medicine, biomarker development, and pain assessment. Mentoring activities will include formal educational coursework, inclusion in EPPIC-Net working groups, and collaborative writing experiences.

NOFO Title: HEAL Initiative: Oral Complications Arising from Pharmacotherapies to Treat Opioid Use Disorders (R21 Clinical Trial Not Allowed)
NOFO Number: RFA-DE-23-016
Summary:

Buprenorphine is used for treatment of opioid use disorder (OUD), and patients often take it for many years by slowly dissolving it in the mouth. In 2022, the U.S. Food and Drug Administration warned about possible oral complications from buprenorphine use, including tooth decay, oral infections, and tooth loss. However, this warning was largely based on small studies with no comparison group and no assessment of other risk factors such as limited dental care. This project will follow two groups of individuals with OUD who take either sublingual buprenorphine or methadone, to compare their oral health and understand barriers and facilitators of dental care. The results will be used to plan an intervention for preventing and treating oral diseases in this patient group.

NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program Technology Research Sites (UH2/UH3 Clinical Trial Optional)
NOFO Number: RFA-AR-19-028
Summary:

Chronic low back pain (cLBP) is recurrent and often nonresponsive to conservative treatments. Biomechanists, physical therapists, and surgeons each utilize a variety of tools and techniques to assess and interpret qualitative movement changes to understand potential mechanical and neurological sources of low back pain and as critical elements in their treatment paradigm. However, objectively characterizing and communicating this information is currently impossible, since clinically feasible (i.e., cost-effective, objective, and accurate) tools and quantitative benchmarks do not exist. This research addresses the challenge to improve cLBP outcomes through the use of unique, inexpensive, screen-printable, elastomer-based, nanocomposite, piezoresponsive sensors, which will be integrated into a SPInal Nanosensor Environment (SPINE) sense system to measure lumbar kinematics and provide an objective, quantitative platform for diagnosis, monitoring, and follow-up assessment of cLBP.

NOFO Title: Notice of Special Interest (NOSI): Availability of Administrative Supplements for Helping to End Addiction Long-term (HEAL) Initiative awardees to make data Findable, Accessible, Interoperable, and Reusable (FAIR) through the HEAL Data Ecosystem
NOFO Number: NOT-OD-22-110
Summary:

This research provides support to strengthen data management, data sharing, and data readiness efforts within the HEAL Initiative. This support further fosters collaboration among HEAL awardees and enables maximal data discoverability, interoperability, and reuse by aligning with the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. It also provides an opportunity for existing HEAL Initiative award recipients to increase data “FAIR”-ness, participate in coordinated HEAL Initiative activities to build community around data sharing, and foster sustainability of HEAL Initiative digital assets.