Funded Projects

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

Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award will allow a selected investigator to train early career investigators in patient-oriented research focusing on the development of diagnostic and prognostic biomarkers for high-impact chronic pain. Mentoring activities will include training in designing and implementing pain research studies, preparing scientific papers and presentations, writing successful grant applications, the responsible conduct of research, and successful navigation of the academic process to achieve scientific independence. This training will allow mentees to advance their independent careers as pain researchers.

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

The HEAL-funded Sequenced-strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP) clinical trial evaluates behavioral, pharmacologic, and procedural interventions for patients with knee osteoarthritis pain. It is designed to mimic clinical care for these patients by first testing the effectiveness of conservative and nonsurgical interventions before considering surgical interventions. It is a large-scale clinical trial with a novel design that evaluates multidisciplinary treatments. Therefore, it offers a unique training opportunity for junior investigators from various disciplines who are interested in pain research and management. This mentoring award will allow a selected investigator to train junior investigators by providing protected, mentorship-focused time.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

MCAM is a novel opioid antagonist that can be used for opioid overdose reversal and has advantages over naloxone, including a pseudo-irreversible interaction with the ?-opioid receptor and a longer duration of action. Studies in animal models demonstrate MCAM’s long duration of action against the reinforcing and respiratory-depressant effects of remifentanil and heroin, indicating that could be a better treatment option for opioid use disorder. This project studies the pharmacodynamics of MCAM through animal toxicity and safety studies to establish the necessary and sufficient conditions from which to establish MCAM’s safety and antagonist activity in animals and humans. MCAM may be able to prevent all actions of any ?-receptor opioid drug in humans for a longer period of time than any other antagonist given acutely.

NOFO Title: Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10)
NOFO Number: RFA-HD-13-014
Summary:

Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost universally used for post-cesarean analgesia management. Studies suggest that most women are prescribed more tablets at discharge than needed. These often go unused, providing an important reservoir contributing to the opioid crisis. Physicians struggle to prescribe and dose postoperative opioids appropriately while tackling the real needs of acute pain from surgery. Without literature to guide obstetric providers on appropriate amounts of opioids to prescribe upon discharge, actual prescription amounts nationally vary widely by up to 65 tablets. To improve post-cesarean opioid prescribing practices without compromising pain management, the study will test an individualized, patient-empowered approach for pain management and opioid prescription quantity. This is a noninferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge.

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:

There is an unmet need for an effective parenteral/oral analgesic for acute post- operative pain management without the risks of opioid addiction. Salsalate, a dimer or salicylic acid, is currently available in oral dosage for the treatment of osteoarthritis and rheumatoid arthritis. Salsalate works at multiple levels to target multiple steps along the surgical pain pathway. Salsalate through its active metabolite, salicylic acid (SA), reduces NF-?B activation via IKK-kinase beta inhibition, and has no direct binding to cyclooxygenase 1 (Cox-1); therefore, does not affect function of platelets, resulting in a safer hematological and gastrointestinal safety profile. RH Nano proposes a plan for manufacturing and pre- clinical testing of parenteral M-salsalate in two animal models to assess the efficacy and safety in the treatment of acute postoperative pain management. In this proposal, the team will develop the optimal formulation under strict Chemistry Manufacturing and Control guidelines. In Phase II, the team proposes to conduct the pharmacokinetics and toxicology studies of M-salsalate in two species of animals (rodent and non-rodent). Additionally, the project will use an animal pain model for preclinical efficacy studies, and an in vivo Receptor Occupancy assay in animal brain tissues to assess the opioid sparing properties of M-salsalate. 

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:

Opioid use disorder interventions need to address the complex needs of patients, which include substantial mental health comorbidity and high rates of chronic pain. This study takes advantage of recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to Medication Assisted Treatment (MAT) with buprenorphine in clinical settings funded through the Washington Opioid State Targeted Response (STR) program. Using a randomized, repeated measures design, the study team will compare those who receive MABT+ MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT outcomes among patients receiving buprenorphine to treat OUD. Results of this study will inform the evidence base for behavioral treatment adjuncts to MAT with buprenorphine and directly impact the future direction of opioid use disorder treatment in Washington state.

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:

New Hampshire can anticipate as many as 1,000 infants born with prenatal opioid exposure each year. Pain management is complicated for pregnant women with opioid use disorder (OUD), and undermanagement of pain is a strong risk factor for relapse. Contemplative interventions, such as yoga and mindfulness, may reduce risks for relapse for pregnant and parenting women with OUD. This project represents a partnership with New Hampshire stakeholders to develop and pilot evaluation of a trauma-informed yoga and mindfulness relapse prevention intervention (Mindful Moms in Recovery: MMORE). It aims to: 1) identify needs and areas of adaptation of trauma-informed yoga and mindfulness-based relapse prevention protocols through formative work with pregnant and parenting woman; 2) develop an integrated 10-session intervention protocol with iterative feedback from client stakeholders; and 3) evaluate feasibility, acceptability, and efficacy trends of MMORE in a pre-post pilot with pregnant women.

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

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOFO Number: PA-18-575
Summary:

Most of the 200k Americans who undergo thoracotomy each year receive opiates to reduce postoperative pain because clinicians have few non-addictive, cost-effective choices to control the severe pain patients often experience in the first two weeks after surgery. Managing pain post-thoracotomy is critical to enable patients to take deep breaths and remove (via coughing) lung secretions that otherwise significantly increase risk of pneumonia and collapsed lung, hospital re-admission and morbidity. The most severe pain associated with thoracotomy is transmitted along the intercostal nerves, but no long-term analgesic or nerve block device exists that can provide safe and effective long-term reduction of pain. A reversible, patient-controlled, non- addictive, intercostal nerve block device would reduce suffering due to thoracotomy, broken ribs and herpes zoster. In this Phase I project, the team will develop a minimally invasive thermal nerve block device that can control nerve conduction by gently warming and cooling a short nerve segment between room temperature and warm water temperature. This novel approach is based on the discovery that warm and cool temperature mechanisms of nerve block are different and additive, enabling moderate-temperature nerve block by cycling neural tissues slightly above and below body temperature. Reversible thermal nerve blocks represent a completely new approach to managing pain.  

NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Monitoring and reporting substance use and substance use disorder is difficult to obtain in real-time using conventional methods. However, social media captures large amounts of data about substance use that are reported by diverse groups of people. Analysis of these data can provide population- or subpopulation-level insights, at low cost and in near real-time. This project aims to convert large amounts of social media data on substance use into actionable knowledge using advanced natural language processing and artificial intelligence approaches. The researchers will publicly release the aggregated statistics through a dedicated dashboard and provide user-friendly, open-source tools to determine trends and analyze disparities.

NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional)
NOFO Number: RFA-DA-23-042
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Clinical and research communities are uncertain about how to assess and manage long-term opioid therapy, despite having diagnostic and treatment frameworks for chronic pain and opioid use disorder. Because of this undefined space, health policy, institutions, and practitioners lack clear advice on long-term opioid prescribing in chronic pain. The goal of the MRC is to provide infrastructure support for the network; create a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered/discontinued; and develop and validate a clinical definition for this population (name, identifying associated symptoms/behaviors, and generating a screening tool). This project will leverage big data analytics in administrative datasets, natural language processing approaches in electronic health records, and cohort modeling techniques to accomplish these key responsibilities. These efforts will complement the qualitative data collection approaches in the Becker Resource Center. 

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

Research is needed to better understand how to make life-saving harm reduction services more accessible to populations that are hard to reach. This project will identify the physical and psychological factors that make harm reduction services most effective. The findings will then be used to inform the development, implementation, and testing of an innovative strategy consisting of several internet- and smartphone-based tools designed to improve access to harm reduction services for people who are hard to reach.