Funded Projects

NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327
Summary:

Currently there are no safe, rapidly acting treatments for methamphetamine use disorder and overdose. This project will evaluate a potential treatment: the small molecule CS-1103, which selectively attaches to methamphetamine in the blood. This molecule quickly removes methamphetamine blood and into urine for elimination from the body. The research will evaluate the safety and compatibility of CS-1103 with the human body, toward future clinical testing in humans. 

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Effective medication-based treatment could prevent overdose deaths and help individuals recover from opioid use disorder, but only a fraction of those in need access treatment or receive a medication approved by the U.S. Food and Drug Administration. One way to improve people’s choice to seek and stay in treatment is to improve training for addiction treatment counselors beyond current methods that rely on brief online or in-person workshops. The goal of this research project is to develop and evaluate the technical feasibility and commercial viability of a scalable digital program to train behavioral addiction professionals in Community Reinforcement and Family Training (CRAFT), an evidence-based approach to increase treatment entry, using ongoing counselor training with feedback and coaching.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-020
Summary:

The primary cause of death associated with opioids is opioid-induced respiratory depression, and there is currently no way to prevent this condition. The goal of this research is to develop a therapy to prevent opioid-induced respiratory depression without disrupting opioids’ analgesic effects. Previous research has shown that the hormone leptin, which suppresses appetite and increases metabolic rate, also stimulates breathing. This research project in a mouse model will test if the novel, brain-penetrant leptin receptor-binding protein E1/Aca can prevent fentanyl-induced breathing failure without diminishing fentanyl’s analgesic effects.

NOFO Title: Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data
NOFO Number: NOT-OD-22-067
Summary:

This research is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain and opioid use disorder or opioid misuse. To allow comparison and analysis of data created in nine unique clinical trials funded across four centers, common data elements (CDEs) were selected to assess all aspects of a patient’s condition and experience. The purpose of this project is to make the IMPOWR CDE data more FAIR (Findable, Accessible, Interoperable, Reusable) by building a tool that will automate the mapping/conversion of HEAL-related data to the Observational Medical Outcomes Partnership data model that allows for systematic analysis of data from different databases. Upon completion, this tool would be shared with the HEAL research community as a new resource to enable broader harmonization and secondary data analysis.

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-009
Summary:

Neuropathic pain adversely affects quality of life and remains challenging to treat, presenting high unmet medical need. One example of this type of pain, chemotherapy-induced peripheral neuropathy, is a chronic, severely debilitating consequence of cancer therapy for which there are no effective treatment strategies. This research is testing a new cannabidiol (CBD) analogue (KLS-13019) with neuroprotective properties and which has improved drug-like properties compared to CBD. This project will optimize the process to manufacture KLS-13019, develop analytical methods, optimize its formulation, evaluate its safety and toxicity, and test KLS-13019’s efficacy of in a rat model of chemotherapy-induced peripheral neuropathy.

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Summary:

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.

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Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of

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Summary:

Inpatient programs are important portals for increasing access to treatment. However, most individuals with opioid use disorder are detoxified but not offered medications to prevent relapse. This randomized-controlled trial will examine whether a rapid-transition protocol to inducting extended release naltrexone (XR-NTX) following detoxification yields a higher proportion of patients successfully receiving the first injection of XR-NTX compared with standard detoxification and naltrexone initiation. This study will also assess facilitators and barriers to implementing rapid XR-NTX initiation. The overall goal is to foster widespread adoption of a five- to seven-day protocol for initiation of treatment with XR-NTX at inpatient/residential programs.

NOFO Number:
Summary:

There is a significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.

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: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-18-494

NOFO Title: Notice of Special Interest (NOSI): Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain
NOFO Number: NOT-NS-22-087
Summary:

Understanding the mechanisms underlying the transition to chronic pain is key to mitigating the dual epidemics of chronic pain and opioid use in the United States. As part of the National Institutes of Health-funded Acute to Chronic Pain Signatures Program, the Data Integration and Resource Center aims to This project will support a post-doctoral trainee to develop the skills and knowledge needed to pursue a successful career in clinical pain research. The research will involve integrating imaging, physiology, -omics, behavioral, and clinical data to develop biosignatures for the transition from acute to chronic pain, toward understanding how the nervous and immune systems affect post-surgical pain and opioid use.

NOFO Title: Data Coordinating Center for the NICHD Neonatal Research Network (U24)
NOFO Number: RFA-HD-18-010
Summary:

The ACT NOW Eat, Sleep, Console (ESC) Clinical Trial approach to the management of neonatal opioid withdrawal syndrome (NOWS) emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Although outcomes following implementation of the ESC care approach, inclusive of the ESC Care Tool, appear promising and initial accounts suggest that it is safe, there has yet to be a rigorous randomized clinical trial to demonstrate the safety, efficacy and generalizability of its use in the care of infants with NOWS. The ESC Clinical Trial leverages the infrastructure and collaborations of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the IDeA States Pediatric Clinical Trials Network to reach the populations most affected by the opioid epidemic. The trial will provide answers to numerous critical gaps in our knowledge with respect to the best practices for the identification and management of infants with NOWS, as well as our understanding of the outcomes of these infants.