Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
1R61DA057675-01	Using System Dynamics Modeling to Foster Real-Time Connections to Care	Cross-Cutting Research	Translating Data 2 Action to Prevent Overdose	NIDA	YALE UNIVERSITY	HECKMANN, REBEKAH (contact); S SABOUNCHI, NASIM	New Haven, CT	2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-22-051 Summary: First responders prevent many overdose deaths by providing life-saving resuscitation and giving naloxone to reverse an opioid overdose. This project will use a modeling approach to assess the impact of Good Samaritan Laws that protect people from certain criminal penalties if they call 911 to save an overdose victim by giving naloxone on overdose mortality. This research will develop and test a novel, scalable, telehealth platform that can be used at the time of an opioid overdose to link patients with access to medication for opioid use disorder, harm reduction services, and recovery support. The research will be informed by patient-outcome data.
1R61DA057683-01	Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder: A Stepped-wedge Randomized Trial to Facilitate Clinic Level Changes	Cross-Cutting Research	Translating Data 2 Action to Prevent Overdose	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	NEIGHBORS, CHARLES J (contact); BAO, YUHUA ; RAMSEY, KELLY S	New York, NY	2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-22-051 Summary: During the COVID-19 public health emergency, the Substance Use and Mental Health Services Administration relaxed regulations for take-home dosing of methadone, offering an opportunity to improve methadone treatment access and address racial and ethnic disparities. This project aims to address regulatory, legal liability, and financial concerns related to clinical practice changes in opioid treatment programs. The project will first review state administrative data and conduct qualitative interviews to inform the intervention approach. The project will then evaluate an opioid treatment program intervention involving take-home methadone and its effect on take-home dosing, retention in care, and health outcomes for Black/African American and Hispanic/Latino individuals who take methadone for opioid use disorder.
1R61DA059027-01	A Multi-Team System Implementation Strategy to Improve Buprenorphine Adherence for Patients who Initiate Treatment in the Emergency Department	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	UNIVERSITY OF CALIFORNIA AT DAVIS	HENRY, STEPHEN G (contact); MOULIN, AIMEE; TU, SHIN-PING	Davis, CA	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: There is an urgent need to identify and rapidly apply strategies to expand treatment for opioid use disorder, particularly among low-income patients. This project will develop and test a novel implementation strategy that uses ongoing community partnerships designed to improve care coordination for patients who start buprenorphine treatment for opioid use disorder in the emergency department and are then referred to primary care for ongoing treatment.
1R61DA059032-01A1	Onsite PTSD Treatment to Improve MOUD Outcomes (OPTIMO): A Hybrid Type 1 Effectiveness-Implementation Trial of Harm Reduction PTSD Care at Syringe Service Programs	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	CITY COLLEGE OF NEW YORK	LOPEZ-CASTRO, TERESA (contact); FOX, AARON D	New York, NY	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: People who inject drugs often have posttraumatic stress disorder (PTSD). Co-occurring PTSD puts these individuals at increased risk of illicit opioid use, opioid use disorder, overdose, HIV, and hepatitis C virus infection. This project will adapt, with input from the community, an evidence-based PTSD treatment program for people with both opioid use disorder and PTSD who are participating in a syringe service program. The treatment will then be tested in multiple syringe service programs to determine its potential for improving outcomes for these individuals who are often marginalized in traditional care.
1R61DA059033-01A1	Implementing a Patient Navigation Intervention Across a Health System to Address Treatment Entry Inequities	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	FRIENDS RESEARCH INSTITUTE, INC.	ALEXANDER, KAREN (contact); GRYCZYNSKI, JAN	Baltimore, MD	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Significant racial, ethnic, socioeconomic, and geographic disparities affect access to opioid use disorder (OUD) treatment and have thus contributed to the opioid overdose crisis. Patient navigator interventions after hospitalization can improve access to treatment, but challenges prevent full adoption of these strategies. These include lack of coordination across institutions, inadequate data sharing, workforce shortages, and lack of awareness, especially in resource-limited communities. This project aims to develop a hospital system-wide patient navigation protocol that can be scaled up to address OUD treatment linkage and continuity after hospitalization.
1R61DA059163-01	Supporting Data-Driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses	Cross-Cutting Research	Translating Data 2 Action to Prevent Overdose	NIDA	CHESTNUT HEALTH SYSTEMS, INC.	CRUDEN, GRACELYN	Bloomington, IL	2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional) NOFO Number: RFA-DA-23-057 Summary: Oregon ranks last in the United States for access to substance use services, having passed a novel ballot measure bringing unprecedented funding levels to expand services and decriminalize possession of personal amounts of substances. This project will develop and evaluate a strategy to inform development of the policy. Cross-sector participants (e.g., community service providers, law enforcement, advocates) will co-design protocols for linking and distributing substance use service data through reports, simulations, and dashboards. This research will test the usability of the developed products and their impact of DDS on service gaps, evidence-based decision-making, quality of evidence-based services, service recipient outcomes, and cross-sector collaboration. The research will also help state decision makers implement strategies for other substance use policies.
1R61DA059168-01	The Use of Novel Linked Databases to Reduce Postoperative Opioid Use Among Patients Undergoing Inpatient Surgery	Cross-Cutting Research	Translating Data 2 Action to Prevent Overdose	NIDA	STANDFORD UNIVERSITY	SUN, ERIC (contact); COLQUHOUN, DOUGLAS ALASTAIR	Stanford, CA	2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional) NOFO Number: RFA-DA-23-057 Summary: Older adults make up more than half of all surgical patients in the United States, putting them at risk for a range of harmful outcomes including misusing opioids, developing opioid use disorder (OUD), opioid overdose, and surgical complications. This project seeks to understand whether pre-surgery interventions can prevent harmful opioid-related outcomes. The research will combine data from a registry of electronic health records and from Medicare claims data to learn about the relationship between these interventions and opioid-related outcomes including persistent opioid use, OUD, and other harmful outcomes.
1R61DA059169-01	Leveraging Data to Action: Accelerating Emergency Department OUD Care by Improving Data Access and Infrastructure	Cross-Cutting Research	Translating Data 2 Action to Prevent Overdose	NIDA	YALE UNIVERSITY	VENKATESH, ARJUN KRISHNA (contact); HAWK, KATHRYN; TAYLOR, RICHARD ANDREW	New Haven, CO	2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional) NOFO Number: RFA-DA-23-057 Summary: Emergency departments (EDs) are key settings for identifying and treating opioid use disorder (OUD), but EDs are underused for this purpose. This project aims to develop a data system that automates and integrates electronic health record and administrative data from EDs into the Clinical Emergency Department Registry, partnering with the American College of Emergency Physicians. The research will assess the digital readiness of ED systems before developing and deploying the enhanced ED OUD data infrastructure. This research aims to guide near-real time hospital quality improvement initiatives, toward development of a web-based, near-real time dashboard that can be used in EDs across the country.
1R61DA059880-01	Evaluation of a Peer Recovery Support Program Adapted to Target Retention in Clinic-Based Medication for Opioid Use Disorder Treatment	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	GEISINGER CLINIC	POULSEN, MELISSA (contact); ZAJAC, KRISTYN	Danville, PA	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Medications for opioid use disorder (OUD) are safe and effective. However, many people do not take them long enough to achieve sustained recovery, putting them at risk of overdose. Peer recovery support services—which are delivered by trained individuals with lived experience of addiction and recovery—may help people with OUD initiate and stay in medication treatment. This project will adapt peer recovery support services for use in outpatient substance use treatment settings and test their implementation and effectiveness in helping people with OUD achieve long-term recovery. If successful, the program could be implemented in a variety of outpatient treatment programs, including in underserved rural areas.
1R61DA059887-01	Testing an Occupational Stress Intervention for Harm Reduction Workers in Substance Misuse Settings	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	UNIVERSITY OF TEXAS AT AUSTIN	CREECH, SUZANNAH K	Austin, TX	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: People who work in harm reduction settings aiming to keep people with substance use disorders safe from overdose and other negative health outcomes are exposed to high rates of lifetime and occupational stress and trauma. Their work conditions can have adverse effects on patient care and also on their own well-being, such as unmet mental health needs, burnout, and relapse. This project will adapt the Stress First Aid intervention for harm reduction workers. The research will test the impact of this intervention on social support, burnout, secondary traumatic stress, use of mental health care, engagement, and turnover. The long-term goal of this work is to implement a sustainable and effective national occupational stress intervention for harm reduction workers to strengthen their important role in helping individuals get treatment and avoid overdose.
1R61DA059889-01	Methadone Patient Access to Collaborative Treatment (MPACT)	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	UNIVERSITY OF ARIZONA	MEYERSON, BETH	Tucson, AZ	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Current practices and culture in treatment programs for opioid use disorder, including treatment with methadone, may contribute to treatment interruption and relapse risk. This project will develop and test a staff-level intervention for opioid treatment programs to increase methadone treatment retention and decrease in-treatment overdose and patient- and staff-reported posttraumatic stress symptoms. The intervention includes components to address trauma in patients and staff as well as separate supervisory structures for counselors/case managers and medical providers.
1R61DA059892-01	Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities via Mobile Health Clinics and Peer Support Services	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	CLEMSON UNIVERSITY	RENNERT, LIOR (contact); LITWIN, ALAIN HARRIS	Clemson, SC	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Although medication-based treatment for opioid use disorder (OUD) can effectively reduce overdose risk and improve health outcomes, most people discontinue treatment too soon. Peer support specialists, who are individuals with direct experience with a substance use disorder, can offer social support to help individuals with OUD overcome barriers to treatment and recovery. This project will develop, deliver, and evaluate an innovative peer support specialist intervention to help individuals begin and stay in a treatment program. The research will focus on rural populations and underserved communities, using a dynamic modeling framework to prioritize at-risk communities for treatment offered through mobile health clinics.
1R61DA059895-01	Promoting Retention in Opioid Treatment among Women Experiencing Intimate Partner Violence: A Novel Stepped Care Model Targeting PTSD	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	YALE UNIVERSITY	SULLIVAN, TAMI P (contact); EDELMAN, E JENNIFER; JOHNSON, DAWN M	New Haven, CT	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Women with opioid use disorder (OUD) are disproportionately impacted by physical, sexual, and psychological intimate partner violence and posttraumatic stress disorder (PTSD). Yet, treatment approaches that address all these conditions together in OUD treatment settings are lacking. To address this gap, this project will evaluate delivery of two evidence-based interventions to address PTSD (Present-Centered Therapy+ and Helping to Overcome PTSD through Empowerment) for women seeking OUD treatment who have experienced intimate partner violence. It will also determine if integrated treatment can help retain the women in medication treatment for OUD.
1R61DA059897-01	Testing a Video and Text Messaging Intervention to Reduce PTSD and Opioid Misuse Among Sexual Violence Survivors	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	UNIVERSITY OF WISCONSIN-MADISON	WALSH, KATIE L	Madison, WI	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: People who survive sexual violence are at increased risk for posttraumatic stress disorder (PTSD) and opioid misuse. Emergency departments are often the first, and in some cases only, contact with the medical care system for survivors of sexual violence. This makes them a suitable setting to initiate interventions to address the risk of PTSD and opioid misuse in these individuals. This project will develop and test a brief, low-cost video and text message intervention that can be initiated in the emergency department to prevent onset or escalation of PTSD and opioid misuse among people who survive sexual violence.
1R61DA059947-01	Developing and Testing Innovative Care Pathways for Screening and Treatment of OUD/PTSD in Jails	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES	ZIELINSKI, MELISSA JEAN (contact); ZALLER, NICKOLAS D	Little Rock, AR	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: Many people in jail have both opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). Among people with OUD released from jail, only few engage in treatment and medication therapy once they are back in the community, and opioid overdose is a leading cause of death in this population. This project will test whether identifying and initiating treatment of PTSD in people receiving OUD treatment in jail can increase these individuals’ likelihood of starting and staying in medication treatment after release and thus reduce overdose risk.
1R61DA059948-01	Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care	Translation of Research to Practice for the Treatment of Opioid Addiction	Optimizing the Quality, Reach, and Impact of Addiction Services	NIDA	INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS	HULVERSHORN, LESLIE A (contact); AALSMA, MATTHEW; ADAMS, ZACHARY WILLIAM	Indianapolis, IN	2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional) NOFO Number: RFA-DA-23-053 Summary: The overdose crisis has expanded rapidly among adolescent populations in recent years, largely due to illicit substances containing lethal amounts of the highly potent synthetic opioid fentanyl. However, a provider shortage limits access to effective treatment for adolescents with opioid use disorder and other substance use disorders (SUD). Although primary care is a promising setting for expanding delivery of SUD treatment to adolescents, many primary care providers lack the training, resources, and support systems to deliver these services confidently and effectively. This project will leverage a large-scale rollout of integrated behavioral health care in a statewide health system. The research will test whether embedding behavioral health specialists into primary care visits, introducing case management and electronic clinical decision support tools, and reducing stigma will increase delivery of SUD treatment to adolescents.
1R61DK135406-01	PAINED: Project Addressing Inequities in the Emergency Department	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NIDDK	Children's Research Institute	GOYAL, MONIKA KUMARI	Washington, DC	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required) NOFO Number: NS22-002 Summary: Clinician bias causes inequities in healthcare, and interventions are needed to mitigate and eradicate this bias. This project aims to develop and test the impact of two interventions on overcoming clinician implicit bias in the management of pain for children from ethnic minorities treated in the emergency department. The study will include pediatric patients from under-represented minority groups with pain from long-bone fractures or acute appendicitis who are cared for by racially and ethnically diverse caregivers. Researchers will use stakeholder-informed approaches to establish quality of care metrics and then use clinician audit and feedback as well as data from electronic health records to quantify evidence of bias.
1R61HL156240-01	Treatment of Fentanyl Overdose-Induced Respiratory Failure by Low-Dose Dexmedetomidine	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NHLBI	PENNSYLVANIA STATE UNIV HERSHEY MED CTR	HAOUZI, PHILIPPE A	Hershey, PA	2020
NOFO Title: HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed) NOFO Number: RFA-HL-20-031
1R61HL156248-01	Intranasal Leptin as A Novel Treatment of Opioid-Induced Respiratory Depression	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NHLBI	JOHNS HOPKINS UNIVERSITY	POLOTSKY, VSEVOLOD Y	Baltimore, MD	2020
NOFO Title: HEAL Initiative: Pharmacotherapies to Reverse Opioid Overdose Induced Respiratory Depression without Central Opioid Withdrawal (Target Validation and Candidate Therapeutic Development (R61/R33 - Clinical Trial Not Allowed) NOFO Number: RFA-HL-20-031
1R61MD018333-01	Group-Based Integrative Pain Management: A Multi-Level Approach to Address Intersectional Stigma and Social Isolation in Diverse Primary Care Safety Net Patients with Chronic Pain	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NIMHD	University of California, San Francisco	CHAO, MARIA	San Francisco, CA	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required) NOFO Number: NS22-002 Summary: Many barriers exist in primary care offices where socioeconomically disadvantaged patients are most often treated. This project seeks to address chronic pain disparities that affect racially diverse, socioeconomically disadvantaged individuals. The study aims to optimize multimodal pain management in primary care clinics for low-income populations. This study includes two group-based models: integrative group medical visits and group acupuncture. These two interventions will be compared to typical treatment to measure both pain interference and social isolation. National experts and patient stakeholders will refine and optimize the design of the study with English- or Spanish-speaking patients with chronic pain in two primary care clinics for low-income populations.
1R61MH132249-01	Latinx Children and Surgery	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NIMH	University of California, Irvine	KAIN, ZEEV	Irvine, CA	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required) NOFO Number: NS22-002 Summary: Both pain experience and treatment response are determined by a variety of factors, including race and ethnicity. Inequities in access to healthcare and pain treatment affect patients from minority populations, such as Hispanic/Latino populations of all age groups. This study will develop and test an online intervention—Web-based Tailored Intervention for Preparation of Parents and Children for Outpatient Surgery (L-WebTIPS)—tailored for Latino families of children having outpatient surgeries. The intervention aims to lower child and family anxiety before surgery as well as to reduce post-surgical pain by enhancing parent self-efficacy and behavioral pain coping strategies. After an exploratory phase to assess usability and acceptability of the intervention, the study will evaluate the impact of L-WebTIPS on child pre-surgery anxiety and post-surgery pain as well assess other child and parent outcomes.
1R61NR020845-01	Equity Using Interventions for Pain and Depression (EQUIPD)	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NINR	INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS	MATTHIAS, MARIANNE	Indianapolis, IN	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain and Comorbidities (R61/R33 Clinical Trial Required) NOFO Number: RFA-NS-22-037 Summary: Opioid overdose deaths disproportionately affect Black individuals in the United States. While the use of complementary and integrative pain treatments is effective and widely recommended, Black pain patients (especially those who also have depression) face barriers to the use of these approaches. This project will refine, test, and prepare to implement a novel approach to overcoming these treatment barriers. The research will partner with and empower Black patients to find safe, effective pain treatments that best match their values, preferences, and lifestyles.
1R61NS113258-01A1	Multi-Omic Biomarkers for Neuropathic Pain Secondary to Chemotherapy	Preclinical and Translational Research in Pain Management	Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions	NINDS	CLEVELAND CLINIC LERNER COM-CWRU	ROTROFF, DANIEL; FOSS, JOSEPH F; JOHNSON, KENWARD B;	Cleveland, OH	2020
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional) NOFO Number: RFA-NS-18-041 Summary: Taxanes are among the most effective chemotherapeutic agents and are frequently used in the treatment of early stage and metastatic breast cancer. However, they are known to produce a pain condition known as Chemotherapy-Induced Peripheral Neuropathic Pain (CIPNP). CIPNP is one of the primary reasons a patient receives a limited dose of taxane. No diagnostic tool exists to identify patients that will develop CIPNP in response to taxane therapy. Biomarker signatures associated with taxane-induced neuropathic pain will be developed to: 1) identify patients at risk for developing debilitating taxane neuropathic pain before chemotherapy is initiated; and 2) to identify patients already on treatment who are at risk of developing neuropathic pain and need dosing adjustments to prevent CIPNP symptoms. This biomarker signature will be used to detect CIPNP-susceptible patients early and personalize their taxane therapy to minimize CIPNP while optimizing the therapeutic taxane dosing.
1R61NS113269-01	Validation of a novel cortical biomarker signature for pain	Preclinical and Translational Research in Pain Management	Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions	NINDS	University of Maryland, Baltimore	SEMINOWICZ, DAVID	Baltimore, MD	2019
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional) NOFO Number: RFA-NS-18-041 Summary: Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The applicant’s team uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). This biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). Analytical validation of this biomarker will be conducted in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain. Specifically the biomarker signature will be tested for its ability to predict an individual’s pain sensitivity, pain severity, and pain duration and will perform initial clinical validation.
1R61NS113315-01	Biomarker Signature to Predict the Persistence of Post-Traumatic Headache	Preclinical and Translational Research in Pain Management	Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions	NINDS	MAYO CLINIC ARIZONA	CHONG, CATHERINE DANIELA	Scottsdale, AZ	2019
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional) NOFO Number: RFA-NS-18-041 Summary: There is currently no recognized way of accurately predicting who will recover from post-traumatic headache (PTH) during the acute phase following concussion and who will go on to develop persistent post-traumatic headache (PPTH), a condition that is difficult to treat effectively. Clinical experience suggests that early treatment is most effective, before headache patterns become persistent, but treating all patients with PTH would expose some patients to unnecessary treatment. Clinicians lack the information needed to make informed treatment decisions. Therefore, the study goals are to develop a prognostic biomarker signature for PPTH using clinical data and structural and functional brain neuroimaging and to assess the predictive accuracy of an ensemble biomarker signature for the early identification of patients at high risk for PPTH. This study can be translated into clinical practice and integrated into PTH clinical trials for early identification of those individuals who are at high risk for PPTH.