Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
3UH3AR077360-03S2
Increasing Participant Diversity in a 'Sequenced-Strategy to Improve Outcomes in People with Knee Osteoarthritis Pain (SKOAP) Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY COHEN, STEVEN P Baltimore, MD 2021
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:

Knee osteoarthritis is one of the leading causes of disability worldwide, particularly among older adults. Despite multiple guidelines for care, most patients do not receive adequate treatment, and about 30% are prescribed long-term opioids. This award will be used to recruit and support an early career faculty member from a group underrepresented in biomedicine. This research, part of the Pain Management Effectiveness Research Network will evaluate conservative and more aggressive treatments for knee osteoarthritis and determine which individual-level factors contribute to treatment outcomes.
3-UH3-AT010739-02
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J (contact); DEBAR, LYNN L Oakland, CA 2021
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
1U18EB030609-01
Novel Implantable Device to Negate Post-Amputation Pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NIBIB NOVAFLUX, INC. LABIB, MOHAMED E (contact); KATHJU, SANDEEP Princeton, NJ 2021
NOFO Title: HEAL Initiative: Translational Development of Devices to Treat Pain (U18 Clinical Trial Not Allowed)
NOFO Number: RFA-EB-18-003
Summary:

Approximately 3.6 million Americans live with an amputated extremity, and the majority of these individuals are likely to suffer from chronic post-amputation pain. There is no consensus as to a recommended therapy for such pain, and many treatments do not provide sufficient pain control. Some studies have shown effective pain suppression from delivering an anesthetic agent directly to an injured nerve. This research aims to develop a device that can be implanted near the injured nerves of an amputated limb to deliver an anesthetic. Findings from this preclinical study will optimize design and delivery features to maximize its effect on pain control for as long as possible without needing a drug refill. The research is expected to advance eligibility for further testing in large animals and humans.
3UG1DA049468-03S3
Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR PAGE, KIMBERLY Albuquerque, NM 2021
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:

Including all population subgroups in clinical research is important to ensure that research results apply to the entire population and can be implemented effectively. However, many communities are underrepresented in health research due to individual, cultural, or structural reasons. This project aims to develop a Health Beliefs Toolkit that will be a readily accessible resource for researchers, providers, and community groups to help them engage diverse and minority populations in clinical research, particularly regarding substance use disorders. The project will examine, adapt, and test existing materials and resources targeting individual and structural barriers to research engagement. The toolkit will also assess individuals’ knowledge of health as well as health-related personal values and beliefs to enhance health and research “literacy.” The toolkit will be targeted to primary care providers, community health workers, peer counselors, agency representatives, and patient and non-patient groups to enhance practice-based research in underserved communities.
3UG1 DA013035
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA YALE UNIVERSITY; NEW YORK UNIVERSITY Gail D'Onofrio/Roger Weiss; John Rotrosen/Edward Nunes New Haven, CT 2021
NOFO Number:
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 4-7.
1U01DA055369-01
14/24 The Healthy Brain & Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO BANDOLI, GRETCHEN E (contact); GAHAGAN, SHEILA San Diego, CA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of San Diego study site will recruit a diverse cohort of mother-infant pairs, including Hispanic and American Indian individuals.
1U01DA055343-01
1/2 Assessing the Cumulative Impact of Early Life Substance and Environment Exposure on Child Neurodevelopment and Health Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA RHODE ISLAND HOSPITAL DEONI, SEAN CL (contact); D'SA, VIREN ANDREW Providence, RI 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

This study aims to determine how exposure to opioids and other substances affects the developing fetal brain and shapes later child cognitive outcomes. Researchers will collect neuroimaging and behavioral data, as well as measures of environmental exposures related to social equity, COVID-19, and socioeconomic factors. The project will reduce traditional barriers to participation by using innovative data collection methods and mobile labs to bring the research to underrepresented and marginalized communities. This approach aims to clarify the impact of substance exposure on child development through an equitable approach to research, with generalizable findings. The study will take place at Rhode Island Hospital, where participants will be drawn from a largely rural population.
3UH3CA261067-02S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2021
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:

Social determinants of heath may affect breast cancer diagnosis and disease staging at time of mastectomy. It is unclear if socioeconomic factors such as annual income, marital status/single parent household, number of children, distance from the hospital, and other life stressors facing individuals from under-resourced populations affect development of postmastectomy pain syndrome or response to the drug ketamine. This research will analyze these factors toward mitigating post-mastectomy pain. This analysis will also serve as the basis for further research to define pathways that minimize health disparities plays in the development of chronic, post-surgical pain. The ultimate goal of this research is to normalize risk for chronic pain after breast surgery.

 
3UG1CA189824-08S2
Developing and Implementing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Hispanic/Latinx Patients with Cancer Pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 2021
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:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.
3U24NS115678-01S1
Increasing Diversity and Community Engagement in EPPIC-Net Research at the University of Washington Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS UNIVERSITY OF WASHINGTON BACKONJA, MIROSLAV MISHA Seattle, WA 2021
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:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve pain management by discovering and validating biomarkers and non-opioid pain medications. This award will leverage the resources at the University of Washington’s EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. The site’s network spans multiple states and specialties, allowing access to geographically and demographically diverse patient populations, including underrepresented and underserved populations. 
1OT2NS122680-01
A 24-week Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects with Moderate to Severe Knee Osteoarthritis Pain. Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS Massachussetts General Hospital FAVA, MAURIZIO Boston, MA 2021
NOFO Title: HEAL Initiative: EPPIC-Net Pain Research Asset Application (OT2)
NOFO Number: OTA-20-008
Summary:

This award funds EPPIC-NET’s first phase 2 clinical trial, testing the novel oral drug CNTX-6970 in patients with moderate to severe knee osteoarthritis pain. It will include 150 participants at EPPIC-Net sites across the United States. Preclinical studies of CNTX-6970, which binds effectively and dose-proportionally to C-C chemokine type 2 (CCR2) receptors, have demonstrated potent analgesia in multiple pain models, with no emergent safety issues. CNTX-6970 has effects both at an affected joint, as well as on neural signaling. Participants will be randomized to receive CNTX-6970, placebo, or a third pain medication and will be followed for 24 weeks.
5R24DA051950-02
Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA OREGON SOCIAL LEARNING CENTER, INC. SHEIDOW, ASHLI J Eugene, OR 2021
NOFO Title: Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations
NOFO Number: RFA-DA-20-014
Summary:

Emerging adults (ages 16-25) involved with public systems and individuals involved with the justice system (including emerging adults) are at the highest risk for problems stemming from opioid use disorder. Emerging adults report the highest rates of drug use, including opiates, and those involved with public systems are more likely to have poor outcomes. For adults of all ages, opioid use increases the likelihood of justice system involvement. Peer recovery support services and recovery residences are growing nationally and may benefit these two groups tremendously, but research on them is limited. This project will establish the Initiative for Justice and Emerging Adult Populations to advance recovery support services research through a partnership between researchers, people in recovery from these two populations, recovery support service providers, and payors.
1K24AR081143-01
Mentorship of Junior Investigators on HEAL-SKOAP Clinical Research in Pain Management NIAMS JOHNS HOPKINS UNIVERSITY Campbell, Claudia Michelle Baltimore, MD 2021
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.
1U01DA055361-01
13/24 The Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA PENNSYLVANIA STATE UNIVERSITY-UNIV PARK PEREZ-EDGAR, KORALY E (contact); ZGIERSKA, ALEKSANDRA EWA University Park, PA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Pennsylvania State University study site is in a region hard hit by opioid and methamphetamine use disorders and will recruit mother-infant pairs from largely rural communities.
1U01DA055370-01
21/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF WISCONSIN-MADISON DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A Madison, WI 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement.
3U2CDA050097-03S1
JCOIN Coordination and Translation Center Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA GEORGE MASON UNIVERSITY TAXMAN, FAYE S (contact); FERGUSON, WARREN J; MOLFENTER, TODD DAVID; RUDES, DANIELLE Fairfax, VA 2021
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:

This research is designed to further understand implementation of medication-delivery programs in jail and/or community treatment programs based on perceptions of staff delivering medications for opioid use disorder and related services. The primary study uses a mainly quantitative approach to examine medication-delivery program implementation in jail and/or treatment settings. The study compliments ongoing research by incorporating a qualitative approach to assess perceptions of diverse staff through two interviews each with 80 individuals working in jail and/or treatment facilities involved in an ongoing study. Qualitative methods will add depth and nuance to our understanding of how medication-delivery programmatic outcomes relate to correctional staff perceptions.
3U24NS114416-01S1
Administrative Supplement to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in EPPIC NET Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS DUKE UNIVERSITY LIMKAKENG, ALEXANDER TAN Durham, NC 2021
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:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve non-opioid pain management. This award will leverage the resources at one of EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. Since environmental, cultural, and genetic factors may account for observed differences in pain responses between racial and ethnic groups, enrollment of a diverse sample in pain research is crucial to obtain a complete understanding of the effectiveness of any proposed pain therapeutic intervention. The success of these activities will be evaluated, and a toolkit will be created to define best practices that can be by other EPPIC-Net sites and additional trials.
9R42NS120548-02A1
Development of KLS-13019 for Neuropathic Pain Cross-Cutting Research Small Business Programs NINDS KANNALIFE SCIENCES, INC. BRENNEMAN, DOUGLAS ERIC (contact); WARD, SARA J Lloyd Harbor, NY 2021
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.
3U19AR076737-01S2
REACH Participant Diversity Program Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO LOTZ, JEFFREY C San Francisco, CA 2021
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:

The University of California, San Francisco, as part of the Back Pain Consortium (BACPAC) Research Program, has established a Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain (REACH). The main goal of REACH is to define different subtypes (phenotypes) of chronic low back pain as well as to identify underlying pain mechanisms that can lead to effective, personalized treatments for patients across all population subgroups. To achieve this goal, REACH is, or will be, participating in several clinical trials, and it is imperative that the patients participating in these trials reflect the diversity of the U.S. population. Therefore, this project seeks to adapt methods that have successfully improved minority participation in other settings as well as to develop and deploy digital strategies that can promote recruitment and engagement of patients from marginalized populations.
5R24DA051973-02
Studies to Advance Recovery Supports (STARS) in Central Appalachia Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA EAST TENNESSEE STATE UNIVERSITY PACK, ROBERT P Johnson City, Tennessee 2021
NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

Central Appalachia has been devastated by opioid use disorder and overdose deaths for decades. Treatment access is improving across that region, yet few individuals successfully remain on treatment with medications for opioid use disorder (MOUD). Peer recovery support services can be highly effective in improving treatment outcomes and recovery, but there is limited evidence of how they can be implemented and used most effectively, particularly for individuals receiving MOUD. This project will create the Studies To Advance Recovery Supports (STARS) Network that aims to expand the infrastructure necessary to implement and evaluate peer recovery support services for these individuals. It will build research capacities at universities and health partners, enroll MOUD clinics and peer recovery support professionals, and promote data harmonization across network partners.
1K24AT011995-01
Providing training in effective non-opioid options for the treatment of pain conditions Clinical Research in Pain Management NCCIH UNIVERSITY OF ILLINOIS AT CHICAGO Doorenbos, Ardith Z Chicago, IL 2021
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.
1UG3DA054799-01
Development of Lofexidine as a First-line Non-Opioid Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA USWM, LLC GULLO, KRISTEN LEANN Louisville, KY 2021
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
Summary:

The nation’s opioid epidemic remains a public health emergency, marked by high rates of opioid use and misuse among adults and a correlated rising incidence of neonatal opioid withdrawal syndrome (NOWS) in infants exposed to opioids before they are born. There are currently no pharmacotherapies approved by the Food and Drug Administration (FDA) for the treatment of NOWS. This research will complete manufacturing and clinical trial activities to evaluate and support FDA approval of a pediatric-appropriate formulation of lofexidine, a non-opioid medication approved for mitigation of opioid withdrawal symptoms in adults, as a first line-therapy in NOWS patients through two clinical trials to (1) identify an optimal dosing regimen of lofexidine for treatment of NOWS, and (2) evaluate the risks and benefits of its use in improving withdrawal symptoms, limiting infant exposure to other off-label narcotic medications and shortening the infant’s overall stay in the hospital.
1U01DA055349-01
10/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA OSU CENTER FOR HEALTH SCIENCES CROFF, JULIE MAY (contact); HAYS-GRUDO, JENNIFER ; MORRIS, AMANDA S Tulsa, OK 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will take place at Oklahoma State University Center for Health Sciences and recruit diverse people from an urban area, including American Indian populations.
3UH3AR076573-03S2
Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity: Understanding Patient Predictors of Response Clinical Research in Pain Management Back Pain Consortium Research Program NIAMS CEDARS-SINAI MEDICAL CENTER SPIEGEL, BRENNAN Los Angeles, LA 2021
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:

Although digital health technologies are now widely available for both therapeutic and monitoring applications, there are wide variations in patient knowledge, attitudes, beliefs, and preferences regarding their uptake and effectiveness. There are also sociodemographic variations in willingness to participate in digital health research studies, both for chronic pain and other common disorders. However, few efforts have systematically examined patient-level predictors of digital health uptake and benefit among diverse individuals who experience chronic pain. This research will employ mixed methods to examine variations in engagement and benefit among diverse participants in a large clinical trial examining the benefits of virtual reality for treatment of chronic lower back pain.
3U24NS113850-03S1
Clinical Coordinating Center for the Health Initiative in Early Phase Pain Investigation Clinical Network - Murray Supplement Clinical Research in Pain Management Early Phase Pain Investigation Clinical Network (EPPIC-Net) NINDS MASSACHUSETTS GENERAL HOSPITAL FAVA, MAURIZIO (contact); EDWARDS, ROBERT R; RATHMELL, JAMES P Boston, MA 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Key goals of the NIH HEAL Initiative are improving non-opioid pain management and expanding the workforce of clinical researchers working on individualized pain treatments know as pain precision medicine. This award enables an exceptional early career clinician with the opportunity to obtain expertise with high-quality pain-related biomarker assessment methods and biomarker-informed clinical trial design. This research centers on eating-related gastrointestinal functional/motility pain disorders – an understudied area of clinical pain science – and will prepare the clinician to be a future leader in the clinical pain research community.