Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title Sort descending | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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1R33DA059884-01
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ADAPT: Adaptive Decision Support for Addiction Treatment | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | YALE UNIVERSITY | MELNICK, EDWARD ROBERT | New Haven, CT | 2023 |
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-054 Summary: Computerized clinical decision support tools offer a promising strategy to standardize and scale evidence-based practices to keep pace with the dynamic nature of the opioid crisis and overcome barriers to substance use disorder treatment. To change practice, such tools must be useful, usable, able to be integrated into routine care delivery, and supported by a multicomponent implementation strategy. This project will refine and evaluate the uptake, usability, and equity of a nationally disseminated multicomponent clinical decision support intervention to increase initiation of medication treatment for opioid use disorder in the emergency department. |
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1UG3NR020930-01
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Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients with Chronic Pain | Clinical Research in Pain Management | Prevention and Management of Chronic Pain in Rural Populations | NINR | UNIVERSITY OF WASHINGTON | TONG, SEBASTIAN (contact); PATEL, KUSHANG | Seattle, WA | 2023 |
NOFO Title: HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3, Clinical Trials Required)
NOFO Number: RFA-NR-23-001 Summary: People who live in rural areas have high rates of chronic pain and poor health outcomes and are less likely to receive evidence-based complementary and integrative treatments for chronic pain. This project will adapt a nurse care management model for use in health systems serving rural patients with chronic pain. The research aims to coordinate care, provide cognitive behavioral therapy, and refer patients to a remotely delivered exercise program. |
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1K01DA059641-01
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Adapting and Implementing a Chronic Disease Self-Management Program for Primary Care Patients with Opioid Use Disorder and Serious Mental Illness | Cross-Cutting Research | Training the Next Generation of Researchers in HEAL | NIDA | UNIVERSITY OF UTAH | SIANTZ, ELIZABETH | Salt Lake City, UT | 2023 |
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required)
NOFO Number: PAS-22-206 Summary: Many people with opioid use disorder (OUD) also have a serious mental illness and other chronic conditions, which can be difficult for individuals and primary care providers to manage. A chronic disease self-management program is an established health care model in which peers help to educate patients about their condition(s) and build problem-solving skills to manage their health. Such programs have been effective in other populations and settings, but they have not been adapted for primary care patients who have OUD and SMI. This project will adapt and test a chronic disease self-management program for this population to understand its feasibility, acceptability, impact, and how best to put such programs into place widely in primary care settings. |
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3R33AT010606-03S1
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Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | UNIVERSITY OF CALIFORNIA-IRVINE | YOUNG, SEAN | Irvine, 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: Effective medications for opioid use disorder (MOUD) are approved by the Food and Drug Administration for the treatment of people with opioid use disorder; however, only a small fraction of patients who would benefit from these medications actually use them. Several reasons contribute to low MOUD use, including lack of insurance; lack of knowledge about the medications, both among patients and providers; stigma associated with MOUD; and social norms. Innovative methods are needed to help increase MOUD use. One such option is peer-led interventions that might increase patients’ interest in MOUD. One existing peer-led intervention is the Harnessing Online Peer Education (HOPE) online community intervention that has been designed to reduce stigma and increase health behavior change among stigmatized populations, such as people living with HIV. This project will investigate whether and how HOPE can be adapted for people with opioid use disorder. It will assess whether HOPE can effectively increase MOUD requests, MOUD uptake, and sustained adherence to MOUD as well as reduce overdose rates. |
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1R61AT010606-01
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Adapting the HOPE Online Support Intervention to Increase MAT Uptake Among OUD Patients | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | UCLA | YOUNG, SEAN | Los Angeles, CA | 2019 |
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006 Summary: Online peer-led support interventions may increase medication-assisted therapy (MAT) initiation and sustainment among participants with opioid use disorder (OUD) because they can leverage peers to widely and rapidly scale changes in social norms (e.g., interest in using MAT) throughout people’s natural, real-world, virtual environments. Harnessing Online Peer Education (HOPE), an online peer support community intervention designed to reduce stigma and increase health behavior change, has effectively changed health behaviors among stigmatized populations, such as for HIV. This study will determine how to adapt the HOPE online support intervention to increase MAT initiation and sustainment among participants with OUD, assess the intervention’s effectiveness at increasing MAT use among OUD participants recruited online who are not using MAT, and use an implementation science approach to determine the relationship between social network dynamics (e.g., network size), topics discussed on the online community, and behavior change. |
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1R34DA057678-01
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Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations | Translation of Research to Practice for the Treatment of Opioid Addiction | Improving Delivery of Healthcare Services for Polysubstance Use | NIDA | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | BUNTING, AMANDA M (contact); RENN, TANYA RAE | New York, NY | 2022 |
NOFO Title: HEAL Initiative: Pilot & Feasibility Trials to Improve Prevention and Treatment Service Delivery for Polysubstance Use (R34 Clinical Trial Optional)
NOFO Number: DA22-048 Summary: Compared to people who use only one type of drug, people who use combinations of drugs, such as opioids and stimulants, are more likely to have histories of childhood trauma, including post-traumatic stress disorder (PTSD). This project will adapt an existing PTSD intervention, Skills Training in Affective and Interpersonal Regulation with Narrative Therapy, to treat individuals with polysubstance use. This research will be piloted in a methadone maintenance treatment program to assess feasibility and acceptability. If successful, the findings will lay the groundwork for a large-scale clinical trial. |
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1R44DA049631-01
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Addressing Opioid Use Disorder with an External Multimodal Neuromodulation Device: Development and Clinical Evaluation of DuoTherm for Opioid-Sparing in Acute and Chronic Low Back Pain. | Cross-Cutting Research | Small Business Programs | NIDA | MMJ LABS, LLC | BAXTER, AMY LYNN | Atlanta, GA | 2019 |
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: Acute and chronic low back pain are among the most common sources of short- and long-term disability. Fear of pain and disability, or “catastrophizing,” increases opioid use, but is reduced when patients have effective options and feel control over pain. The goal of this project is to develop an opioid-sparing therapeutic consumer device for low back pain, with multiple patient-controlled effective neuromodulatory pain relief options, including vibration, pressure, cold, and heat. After proving that providing a multimodal device is effective for pain, the project will determine whether the availability of an effective home therapy device reduces opioid use for patients with acute and chronic low back pain. |
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3R61AG081034-01S1
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Addressing the Chronic Pain Epidemic Among Older Adults in Underserved Community Center: The GetActive+ Study (McDermott-Career Enhancement Supplement) | Clinical Research in Pain Management | Advancing Health Equity in Pain Management | NIA | MASSACHUSETTS GENERAL HOSPITAL | VRANCEANU, ANA-MARIA (contact); RITCHIE, CHRISTINE S | Boston, MA | 2023 |
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: This project supports a post-doctoral trainee to develop the skills and knowledge needed to pursue a career in clinical pain research. The research will involve optimizing a GetActive mind-body activity program to overcome barriers that prevent disadvantaged older adult populations in community health clinics from access to non-pharmacological pain management strategies. The research will include qualitative analysis of secondary data, a literature review to evaluate methods, and feasibility for establishing a community advisory board for the GetActive project. |
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1R61AG081034-01
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Addressing the Chronic Pain Epidemic among Older Adults in Underserved Community Center; The GetActive+ Study | Clinical Research in Pain Management | Advancing Health Equity in Pain Management | NIA | Massachusetts General Hospital | VRANCEANU, ANA-MARIA (contact); RITCHIE, CHRISTINE S | Boston, MA | 2022 |
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002 Summary: This research project will include focus group interviews with clinicians, patients, medical interpreters, and healthcare administrators to identify barriers and facilitators to administering the GetActive+ intervention in a group visit at a clinic for older adults with chronic pain, to inform development of a therapy manual. The project will then test the GetActive+ intervention for changes in physical function immediately post-intervention and after 6 months, as well as for changes in pain, sleep, depression, and anxiety at both time points. This research will also assess feasibility, acceptability, fidelity, and adoption of the intervention with patients, providers, and healthcare staff. |
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1K23DA058785-01
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Addressing the Readiness Gap: An eHealth Intervention to Increase Patient Motivation for Evidence-Based Chronic Pain Interventions and Reduced Opioid Reliance | Cross-Cutting Research | Training the Next Generation of Researchers in HEAL | NIDA | VIRGINIA COMMONWEALTH UNIVERSITY | CROUCH, TAYLOR BERENS | Richmond, VA | 2023 |
NOFO Title: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOFO Number: PAS-22-207 Summary: Evidence-based behavioral treatments for pain are among the most effective and safe approaches, but they are underused, especially among patients taking opioids long-term. Despite known risks to long-term opioid therapy (including opioid use disorder and overdoses), patients may be reluctant to try something different to manage their pain. This project brings together two evidence-based behavior change interventions—motivational interviewing and contingency management—into an online format. The research will test whether web-based tools or mobile apps influence a patient’s willingness to consider using non-medication treatments for pain. The research will assess feasibility, acceptability to patients and providers, and broad-scale implementation. |
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Adjuvanted Opioid Vaccine for Treating Fentanyl Use Disorder to Reduce Poisoning and Fatal Overdose | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Development of Novel Immunotherapeutics for Opioid Addiction | NIAID | University of Montana | Jay Evans | Missoula, Montana | 2020 |
NOFO Title: Development of Vaccines for the Treatment of Opioid Use Disorder
NOFO Number: BAA-DAIT-75N93019R00009 Summary: High rates of relapse and overdose deaths pose significant challenges to the treatment of Opioid Use Disorder (OUD). Anti-opioid immunotherapies (i.e., vaccines and monoclonal antibodies) have great potential to reduce long-term opioid use and overdose, with minimal risk of side effects, when used in conjunction with pharmacological treatments and/or behavioral therapies. The ability of an anti-opioid vaccine to induce antibodies that render an opioid less effective, or less rewarding, and protect from accidental overdose could provide an important therapeutic option for patients undergoing treatment for OUD. The goal of this collaborative study is to design, develop, and evaluate vaccines for use in the treatment of opioid use disorder |
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3PL1HD101059-01S3
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Administrative Supplement for ACT NOW OBOE Longitudinal Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | RESEARCH TRIANGLE INSTITUTE (NC) | BANN, CARLA M | Research Triangle Park, NC | 2021 |
NOFO Title:
NOFO Number: PA-20-272 |
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3PL1HD101059-01S2
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Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study | Enhanced Outcomes for Infants and Children Exposed to Opioids | Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) | NICHD | RESEARCH TRIANGLE INSTITUTE | BANN, CARLA M | Research Triangle Park, 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: The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study – also called the ACT NOW Longitudinal Study – is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of this study are to i) determine the impact of pre-birth opioid exposure on brain structure and connectivity over the first 2 years of life, ii) define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids, and iii) Explore whether and how the home environment, maternal mental health, and parenting affect brain connectivity and neurodevelopment trajectories over the first 2 years of life. This research will use an innovative approach to engage a more diverse study population and thereby improve the generalizability of the research findings. |
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3U24NS114416-01S1
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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. |
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1UG3DA048743-01
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Advancing KNX100 for the treatment of opioid withdrawal: preclinical efficacy and toxicology, and a phase 1 clinical program. | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Kinoxis Therapeutics, PTY LTD | MacGregor, Iain | Camberwell, Vic, Australia | 2019 |
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: Kinoxis has developed a novel small-molecule lead, KNX100, that reduces the severity of opioid withdrawal symptoms in preclinical animal models of opioid use disorder (OUD). KNX100 was discovered from a phenotypic screen of compounds derived from a fragment-based drug discovery program targeting the brain oxytocin system. KNX100 has a favorable pharmacokinetic and safety profile and has undergone testing for efficacy signals in two rodents and two non-human primate species. The proposed activity is to progress the development of KNX100 to treat opioid withdrawal in OUD. The overall objective of the project is to establish the safety and tolerability of KNX100 to enable human efficacy testing to commence in patients requiring treatment for opioid withdrawal. The long-term objective for this development program is to generate human efficacy data to support KNX100 as a potential treatment for opioid withdrawal symptoms and ultimately enable a New Drug Application to the FDA. |
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9SB1NS137964-04
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Advancing precision pain medicines to the clinic | Cross-Cutting Research | Small Business Programs | NINDS | NAVEGA THERAPEUTICS, INC. | MORENO, ANA MARIA (contact); ALEMAN GUILLEN, FERNANDO | San Diego, CA | 2023 |
NOFO Title: HEAL Commercialization Readiness Pilot (CRP) Program: Embedded Entrepreneurs for Small Businesses in Pain Management (SB1 Clinical Trial Not Allowed)
NOFO Number: PAR-23-069 |
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5R24DA051988-02
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Advancing the science on recovery community centers to support persons treated with medications for opioid use disorder | Translation of Research to Practice for the Treatment of Opioid Addiction | Recovery Research Networks | NIDA | MASSACHUSETTS GENERAL HOSPITAL | KELLY, JOHN F. | Boston, MA | 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: Individuals with opioid use disorder tend to be more in need of additional services; feel more isolated and marginalized; have less available resources such as education, training, employment, and housing opportunities (collectively known as “recovery capital”); and report lower quality of life than those with other substance use disorders. Recovery Community Centers (RCCs) are designed specifically to help grow recovery capital and enhance remission and quality of life. Preliminary evidence suggests RCCs are particularly valuable for people with opioid use disorder, but little is known about their clinical and public health benefits and cost-effectiveness. This project will organize activities on a national level to enhance research on RCCs. It builds on existing professional and academic resources, including an established recovery dissemination platform (i.e., the Recovery Research Institute). |
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5R01NS102432-02
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AIBP and regulation of neuropathic pain | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | Univ. of Calif., U.C. San Diego | Miller, Yury | La Jolla, CA | 2018 |
NOFO Title: Administrative Supplements for Validation of Novel Non-Addictive Pain Targets (Clinical Trials Not Allowed)
NOFO Number: NOT-NS-18-073 Summary: Persistent pain states arising from inflammatory conditions, such as in arthritis, diabetes, HIV, and chemotherapy, exhibit a common feature in the release of damage-associated molecular pattern molecules, which can activate toll-like receptor-4 (TLR4). Previous studies suggest that TLR4 is critical in mediating the transition from acute to persistent pain. TLR4 as well as other inflammatory receptors localize to lipid raft microdomains on the plasma membrane. We have found that the secreted apoA-I binding protein (AIBP) accelerates cholesterol removal, disrupts lipid rafts, prevents TLR4 dimerization, and inhibits microglia inflammatory responses. We propose that AIBP targets cholesterol removal to lipid rafts harboring activated TLR4. The aims of this proposal are to: 1) determine whether AIBP targets lipid rafts harboring activated TLR4; 2) test whether AIBP reduces glial activation and neuroinflammation in mouse models of neuropathic pain; and 3) identify the origin and function of endogenous AIBP in the spinal cord. |
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3R01NS102432-02S1
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AIBP AND REGULATION OF NEUROPATHIC PAIN | Preclinical and Translational Research in Pain Management | Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain | NINDS | UNIVERSITY OF CALIFORNIA, SAN DIEGO | MILLER, YURY; YAKSH, TONY L. | LA JOLLA, CA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Persistent pain states arising from inflammatory conditions, such as in arthritis, diabetes, HIV, and chemotherapy, exhibit a common feature in the release of damage-associated molecular pattern molecules, which can activate toll-like receptor-4 (TLR4). Previous studies suggest that TLR4 is critical in mediating the transition from acute to persistent pain. TLR4 as well as other inflammatory receptors localize to lipid raft microdomains on the plasma membrane. We have found that the secreted apoA-I binding protein (AIBP) accelerates cholesterol removal, disrupts lipid rafts, prevents TLR4 dimerization, and inhibits microglia inflammatory responses. We propose that AIBP targets cholesterol removal to lipid rafts harboring activated TLR4. The aims of this proposal are to: 1) determine whether AIBP targets lipid rafts harboring activated TLR4; 2) test whether AIBP reduces glial activation and neuroinflammation in mouse models of neuropathic pain; and 3) identify the origin and function of endogenous AIBP in the spinal cord. |
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1UG3NS128439-01
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Allosteric Targeting of Cannabinoid CB1 Receptor to Develop Non-Addictive Small Molecule Analgesics | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | Texas A&M Health Science Center | LU, DAI (contact); SELLEY, DANA E; TAO, FENG | College Station, TX | 2022 |
NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-21-010 Summary: Overreliance on opioids to treat chronic pain has been a contributor to the increase in individuals experiencing opioid addiction. This project aims to develop an innovative treatment approach for chronic pain that targets the cannabinoid receptor 1 (CB1R) to block the sensation of pain. The approach seeks to identify molecules that interact with a different part of the CBR1 receptor than do endocannabinoids and the primary active component of cannabis, tetrahydrocannabinol. Molecules that bind to and activate CBR1 in this different way (at an “allosteric” site) may produce nerve signaling that might differ from the effects of cannabis and endocannabinoids. This redirection of signaling pathways could help eliminate the risk of adverse effects observed with natural cannabinoids and other CBR1-binding molecules. The goal of this project is to identify a CB1R allosteric molecule, conduct studies toward obtaining federal permission to develop it as a medication, and to test it in a Phase I clinical study. |
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1UG3DA050923-01
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AMPA Antagonism: A Novel Pharmacology for Launching Recovery from Opioid Addiction | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS | Chambers, Robert | Indianapolis, IN | 2020 |
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: The excruciating multiday experience of opioid withdrawal syndrome (OWS), is exacerbated by the opioid antagonist drugs naloxone and naltrexone. This industry-academia collaboration will explore the potential of the glutamate AMPA receptor antagonist Tezampanel (TZP). Animal studies have shown reduced hyperactivity in brain circuits involved in OWS, without relying on direct stimulation or antagonism of the opioid system ,and has already been delivered to over 500 human subjects and found to be safe for a potential migraine indication. This proposal will build up the evidence needed to apply for and conduct open label and blinded placebo-controlled human trials of TZP safety and efficacy for OWS. If successful, this project will allow planning for a pivotal registration trial for TZP for OWS, and as a transitional treatment to long-term recovery on naltrexone and help us stem the tide of the opioid crisis. |
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1R44NS113740-01
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An Instrument to Assess the Functional Impact of Chronic Pain | Cross-Cutting Research | Small Business Programs | NINDS | BARRON ASSOCIATES, INC. | CLARK, BRIAN R | Charlottesville, VA | 2019 |
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: The proposed Fast Track SBIR effort will develop and validate the reliable, low-cost KnowPain instrument. KnowPain will objectively and quantitatively assess the functional impact of chronic pain using measures derived from six degrees-of-freedom motion, heart rate, skin surface temperature, and skin conductivity collected via a specially designed, ergonomic wrist-worn biometric sensing instrument. The new assessment instrument will apply advanced psychometric methods to both physiologic and kinematic data to provide precise scores for functional impairment due to chronic pain. The assessment results will be presented to the clinician in an easy-to-understand report and will include longitudinal results, confidence estimates, and normative data to enable comparisons both within and between patients. The system will include provision to interface with electronic medical records. Accurate functional assessment is a crucial component in the effective treatment of chronic pain. The proposed approach will supplement existing methods for assessing patient function by providing novel and highly complementary information for a more complete (and often unobserved) picture of the impact of chronic pain on patient function. KnowPain measures will provide important data on the practical consequences of pain and on treatment efficacy. |
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1UG3DA050942-01A1
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An Intranasal GDNF Gene Therapy for Opioid Relapse Reduction | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | NORTHEASTERN UNIVERSITY | WASZCZAK, BARBARA LEE | Boston, MA | 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: There are currently no effective non-opioid-based pharmacotherapies for treatment of opioid use disorder (OUD). Glial cell line-derived neurotrophic factor (GDNF) is a beneficial protein normally present in low levels in the adult brain, and there is strong evidence that it has clinical potential as a therapy for OUD and relapse reduction. Researchers have developed a non-invasive approach that bypasses the blood-brain barrier to increase levels of GDNF using intranasal administration of gene nanoparticles that make GDNF protein within the brain. This project will test whether this intranasal GDNF gene therapy can suppress drug craving and reduce the tendency to start using a drug again after a period of abstinence in experimental models, thus providing a long-term therapeutic strategy for reducing opioid craving and preventing relapse. |
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1R44DA050357-01
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An optimized screening platform for identifying and quantifying biased agonists as drugs for the treatment of Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | MONTANA MOLECULAR, LLC | QUINN, ANNE MARIE (contact); HUGHES, THOMAS E | Bozeman, MT | 2019 |
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: As the opioid crisis claims more and more lives, there is a need to develop new, safer analgesics. Biased agonists could activate beneficial signaling pathways while avoiding those that cause adverse effects. This project aims to speed the discovery of non-addictive analgesics by providing drug discovery teams with simpler, more robust, more quantitative assays for agonist bias. The goal is to optimize and test new assays for agonist bias at NOP, D3 dopamine, CB1 cannabinoid, and OPRM1 opioid receptors, which couple to both the Gi and ?-arrestin signaling pathway, and create new tools to improve the analysis of structure/activity relationships that can be used in drug discovery and distribute to researchers who are developing new drugs for OUD. |
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1UG3DA047709-01
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An ultra-long-acting oral treatment for opioid use disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | LYNDRA THERAPEUTICS, INC. | BELLINGER, ANDREW MARTIN | Boston, MA | 2019 |
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: Buprenorphine (BUP) is an FDA-approved medication-assisted therapy (MAT) that improves outcomes and saves lives in patients with opioid use disorder (OUD). It is available in multiple dosage forms and routes of administration, including daily sublingual (SL) and buccal tablets and films, a monthly subcutaneous (SC) injectable, and a 6-month SC implant; however, these forms leave many patients untreated or undertreated. This product, in a partnership with Lyndra Therapeutics, aims to develop a once-weekly oral BUP dosage form for maintenance therapy for OUD, using a new oral dosage formulation developed by Lyndra. A long-acting oral BUP may address important limitations of current MATs by providing improved PK with less euphoria than SL, a patient- and provider-preferred route of administration, and an optimal dosing interval for improved patient adherence with the potential for cost-effective direct observed therapy. |