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 | Research Focus Area | Research Program | Administering IC Sort descending | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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1U01DA058541-01
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PDE7 Inhibitor for the Treatment of Cocaine Use Disorder | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | OMEROS CORPORATION | GAITANARIS, GEORGE | Seattle, WA | 2023 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327 Summary: Currently there are no effective treatments approved by the U.S. Food and Drug Administration for cocaine use disorder. This project will explore the use of a novel class of small molecules that selectively block the molecule phosphodiesterase 7 (PDE7). Past research suggests that the PDE7 class of compounds helps restore normal functions of the dopamine reward system altered by chronic exposure to cocaine. This research will use both preclinical and clinical research studies to develop and test a PDE7 blocker, toward development of the first oral treatment for cocaine use disorder. |
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1R61DA057629-01A1
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Chicago Data-driven OUD Screening, Engagement, Treatment and Planning (C-DOSETaP) System | Cross-Cutting Research | Translating Data 2 Action to Prevent Overdose | NIDA | UNIVERSITY OF ILLINOIS AT CHICAGO | KARNIK, NIRANJAN | Chicago, 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: Health services for the treatment of opioid use disorder (OUD) are fragmented in west Chicago, an epicenter for overdose deaths. This project will develop a data-driven opioid response plan involving key partners. These include local health departments, community organizations, health care systems, and people with lived experience. The research will develop a digital screening tool for OUD that can be used in hospitals and their emergency departments. The tool will be built from machine learning of data from electronic health records, the prescription drug monitoring program, and patient-reported measures. The research will test the value of the screening tool for connecting people to treatment and preventing fatal overdoses mortality in local neighborhoods. |
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3UG1DA013714-18S3
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Rural Expansion of Medication Treatment for Opioid Use Disorder (CTN-0102) | 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 Washington | Donovan, Dennis | Seattle, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites. |
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1R43DA049617-01
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At-Home Virtual Reality Guided Imagery Intervention for Chronic Pain | Cross-Cutting Research | Small Business Programs | NIDA | LIMBIX HEALTH, INC. | LEWIS, BENJAMIN (contact); RICHEIMER, STEVEN H | Palo Alto, CA | 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: Chronic pain affects more than 100 million adults in the United States, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560–635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15% to 26% risk of misuse and abuse among pain patients. Guided imagery (GI) is an effective non-pharmacological intervention for reducing pain, but its effectiveness is limited by patients’ imaging abilities. This project will develop and assess the feasibility of an at-home virtual reality system, Limbix VR Kit, to reduce chronic pain and opioid reliance, as well as improve other functional outcomes, by delivering an immersive GI experience. |
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1UG1DA049468-01
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New Mexico Clinical Trials Node: Clinical research and practice to address substance use in diverse, rural and underserved populations | 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; KOMAROMY, MIRIAM | Albuquerque, NM | 2019 |
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008 Summary: New Mexico (NM) is an epicenter of the opioid crisis in the United States. Many challenging social determinants, including poverty and unemployment, contribute to high rates of opioid use disorder (OUD) in NM. The aims of the NM node are to (1) develop and maintain a highly efficient platform to conduct clinical trials that will inform evidence-based prevention and treatment of OUD; (2) collaborate on and lead research that addresses and improves outcomes across the OUD Cascade of Care (CoC); and (3) promote uptake of best practices in OUD prevention and care in NM and nationwide through effective dissemination of evidence-based innovations. NM node research will ensure the development of robust and generalizable methods for prevention, identification, and treatment of OUD, including evaluation and modification of the CoC to expand the local and national knowledge base. |
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1R34DA050266-01
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2/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | NORTHWESTERN UNIVERSITY AT CHICAGO | WAKSCHLAG, LAUREN S | Evanston, IL | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods. |
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1UG3DA048502-01A1
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Non-Invasive Vagal Nerve Stimulation in Patients with Opioid Use Disorders | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | EMORY UNIVERSITY | Bremner, James Douglas | Atlanta, Georgia | 2020 |
NOFO Title:
NOFO Number: PAR18-494 |
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1U2CDA057717-01
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HD2A Research Adoption Support Center (RASC) | Cross-Cutting Research | Translating Data 2 Action to Prevent Overdose | NIDA | STANFORD UNIVERSITY | MCGOVERN, MARK P (contact); BECKER, SARA J; BECKER, WILLIAM C; BROWN, C HENDRICKS | Redwood City, CA | 2022 |
NOFO Title: HEAL Initiative: HEAL Data2Action Research Adoption Support Center (U2C Clinical Trial Optional)
NOFO Number: RFA-DA-22-050 Summary: This project creates the HEAL Data2Action Research Adoption Support Center to support the HEAL Data2Action Innovation Projects. It will provide supportive evidence for prevention and treatment practices, form implementation strategies, assess outcomes, obtain feedback from the projects, and assess readiness for scalability. This center will offer on-demand technical assistance, host a learning collaborative, harmonize dissemination and implementation data, provide implementation support, and help with stakeholder engagement. The research will also catalogue evidence-based and emerging opioid use disorder and pain management practices as a resource to the field. The center will address timely, high-priority implementation challenges. |
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1R44DA058467-01
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Development of a Novel Calcium Channel Therapeutic for Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | VIVREON BIOSCIENCES, LLC | GREENBERG, MILTON L | San Diego, CA | 2023 |
NOFO Title: Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-021 Summary: Hospitalized patients often receive opioids for pain and sleep management, which can contribute to opioid dependence and continued use after leaving the hospital. Even when hospital stays are extended to wean people from opioids, these patients remain at increased risk for opioid use disorder and withdrawal. This project will develop a novel small molecule medication that blocks nerve inflammation to prevent opioid dependence in hospitalized patients receiving opioids. |
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3R01DA045872-01A1S1
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Examining the synergistic effects of cannabis and prescription opioid policies on chronic pain, opioid prescribing and opioid poisoning | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | New York University School of Medicine | Cerda, Magdalena; Martins, Silvia Saboia | New York, NY | 2019 |
NOFO Title: Public Policy Effects on Alcohol-, Marijuana-, and Other Substance-Related Behaviors and Outcomes (R01)
NOFO Number: PA-17-135 Summary: As states make unprecedented changes to prescription opioid (PO) policies and cannabis laws, the independent and synergistic contributions that both types of measures have on opioid-prescribing practices and opioid overdoses, with and without benzodiazepines (BZDs), are not known. This study will pursue this aim in the U.S. population and Medicaid patients with chronic pain, aiming to: (1) examine whether nonmedical use of POs, BZDs, and heroin and opioid- and BZD-use disorders decreased following enactment of more restrictive PO policies and less restrictive cannabis laws in 2004–2019; and (2) test whether Medicaid patients are less likely to have claims for opioid prescribing, clinic visits for chronic pain, and opioid overdoses following enactment of more restrictive PO policies and less restrictive cannabis laws in 2001–2019. This study will provide findings about the types of policies that are most likely to end the opioid epidemic. |
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1R43DA049623-01
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Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder | Cross-Cutting Research | Small Business Programs | NIDA | THERANOVA, LLC | JAASMA, MICHAEL | San Francisco, CA | 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: Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD. |
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1R21DA048074-01
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Prescription Opioid Formulation to Deter Extraction, Injection, Insufflation, and Smoking | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | PURDUE UNIVERSITY | Solorio, Luis | West Lafayette, IN | 2019 |
NOFO Title: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
NOFO Number: PA-18-489 Summary: This project aims to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The study will focus on the development of the ADF with design aspects specifically focused on abuse through insufflation, smoking, injection, and taking multiple pills. The study will also validate the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent-Opioids-Evaluation and Labeling guidelines. The study could result in the development of a novel ADF that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design. |
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3UG1DA015831-17S5
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Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy | New Strategies to Prevent and Treat Opioid Addiction | Optimizing the Duration, Retention, and Discontinuation of Medication Treatment for Opioid Use Disorder | NIDA | McLean Hospital | WEISS, ROGER D | Belmont, MA | 2019 |
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008 Summary: This study will (1) test pharmacologic and behavioral strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have been successfully stabilized on OUD medications and want to stop medication and (2) identify predictors of successful outcome and develop a stage model of relapse risk. |
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1U01DA055342-01
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4/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | CINCINNATI CHILDRENS HOSP MED CTR | MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J | Cincinnati, OH | 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 objective of the HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Cincinnati Children’s Hospital study site is in a region hit hard by the opioid crisis and has a large catchment area that includes many rural counties in Ohio, Kentucky, Indiana, and West Virginia. |
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1UG3DA054785-01A1
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Development of Specific Mu Opioid Receptor Antagonists to Reverse the Acute and Chronic Toxicity of Fentanyls | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Virginia Commonwealth University | ZHANG, YAN | Richmond, Virginia | 2022 |
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: Fentanyl and its analogs are synthetic opioids that are 100 to 10,000 times more potent than morphine. Overdose from these opioids is extremely dangerous due to their ultra-potency and longer half-life than naloxone, the front-line treatment for fentanyl overdose. This research study will develop novel mu opioid receptor antagonists that bind to the same receptor as the opioid drugs and specifically counteract fentanyl and its analogs, thereby reversing the drugs’ acute toxicity more effectively and with fewer side effects than current treatments. The researchers will characterize novel fentanyl derivatives, identify promising compounds, and pursue preclinical development of these compounds as novel reversal agents against the acute toxicity of fentanyl. The goal is to file an Investigational New Drug application with the U.S. Food and Drug Administration. |
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1R01DA057655-01
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Implementing and Evaluating the Impact of Novel Mobile Harm Reduction Services on Overdose Among Women who use Drugs: The SHOUT Study | Translation of Research to Practice for the Treatment of Opioid Addiction | Harm Reduction Approaches to Reduce Overdose Deaths | NIDA | JOHNS HOPKINS UNIVERSITY | SHERMAN, SUSAN G | Baltimore, MD | 2022 |
NOFO Title: HEAL Initiative: HEAL Data2Action Data Infrastructure Support Center
NOFO Number: RFA-DA-22-046 Summary: This project will evaluate a previously developed harm reduction intervention that addresses the needs of women who use drugs in an urban environment. The approach uses a mobile van to offer naloxone, fentanyl test strips, and other harm reduction supplies – along with necessities such as food and clothing, brief trauma-informed counseling, and referrals to drug treatment, medical care, and social services. This research aims to test the impact of an intervention that may increase access to harm reduction services for women, as well as assess how to put it into place. |
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5U54DA049110-04
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Data Center for Acute to Chronic Pain Biosignatures | Clinical Research in Pain Management | Acute to Chronic Pain Signatures Program | NIDA | JOHNS HOPKINS UNIVERSITY | LINDQUIST, MARTIN (contact); WAGER, TOR D | Baltimore, MD | 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: Understanding the mechanisms underlying the transition to chronic pain is key to mitigating the dual epidemics of chronic pain and opioid use in the United States. As part of the National Institutes of Health-funded Acute to Chronic Pain Signatures Program, the Data Integration and Resource Center aims to This project will support a post-doctoral trainee to develop the skills and knowledge needed to pursue a successful career in clinical pain research. The research will involve integrating imaging, physiology, -omics, behavioral, and clinical data to develop biosignatures for the transition from acute to chronic pain, toward understanding how the nervous and immune systems affect post-surgical pain and opioid use. |
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1RM1DA059365-01
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Improving Quality and Equity of Opioid Use Disorder Treatment Using a Multi-State Medicaid Research Network | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | DONOHUE, JULIE MARIE (contact); BARNES, ANDREW JAMES | Pittsburgh, PA | 2023 |
NOFO Title: HEAL Initiative: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (RM1 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-046 Summary: Medicaid covers the cost of treatment for opioid use disorder (OUD) for most individuals who need it, including minoritized populations and those with risk factors related to low income, education, and employment. The Medicaid Outcomes Distributed Research Network has supported efforts to improve OUD treatment by developing novel measures of treatment quality and examining effects of treatment quality on overdoses. Using this network, this project will leverage university-state partnerships in 12 states to inform quality improvement initiatives and Medicaid policy. The research will develop provider-level quality measures for OUD using Medicaid administrative data and measure patient-reported outcomes. The research will also look for approaches to use claims-based quality measures and practice-level quality improvement strategies to improve treatment outcomes for people with OUD. |
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3UG1DA040316-04S3
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A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | HENNEPIN HEALTHCARE RESEARCH INSTITUTE | BART, GAVIN; JOSEPH, ANNE | Minneapolis, MN | 2018 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: This health care data mining study analyzes existing Veterans Health Administration data sets to examine patient and organizational characteristics associated with buprenorphine termination during outpatient OUD treatment. This project will generate data useful for predictive modeling on how to implement targeted approaches to improve retention in OUD treatment. An objective is to identify patient, provider and system targets to reduce unnecessary or inappropriate discontinuation of buprenorphine care. These analyses are critical for establishing initial constructs to evaluate reasons for treatment discontinuation based upon patient, provider and system factors in different health care settings. |
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3UG3DA047711-02S1
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PHASE 1A/1B CLINICAL TRIALS OF MULTIVALENT OPIOID VACCINE COMPONENTS | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | NEW YORK STATE PSYCHIATRIC INSTITUTE | COMER, SANDRA D; PRAVETONI, MARCO | New York, NY | 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: Opioid use disorder (OUD) is a serious public health problem that is associated with high rates of morbidity and mortality. The proposed Phase 1a/1b studies are designed to evaluate a novel treatment strategy for OUD. Specifically, the safety, immunogenicity and preliminary efficacy of a vaccine (OXY-KLH) targeted against oxycodone (Study 1) and a vaccine (M-KLH) targeted against heroin/morphine (Study 2) will be evaluated in participants diagnosed with OUD. |
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1UG3DA050174-01
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Prevention of OUD: The HOME (Housing, Opportunities, Motivation and Engagement) Randomized Trial | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | Ohio State University | SLESNICK, NATASHA (contact); KELLEHER, KELLY J | Columbus, OH | 2019 |
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035 Summary: Evidence suggests that homeless youth have the highest rates of opioid use among youth subgroups in the country (Brands et al., 2005). Resolution of youth homelessness through housing and prevention services, often referred to as “Housing First”, has great potential to reduce the likelihood for the development of an opioid use disorder as well as other problem behaviors associated with living on the streets. However, only 20 percent to 30 percent of homeless youth samples report ever having stayed at a crisis shelter, 9 percent report having ever accessed mental health services, and 15 percent report ever having received treatment for substance use disorder (Ray, 2006), indicating a need to reach and engage youth in services that are feasible and acceptable. The results of this study will provide essential information for researchers and providers on the efficacy of housing plus opioid and related risk prevention services in a randomized controlled trial on opioid use, how moderators affect the response, and mechanisms underlying change. |
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1R34DA050272-01
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1/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | WASHINGTON UNIVERSITY | ROGERS, CYNTHIA ELISE (contact); SMYSER, CHRISTOPHER DANIEL | St. Louis, MO | 2019 |
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029 Summary: Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods. |
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1UG3DA047680-01
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A novel therapeutic to ameliorate chronic pain and reduce opiate use | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | LOHOCLA RESEARCH CORPORATION | TABAKOFF, BORIS | Aurora, CO | 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: More than 100 million adults in the U.S. suffer from intermittent or constant chronic pain, and chronic pain affects at least 10 percent of the world’s population. The primary pharmaceuticals for treatment of chronic pain have been natural or synthetic opioids, and the use of opioids for pain treatment has resulted in what has been called an “epidemic” of opioid abuse, addiction, and lethal overdoses. Through a process of rational drug design, the research team has generated a new chemical entity (NCE) and have given it the name Kindolor, a non-opiate, non-addicting molecule that was shown to reduce or eliminate chronic pain in five animal models at doses compatible with use of Kindolor in humans. This project intends to complete the pre-clinical studies required for an IND application, which, if approved, would allow for proceeding onto the Phase 1 and 2 studies to assess safety and efficacy of the compound against osteoarthritic pain. |
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1UG3DA048768-01A1
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Novel LAAM formulations to treat 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 | Virginia Commonwealth University | Xu, Qingguo | Richmond, VA | 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: Levo-alpha-acetylmethadol (LAAM) offers numerous behavioral and clinical advantages for select opioid use disorder (OUD) patients who do not respond to standard treatment. While LAAM was withdrawn from the market despite being approved for OUD treatment, this project seeks to develop novel, patentable, convenient dosage forms of LAAM, including novel LAAM oral dosage formulations and novel buccal film formulations of LAAM. Morphology, mechanical property, drug release kinetics, and stability of the oral dosage and buccal film formulations will be characterized to determine the instant release or steady release of LAAM, respectively. The two lead LAAM formulations with adequate release and stability profiles will be chosen through optimization studies both in vitro and in vivo. A human pharmacokinetic/pharmacodynamic study will then be carried out on the two selected formulations. |
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1UF1DA053806-01A1
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Development of a novel OTC naloxone product to be affordably priced and widely accessible | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | POCKET NALOXONE CORP. | KIM, SONNIE | Bethesda, MD | 2021 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327 Summary: Naloxone is a safe and effective opioid antagonist, but currently available products are burdened with high cost and limited accessibility due to a need for a prescription or being kept behind-the-counter. In response to the FDA putting out an unprecedented call for an over the counter naloxone product, Pocket Naloxone Corp. is developing a novel intranasal delivery method for naloxone intended to be low-priced and widely accessible. This project will culminate in a New Drug Application to the FDA for over-the-counter approval to meet the urgent need for widespread access to a reliable, easy-to-use naloxone product for use in an emergency by non-medical individuals. |