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 | Institution(s) Sort ascending | Investigator(s) | Location(s) | Year Awarded |
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1R61NS126029-01A1
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Inhibiting RIPK1 with Necrostatin-1 for Safe and Effective Pain Treatment | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | Massachusetts General Hospital | SHEN, SHIQIAN (contact); HOULE, TIMOTHY T; WANG, CHANGNING ; ZHANG, CAN MARTIN | Boston, MA | 2022 |
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: NS21-029 Summary: Recent studies have reported that neuropathic pain involves changes in the central nervous system that are linked to necroptosis (programmed necrotic cell death) and release of cellular components that create neuroinflammation. Necroptosis is a type of necrotic cell death affected by the protein receptor-interacting serine/threonine-protein kinase 1 (RIPK1 or RIP1). Preliminary studies also indicate that pain increases levels of RIPK1 in key brain regions implicated in pain processing. This project aims to further validate RIPK1 as a target for neuropathic pain using a newly developed positron emission tomography imaging approach. The work will pave the way for new brain-penetrant RIPK1 inhibitors as a safe, effective, and nonaddictive treatment approach for neuropathic pain. |
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1R34DA057627-01
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Peer Recovery Support Services for Individuals in Recovery Residences on MOUD | Translation of Research to Practice for the Treatment of Opioid Addiction | Recovery Research Networks | NIDA | MARYLAND TREATMENT CENTERS, INC. | FISHMAN, MARC (contact); WENZEL, KEVIN R | Baltimore, MD | 2022 |
NOFO Title: HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional)
NOFO Number: RFA-DA-22-034 Summary: Patients choosing treatment with medications for opioid use disorder as part of their recovery pathway often have difficulties staying on these medications for extended periods of time. Currently, no established evidence-based interventions are available to help. This project will leverage the impact of two widely used recovery support services: peer recovery support services and recovery housing. Delivered by community-based peers with lived recovery experience, the intervention will include assertive outreach, which encourages people in recovery between episodes of care to continue treatment and return to care after treatment dropout and/or resumed opioid use. This research will also examine whether these services can enhance benefits offered by the supportive recovery housing living environment. |
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1R61AT010614-01
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The Youth Opioid Recovery Support (YORS) Intervention: An assertive community treatment model for improving medication adherence in young adults with opioid use disorder | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | Maryland Treatment Centers | FISHMAN, MARC | Baltimore, MD | 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: Young people are disproportionately affected by the opioid crisis due to lack of access to medications for opioid use disorder (OUD) and poor adherence to these treatments. The Youth Opioid Recovery Support (YORS) model is an innovative wraparound approach that attempts to address barriers to treatment engagement in the young adult population, especially difficulties with medication adherence. The YORS model components include home delivery of extended-release naltrexone for OUD, engagement of families in collaborative treatment planning and monitoring focusing on medication adherence, assertive outreach from the treatment team by text messaging and social media to promote engagement and adherence, and contingency management to provide incentives for medication adherence. If the refining and testing demonstrates the efficacy of the YORS intervention, future work could include an economic analysis, a larger multisite study, longer intervention duration, study of extended-release buprenorphine, and study of step-down to less intensive interventions. |
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1U19NS126038-01
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Site-directed RNA editing of Nav1.7 as a novel analgesic | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | MARINE BIOLOGICAL LABORATORY, WOODS HOLE | ROSENTHAL, JOSHUA J C (contact); DIB-HAJJ, SULAYMAN D; DUSSOR, GREGORY O; EISENBERG, ELI | New Haven, CT | 2021 |
NOFO Title: HEAL Initiative: Team Research for Initial Translational Efforts in Non-addictive Analgesic Therapeutics Development (U19 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-015 Summary: Opioids are widely used pain treatments, despite their relative ineffectiveness for chronic pain and their high potential for misuse and addiction. There is thus an urgent need for alternative, non-addictive pain treatments. Genetic and functional studies of human pain disorders and animal models of pain have validated Nav1.7, a voltage-gated sodium channel as an attractive target for new pain treatments. Currently available blockers of these channels can sometimes provide symptomatic relief for patients but have worrisome side effects affecting the brain and heart. This study aims to develop and validate an innovative site-directed RNA editing strategy that will offer the ability to create new versions of molecules to block Nav1.7, toward establishing a novel, non-addictive approach to treat chronic pain. |
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1R01HD096796-01
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PHARMACOLOGICALLY-BASED STRATEGIES FOR BUPRENORPHINE TREATMENT DURING PREGNANCY | Enhanced Outcomes for Infants and Children Exposed to Opioids | NICHD | Magee-Women's Research Institute and Foundation | CARITIS, STEVE N | Pittsburgh, PA | 2018 | |
NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036 Summary: This study will challenge current clinical approaches to managing the pregnant woman with opioid use disorder. Dosing of buprenorphine (BUP) in pregnant women is based on studies in non-pregnant subjects, which suggests that symptoms of withdrawal occur when plasma BUP concentrations are < 1ng/ml. No such data exist for pregnant women, but this is a prerequisite for defining an appropriate dosing regimen of BUP in pregnant women. We will define this threshold by monitoring women undergoing mild, medically directed withdrawal. The Clinical Opioid Withdrawal Scale score and the Finnegan score for NAS are key to defining when withdrawal occurs and thus dictate treatment in mother and baby. Neither scoring system is based on plasma BUP concentrations and thus, may not reflect true opioid withdrawal. This proposal aims to develop physiologic-based scoring systems that refine the accuracy of diagnosis and optimize treatment. |
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1R01DA059176-01
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Multimodal Analysis of Gestational Health and Placental Injury in Opioid-Affected Pregnancies | Enhanced Outcomes for Infants and Children Exposed to Opioids | The Biology of Opioid Exposure During Pregnancy and Effects on Early Neuro-Behavioral Development | NIDA | MAGEE-WOMEN'S RES INST AND FOUNDATION | OUYANG, YINGSHI (contact); KRANS, ELIZABETH E; SADOVSKY, YOEL | Pittsburgh, PA | 2023 |
NOFO Title: HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-HD-23-038 Summary: This project will study the harmful effects of illicit and prescription opioid use during pregnancy and its consequences on the mother, fetus, and placenta. The research will integrate multiple different technologies to study molecular changes in biospecimens taken from research participants. Samples to be collected at birth and characterized include plasma and urine from the mother across the three trimesters of pregnancy, tissue samples of the placenta, and fetal cord blood. This research aims to shed new light on the underlying biology of opioid exposure on the placenta during pregnancy toward development of early interventions during opioid-exposed pregnancies. |
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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. |
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1UG3DA050310-01
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A once-weekly oral methadone for maintenance therapy 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; Zale, Steve | 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: Methadone maintenance therapy has been shown to facilitate recovery and prevent deaths from opioid use disorder (OUD). This proposal is for development of a once-weekly oral methadone for maintenance therapy for OUD. Lyndra has developed an oral gastric residence dosage form that has been demonstrated to provide at least seven days of continuous delivery. A once-weekly oral methadone product could lower a major barrier to treatment for many patients, reduce the stigma and socioeconomic impact of medication-assisted therapy, and increase the capacity of methadone treatment centers by reducing the number of patient visits. This study will perform pharmaceutical development and pharmacological characterization of a once-weekly oral methadone dosage form, leading to the selection of a clinical candidate for a first-in-human trial and submission of an IND. Clinical trials will then be performed to evaluate the safety and pharmacokinetics of the once-weekly oral methadone dosage form in subjects with OUD. |
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1UG3NS135173-01
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Developing Radiocaine NaV imaging as a response monitoring biomarker for chronic pain | Clinical Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NINDS | LUTROO IMAGING LLC | NORWOOD, BRAXTON (contact); IBRAHIM, MOHAB M | Kalispell, MT | 2023 |
NOFO Title: HEAL Initiative: Discovery of Biomarkers and Biomarker Signatures to Facilitate Clinical Trials for Pain Therapeutics (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-22-050 Summary: There are currently no reliable tools to measure pain objectively, and health care providers must rely on patient’s subjective reports and observations of patient behavior to determine the level of pain a person experiences. This hampers both effective pain management and the development of new pain medications. This project will assess an imaging technology called Radiocaine that in animal studies has been able to identify the origin of pain as well as its intensity. The goal is to use Radiocaine in clinical trials for pain treatments, thereby enhancing treatment effectiveness and facilitating development of new treatments. |
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1R01DA057658-01
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Weighting Longitudinal Data to Access Opioid Analgesia Tapering Outcomes Among Patients with Co-Occurring Chronic Pain and Substance Use Disorder | Cross-Cutting Research | Leveraging Existing and Real-Time Opioid and Pain Management Data | NIDA | LOYOLA UNIVERSITY CHICAGO | QEADAN, FARES | Maywood, IL | 2022 |
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044 Summary: Guidelines published by the Centers for Disease Control and Prevention in 2016 recommended gradual reductions in opioid medication doses (opioid tapering) for people with chronic pain and substance use disorder and recommended that those patients with pain and opioid use disorder should be switched to opioid use disorder medications. Despite wide implementation, little is known about the consequences of opioid tapering among patients with co-occurring chronic pain and substance use disorder. This project will use various databases (Cerner Real-World DataTM, American Hospital Association data, and U.S. Census data) to create a representative electronic health records database. This database will be used to determine the relationship between opioid tapering, multidisciplinary pain treatment, and medications for opioid use disorder – as well as monitor outcomes for patients with chronic pain and co-occurring substance use disorder. |
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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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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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1UG3DA057853-01
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Naltrexone Transdermal Patch - An Accessible, Patient-Focused Option to Treat OUD Relapse | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | LIBERO PHARMA LIMITED | GARDINER, ANDREW | Edinburgh, United Kingdom | 2022 |
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3)
NOFO Number: PAR-20-092 Summary: Naltrexone is the only medication approved by the U.S. Food and Drug Administration to prevent relapse from opioid use disorder. This medication remains underused because it must be injected into muscle by a nurse and is relatively expensive. This project will develop and test a novel naltrexone skin patch that is easier to use, more comfortable, and inexpensive. |
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1R43DE029369-01
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A Novel Opioid-Free Targeted Pain Control Method for Acute Post-Operative Localized Pain Related to Oral Surgical Procedures | Cross-Cutting Research | Small Business Programs | NIDCR | LAUNCHPAD MEDICAL, LLC | JADIA, RAHUL; KAY, GEORGE | Boston, MA | 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: There is a compelling need to develop a front line, non-opioid-based acute pain management strategy for outpatient oral surgical procedures. LaunchPad Medical has developed Tetranite® (TN), a novel bone regenerative mineral-organic self-setting adhesive biomaterial. TN has been extensively studied in vivo in a canine jaw model and shown to be effective and well-tolerated. In this project, researchers will demonstrate that drug-loaded TN can be a novel route to providing localized and time release pain medication following wisdom tooth extraction by determining the release profile of various pain medications from TN at different concentrations. The ability to release pain therapeutics in a controlled fashion and directly at the site of injury offers improved pain control following oral surgical procedures without exposing the patient to opioids. This novel approach to pain management can be extended to more invasive orthopedic procedures such as joint replacement, spinal fusions or reconstructive trauma surgery. In Phase II the team will conduct an in vivo study to assess efficacy of medicated TN to address post-operative pain following wisdom tooth odontectomy, optimize incorporation and release of medications in TN formulations, develop cGMP manufacturing process for the compounded product, and ultimately conduct clinical trials for bone void filler using medicated TN. |
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1U44NS115732-01
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Selective Kv7.2/3 activators for the treatment of neuropathic pain | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | KNOPP BIOSCIENCES, LLC | SIGNORE, ARMANDO (contact); RESNICK, LYNN | Pittsburgh, PA | 2019 |
NOFO Title: HEAL Initiative: Optimization of Non-addictive Therapies [Small Molecules and Biologics] to Treat Pain
NOFO Number: RFA-NS-19-020 Summary: The development of non-addictive pain therapeutics can help counter opioid addiction and benefit patients, including those who suffer from neuropathic pain, in particular diabetic neuropathic pain (DNP). This project’s goal is to develop a safe, efficacious, and non-addictive small-molecule drug that activates Kv7 voltage-gated potassium channels to address overactive neuronal activity in DNP. Researchers will discover Kv7 activators that favor Kv7 isoforms altered in DNP and found in dorsal root ganglia, decrease off-target side effects observed with the use of earlier non-biased Kv7 activators, and optimize the absorption, distribution, metabolism, excretion, and toxicity profiles of these activators. This screening paradigm is intended to establish a clinic-ready, well-tolerated, and widely effective product to treat neuropathic pain. |
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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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9R42NS120548-02A1
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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. |
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3UG1DA040314-05S3
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Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | KAISER FOUNDATION RESEARCH INSTITUTE | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective. |
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3UG1DA040314-05S4
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Developing a Prescription Opioid Registry Across Diverse Health Systems | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | KAISER FOUNDATION RESEARCH INSTITUTE | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products. |
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3UG1DA040314-05S5
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Determining the Optimal Duration of Buprenorphine Treatment to Reduce the Risk of Relapse, Overdose, and Mortality | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | KAISER FOUNDATION RESEARCH INSTITUTE | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: This study seeks to address the priority of the optimal duration of buprenorphine treatment to reduce the risk of relapse, overdose and mortality outcomes using observational data. Answering this question with a randomized trial raises ethical concerns. Observational studies with large datasets can address these important questions relatively quickly. At the same time, observational studies pose their own methodologic challenges related to confounding, misclassification of exposure and outcome, and informative loss to follow-up. This study will identify and quantify the potential for these sources of bias and then conduct analyses to address the questions of interest (risk of relapse, overdose and mortality). |
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3UG1DA040314-05S6
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OUD Phenotyping Feasibility for 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 | KAISER FOUNDATION RESEARCH INSTITUTE | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials. |
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3UG1DA040314-04S3
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Developing a Prescription Opioid Registry Across Diverse Health Systems | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | KAISER FOUNDATION RESEARCH INSTITUTE | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products. |
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5UH3AT010739-04
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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 | DEBAR, LYNN L (contact); COOK, ANDREA J | Oakland, CA | 2023 |
NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005 |
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3UG1DA040314-04S4
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Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | Kaiser Foundation Research Institute | CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. | Oakland, 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: Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective. |
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3-UH3-AT010739-02
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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 |