Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3DA056247-01
Phase 1 and 2 Studies of Sublingual Dexmedetomidine, an Alpha 2 Adrenergic Agonist, for Treating Opioid Withdrawal 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 dba RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC LEVIN, FRANCES RUDNICK New York, NY 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:

Withdrawal symptoms associated with current opioid use disorder treatments, such as naltrexone or buprenorphine, can be serious obstacles to successful treatment. This project aims to develop a U.S. Food and Drug Administration-approved sedative medication (dexmedetomidine) as an under-the-tongue film to treat opioid withdrawal symptoms at doses that have minimal ill effects on blood pressure and heart rate. This research will compare the safety and efficacy of dexmedetomidine to lofexidine, which is currently approved to treat opioid withdrawal.
3UG1DA013035-18S4
Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. ED patients have a disproportionately high prevalence of substance use disorders and are at an elevated risk of overdose, and many do not access health care elsewhere. Despite this, OUD interventions are rarely initiated in EDs. The Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder study (CTN-0079) will assess the feasibility, acceptability and impact of introducing clinical protocols for screening for OUD, buprenorphine treatment initiation, and referral for ongoing treatment in ED settings with high need, limited resources and different staffing structures. This extension study will use the existing infrastructure to evaluate the adoption and sustainability of the clinical protocols introduced at each of the study sites and to identify factors influencing their diffusion and effectiveness.
1UG3DA058553-01
Development of Sigma Receptor/DAT Dual-Targeting Compounds to Treat Stimulant Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA SPARIAN BIOSCIENCES, INC. REICH, JEFFREY New York, NY 2023
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:

An increasing number of Americans use multiple drugs at the same time, and overdose deaths from stimulants have increased. However, there are no available treatments for stimulant use disorder. This project aims to develop new treatment (SBS-518) for cocaine use disorder. Previous research using animal models showed that SBS-518 decreases stimulant self-administration without being rewarding itself. The research will continue the development of SBS-518 toward testing in human research participants.
1UG1DA050071-01
Facilitating Opioid Care Connections: System level strategies to improve use of MAT and movement through the opioid care cascade for defendants in a new Opioid Court system Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK STATE PSYCHIATRIC INSTITUTE ELKINGTON, KATHERINE S (contact); NUNES, EDWARD V; WAINBERG, MILTON L New York, NY 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Rates of opioid use (OU), opioid use disorder (OUD), and overdose (OD) disproportionately affect those in the justice system. Yet, despite such high rates of misuse and associated negative outcomes of untreated OUD, screening and the availability or use of evidence-based treatments for OU and OUD—including medication to treat OUD—are substantially underused in justice populations. This project will leverage the unique, real-time scale-up of a new opioid court model (OCM) to address a critical public and correctional health problem by developing and evaluating an implementation intervention (OCM RISE), designed to build cross-system partnerships to permit the development of generalizable yet tailored strategies that allow the OCM to be scaled up across a variety of contexts.
3UG1DA013035-18S5
Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.
1U01DA055338-01
8/24 The Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE THOMASON, MORIAH E (contact); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE New York, NY 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country and include racial and ethnic minorities of varying economic levels.
1U01DA047982-01
Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE LEE, JOSHUA D; FARABEE, DAVID J; MARSCH, LISA A; SCHWARTZ, ROBERT P; SPRINGER, SANDRA ANN; WADDELL, ELIZABETH NEEDHAM New York, NY 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.
1R21NS130409-01
Novel Genetically Encoded Inhibitors to Probe Functional Logic of Cav-Beta Molecular Diversity Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS COLUMBIA UNIVERSITY HEALTH SCIENCES COLECRAFT, HENRY M New York, NY 2022
NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011
Summary:

High-voltage-gated calcium channels convert electrical signals into physiological responses. After a nerve injury, levels of these channels go down in some neurons in the dorsal root ganglia that communicates pain signals to and from the brain. This decline results in reduced flow of calcium that may underlie pain. This project will develop novel approaches to block these calcium channels p to further study their roles in controlling pain.
1R61DA057683-01
Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder: A Stepped-wedge Randomized Trial to Facilitate Clinic Level Changes Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE NEIGHBORS, CHARLES J (contact); BAO, YUHUA ; RAMSEY, KELLY S New York, NY 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
Summary:

During the COVID-19 public health emergency, the Substance Use and Mental Health Services Administration relaxed regulations for take-home dosing of methadone, offering an opportunity to improve methadone treatment access and address racial and ethnic disparities. This project aims to address regulatory, legal liability, and financial concerns related to clinical practice changes in opioid treatment programs. The project will first review state administrative data and conduct qualitative interviews to inform the intervention approach. The project will then evaluate an opioid treatment program intervention involving take-home methadone and its effect on take-home dosing, retention in care, and health outcomes for Black/African American and Hispanic/Latino individuals who take methadone for opioid use disorder.
1UG3NS135170-01
Predictive Biosignature for Endoscopic Therapy for Chronic Pancreatitis Pain Clinical Research in Pain Management Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE DOAN, LISA (contact); CHEN, ZHE SAGE; GONDA, TAMAS ADAM; PARK, HYUNG; WANG, JING New York, NY 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:

Chronic pancreatitis is a painful condition often caused by long-term alcohol use, and patients often require treatment with strong pain medications, including opioids. Therefore, alternative treatments for chronic pancreatitis are needed. This project will use machine learning approaches to create a prediction tool based on electroencephalography analyses, sensory tests, and psychological questionnaires that can help determine which patients with chronic pancreatitis will benefit most from a specific type of treatment called endoscopic therapy.
1UG3DA050323-01
Cannabidiol in the treatment of 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 Icahn School of Medicine Mount Sinai Hurd, Yasmin 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:

Responding to urgent calls for non-opioid treatment, this research group has been evaluating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid, for the treatment of some clinical aspects of opioid use disorder (OUD). Preclinical animal studies show that CBD decreases cue-induced heroin-seeking behavior during drug abstinence, associated with incubation of craving. Clinical work has also shown that CBD was safe in combination with a potent opioid agonist to address a potential relapse condition and decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder. Building on this foundation, the researchers will investigate an oral CBD powered by a novel patented technology (leveraging the kinetics of long-chain fatty acid absorption) in a gelcap delivery system that improves bioavailability, reduces the incidence of gastrointestinal side effects, reduces first pass metabolism, and enhances onset time. This study could lead to the development of a non-opioid, non-intoxicating FDA-approved medication to reduce opioid craving and relapse and restore global functioning in individuals with OUD.
1R01DA057654-01
Expansion of Mail-Delivered Harm Reduction Services in the U.S. Translation of Research to Practice for the Treatment of Opioid Addiction Harm Reduction Approaches to Reduce Overdose Deaths NIDA WEILL MEDICAL COLL OF CORNELL UNIV BEHRENDS, CZARINA NAVOS New York, NY 2022
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

Harm reduction supplies include fentanyl test strips that allow people who use drugs to identify whether the substance(s) they plan to take contain fentanyl and sterile syringes that help to prevent the spread of infectious diseases among people who inject drugs. One potential way to increase access to harm reduction supplies is mail delivery. This project will describe state-level policies that deter the use of mail-based delivery of harm reduction services, examine characteristics of people who use mail-based harm reduction services, and assess individual preferences related to mail-based harm reduction services.
3UG1DA013035-18S6
Culturally Centered Medication for OUD (MOUD) Implementation Facilitation for Primary Care and Addiction Treatment Programs Serving American Indian/Alaska Natives Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 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 U.S. is in the midst of a devastating opioid epidemic. Since 1999, the number of overdose (OD) deaths involving opioids has quadrupled. These trends are magnified among American Indians/Alaska Natives (AI/ANs) compared to other racial/ethnic groups. AI/ANs are second only to Whites in the rate of OD mortality (8/100,000 versus 12/100,000 deaths, respectively). Medications for opioid use disorder (OUD; i.e., methadone, buprenorphine and naltrexone) are considered the most effective treatment, reducing mortality and increasing abstinence and retention. However, numerous barriers limit the uptake of medications for OUD in tribal communities and within urban treatment settings serving AI/AN individuals. This is a two-phase formative research study to develop and test an implementation intervention for programs to provide medications to treat OUD specifically with AI/AN consumers. The objective of Phase I (12 months) is to develop a culturally centered implementation intervention to integrate medications for opioid use disorder (MOUD) into health care/addiction specialty settings. The objective of Phase II (24 months) is to conduct a preliminary test of the implementation intervention at four sites serving AI/AN communities. Community-based participatory research (CBPR) methods will be used throughout both phases. This study will help with decreasing stigma and increase the utilization of MOUD in health care settings that serve AI/AN populations.
1UG3DA048234-01
Development of a novel drug for treating 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 NIRSUM LABORATORIES, INC. TUSCHE, MICHAEL; SHAH, NIKEJ 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:

The ongoing epidemic of opioid use disorder (OUD), overdose, and death is unprecedented. Available pharmacologic therapies for OUD have failed to stem the tide, plagued by poor adherence and retention, the principal factors associated with relapse and treatment failure. More than 80 percent of individuals with OUD are untreated. More treatment options are needed. This proposal seeks to develop a better antagonist-based OUD pharmacotherapy for populations highly motivated to achieve abstinence, such as military personnel, criminal justice clients, and the currently employed. A series of novel and proprietary small molecules will be designed and synthesized to address the adherence problem by inducing effective opioid antagonism with a single injection lasting at least 2 months, and up to 4 months or more. The goal of this project is to advance to Phase 3 clinical trials toward FDA approval of our lead compound. If successful, this project could lead to a novel therapeutic with superior adherence and retention, resulting in a significant public health impact by reducing rates of relapse, overdose, and death.
3UH3CA261067-03S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Cross-Cutting Research Training the Next Generation of Researchers in HEAL NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2022
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-20-028
Summary:

Approximately 20% of patients who undergo surgery develop chronic Postsurgical Pain, which is linked with slow recovery, persistent opioid use and dependence. This project supports a scientist from a group underrepresented in biomedicine to expand ongoing research testing ketamine during and/or after surgery to prevent post-mastectomy pain syndrome. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings.
1UG3DA058439-01
Transcutaneous Phrenic Nerve Stimulation for Treating Opioid Overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA CORIDEA, LLC LEVIN, HOWARD (contact); COMER, SANDRA D; GUEDES, ALONSO; WAGENER, GEBHARD New York, NY 2023
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)
NOFO Number: PAR-20-279
Summary:

Difficulty breathing is a hallmark symptom of an opioid-related overdose and can result in permanent brain injury or death within minutes. This project will develop a community-deployable Automated External Respiration System device that can restore and sustain breathing in people experiencing opioid-induced respiratory depression. The device stimulates the phrenic nerve in the chest that controls breathing until other medical interventions are available or the patient recovers. The research will develop and validate the automated external respiration system for testing in human research participants and ultimately aims to develop a system usable in a community setting.
3UG3TR002151-01S1
INTEGRATED MICROPHYSIOLOGICAL SYSTEM OF CEREBRAL ORGANOID AND BLOOD VESSEL FOR DISEASE MODELING AND NEUROPSYCHIATRIC DRUG SCREENING Preclinical and Translational Research in Pain Management NCATS COLUMBIA UNIVERSITY HEALTH SCIENCES LEONG, KAM W NEW YORK, NY 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The clinical utility of opioids for pain treatment is limited by its risk for developing opioid usage disorders (OUD). These untoward effects impose a severe burden on society and present difficult therapeutic challenges for clinicians. We propose to extend our cerebral organoid MPS to facilitate the investigation of neuronal response to opioids and identify cellular and molecular signatures in patients vulnerable to OUD. We have assembled a team with complementary expertise in clinical characterization of OUD, cerebral organoid MPS modeling, single cell RNA-seq technology, and functional characterization of neurons in a mesolimbic reward system to test the hypothesis that midbrain MPS is a clinically relevant pre-clinical model for study of opioid usage disorder.
1R24DA051946-01
Family-based Recovery Support Service Network for Youth OUD Translation of Research to Practice for the Treatment of Opioid Addiction NIDA NATIONAL CENTER ON ADDICTION/SUB ABUSE HOGUE, AARON New York, NY 2020
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:

Opioid Use Disorder (OUD) prevalence has reached unprecedented levels among adolescents and emerging adults. Recovery Support Services (RSS) for persons with SUDs typically focus on the individual client after acute care. But for youth, developmental theory underscores the primacy of family-level risk and protective factors, and family-based interventions have the strongest empirical support. Yet there is a lack of research, clinical resources, and generalizable metrics focused on family-based RSS for youth with OUD. This study will establish a sustainable research network to develop and evaluate innovative family-based RSS across the youth OUD services cascade. The overall goal is to conduct research to strategies to promote family integration in youth OUD services, increase service engagement, and build supportive family environments for youth recovery. The specific goals focus on 1) innovations in family RSS interventions and metrics to assist youth OUD providers with integrating families in OUD services and, 2) innovations in measurement of direct-to-family RSS for families of youth with OUD. If successful, this study will systematically build a research and technical assistance infrastructure designed to develop and evaluate innovative family-based RSS for youth with OUD that span all phases of the services cascade: screening and referral, treatment initiation, treatment delivery, and continuing care.
1R01DA057651-01
Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who use Drugs Translation of Research to Practice for the Treatment of Opioid Addiction Harm Reduction Approaches to Reduce Overdose Deaths NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE JORDAN, AYANA New York, NY 2022
NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

There has been a substantial increase in overdose deaths among Black and Hispanic/Latino people who use drugs. This project will test and evaluate delivery of harm reduction services from a mobile van. A community-based care coordinator will assess the specific needs of each participant (such as housing, food assistance, and mental health treatment) toward the goal of linking each person to appropriate services.
1R01DA059415-01
Integrating Eye-Tracking and ECG Methodologies for Remote Infant Neurocognitive Assessments in the Home Enhanced Outcomes for Infants and Children Exposed to Opioids Virtual Assessments to Understand Developmental Trajectories of Substance Use Exposure NIDA NEW YORK UNIVERSITY BRITO, NATALIE HIROMI New York, NY 2023
NOFO Title: HEAL Initiative: Development and validation of virtual assessments to study children and caregivers in their natural environment (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-23-050
Summary:

Use of remote data collection in developmental research can make it easier for families to participate in such research and increase sociodemographic diversity of participants. The goal of this project is to validate remote methods for testing early cognitive development, particularly attention and memory skills, in 4-, 8-, and 12-month-old infants from traditionally underrepresented populations in neuroscience research. The project will integrate multiple types of data to improve remote measurement of infant cognition within the home and will help expand understanding of developmental trajectories and mechanisms across diverse environments and contexts.
3UG3DA047720-01S1
Evaluation of safety and pharmacokinetics of naltrexone implant 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 Bisaga, Adam New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

New medication treatment approaches are needed to help address the severe epidemic of opioid use disorder (OUD) and opioid overdose deaths in the U.S. Currently available medications, such as methadone, buprenorphine, and extended release injection naltrexone (XR-NTX; trade name: Vivitrol), are highly efficacious, but their effectiveness in practice is limited by poor adherence, with many patients stopping treatment prematurely and relapsing. The goal of this proposal is to develop an innovative long-acting subcutaneous implanted formulation of naltrexone, the O’Neil Long-Acting Naltrexone Implant (OLANI), toward FDA approval. Expected to produce naltrexone blood levels sufficient to block the effects of opioids for 6 months after implant, OLANI circumvents the need for adherence to monthly injections with XR-NTX and could represent an important new addition to the medical armamentarium for treatment of OUD.
3UG1DA013035-18S3
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE ROTROSEN, JOHN P; NUNES, EDWARD V. New York, NY 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of
3UH3CA261067-02S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

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

 
1UG3CA261067-01
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2020
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-20-028
Summary:

Approximately 20% of patients who undergo surgery develop chronic pain, or Chronic Postsurgical Pain (CPSP). CPSP is highly associated with impaired functional recovery and persistent opioid use and dependence, and current standard postoperative multimodal analgesia is only moderately effective for its prevention. This study aims to determine whether the use of ketamine during and/or after surgery prevents Post-Mastectomy Pain Syndrome (PMPS), one of the most common CPSP conditions. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings. If successful, this treatment could improve postoperative pain management in individuals undergoing mastectomy and help combat the opioid epidemic.
1R21TR004333-01
Discovery of Novel Openers of the Understudied Human Drug Target Kir6.1 Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NCATS NEW YORK UNIVERSITY SCHOOL OF MEDICINE CARDOZO, TIMOTHY J New York, NY 2022
NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011
Summary:

Routine treatment of pain with prescription opioid medications may evolve into opioid use disorder, addiction, and potentially overdose. New, non-opioid molecular targets for pain are needed as a key element of responding to the opioid and overdose crisis. Ion channels are molecular gateways that convert electrical signals into physiological responses, and many have been implicated in transmitting pain signals. The ion channel Kir6.1/KCNJ8 has been linked to the control of postoperative and cancer pain. Studies in animal models show that low levels of this ion channel are evident after an injury. This research will identify compounds that can open the Kir6.1/KCNJ8 channel as potential treatment strategy for pain.