Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R01NS118504-01
Targeting GPCRs in Amygdalar and Cortical Neural Ensembles to Treat Pain Aversion Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIV OF NORTH CAROLINA CHAPEL HILL SCHERRER, GREGORY Chapel Hill, NC 2020
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043
Summary:

There is a distinct neural ensemble in the brain that encodes the negative affective valence of pain. This project will identify novel targets to treat pain by determining the molecular identity of these BLA nociceptive cells via in situ hybridization and single cell RNAsequencing (scRNA-seq). Resolving the molecular identity of these ACC nociceptive cells will also reveal new targets to treat pain affect. To achieve these results the project will catalog candidate Gi/o-GPCR targets in BLA and ACC, test their utility to treat pain, and verify these new targets have no effect in the brain?s reward and breathing circuitry. The experiments in this project will also evaluate each target for abuse potential and effects on breathing by using behavioral assays for reward processing and whole-body plethysmography, respectively. To evaluate whether our results in rodents are likely to translate clinically, there will be an analysis of expression patterns of these drug targets in human tissue using in situ hybridization.
2R44DA050358-02A1
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders Cross-Cutting Research Small Business Programs NIDA MINDLIGHT, LLC SCHIFFER, FREDRIC (contact); TEICHER, MARTIN H Newton, MA 2022
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:

This project will refine an experimental non-invasive light therapy to create an effective, safe, convenient, and affordable method for treating opioid use disorder. This research will test whether a short treatment of near infra-red light administered through the skull can reduce drug use, relapse, and craving, and improve overall function in people with opioid use disorder. If effective, the findings could support a path toward commercialization of this new treatment.
1R43DA050358-01
A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders Cross-Cutting Research Small Business Programs NIDA MINDLIGHT, LLC SCHIFFER, FREDRIC (contact); TEICHER, MARTIN H Newton, MA 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:

This project aims to demonstrate the safety and effectiveness of a novel treatment for opiate addiction using a technique called photobiomodulation, application of light to the forehead. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near-infrared mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that has been determined to have a more positive emotional valence. The study will examine differences in opioid cravings, anxiety, depression, and opioid use between participants receiving the treatment and those receiving a sham treatment. We will evaluate patients weekly for safety and efficacy for 3 weeks post-treatment. In Aim II, a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.
1RM1DE033491-01
Endosomal Mechanisms Signaling Oral Cancer Pain Preclinical and Translational Research in Pain Management Integrated Basic and Clinical Team-Based Research in Pain NIDCR NEW YORK UNIVERSITY SCHMIDT, BRIAN L (contact); BUNNETT, NIGEL W; KHANNA, RAJESH; LEONG, KAM W; YE, YI New York, NY 2023
NOFO Title: HEAL Initiative Integrated Basic and Clinical Team-based Research in Pain (RM1 Clinical Trial Optional)
NOFO Number: RFA-NS-22-069
Summary:

Human oral cancer is associated with significant chronic pain, and a comprehensive understanding of the biology and mechanisms underlying this chronic pain is critical for developing better pain management strategies. This project will determine molecular characteristics, including a specific signaling system (endosomal GPCR kinase), associated with chronic oral cancer pain, using tissue samples obtained from patients with this condition. The findings will then be used to inform studies in animal models of human oral cancer pain to enhance understanding how endosomal GPCR kinase contributes to human oral cancer pain.
1UG3DA049598-01
Novel Therapeutics for Opioid Use Disorder in the Acute Overdose and Maintenance Settings Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Epiodyne, Inc. Schmidt, William San Francisco, CA 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) and opioid overdose (OD) are major health issues. Breathing can be restored after OD by naloxone, but its short half-life can require multiple administrations to reverse OD, and OD symptoms may return after initial reversal if illicit opioids are still present after the effects of naloxone have worn off. Additionally, while the standard treatment of OUD with buprenorphine and methadone reduces relapse and mortality, access and adoption are limited by dosage forms, metabolic liabilities, and potential for misuse and diversion. This study seeks to develop chemically novel, potent mu-opioid receptor (MOR) antagonists and low- and mid-efficacy partial agonists. Current lead counts can outcompete opioid overdoses in preclinical models with a longer half-life, a key naloxone liability for treating OD. The potent, low-efficacy partial agonists add a low opioid tone, diminishing the aversive effects of pure antagonists. These, and the mid-efficacy partial agonists, are leads to maintenance therapeutics for OUD.
1U2CDA050098-01
Methodology and Advanced Analytics Resource Center Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA UNIVERSITY OF CHICAGO SCHNEIDER, JOHN (contact); POLLACK, HAROLD ALEXANDER Chicago, IL 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Methodology and Advanced Analytics Resource Center (U2C Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-023
Summary:

Many individuals with opioid use disorder (OUD) pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings will be critical to addressing the opioid crisis. Through the Justice Community Opioid Innovation Network (JCOIN), the National Institutes of Health will study approaches to increase high-quality care for people with opioid misuse and OUD in justice populations. The Methodology and Advanced Analytics Resource Center (MAARC) will provide data infrastructure support across the network using advanced methods that provide best-in-class data storage, management and security with added value to clinical trials through products of forecasting, rapid real-time assessments, explication and exploration of trial findings, and cost-effectiveness analysis.
4R33AT010125-02
Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH CAMBRIDGE HEALTH ALLIANCE SCHUMAN OLIVIER, Z Cambridge, MA 2019
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
1R21AT010125-01
EFFECT OF MINDFULNESS TRAINING ON OPIOID USE AND ANXIETY DURING PRIMARY CARE BUPRENORPHINE TREATMENT Translation of Research to Practice for the Treatment of Opioid Addiction Behavioral Research to Improve Medication-Based Treatment NCCIH Cambridge Health Alliance SCHUMAN OLIVIER, ZEV DAVID CAMBRIDGE, MA 2018
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

Office-based opioid treatment (OBOT) with buprenorphine/naloxone prevents overdose deaths. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for opioid use disorder (OUD) treatment in most U.S. counties. Mindfulness-based interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention while reducing rates of relapse and overdose deaths. Current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project proposes to adapt, refine, and compare the effectiveness of the 6-month Mindful Recovery OUD Care Continuum delivered within group-based opioid treatment (GBOT) versus standard GBOT alone.
3R44DA044053-02S1
DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE Cross-Cutting Research Small Business Programs NIDA emocha Mobile Health, Inc. Seiguer, Sebastian Owings Mills, MD 2019
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302
Summary:

Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.
3R44DA044053-03S1
DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE Cross-Cutting Research Small Business Programs NIDA emocha Mobile Health, Inc. Seiguer, Sebastian Owings Mills, MD 2019
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302
Summary:

Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.
1R61NS113269-01
Validation of a novel cortical biomarker signature for pain Preclinical and Translational Research in Pain Management Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions NINDS University of Maryland, Baltimore SEMINOWICZ, DAVID Baltimore, MD 2019
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041
Summary:

Chronic pain is a major health burden associated with immense economic and social costs. Predictive biomarkers that can identify individuals at risk of developing severe and persistent pain, which is associated with worse disability and greater reliance on opioids, would promote aggressive, early intervention that could halt the transition to chronic pain. The applicant’s team uncovered evidence of a unique cortical biomarker signature that predicts pain susceptibility (severity and duration). This biomarker signature could be capable of predicting the severity of pain experienced by an individual minutes to months in the future, as well as the duration of pain (time to recovery). Analytical validation of this biomarker will be conducted in healthy participants using a standardized model of the transition to sustained myofascial temporomandibular pain. Specifically the biomarker signature will be tested for its ability to predict an individual’s pain sensitivity, pain severity, and pain duration and will perform initial clinical validation.
1R43DA049616-01
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for relapse preventionin patients with Opioid Use (OUD) Cross-Cutting Research Small Business Programs NIDA EVON MEDICS, LLC SETH, SUMEET (contact); NWULIA, EVARISTUS A Elkridge, MD 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:

The orbitofrontal cortex (OFC) plays an important role in regulation of addiction, and OFC impairment from cocaine and opioids use leads to repetitive drug use. Brief optogenetic activation of the OFC reduces self-administration of drugs in neurobiology studies. However, the OFC is less accessible for noninvasive stimulation using direct transcutaneous current stimulation or transcranial magnetic stimulation. The small business EvON Medics LLC and Howard University have created a home-based olfactory pulsing prototype, called computerized chemosensory-based orbitofrontal cortex training (CBOT), using a high-fidelity chemosensory and computerized olfactory training approach to enable home-based neuromodulation of the OFC for treatment of opioid use disorder (OUD). A pilot feasibility study in OUD samples suggests that CBOT can minimize withdrawal symptoms, reduce drug cravings, enhance positive affect, and reduce rate of positive urine drug tests. The project seeks to establish CBOT stimulation parameters needed to maximally improve outcome inference and emotion regulation in OUD.
5R01NS094461-04
Clustering of individual and diverse ion channels together into complexes, and their functional coupling, mediated by A-kinase anchoring protein 79/150 in neurons Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF TEXAS HLTH SCI CTR SAN ANTONIO SHAPIRO, MARK S San Antonio, TX 2018
NOFO Title: Administrative Supplements for Validation of Novel Non-Addictive Pain Targets (Clinical Trials Not Allowed)
NOFO Number: NOT-NS-18-073
Summary:

Multi-protein complexes have emerged as a mechanism for spatiotemporal specificity and efficiency in the function and regulation of cellular signals. Many ion channels are clustered either with the receptors that modulate them or with other ion channels whose activities are linked. Often, the clustering is mediated by scaffolding proteins, such as AKAP79/150. We will probe complexes containing AKAP79/150 and three different channels critical to nervous function: KCNQ/Kv7, TRPV1, and CaV1.2. We will use"super-resolution" STORM imaging of primary sensory neurons and heterologously expressed tissue-culture cells, in which individual complexes can be visualized at 10–20 nm resolution with visible light. We hypothesize that AKAP79/150 brings several of these channels together to enable functional coupling, which we will examine by patch-clamp electrophysiology of the neurons. Since all three of these channels bind to AKAP79/150, we hypothesize that they co-assemble into complexes in neurons and that they are dynamically regulated by other cellular signals.
3R01NS094461-04S2
TARGETING SPECIFIC INTERACTIONS BETWEEN A-KINASE ANCHORING PROTEINS (AKAPS) AND ION CHANNELS WITH CELL-PERMEANT PEPTIDES AS A NOVEL MODE OF THERAPEUTIC INTERVENTION AGAINST PAIN DISORDERS Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NINDS UNIVERSITY OF TEXAS HLTH SCIENCE CENTER SHAPIRO, MARK S SAN ANTONIO, TX 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Multi-protein complexes have emerged as a mechanism for spatiotemporal specificity and efficiency in the function and regulation of myriad cellular signals. In particular, many ion channels are clustered either with the receptors that modulate them, or with other ion channels whose activities are linked. Often the clustering is mediated by scaffolding proteins, such as the AKAP79/150 protein that is a focus of this research. This research will focus on three different channels critical to nervous function. One is the"M-type" (KCNQ, Kv7) K+ channel that plays fundamental roles in the regulation of excitability in nerve and muscle. It is thought to associate with Gq/11- coupled receptors, protein kinases, calcineurin (CaN), calmodulin (CaM) and phosphoinositides via AKAP79/150. Another channel of focus is TRPV1, a nociceptive channel in sensory neurons that is also thought to be regulated by signaling proteins recruited by AKAP79/150. The third are L-type Ca2+ (CaV1.2) channels that are critical to synaptic plasticity, gene regulation and neuronal firing. This research will probe complexes containing AKAP79/150 and these three channels using"super-resolution" STORM imaging of primary sensory neurons and heterologously-expressed tissue-culture cells, in which individual complexes can be visualized at 10-20 nm resolution with visible light, breaking the diffraction barrier of physics. The researchers hypothesize that AKAP79/150 brings several of these channels together to enable functional coupling, which the researchers will examine by patch-clamp electrophysiology of the neurons. Förster resonance energy transfer (FRET) will also be performed under total internal reflection fluorescence (TIRF) or confocal microscopy, further testing for complexes containing KCNQ, TRPV1 and CaV1.2 channels. Since all three of these channels bind to AKAP79/150, the researchers hypothesize that they co-assemble into complexes in neurons, together with certain G protein-coupled receptors. Furthermore, the researchers hypothesize these complexes to not be static, but rather to be dynamically regulated by other cellular signals, which the researchers will examine using rapid activation of kinases or phosphatases. Several types of mouse colonies of genetically altered AKAP150 knock-out or knock-in mice will be utilized.
5R24DA051950-02
Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations Translation of Research to Practice for the Treatment of Opioid Addiction Recovery Research Networks NIDA OREGON SOCIAL LEARNING CENTER, INC. SHEIDOW, ASHLI J Eugene, OR 2021
NOFO Title: Building a Lasting Foundation to Advance Actionable Research on Recovery Support Services for High Risk Individuals with Opioid Use Disorder: The Initiative for Justice and Emerging Adult Populations
NOFO Number: RFA-DA-20-014
Summary:

Emerging adults (ages 16-25) involved with public systems and individuals involved with the justice system (including emerging adults) are at the highest risk for problems stemming from opioid use disorder. Emerging adults report the highest rates of drug use, including opiates, and those involved with public systems are more likely to have poor outcomes. For adults of all ages, opioid use increases the likelihood of justice system involvement. Peer recovery support services and recovery residences are growing nationally and may benefit these two groups tremendously, but research on them is limited. This project will establish the Initiative for Justice and Emerging Adult Populations to advance recovery support services research through a partnership between researchers, people in recovery from these two populations, recovery support service providers, and payors.
3R01DA041434-03S1
IMPROVING ACCESS TO SUBSTANCE ABUSE EVIDENCE-BASED PRACTICES FOR YOUTH IN THE JUSTICE SYSTEM: STRATEGIES USED BY JPOS New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Oregon Social Learning Center, Inc. SHEIDOW, ASHLI J Eugene, OR 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Justice-involved young adults are one of the highest-risk populations for the development of opioid use disorder (OUD) and other significant public health problems, but they usually lack access to evidence-based practices that could potentially prevent this trajectory. The risk of unintentional death and other deleterious outcomes and long-term costs for opioid misuse for young adults, their communities and society (costs estimated at more than $115 billion annually) make this a priority, with rural areas in need of the most attention and assistance. The overriding purpose of the proposed pilot study is to prevent the onset of OUD by improving young adult offenders’ access to evidence-based risk reduction interventions, like contingency management (CM), by testing whether officers in the adult probation and parole setting can deliver such an intervention to their young adult substance using probationers who have not yet developed OUD. The primary motivation for this pilot is the clear public health need for improving and expanding delivery of substance use risk reduction interventions for young adults in the justice system. The ultimate outcome would be prevention of OUD in this high-risk population.
1R21CA277849-01
The Effects of Hydrocodone Rescheduling on Pain Management of Older Lung Cancer Patients Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NCI PENNSYLVANIA STATE UNIV HERSHEY MED CTR SHEN, CHA Hershey, PA 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Managementin Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Pain is common, complex, and debilitating in many cancer patients. Although adequate pain management can significantly improve health-related quality of life for these individuals, substantial disparities limit care access, especially among underserved populations. After the 2014 Drug Enforcement Agency policy that raised the risk potential of the opioid hydrocodone (from Schedule III to Schedule II), few studies examined the impact of this policy on pain management strategies and outcomes among cancer patients. This project will use national cancer registry data linked with Medicare claims to assess the change in opioid and non-opioid medication use among older lung cancer patients before and after this policy change. By focusing on older racial/ethnic minority groups dually eligible for both Medicare and Medicaid, the research will also examine disparities in the use of medications for pain management and service use consistent with inadequate pain management.
1R61NS126029-01A1
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.
3UH3AT010739-03S1
Improving Diversity, Inclusion, and Retention in BackinAction/AcuOA Clinical Research in Pain Management NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J 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
Summary:

Participants in many clinical trials do not represent the U.S. population. Racial/ethnic minorities are often underrepresented, as are people with lower socioeconomic status and lower education levels, who face additional barriers, such as lack of transportation or childcare. Thus, both recruitment and retention of such populations is challenging, particularly for complementary and integrative health trials. This project proposes to enhance diversity, inclusion, and retention of participants in an ongoing study by creating a patient and caregiver Diversity, Recruitment, and Retention Advisory Board as well as adding a recruitment and retention specialist to coordinate the advisory board and implement necessary activities. The project will also provide evidence-based recruitment tools and will conduct structured interviews with patients who choose not to participate in a study as well as those who are at risk of dropping out to enhance understanding of the barriers and factors contributing to trial recruitment, loss to follow-up, and successful completion.
3-UH3-AT010739-02
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J (contact); DEBAR, LYNN L Oakland, CA 2021
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
1UG3AT010739-01
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 2019
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
Summary:

Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.
1R01DA057655-01
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.
1R34NS126032-01
Stem cell-loaded microgels to treat discogenic low back pain Preclinical and Translational Research in Pain Management Development and Optimization of Non-Addictive Therapies to Treat Pain NINDS CEDARS-SINAI MEDICAL CENTER SHEYN, DMITRIY Los Angeles, CA 2021
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-016
Summary:

Pain caused by the degeneration of discs between vertebrae in the spine makes up a significant proportion of all chronic low back pain conditions. Although opioids are prescribed as treatments for this chronic condition, they often do not provide effective pain management, and currently there are no treatments that target the underlying disc disease. Notochordal cells mature into the cells that make up discs between vertebrae. Preliminary studies have shown that notochordal cells can be made from induced pluripotent stem cells, offering a potential replacement for diseased cells between discs. This study aims to develop a novel treatment for painful disc degeneration using a microgel/microtissue embedded with human notochordal cells made in the lab from induced pluripotent stem cells.
1UH3NS115631-01
Multisite adaptive brain stimulation for multidimensional treatment of refractory chronic pain Preclinical and Translational Research in Pain Management Translating Discoveries into Effective Devices to Treat Pain NINDS UNIVERSITY OF CALIFORNIA, SAN FRANCISCO SHIRVALKAR, PRASAD San Francisco, CA 2019
NOFO Title: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-19-018
Summary:

The research team will develop stimulation control algorithms to treat chronic pain using a novel device that allows longitudinal intracranial signal recording in an ambulatory setting. Subjects with refractory chronic pain syndromes will undergo bilateral surgical implant of temporary electrodes in the thalamus, anterior cingulate, prefrontal cortex, insula, and amygdala to identify candidate biomarkers of pain and optimal stimulation parameters. Six patients will proceed to chronic implantation of “optimal” brain regions for long-term recording and stimulation. The team will first validate biomarkers of low- and high-pain states to define neural signals for pain prediction in individuals. They will then use these pain biomarkers to develop personalized closed-loop algorithms for deep-brain stimulation (DBS) and test the feasibility of closed-loop DBS for chronic pain in weekly blocks. Researchers will assess the efficacy of closed-loop DBS algorithms against traditional open-loop DBS or sham in a double-blinded cross-over trial and measure mechanisms of DBS tolerance.
1R01DA057630-01
Predicting Fatal and Non-Fatal Overdose in Los Angeles County with Rapid Overdose Surveillance Dashboard to Target Street-Based Addiction Treatment and Harm Reduction Services Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF CALIFORNIA LOS ANGELES SHOVER, CHELSEA LEIGH (contact); GOODMAN, DAVID Los Angeles, CA 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:

Effective overdose prevention requires timely, location-specific data to efficiently direct resources and interventions as well as to inform healthcare policy. However, rarely is such information available, resulting in responses that are frequently too late. This project will partner with local government agencies from Los Angeles County, California, to rapidly acquire and analyze information in near real-time from multiple sources to identify overdose hotspots and determine overdose metrics. This information will be used to develop a publicly available Rapid Overdose Surveillance Los Angeles online dashboard with built-in analytics. The dashboard will help determine the scope and specifics of overdose and opioid use in Los Angeles County to help target response and guide mobile addiction treatment and harm reduction services.