Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R44NS113740-01
An Instrument to Assess the Functional Impact of Chronic Pain Cross-Cutting Research Small Business Programs NINDS BARRON ASSOCIATES, INC. CLARK, BRIAN R Charlottesville, VA 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

The proposed Fast Track SBIR effort will develop and validate the reliable, low-cost KnowPain instrument. KnowPain will objectively and quantitatively assess the functional impact of chronic pain using measures derived from six degrees-of-freedom motion, heart rate, skin surface temperature, and skin conductivity collected via a specially designed, ergonomic wrist-worn biometric sensing instrument. The new assessment instrument will apply advanced psychometric methods to both physiologic and kinematic data to provide precise scores for functional impairment due to chronic pain. The assessment results will be presented to the clinician in an easy-to-understand report and will include longitudinal results, confidence estimates, and normative data to enable comparisons both within and between patients. The system will include provision to interface with electronic medical records. Accurate functional assessment is a crucial component in the effective treatment of chronic pain. The proposed approach will supplement existing methods for assessing patient function by providing novel and highly complementary information for a more complete (and often unobserved) picture of the impact of chronic pain on patient function. KnowPain measures will provide important data on the practical consequences of pain and on treatment efficacy. 
3R42TR001270-03S1
PERIPHERAL NERVE-ON-A-CHIP FOR PREDICTIVE PRECLINICAL PHARMACEUTICAL TESTING Cross-Cutting Research Small Business Programs NCATS AXOSIM, INC. CURLEY, JABE L; MOORE, MICHAEL J NEW ORLEANS, LA 2018
NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])
NOFO Number: PA-16-303
Summary:

The ability to de-risk lead compounds during pre-clinical development with advanced “organoid-on-a-chip” technologies shows promise. Development of microphysiological models of the peripheral nervous system is lagging. The technology described herein allows for 3D growth of high-density axonal fiber tracts, resembling peripheral nerve anatomy. The use of structural and functional analyses should mean drug-induced neural toxicity will manifest in these measurements in ways that mimic clinical neuropathology. The goals of this proposal are to establish our human model using relevant physiological measurements in tissues fabricated from human iPS cells and to validate the model system with a library of compounds, comparing against conventional cell culture models. Validating the peripheral nerve model system with drugs known to induce toxicity via a range of mechanisms will demonstrate the ability of the system to predict various classifications of neuropathy, yielding a high-content assay far more informative than traditional in vitro systems.
1R43DA046998-01
DEVELOPMENT OF A MULTIPLEX PEPTIDE ARRAY TO IDENTIFY PATIENTS WITH AN AUTOANTIBODY SIGNATURE FOR CHRONIC PAIN Cross-Cutting Research Small Business Programs NIDA Affinergy, LLC Darby, Martyn Durham, NC 2019
NOFO Title: Development of a Device to Objectively Measure Pain (R43/R44)
NOFO Number: RFA-DA-18-012
Summary:

One of the most widely used treatments for chronic pain is opioid analgesics. Importantly, there is evidence of a pathological interaction between opioids and the immune system that can contribute to both opioid tolerance and elevated levels of pain. Chronic pain conditions for which opioids are most often prescribed have been shown to involve dysregulation of the immune system, which may contribute to pathological effects of opioid use in these patients. To address this unmet need, this study aims to develop a reliable, cost-effective, and non-invasive in vitro diagnostic assay for chronic pain with an underlying inflammatory pathology, as a blood test available in primary care settings, with the hope that doctors can use the test to identify which patients might benefit less from opioids and be more likely to become addicted.
1R44DA049685-01
Noninvasive Brain Stimulation for Treating Addiction Cross-Cutting Research Small Business Programs NIDA HIGHLAND INSTRUMENTS, INC DIPIETRO, LAURA; WAGNER, TIMOTHY ANDREW Cambridge, MA 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

Noninvasive brain stimulation (NIBS) may be effective in treating some forms of addiction, but the most common NIBS methods, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), have not been found to be effective in treating opioid use disorder (OUD). This project seeks to test the efficacy in OUD patients of Electrosonic Stimulation (ESStim™), an improved NIBS modality that combines independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue.
1R43DA049650-01
Patient-level Risk Identifier Models for a Multifactor Opioid Abuse Risk Assessment Strategy Cross-Cutting Research Small Business Programs NIDA PRINCIPLED STRATEGIES, INC. DuBose, Paul ENCINITAS, CA 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:

This project, a partnership with Principled Strategies, will develop innovative, patient-level models for opioid risk identification and integrate them into the SafeUseNow managed care system—an actionable solution for combating prescription drug abuse that currently operates at the prescriber level only. Incorporating patient-level risk identifier models will strengthen an already powerful and demonstrably effective program and constitutes a critical step in generating a first-in-class, multifactor risk assessment strategy that is truly holistic. Using a variety of data sources, advanced analytics, and multiple empirically validated risk identification models, the groundbreaking advancement in SafeUseNow technology will enable health care stakeholders to identify combinations of prescribers, patients, and pharmacies whose behaviors may contribute to prescription drug abuse. This project will work to obtain new datasets for analysis, assess them, and use them to build national patient-level risk models for relevant outcomes, which will enable the development and evaluation of a next-generation prototype for a patient-level version of SafeUseNow.
1R43DE029379-01
Therapeutic in Situ Analgesic Implant for improved Oral-Facial Post-Operative Pain Outcomes Cross-Cutting Research Small Business Programs NIDCR EPIGEN BIOSCIENCES, INC. FRIEDMAN, CRAIG; CAUDLE, ROBERT M San Diego, CA 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:

Analgesia for post-operative populations remains a significant health need that calls for innovative therapies which improve both safety and outcome measures. Recent FDA drug safety warnings and studies focusing on post-operative analgesia have highlighted the imperative need for new approaches that can be utilized for common clinical scenarios. Accordingly, novel treatment options that are safe and afford additional benefit in relief of pain are needed. In this proposal, the development of an innovative surgical sealant technology is proposed that functions at the level of the surgical wound bed and actively delivers local pharmacologic agents to therapeutically address post-operative pain. New formulations of several analgesic regimens will be assessed for their ability to seal wounds and provide appropriate pain management.
1R61AT010800-01
Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use Cross-Cutting Research Small Business Programs NCCIH UCLA GLASNER-EDWARDS, SUZETTE V Los Angeles, CA 2019
NOFO Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-AT-19-006
Summary:

Medications for the treatment of opioid use disorders (MOUD) are effective at reducing opioid use, opioid overdose risk, and opioid-related deaths; however, retention and adherence to MOUD treatment, particularly buprenorphine (BUP), are discouragingly low. The objective of the current research is to adapt and extend a cognitive behavioral therapy-based short message system (SMS) intervention (TXT-CBT) to address MOUD treatment retention and adherence using the imFREE (Interactive Messaging for Freedom from Opioid Addiction) platform. imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for dropout, and features to notify social and provider support contacts in the face of treatment discontinuation and/or other indicators of relapse and overdose risk. By providing support to maximize BUP treatment adherence, coupled with skills to prevent relapse, imFREE may provide a cost-effective, easily deployable strategy for OUD treatment and prevention of overdose deaths.
1R43DA050395-01
Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse Cross-Cutting Research Small Business Programs NIDA SYNVENTA, LLC GOMTSIAN, ARTOUR Tucson, AZ 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:

With nearly 116 million people suffering from chronic pain in the United States, there is a need for new analgesics without the risks posed by opioids. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Initial tests in humans have confirmed that this class of drugs produces analgesia and is safe and well-tolerated, but side effects include hyperthermia and partial loss of heat sensitivity, leading to most research being halted. This project will conduct a set of preclinical proof-of-concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable, or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists.
1R43DA049495-01
Removing implementation obstacles and tailoring reward-based technology programs to patient psychographic characteristics to sustainably increase adherence to substance use disorder pharmacotherapies Cross-Cutting Research Small Business Programs NIDA TRANSCENDENT INTERNATIONAL, LLC Grosso, Ashley Lynn New York, NY 2019
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-014
Summary:

While effective treatments exist for substance use disorders, adhering to treatment and retaining patients in treatment can be a challenge. The objectives of this project are to facilitate the implementation of loyalty/reward-based programs to increase adherence to medical treatment among patients with substance use disorders through innovative solutions to common challenges. Building on experience developing software to promote patient appointment attendance, the project will build a new tool to test on a sample of 10 providers and 10 patients who are prescribed but not fully adherent to substance use disorder treatment. Patients will receive tailored text messages (in English or Spanish) encouraging adherence, self-report their treatment adherence (which will be verified through smart pill caps and biological testing), earn points for adherence that can be exchanged for rewards customized for them based on a baseline survey, and report their satisfaction with the program and process at the end of the 4-week study. This pilot will assess the feasibility and perceived usefulness of the product in support of eventual larger-scale testing in a clinical trial.
2R44DA043325-02
SENSITIVE AND PORTABLE PHYSICIAN OFFICE-BASED URINE ANALYZER TO TACKLE PRESCRIPTION DRUG ABUSE Cross-Cutting Research Small Business Programs NIDA BreviTest Technologies, LLC Heffernan, Michael John HOUSTON, TX 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:

Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. This project, a partnership with BreviTest Technologies, LLC, aims to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for a portable platform to deliver quantitative performance similar to a standard laboratory test for opioids within a 10-minute run time. If successful, this will provide a technology capable of performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way toward lower toxicity and a better quality of life.
1R43NS110117-01
Development of a novel anti-migraine therapeutics Cross-Cutting Research Small Business Programs NINDS ADEPTHERA, LLC HSU, SHEAU-YU TEDDY Palo Alto, CA 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:

New approaches that can effectively ameliorate acute and chronic migraine pain are urgently needed. Due to its critical roles in inducing migraine pain, CGRP and its receptor complex, the calcitonin receptor-like receptor (CLR) and receptor activity-modifying protein 1 (RAMP1) have been targeted for migraine treatment. A new strategy for targeting the CGRP-mediated signaling pathway is needed to meet the medical need of migraine patients. The team developed a group of long-acting CGRP/RAMP1-specific peptide super-antagonists that form gels in situ in aqueous solution. Based on this exciting finding, the investigators propose to develop and identify the most potent antagonistic analog candidates (Aim 1), and characterize the pharmacokinetics of gel depots made of the selected candidates in vivo (Aim 2). This feasibility study is needed to explore the translational potential of these newly invented super-antagonists for the treatment of chronic migraine in combination with conventional migraine agents. 
1R43DA049623-01
Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA THERANOVA, LLC JAASMA, MICHAEL San Francisco, CA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.
1R44DA047866-01
NEONATAL OPIOID SCREENING USING APTAMERS AND COMPENSATED INTERFEROMETRY Cross-Cutting Research Small Business Programs NIDA Base Pair Biotechnologies, Inc. Jackson, George W PEARLAND, TX 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:

Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that affects approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. Providing a platform to accurately monitor actual levels of these drugs and their metabolites in such patients would allow better-controlled use of these pain management treatments, personalized to the needs of the individual neonate, and would reduce the probability of addiction and resulting complications, which include deleterious neurological effects. The purpose of this FastTrack SBIR project is to expand upon preliminary results that a device can sensitively and accurately detect opioids and their primary urinary metabolites in one-microliter urine samples, in less than a minute after sample introduction into the device, and adapt the device into a point-of-care instrument for use in hospitals, clinics, and other venues in which such tests are likely to be deployed.
1R43DE029369-01
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.
1R41DA047779-01
DEVELOPMENT OF A TRACHEAL SOUND SENSOR FOR EARLY DETECTION OF HYPOVENTILATION DUE TO OPIOID OVERDOSE. Cross-Cutting Research Small Business Programs NIDA RTM Vital Signs, LLC Joseph, Jeffrey I FORT WASHINGTON, MD 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
NOFO Number: PA-18-575
Summary:

One of the current critical needs in addressing the opioid crisis is the development of new overdose-reversal interventions, including wearable technologies that can detect an (impending) overdose from physiological signals to signal for help, or trigger a coupled automated injection of naloxone. This project tests the approach of monitoring respiration by detecting the sounds of breathing in the trachea. This proposal aims to develop a machine learning algorithm that could process those sounds, detect the kinds of patterns of reduced breathing that occur during an opioid overdose, and design a miniature wireless sensor that could be used to detect those sounds. Such a sensor and algorithm could be a key component to a device to detect and intervene in overdoses.
1R44DA046316-01A1
A Phase 1 Randomized Single Oral Dose Four Period Cross-Over Study Investigating Omnitram Dose Proportionality and Food Effect in Normal Human Subjects Cross-Cutting Research Small Business Programs NIDA SYNTRIX BIOSYSTEMS, INC. Kahn, Stuart J Auburn, WA 2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-17-302
Summary:

From 2009 to 2013, the utilization of the Schedule II opioids codeine, OxyContin, and fentanyl declined significantly, down about 14 percent for all three drugs. In sharp contrast, the use of tramadol, a Schedule IV controlled substance, increased by 32.5 percent. Schedule IV substances have lower potential for abuse and harm than Schedule II substances, and the fortuitous trend to tramadol has reduced the use of the relatively unsafe Schedule II opioids dramatically. However, tramadol is less effective in some individuals with a particular gene variant that makes them unable to metabolize it well. A new analgesic, omnitram, uses similar mechanisms to tramadol but is not as dependent on this gene. This SBIR Fast-Track project will conduct a Phase 1 clinical trial of Omnitram in normal human subjects. Success in this in-patient Phase 1 clinical trial will provide direct support for Omnitram’s continued clinical development toward FDA approval.
1R44DA050375-01
A Novel Workflow to Screen for Illicit Drug Exposure in Newborns Cross-Cutting Research Small Business Programs NIDA BAEBIES, INC. KENNEDY, ADAM Durham, NC 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:

Rates of neonatal abstinence syndrome (NAS) have skyrocketed during the last decade, and estimates suggest that 5% of mothers use at least one addictive drug during their pregnancy. To address this public health crisis, multiple groups—including the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics—recommend universal screening of substance use in pregnancy using standardized behavioral scoring tools. Unfortunately, such tools are often biased due to subjective scoring or self-reporting errors, and fail to identify babies who did not receive proper prenatal care. This project will develop a fast and accurate NAS screening tool that pairs a simple sample preparation protocol with a high-sensitivity panel of homogeneous enzyme immunoassays recognizing five common classes of drugs: fentanyl, morphine, amphetamine/methamphetamine, cocaine, and benzodiazepines. The potential benefits of such a system include reduced length of hospitalization for unaffected newborns, accelerated time to confirmatory results (under 2 hours), faster resolution of acute withdrawal symptoms, and improved referral to family/maternal support services.
1R44DA049493-01
A Prescription Digital Therapeutic to Promote Adherence to Buprenorphine Pharmacotherapy for Patients with Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA PEAR THERAPEUTICS, INC. KERN, AUDREY; PALLONE, DAVINA Boston, MA 2019
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-014
Summary:

Opioid use disorder (OUD) is a key driver of the current opioid epidemic in the United States, but nearly 80% of individuals with OUD do not receive treatment. Buprenorphine medication-assisted treatment (MAT) is an effective form of care for OUD. This project will develop a state-of-the-art, digital therapeutic tool that effectively promotes buprenorphine adherence by providing contingency management rewards and educational content and enables home induction using a new self-monitoring support tool. This tool, named reSET-O+, will be integrated with Pear Therapeutics’ reSET-O, an FDA market-authorized mobile application delivering validated behavioral therapy and intended for use in conjunction with buprenorphine and standard outpatient treatment for OUD.
1R41DA050364-01
Optimization of Betulinic Acid analogs for T-type calcium channel inhibition for non-addictive relief of chronic pain Cross-Cutting Research Small Business Programs NIDA REGULONIX, LLC KHANNA Tucson, AZ 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 increase in prevalence of cancer coupled with an increase in the cancer survival rates due to chemotherapy regimens is transforming cancer pain into a large, unmet medical problem. Chemotherapy-induced peripheral neuropathy (CIPN) is a common and potentially dose-limiting side effect of many cancer drug treatment regimens and is caused in part by alterations in ion channels; blocking or depleting Cav3.2 channels in dorsal root ganglion (DRG) neurons should thus mediate analgesic effects. This proposal aims to develop and test potent, orally available, and selective Cav3.2 channel antagonists, building on the structure of a medicinal plant product—betulinic acid (BA)—that has been identified to be Cav3.2-selective and antinociceptive in CIPN. Such compounds could reduce the reliance on opioids in cancer patients.
1R41NS116784-01
Discovery of T-type Calcium Channel Antagonists from Multicomponent Reactions and Their Application in Paclitaxel-induced Peripheral Neuropathy Cross-Cutting Research Small Business Programs NINDS REGULONIX, LLC KHANNA, RAJESH Tucson, AZ 2019
NOFO Title: PHS 2017-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42])
NOFO Number: PA-17-303
Summary:

Chemotherapy-induced peripheral neuropathy (CIPN) is detected in 64% of cancer patients during all phases of cancer. CIPN can result in chemotherapy dose reduction or discontinuation, and can also have long-term effects on the quality of life. Taxanes (like Paclitaxel) may cause structural damage to peripheral nerves, resulting in aberrant somatosensory processing in the peripheral and/or central nervous system. Dorsal root ganglia (DRG) sensory neurons as well as neuronal cells in the spinal cord are key sites in which chemotherapy induced neurotoxicity occurs. T-type Ca2+ channels are critical determinants of increased neuronal excitability and neurotransmission accompanying persistent neuropathic pain. Though Cav3.2 has been targeted clinically with small molecule antagonists, no drugs targeting these channels have advanced to phase II human clinical trials. This proposal aims to explore multicomponent reaction products, for the rapid identification of potent and selective T-type Ca2+ channel antagonists. The work proposed here is the first step in developing non-opioid pain treatments for CIPN. The team anticipates success against paclitaxel-induced chronic pain will translate into other chronic pain types as well, but CIPN provides focus for early stage proof-of-concept.
1R43DA050360-01
Transcutaneous auricular neurostimulation for neonatal abstinence syndrome Cross-Cutting Research Small Business Programs NIDA SPARK BIOMEDICAL INC KHODAPARAST, NAVID (contact); JENKINS, DOROTHEA DENISE Friendswood, TX 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

As of 2012, an infant with neonatal abstinence syndrome (NAS) was born every 25 minutes in the United States, accounting for more than $1.5 billion in national health care expenditures. These infants frequently require hospital stay in a neonatal intensive care unit (NICU), with an average hospital stay of 25 days at an average treatment cost of $66,000. Treatment of NAS usually follows a multimodal regime based on drug therapy with an oral morphine solution, mostly in combination with a sedative, but there is a need for nonpharmacological approaches. This project will test a transcutaneous auricular neurostimulation device to help NAS babies recover from opioid withdrawal without harmful side effects. The non-invasive, auricular neurostimulation device will be placed around the ear (similar to a hearing aid), and stimulation will be delivered transcutaneously.
3R44DA044083-03S1
CLINICAL DATA INTELLIGENCE & ADVANCED ANALYTICS TO REDUCE DRUG DIVERSION ACROSS THE CARE DELIVERY CYCLE AND DRUG SUPPLY CHAIN IN HEALTH SYSTEMS Cross-Cutting Research Small Business Programs NIDA Invistics Corporation Knight, Thomas Peachtree Corners, GA 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:

There are alarming rates of substance abuse and diversion in hospitals, with multiple studies finding that roughly 10% of our nation’s nurses, anesthesiologists, and pharmacists are currently diverting drugs in their workplaces. Diversion continues even though most hospitals already lock addictive drugs in Automated Dispensing Machines (ADMs) and run monthly “anomalous usage” computer reports to try to detect diversion. This SBIR project will research mechanisms to detect when health care workers (HCWs) in hospitals steal or “divert” legal drugs, either to abuse themselves or to illegally sell to others, by building a computer system with (a) automated data feeds from multiple existing hospital computer systems and (b) advanced analytics to flag potential diversion for investigation. This research has the potential to reduce injuries to HCWs who are becoming addicted, destroying their careers, jeopardizing their patients’ safety, and increasingly dying from drug diversion overdoses.
1R43DA049300-01A1
PRAPELA™ SVS: A COST-EFFECTIVE STOCHASTIC VIBROTACTILE STIMULATION DEVICE TO IMPROVE THE CLINICAL COURSE OF INFANTS WITH NEONATAL ABSTINENCE SYNDROME Cross-Cutting Research Small Business Programs NIDA PRAPELA, Inc. KONSIN, JOHN PHILLIP (contact); SINGH, RACHANA Concord, 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:

Maternal use and addiction to opioids or other drugs has resulted in an unprecedented rise in drug withdrawal complications in newborns known as neonatal abstinence syndrome (NAS). While there is no accepted standard for treating NAS, non-pharmacological bundles are recommended as an initial course of treatment. Unfortunately, non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of human resources. This project studies the technical feasibility of a stochastic vibrotactile stimulation (SVS) technology incorporated into the hospital bassinet pad, which provides gentle vibrating sensory stimulation to soothe infants with NAS. Building on preliminary evidence that this type of stimulation calms NAS infants without altering their sleep, this study aims to develop a commercially viable bassinet pad that could be used in a hospital setting.
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.
1R44DA049629-01
Connected Pharmacy Platform to Improve Adherence to Buprenorphine-Naloxone Prescription Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA PILLSY INC. LEBRUN, JEFFREY (contact); MCPHERSON, STERLING M Seattle, WA 2019
NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Opioid agonist therapy (OAT), such as buprenorphine/naloxone (BUP/NAL), is proven effective against opioid use disorder (OUD), but poor medication adherence is a major barrier. This project aims to substantially increase adherence to oral BUP/NAL with Pillsy, a smart technology platform, which acts like a digital medication coach, providing education and reminders using a mobile app, text messages, and automated phone calls. The platform is built around a Bluetooth-based smart pill bottle cap that automatically tracks doses and timing, and sends intelligent reminders to create a unique feedback loop, which allows constant optimization of the incentive/reminder messages to meet user needs to increase adherence. A dashboard enables providers to easily track medication use and patient engagement. The Pillsy platform only nominally increases the cost of oral BUP/NAL treatment, and physicians can bill for monitoring time (CPT code 99091). The project team will adapt the current Pillsy platform and perform a randomized efficacy trial of BUP/NAL adherence.