Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Sort descending Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
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.

1K99AR083482-01
Elucidating the Neuroimmune Mechanisms Underlying Pain and Inflammation in Autoimmune Arthritis Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS BOSTON CHILDREN'S HOSPITAL JAIN, AAKANKSHA Boston, MA 2023
NOFO Title: HEAL Initiative Advanced Postdoctoral-to-Independent Career Transition Award in PAIN and SUD Research (K99/R00 Independent Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-022
Summary:

Rheumatoid arthritis is an autoimmune disease characterized by episodes of joint inflammation and pain. There are currently no safe and effective treatments that achieve long-term remission of the condition or the associated pain. Many patients use opioid medications to manage the pain and are at increased risk of developing opioid use disorder; therefore, additional treatment options are needed. In rheumatoid arthritis, pain-triggering sensory neurons interact with immune cells in the joints. This project aims to dissect the neuroimmune crosstalk underlying pain and inflammation in arthritic joints and uncover novel therapeutic avenues for this painful condition.

1R44AR076885-01
Enhancing Physical Therapy: Noninvasive Brain Stimulation System for Treating Carpal Tunnel Syndrome Cross-Cutting Research Small Business Programs NIAMS HIGHLAND INSTRUMENTS, INC. WAGNER, TIMOTHY ANDREW; DIPIETRO, LAURA Cambridge, 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 Required)
NOFO Number: PA-18-573
Summary:

 Non-Invasive Brain Stimulation (NIBS) has been successfully applied for the treatment of chronic pain (CP) in some disease states, where treatment induced changes in brain activity revert maladaptive plasticity associated with the perception/sensation of CP [25-28]. However, the most common NIBS methods, e.g., transcranial direct current stimulation, have shown limited, if any, efficacy in treating neuropathic pain. It has been postulated that limitations in conventional NIBS techniques’ focality, penetration, and targeting control limit their therapeutic efficacy . Electrosonic Stimulation (ESStim™) is an improved NIBS modality that overcomes the limitations of other technologies by combining independently controlled electromagnetic and ultrasonic fields to focus and boost stimulation currents via tuned electromechanical coupling in neural tissue . This proposal is focused on evaluating whether our noninvasive ESStim system can effectively treat CP in carpal tunnel syndrome (CTS), both as a lone treatment and in conjunction with physical therapy (PT). Investigators hypothesize ESStim can be provided synergistically with PT, as both can encourage plasticity-dependent changes which could maximally improve a CTS patient’s pain free mobility. In parallel with the CTS treatments, the team will build multivariate linear and generalized linear regression models to predict the CTS patient outcomes related to pain, physical function, and psychosocial assessments as a function of baseline disease characteristics. The computational work will be used to develop an optimized CTS ESStim dosing model. 

1R43NS119087-01A1
Evaluating the Blood-Brain Barrier Bioavailability and in vivo Efficacy Potential of a Novel TAK1 Inhibitor Targeting Chronic Pain Cross-Cutting Research Small Business Programs NINDS EYDIS BIO, INC. SCARNEO, SCOTT (contact); HAYSTEAD, TIMOTHY A Durham, NC 2021
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: NS-20-011
Summary:

Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA  Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment.

2R44DA050393-02
Evaluation of the Therapeutic Potential of Exclusive Antagonists of Extrasynaptic NMDA Receptors for the Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA NEURANO BIOSCIENCE MOLOKANOVA, ELENA La Jolla, CA 2023
NOFO Title: Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-023
Summary:

New and safe therapeutic targets for treating opioid use disorder are needed. One promising approach is to test drugs currently approved by the U.S. Food and Drug Administration that work independently of the body’s opioid system. The medication memantine targets N-methyl-D-aspartate (NMDA) receptors in the brain, which have been implicated in the development and maintenance of addiction. This project will study a miniature version of multiple memantine molecules bound together that attaches only to NMDA receptors that are not within nerve connections. The research will evaluate the safety, misuse potential, and effectiveness of this molecular assembly in preclinical models. 

1R43DA050393-01
Evaluation of the therapeutic potential of exclusive antagonists of extrasynaptic NMDA receptors for treatment of opioid use disorders Cross-Cutting Research Small Business Programs NIDA NEURANO BIOSCIENCE MOLOKANOVA, ELENA Encinitas,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:

Novel therapies that could alleviate the severe symptoms of opioid withdrawal and/or reduce risk of relapse could help address the devastating opioid crisis. Memantine, an FDA-approved NMDA receptor antagonist, has shown encouraging results as an adjunct to existing opioid use therapies. Its therapeutic efficacy likely derives from its preferential binding to NMDA receptors located outside the synapse, since broad spectrum NMDA receptor antagonists are associated with multiple clinical side effects. This project will use a preclinical model to evaluate a nanostructured version of memantine (AuM) that physically prevents its binding to synaptic NMDA receptors but allows activation of extrasynaptic receptors with potency exceeding that of free memantine.

3R01AT010742-01S1
Examining Trauma Prevalence and Exploring Interoception as a Mechanism of Emotion Regulation in MOUD Cross-Cutting Research Training the Next Generation of Researchers in HEAL NCCIH UNIVERSITY OF WASHINGTON PRICE, CYNTHIA J; MERRILL, JOSEPH O Seattle, WA 2022
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; PA-21-071
Summary:

Effective treatments for opioid use disorder need to address the complex needs of patients, which may include mental health problems and substantial chronic pain. This project will measure lifetime trauma experienced by men and women who take medication for opioid use disorder, as well analyze the association between types of trauma and symptomatic distress. The project will also explore whether an individual’s perceptions of sensations from inside their body (interoceptive awareness) affect emotional control and mental health. This research will fill knowledge gaps i critical to better understanding opioid use disorder treatment and relapse.

1R01DA057686-01
Fast and Fine: NLP Methods for Near Real-Time and Fine-Grained Overdose Surveillance Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF KENTUCKY KAVULURU, VENKATA NAGA RAMAKANTH Lexington, KY 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:

Timely and accurate surveillance of fatal and non-fatal overdoses is necessary in light of the worsening overdose crisis, but data is rarely available in real-time. Tracking non-fatal overdoses is especially important because patients who overdose once are likely to experience additional and potentially fatal overdoses. This project aims to increase the quality and timeliness of non-fatal overdose data estimates by analyzing clinicians’ notes rather than clinical codes from emergency department and emergency medical services records. The datasets and models produced from this research will be used to build an interactive dashboard with up-to-date, county-level overdose-surveillance estimates for use by Kentucky first responders to aid in rapid allocation of resources.

R44DA053845-01A1
Fast-track: Scalable Digital Delivery of Evidence-Based Training for Addiction Professionals to Maximize Treatment Admission and Retention Rates of Opioid Use Disorder in Affected Families Cross-Cutting Research Small Business Programs NIDA Public Health Management Corporation; We the Village, Inc MACKY, JANE Philadelphia, PA; New York, NY 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:

Effective medication-based treatment could prevent overdose deaths and help individuals recover from opioid use disorder, but only a fraction of those in need access treatment or receive a medication approved by the U.S. Food and Drug Administration. One way to improve people’s choice to seek and stay in treatment is to improve training for addiction treatment counselors beyond current methods that rely on brief online or in-person workshops. The goal of this research project is to develop and evaluate the technical feasibility and commercial viability of a scalable digital program to train behavioral addiction professionals in Community Reinforcement and Family Training (CRAFT), an evidence-based approach to increase treatment entry, using ongoing counselor training with feedback and coaching.

1R61DA057660-01
Fatal Overdose Review Teams – Research to Enhance Surveillance Systems (FORTRESS) Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS AALSMA, MATTHEW (contact); RAY, BRADLEY ; REDA, KHAIRI Indianapolis, IN 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
Summary:

Overdose fatality review teams review cases of overdose deaths to identify system gaps and innovative prevention and intervention strategies. With the rise in overdose deaths, these multidisciplinary teams require more timely population-level data to inform their recommendations. This project will develop the Overdose Touchpoints Dashboard that uses real-time data and records from multiple sources to help visualize common “overdose touchpoints” for harm reduction services and treatment opportunities. This research will compare use of the dashboard to standard overdose fatality review practices. The project will assess multiple aspects related to use of the dashboard, including process, staff attitudes, implementation successes, and usability.

3UH3AR076387-02S2
Fibromyalgia TENS in Physical Therapy Study (TIPS): An Embedded Pragmatic Clinical Trial Cross-Cutting Research Increasing Participant Diversity, Inclusion, and Engagement in HEAL Research NIAMS UNIVERSITY OF IOWA SLUKA, KATHLEEN A Iowa City, IA 2022
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-22-066
Summary:

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, stiffness, fatigue, and sleep disturbance. The FAST trial (Fibromyalgia Activity Study with transcutaneous electrical nerve stimulation [TENS]) was the first study to conclusively demonstrate the clinical value of TENS for treating musculoskeletal pain. While physical therapists are trained in the use of TENS, it is underused in clinical practice. This project will test TENS in fibromyalgia patients receiving physical therapy in a real-world physical therapy practice setting. This research will determine if adding TENS to physical therapy reduces pain, increases adherence to physical therapy and allows fibromyalgia patients to reach their self-defined functional goals with less use of medication.

3UH3AR076387-02S1
Fibromyalgia TENS in Physical Therapy Study (TIPS): An Embedded Pragmatic Clinical Trial: Administrative Supplement Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIAMS UNIVERSITY OF IOWA SLUKA, KATHLEEN A; CROFFORD, LESLIE J Iowa City, IA 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-22-087
Summary:

This research is using a pragmatic clinical trial to test transcutaneous electrical nerve stimulation in patients with widespread muscle pain and tenderness (fibromyalgia). The research will determine if the addition of TENS to physical therapy reduces pain, increases physical therapy adherence, and helps achieve functional goals with less medication use. This project will involve early career scientists who will gain access to pragmatic research tools as well as develop the skills needed to pursue a career in clinical pain research focused on fibromyalgia.

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.

3UG1DA049467-04S1
Great Lakes Node of the Drug Abuse Clinical Trials Network Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF ILLINOIS AT CHICAGO KARNIK, NIRANJAN Chicago, IL 2022
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The Great Lakes Node of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) represents all of the major academic medical centers in the Greater Chicago and Wisconsin areas and serves as a vital Midwestern hub for the CTN. This project supports a scientist from a group underrepresented in biomedicine to expand the work of this CTN node on research in several areas. These include mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; focus on youth/adolescent health and seniors/aging; health disparities; and professional education about opioid and substance treatment.

1U2CDA057717-01
HD2A Research Adoption Support Center (RASC) Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA STANFORD UNIVERSITY MCGOVERN, MARK P (contact); BECKER, SARA J; BECKER, WILLIAM C; BROWN, C HENDRICKS Redwood City, CA 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Research Adoption Support Center (U2C Clinical Trial Optional)
NOFO Number: RFA-DA-22-050
Summary:

This project creates the HEAL Data2Action Research Adoption Support Center to support the HEAL Data2Action Innovation Projects. It will provide supportive evidence for prevention and treatment practices, form implementation strategies, assess outcomes, obtain feedback from the projects, and assess readiness for scalability. This center will offer on-demand technical assistance, host a learning collaborative, harmonize dissemination and implementation data, provide implementation support, and help with stakeholder engagement. The research will also catalogue evidence-based and emerging opioid use disorder and pain management practices as a resource to the field. The center will address timely, high-priority implementation challenges.

1U24DA057650-01
HEAL Data2Action Modeling and Economic Resource Center Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA WEILL MEDICAL COLL OF CORNELL UNIV SCHACKMAN, BRUCE R (contact); LINAS, BENJAMIN P; MCCOLLISTER, KATHRYN E New York, NY 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Modeling and Economic Resource Center (U24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-049
Summary:

This project creates the HEAL Data2Action Modeling and Economic Resource Center that will conduct research as well as support the HEAL Data2Action Innovation Projects with expertise and consultation about simulation modeling and economic evaluation methods. The consultation service will advise on how to select and use various research methods, including economic evaluation, simulation modeling, advanced statistical analysis, behavioral economics, treatment program organization research, and cost analysis. The center will use a dynamic simulation model of opioid use disorder to enhance data-driven decision making. The center will also provide online training resources, tools, and other resources to assess a variety of economic aspects related to the HEAL Data2Action Innovation Projects.

1R21DE032584-01
Identifying Chronic Pain Phenotypes and Treatment Disparities in Adults with Cerebral Palsy Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR UNIVERSITY OF MICHIGAN PETERSON, MARK D Ann Arbor, MI 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Cerebral palsy is the most common physical disability in children. Those who have this condition experience pain throughout their lives. Although opioids are generally not recommended, many adults with cerebral palsy are prescribed them for pain. This project will assess the incidence of chronic pain conditions in adults with and without cerebral palsy as well as measure opioid treatment-related health outcomes in adults with cerebral palsy. This research will also evaluate pain treatment disparities related to race/ethnicity and insurance coverage using national medical claims databases.

1DP2HD112176-01
Identifying Plasma Proteomic Profiles of Chronic Pain Development in Endometriosis From Adolescence to Adulthood Cross-Cutting Research Training the Next Generation of Researchers in HEAL NICHD BRIGHAM AND WOMEN'S HOSPITAL SASAMOTO, NAOKO Boston, MA 2023
NOFO Title: Emergency Awards: HEAL Initiative- New Innovator Award (DP2 Clinical Trial Not Allowed)
NOFO Number: RFA-TR-22-013
Summary:

Endometriosis is a gynecologic disorder characterized by severe pelvic pain, affecting 10% of reproductive aged women and adolescents worldwide. These individuals are at an increased risk for chronic opioid use, dependence, and overdose. Adolescents and young adults in particular are understudied in endometriosis research. This project will conduct a longitudinal study of adolescent endometriosis. The research will identify novel biomarkers and biological pathways involved in the transition of acute to chronic pain. The research aims to improve non-surgical endometriosis diagnosis, risk, and treatment. 

1R01DA057685-01
Identifying Suspected Drug Overdose Deaths in Near Real-Time Using Data Collected by Death Investigators Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA FRIENDS RESEARCH INSTITUTE, INC. HOCHSTATTER, KARLI RAE Baltimore, MD 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 responses to the highly dynamic overdose crisis require accurate and timely information about the timing and location of drug overdoses, which is currently reported mainly through death certificates that take time to become available and thus limit life-saving responses. This project will comprehensively evaluate, optimize, and assess barriers and facilitators to adoption of a surveillance tool developed by the New York City Office of the Chief Medical Examiner. The tool uses data routinely collected during death investigations to predict in near real-time whether a death was due to an unintentional drug overdose. The findings will inform drug overdose mortality surveillance efforts in other states.

1R43DA046974-01
IMPACT-Instrument to Measure Pain and Assess Correlation to Treatment. Create a smartphone pupillometry to objectively determine the presence of acute pain, evaluate opioid as the treatment for pain. Cross-Cutting Research Small Business Programs NIDA BENTEN TECHNOLOGIES, INC MA, TONY XUYEN Manassa, VA 2019
NOFO Title: Development of a Device to Objectively Measure Pain (R43/R44)
NOFO Number: RFA-DA-18-012
Summary:

While patient self-report of pain is the gold standard of pain measurement, this may not be feasible in critically ill patients who are sedated and intubated, unconscious, or unable to verbally communicate. Pupillary dilation (PD) is a reliable indicator of acute pain, and measurement of pupil size changes may be useful in determining the intensity of pain experienced as well as the efficacy of an analgesia. Research also demonstrates that pupillary unrest under ambient light (PUAL) is an objective marker of sensitivity to opioids, and facial expression analysis can help detect pain. Benten Technologies, Inc. aims to develop and validate IMPACT, a device that uses pupillometry with a proprietary algorithm to measure both PD and PUAL and conduct facial expression analysis using computer vision. The project team will then demonstrate the feasibility of IMPACT in helping clinicians objectively determine pain and assess opioid efficacy and compare results obtained to pain scores reported by patients.

1R43HL167661-01A1
Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions Cross-Cutting Research Small Business Programs NHLBI OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Indianapolis, IN 2023
NOFO Title: HEAL INITIATIVE: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
1R43HL167661-01A1
Improving Analgesic Effectiveness and Safety with Proactive Precision Pain Management in Thoracic Surgical Patients with Lung Lesions Cross-Cutting Research Small Business Programs NHLBI OPALGENIX, INC. PLUMP, STEVEN R (contact); SADHASIVAM, SENTHILKUMAR Carmel, IN 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Thoracic (chest) surgeries often cause both short-term (acute) and long-term (chronic) pain and long-term opioid use. Unique genetic and clinical risk factors affect individual responses to surgical pain and pain medications. Current trial-and-error approaches to managing post-surgical pain and opioid prescribing are not ideal. This project will develop predictive software within a medical device that takes into account an individual’s genetic and clinical information to predict the likelihood of chronic pain following thoracic surgery. 

1R61DA057610-01
Improving Pain Management and Opioid Safety Through a Systemwide, Data Driven Evaluation of the CDC Opioid Prescribing Guideline Best Practices and the Use of Clinical Decision Support Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA UNIVERSITY OF COLORADO DENVER HOPPE, JASON Aurora, CO 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects
NOFO Number: RFA-DA-22-051 
Summary:

Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.

2R44NS086343-04
IND-ENABLING STUDIES ON NOVEL CAV3 T-CHANNEL MODULATORS FOR TREATMENT OF NEUROPATHIC PAIN Cross-Cutting Research Small Business Programs NINDS AFASCI, INC. XIE, XINMIN SIMON REDWOOD CITY, CA 2018
NOFO Title: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)
NOFO Number: PAR-17-480
Summary:

We discovered a class of non-opioid modulators of the T-type Cav3.2 channel that could treat neuropathic pain. In vivo pharmacokinetic and pharmacodynamic studies and preliminary toxicological studies identified AFA-279 and other candidates, which did not produce observable side-effects and showed greater analgesic effects than other neuropathic pain medications in rodent models. The goal of this proposed project is to submit the IND application on our Cav3.2 modulator to the Food and Drug Administration (FDA). We will produce AFA-279 under Good Manufacturing Practice (GMP)–like conditions using chemical manufacturing controls for Good Laboratory Practice (GLP) nonclinical toxicity studies and GMP clinical batch future Phase 1 clinical trials, complete toxicological and safety studies to establish the safety profile of AFA-279, prepare and submit the IND application, and then initiate early clinical trials. Our ultimate goal is to deliver a safer, more effective, non-opioid Cav3.2 channel modulator to patients suffering from neuropathic pain.

1R43CA233371-01A1
Inhibiting soluble epoxide hydrolase as a treatment for chemotherapy inducedperipheral neuropathic pain Cross-Cutting Research Small Business Programs NCI EICOSIS, LLC BUCKPITT, ALAN R Davis, 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:

 Investigating the broader efficacy of sEH inhibition and specifically our IND candidate, EC5026, has indicated that it is efficacious against chemotherapy induced peripheral neuropathy (CIPN). This painful neuropathy develops from chemotherapy treatment, is notoriously difficult to treat, and can lead to discontinuation of life-prolonging cancer treatments. Thus, new therapeutic approaches are urgently needed. The research team will investigate if EC5026 has potential drug-drug interaction with approved chemotherapeutics or alters immune cells function, and assess the effects of sEHI on the lipid metabolome and probe for changes in endoplasmic reticulum stress and axonal outgrowth in neurons. The team proposes to more fully characterize the analgesic potential of our compound and investigate on and off target actions in CIPN models and model systems relevant to cancer therapy.